Oxycodone

Dosage Form: tablet
Oxycodone HYDROCHLORIDE TABLETS, USP


CII


Rx Only

DESCRIPTION

Oxycodone Hydrochloride Tablets, USP are an opioid analgesic.

Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg of Oxycodone hydrochloride, USP.

Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine.  Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).

Chemically, Oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride and has the following structural formula:

The tablets contain the following inactive ingredients: Microcrystalline cellulose, lactose monohydrate, crospovidone, and magnesium stearate.

The 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets contain the equivalent of 4.5 mg, 9 mg, 13.5 mg, 18 mg and 27 mg, respectively, of Oxycodone free base.

CLINICAL PHARMACOLOGY

Pharmacology:

The analgesic ingredient, Oxycodone, is a semi-synthetic narcotic with multiple actions qualitatively similar to those of morphine; the most prominent of these involves the central nervous system and organs composed of smooth muscle.

Oxycodone, as the hydrochloride salt, is a pure agonist opioid whose principal therapeutic action is analgesia and has been in clinical use since 1917. Like all pure opioid agonists, there is no ceiling effect to analgesia, such as is seen with partial agonists or non-opioid analgesics. Based upon a single-dose, relative-potency study conducted in humans with cancer pain, 10 to 15 mg of Oxycodone given intramuscularly produced an analgesic effect similar to 10 mg of morphine given intramuscularly. Both drugs have a 3 to 4 hour duration of action. Oxycodone retains approximately one half of its analgesic activity when administered orally.

Effects on Central Nervous System: The precise mechanism of the analgesic action is unknown; however, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug. A significant feature of opioid-induced analgesia is that it occurs without loss of consciousness. The relief of pain by morphine-like opioids is relatively selective, in that other sensory modalities, (e.g., touch, vibrations, vision, hearing, etc.) are not obtunded.

Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation.

Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia. Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings). Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.

Effects on Gastrointestinal Tract And Other Smooth Muscle: Oxycodone, like other opioid analgesics, produces some degree of nausea and vomiting which is caused by direct stimulation of the chemoreceptor trigger zone (CTZ) located in the medulla. The frequency and severity of emesis gradually diminishes with time.

Oxycodone may cause a decrease in the secretion of hydrochloric acid in the stomach that reduces motility while increasing the tone of the antrum, stomach, and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Effects on Cardiovascular System: Oxycodone, in therapeutic doses, produces peripheral vasodilatation (arteriolar and venous), decreased peripheral resistance, and inhibits baroreceptor reflexes. Manifestations of histamine release and/or peripheral vasodilatation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Caution should be used in hypovolemic patients, such as those suffering acute myocardial infarction, because Oxycodone may cause or further aggravate their hypotension. Caution should also be used in patients with cor pulmonale who have received therapeutic doses of opioids.

Pharmacodynamics:

The relationship between the plasma level of Oxycodone and the analgesic response will depend on the patient's age, state of health, medical condition and extent of previous opioid treatment.

The minimum effective plasma concentration of Oxycodone to achieve analgesia will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. Thus, patients need to be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of Oxycodone for any individual patient may increase with repeated dosing due to an increase in pain and/or development of tolerance.

Pharmacokinetics:

The activity of Oxycodone Hydrochloride Tablets is primarily due to the parent drug Oxycodone. Oxycodone Hydrochloride Tablets are designed to provide immediate release of Oxycodone.

Table 1: Pharmacokinetic Parameters (Mean±SD)

DoseParameters	AUC (ngxhr/mL)	Cmax (ng/mL)	Tmax (hr)	Cmin (ng/mL)	Cavg (ng/mL)	Half-Life(hr)
Single Dose    Pharmacokinetics
Oxycodone HCl 5 mg tabs x 3	133.2±33	22.3±8.2	1.8±1.8	n/a	n/a	3.73±0.9
Oxycodone HCl 15 mg tab	128.2±35.1	22.2±7.6	1.4±0.7	n/a	n/a	3.55±1.0
Oxycodone HCl Liquid Concentrate 15 mg oral solution	130.6±34.7	21.1±6.1	1.9±1.5	n/a	n/a	3.71±0.8
Oxycodone HCl 30 mg tab	268.2±60.7	39.3±14.0	2.6±3.0	n/a	n/a	3.85±1.3
Food-Effect, Single Dose
Oxycodone HCl 10 mg/10 mL oral sol'n (fasted)	105±6.2	19.0±3.7	1.25±0.5	n/a	n/a	2.9±0.4
Oxycodone HCl 10 mg/10 mL oral sol'n (fed)	133±25.2	17.7±3.0	2.54±1.2	n/a	n/a	3.3±0.5
Multiple-Dose Studies	AUC (72-84)
Oxycodone HCl 5 mg tabs    q6h x 14 doses	113.3±24.0	15.7±3.2	1.3±0.3	7.4±1.8	9.4±2.0	n/a
Oxycodone HCl 3.33 mg (3.33 mL)    oral sol'n. q4h x 21 doses	99.0±24.8	12.9±3.1	1.0±0.3	7.2±2.3	9.7±2.6	n/a

Absorption: About 60% to 87% of an oral dose of Oxycodone reaches the systemic circulation in comparison to a parenteral dose. This high oral bioavailability (compared to other oral opioids) is due to lower pre-systemic and/or first-pass metabolism of Oxycodone. The relative oral bioavailability of Oxycodone Hydrochloride 15 mg and 30 mg Tablets compared to the 5 mg Oxycodone Hydrochloride Tablets is 96% and 101% respectively. Oxycodone Hydrochloride 15 mg Tablets and 30 mg Tablets are bioequivalent to the 5 mg Oxycodone Hydrochloride Tablets (see Table 1 for pharmacokinetic parameters). Dose proportionality of Oxycodone has been established using the Oxycodone Hydrochloride 5mg Tablets at doses of 5 mg, 15 mg (three 5 mg tablets) and 30 mg (six 5 mg tablets) based on extent of absorption (AUC) (see Figure 1). It takes approximately 18 to 24 hours to reach steady-state plasma concentrations of Oxycodone with Oxycodone Hydrochloride Tablets.

Figure 1 – Oxycodone Hydrochloride Tablets, USP  Dose-Proportionality Study 5mg, 15mg, 30mg (single-dose)

Food Effect: A single-dose food effect study was conducted in normal volunteers using the 5 mg/5 mL solution. The concurrent intake of a high fat meal was shown to enhance the extent (27% increase in AUC), but not the rate of Oxycodone absorption from the oral solution (see Table 1). In addition, food caused a delay in Tmax (1.25 to 2.54 hour). Similar effects of food are expected with the 15 mg and 30 mg tablets.

Distribution: Following intravenous administration, the volume of distribution (Vss) for Oxycodone was 2.6 L/kg. Plasma protein binding of Oxycodone at 37°C and a pH of 7.4 was about 45%. Oxycodone has been found in breast milk (see PRECAUTIONS-Nursing Mothers.)

Metabolism: Oxycodone hydrochloride is extensively metabolized to norOxycodone, oxymorphone, and their glucuronides. The major circulating metabolite is norOxycodone with an AUC ratio of 0.6 relative to that of Oxycodone. Oxymorphone is present in the plasma only in low concentrations. The analgesic activity profile of other metabolites is not known at present.

The formation of oxymorphone, but not norOxycodone, is mediated by CYP2D6 and as such its formation can, in theory, be affected by other drugs (see PRECAUTIONS-Drug Interactions.)

Elimination: Oxycodone and its metabolites are excreted primarily via the kidney. The amounts measured in the urine have been reported as follows: free Oxycodone up to 19%; conjugated Oxycodone up to 50%; free oxymorphone 0%; conjugated oxymorphone ≤ 14%; both free and conjugated norOxycodone have been found in the urine but not quantified. The total plasma clearance was 0.8 L/min for adults. Apparent elimination half-life of Oxycodone following the administration of Oxycodone Hydrochloride Tablets was 3.5 to 4 hours.

Special Populations:

Geriatric: Population pharmacokinetic studies conducted with Oxycodone Hydrochloride Tablets indicated that the plasma concentrations of Oxycodone did not appear to be increased in patients over the age of 65.

Gender: Population pharmacokinetic analyses performed in the clinical study support the lack of gender effect on the pharmacokinetics of Oxycodone from Oxycodone Hydrochloride Tablets.

Race: Population pharmacokinetic analyses support the lack of race effect on Oxycodone pharmacokinetics after administration of Oxycodone Hydrochloride Tablets but these data should be interpreted conservatively, since the majority of patients enrolled into the studies were Caucasians (94%).

Renal Insufficiency: In a clinical trial supporting the development of Oxycodone Hydrochloride Tablets, too few patients with decreased renal function were evaluated to study these potential differences. In previous studies, patients with renal impairment (defined as a creatinine clearance < 60 mL/min) had concentrations of Oxycodone in the plasma that were higher than in subjects with normal renal function. Based on information available on the metabolism and excretion of Oxycodone, dose initiation in patients with renal impairment should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

Hepatic Failure: In a clinical trial supporting the development of Oxycodone Hydrochloride Tablets, too few patients with decreased hepatic function were evaluated to study these potential differences; however, since Oxycodone is extensively metabolized, its clearance may decrease in hepatic failure patients. Dose initiation in patients with hepatic impairment should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

INDICATIONS AND USAGE

Oxycodone Hydrochloride Tablets, USP are an immediate-release oral formulation of Oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

CONTRAINDICATIONS

Oxycodone Hydrochloride Tablets are contraindicated in patients with known hypersensitivity to Oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone Hydrochloride Tablets are contraindicated in any patient who has or is suspected of having paralytic ileus.

WARNINGS

Respiratory Depression:

Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.

Oxycodone Hydrochloride Tablets should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of Oxycodone Hydrochloride Tablets may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

Hypotensive Effect:

Oxycodone Hydrochloride Tablets, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Oxycodone Hydrochloride Tablets may produce orthostatic hypotension in ambulatory patients. Oxycodone Hydrochloride Tablets, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure.

Head Injury and Increased Intracranial Pressure:

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

PRECAUTIONS

General:

Oxycodone Hydrochloride Tablets are intended for use in patients who require oral pain therapy with an opioid agonist. As with any opioid analgesic, it is critical to adjust the dosing regimen individually for each patient (see DOSAGE AND ADMINISTRATION).

Selection of patients for treatment with Oxycodone Hydrochloride Tablets should be governed by the same principles that apply to the use of other potent opioid analgesics. Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Physicians should individualize treatment in every case, using nonopioid analgesics, prn opioids and /or combination products, and chronic opioid therapy with drugs such as Oxycodone Hydrochloride Tablets in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Health Care Policy and Research, and the American Pain Society.

Use of Oxycodone Hydrochloride Tablets is associated with increased potential risks and should be used only with caution in the following conditions: Acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); convulsive disorders; CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.

The administration of Oxycodone Hydrochloride Tablets, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Tolerance and Physical Dependence:

Physical dependence and tolerance are not unusual during chronic opioid therapy. Significant tolerance should not occur in most patients treated with the lowest doses of Oxycodone.  It should be expected, however, that a fraction of patients will develop some degree of tolerance and require progressively higher dosages of Oxycodone Hydrochloride Tablets to maintain pain control during chronic treatment. The dosage should be selected according to the patient's individual analgesic response and ability to tolerate side effects. Tolerance to the analgesic effects of opioids is usually paralleled by tolerance to side effects except for constipation.

Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug or may be precipitated through the administration of drugs with opioid antagonist activity. If Oxycodone Hydrochloride Tablets are abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see DRUG ABUSE AND DEPENDENCE).  If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of Oxycodone Hydrochloride Tablets combined with symptomatic support (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

Use In Pancreatic/Biliary Tract Disease:

Oxycodone Hydrochloride Tablets may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like Oxycodone Hydrochloride Tablets may cause increases in the serum amylase level.

Information for Patients/Caregivers:

If clinically advisable, patients (or their caregivers) receiving Oxycodone Hydrochloride Tablets should be given the following information by the physician, nurse, pharmacist or caregiver:

1. Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.


2. Patients should be advised not to adjust the dose of Oxycodone Hydrochloride Tablets without consulting the prescribing professional.


3. Patients should be advised that Oxycodone Hydrochloride Tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).


4. Patients should not combine Oxycodone Hydrochloride Tablets with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.


5. Women of childbearing potential who become, or are planning to become pregnant, should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.


6. Patients should be advised that Oxycodone Hydrochloride Tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.


7. Patients should be advised that if they have been receiving treatment with Oxycodone Hydrochloride Tablets for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the Oxycodone Hydrochloride Tablets dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

Drug Interactions:

Oxycodone is metabolized in part to oxymorphone via the cytochrome p450 isoenzyme CYP2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent; however, clinicians should be aware of this possible interaction.

Neuromuscular Blocking Agents: Oxycodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

CNS Depressants: Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Oxycodone Hydrochloride Tablets may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of Oxycodone Hydrochloride Tablets. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Mixed Agonist/Antagonist Opioid Analgesics: Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as Oxycodone Hydrochloride Tablets. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of Oxycodone Hydrochloride Tablets and/or may precipitate withdrawal symptoms in these patients.

Monoamine Oxidase Inhibitors (MAOIs): MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of Oxycodone Hydrochloride Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies have not been performed in animals to evaluate the carcinogenic potential of Oxycodone Hydrochloride Tablets or Oxycodone. The possible effects on male or female fertility have not been studied in animals.

Oxycodone hydrochloride was genotoxic in an in vitro mouse lymphoma assay in the presence of metabolic activation. There was no evidence of genotoxic potential in an in vitro bacterial reverse mutation assay (Salmonella typhimurium and Escherichia coli ) or in an assay for chromosomal aberrations (in vivo mouse bone marrow micronucleus assay).

Pregnancy:

Teratogenic Effects:

Category B: Reproduction studies in Sprague-Dawley rats and New Zealand rabbits revealed that when Oxycodone was administered orally at doses up to 16 mg/kg (approximately 2 times the daily oral dose of 90 mg for adults on a mg/m2 basis) and 25 mg/kg (approximately 5 times the daily oral dose of 90 mg on a mg/m2 basis) respectively, was not teratogenic or embryo-fetal toxic. There are no adequate and well controlled studies of Oxycodone in pregnant women. Because animal reproductive studies are not always predictive of human responses, Oxycodone Hydrochloride Tablets should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects:

Neonates whose mothers have taken Oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.

Labor and Delivery:

Oxycodone Hydrochloride Tablets are not recommended for use in women during or immediately prior to labor. Occasionally, opioid analgesics may prolong labor through actions which temporarily reduce the strength, duration and frequency of uterine contractions. Neonates, whose mothers received opioid analgesics during labor, should be observed closely for signs of respiratory depression. A specific narcotic antagonist, naloxone, should be available for reversal of narcotic-induced respiratory depression in the neonate.

Nursing Mothers:

Oxycodone has been detected in breast milk. Withdrawal symptoms can occur in breastfeeding infants when maternal administration of an opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving Oxycodone Hydrochloride Tablets since Oxycodone may be excreted in milk.

Pediatric Use:

The safety and efficacy of Oxycodone in pediatric patients have not been evaluated.

Geriatric Use:

Of the total number of subjects in clinical studies of Oxycodone Hydrochloride Tablets, 20.8% (112/538) were 65 and over, while 7.2% (39/538) were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment:

Since Oxycodone is extensively metabolized, its clearance may decrease in hepatic failure patients. Dose initiation in patients with hepatic impairment should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

Renal Impairment:

Published data reported that elimination of Oxycodone was impaired in end-stage renal failure. Mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Dose initiation should follow a conservative approach. Dosages should be adjusted according to the clinical situation.

Ambulatory Patients:

Oxycodone Hydrochloride Tablets may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

ADVERSE REACTIONS

Oxycodone Hydrochloride Tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. Oxycodone Hydrochloride Tablets are associated with adverse experiences similar to those seen with other opioids.

Serious adverse reactions that may be associated with Oxycodone Hydrochloride Tablets therapy in clinical use are those observed with other opioid analgesics and include: Respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock (see OVERDOSE, WARNINGS).

The less severe adverse events seen on initiation of therapy with Oxycodone Hydrochloride Tablets are also typical opioid side effects. These events are dose dependent, and their frequency depends on the clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent of these include nausea, constipation, vomiting, headache, and pruritus.

In many cases the frequency of adverse events during initiation of opioid therapy may be minimized by careful individualization of starting dosage, slow titration and the avoidance of large rapid swings in plasma concentration of the opioid. Many of these adverse events will abate as therapy is continued and some degree of tolerance is developed, but others may be expected to remain throughout therapy.

In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving Oxycodone Hydrochloride Tablets, the following adverse events were recorded in Oxycodone Hydrochloride Tablets treated patients with an incidence ≥ 3%. In descending order of frequency they were: Nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.

The following adverse experiences occurred in less than 3% of patients involved in clinical trials with Oxycodone:

Body as a Whole: Abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis.

Cardiovascular: Deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia.

Digestive: Anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting.

Hemic and Lymphatic: Anemia and leukopenia.

Metabolic and Nutritional: Edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema.

Musculoskeletal: Arthralgia, arthritis, bone pain, myalgia and pathological fracture.

Nervous: Agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation.

Respiratory: Bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis.

Skin and Appendages: Herpes simplex, rash, sweating, and urticaria.

Special Senses: Amblyopia.

Urogenital: Urinary tract infection

DRUG ABUSE AND DEPENDENCE

Controlled Substance:

Oxycodone Hydrochloride Tablets contain Oxycodone, a mu-agonist opioid of the morphine type and is a Schedule II controlled substance. Oxycodone Hydrochloride Tablets, like other opioids used in analgesia, can be abused and are subject to criminal diversion.

Abuse:

Drug addiction is characterized by compulsive use, use for non-medical purposes, and continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a multi-disciplinary approach, but relapse is common.

"Drug-seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by misuse for nonmedical purposes, often in combination with other psychoactive substances. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Oxycodone Hydrochloride Tablets are intended for oral use only. Abuse of Oxycodone Hydrochloride Tablets poses a risk of overdose and death. The risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.

Dependence:

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: Restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued.

OVERDOSAGE

Signs and Symptoms:

Acute overdose with Oxycodone Hydrochloride Tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, and death.

Treatment:

To treat Oxycodone Hydrochloride Tablets overdose, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

The narcotic antagonists, naloxone or nalmefene, are specific antidotes for opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to Oxycodone Hydrochloride Tablets overdose. If needed the appropriate dose of naloxone hydrochloride or nalmefene should be administered simultaneously with efforts at respiratory resuscitation (see package insert for each drug for the details). Since the duration of action of Oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Gastric emptying may be useful in removing unabsorbed drug.

Opioid antagonists should be administered cautiously to persons who are suspected to be physically dependent on any opioid agonist, including Oxycodone (see Opioid-Tolerant Individuals).

Opioid-Tolerant Individuals: In an individual physically dependent on opioids, administration of a usual dose of antagonist will precipitate an acute withdrawal. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Use of an opioid antagonist should be reserved for cases where such treatment is clearly needed. If it is necessary to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses.

DOSAGE AND ADMINISTRATION

Oxycodone Hydrochloride Tablets are intended for the management of moderate to severe pain in patients who require treatment with an oral opioid analgesic. The dose should be individually adjusted according to severity of pain, patient response and patient size. If the pain increases in severity, if analgesia is not adequate, or if tolerance occurs, a gradual increase in dosage may be required.

Patients who have not been receiving opioid analgesics should be started on Oxycodone Hydrochloride Tablets in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose should be titrated based upon the individual patient's response to their initial dose of Oxycodone Hydrochloride Tablets. Patients with chronic pain should have their dosage given on an around-the-clock basis to prevent the reoccurrence of pain rather than treating the pain after it has occurred. This dose can then be adjusted to an acceptable level of analgesia taking into account side effects experienced by the patient.

For control of severe chronic pain, Oxycodone Hydrochloride Tablets should be administered on a regularly scheduled basis, every 4-6 hours, at the lowest dosage level that will achieve adequate analgesia.

As with any potent opioid, it is critical to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Although it is not possible to list every condition that is important to the selection of the initial dose of Oxycodone Hydrochloride Tablets, attention should be given to: 1) the daily dose, potency, and characteristics of a pure agonist or mixed agonist/antagonist the patient has been taking previously, 2)  the reliability of the relative potency estimate to calculate the dose of Oxycodone needed, 3)  the degree of opioid tolerance, 4)  the general condition and medical status of the patient, and 5) the balance between pain control and adverse experiences.

Conversion from Fixed-Ratio Opioid/Acetaminophen, Opioid/Aspirin, or Opioid/Nonsteroidal Combination Drugs:

When converting patients from fixed ratio opioid/non-opioid drug regimens a decision should be made whether or not to continue the non-opioid analgesic. If a decision is made to discontinue the use of non-opioid analgesic, it may be necessary to titrate the dose of Oxycodone Hydrochloride Tablets in response to the level of analgesia and adverse effects afforded by the dosing regimen. If the non-opioid regimen is continued as a separate single entity agent, the starting dose Oxycodone Hydrochloride Tablets should be based upon the most recent dose of opioid as a baseline for further titration of Oxycodone. Incremental increases should be gauged according to side effects to an acceptable level of analgesia.

Patients Currently on Opioid Therapy:

If a patient has been receiving opioid-containing medications prior to taking Oxycodone Hydrochloride Tablets, the potency of the prior opioid relative to Oxycodone should be factored into the selection of the total daily dose (TDD) of Oxycodone.

In converting patients from other opioids to Oxycodone Hydrochloride Tablets close observation and adjustment of dosage based upon the patient's response to Oxycodone Hydrochloride Tablets is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of Oxycodone Hydrochloride Tablets may be necessary, especially in patients who have disease states that are changing rapidly.

Maintenance of Therapy:

Continual re-evaluation of the patient receiving Oxycodone Hydrochloride Tablets is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. If the level of pain increases, effort should be made to identify the source of increased pain, while adjusting the dose as described above to decrease the level of pain.

During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), the continued need for the use of opioid analgesics should be reassessed as appropriate.

Cessation of Therapy:

When a patient no longer requires therapy with Oxycodone Hydrochloride Tablets or other opioid analgesics for the treatment of their pain, it is important that therapy be gradually discontinued over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence section for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. It is not known at what dose of Oxycodone Hydrochloride Tablets that treatment may be discontinued without risk of the opioid abstinence syndrome.

HOW SUPPLIED

Oxycodone HYDROCHLORIDE TABLETS, USP are available as follows:

5 mg white to off-white round, biconvex tablets embossed with “R” above the bisect and “P” below on one side and “5” on the other side.

NDC 42858-001-10:  Unit Dose Packages of 100 (10X10)

NDC 42858-001-01:  Bottles of 100 tablets

10 mg white to off-white round, biconvex tablets embossed with “R” above the bisect and “P” below on one side and “10” on the other side

NDC 42858-002-10:  Unit Dose Packages of 100 (10X10)

NDC 42858-002-01:  Bottles of 100 tablets

15 mg white to off-white oval tablets embossed with “R” above the bisect and “P” below on one side and “15” on the other side.

NDC 42858-003-01:  Bottles of 100 tablets

20 mg white to off-white round, biconvex tablets embossed with “R” above the bisect and “P” below on one side and “20” on the other side

NDC 42858-004-01:  Bottles of 100 tablets

30 mg white to off-white round, biconvex tablets embossed with “R” above the bisect and “P” below on one side and “30” on the other side

NDC 42858-005-01:  Bottles of 100 tablets

Dispense in a tight, light-resistant container.

Protect from moisture.

DEA Order Form Required

Storage and Handling

Store at 25°C (77°F); excursions are permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Distributed by:

Rhodes Pharmaceuticals L.P.

Coventry, RI 02816

Manufactured by:

Purdue Pharmaceuticals L.P.

Wilson, NC 27893

Component No: 302427-0B

Rev. 11/2010

Package Label, Oxycodone Hydrochloride Tablets, USP – 5 mg Blister Card - 10 Tablets

Blister Card - 10 tablets                               NDC 42858-001-10

CII                                                                  Rx Only

Package Label, Oxycodone Hydrochloride Tablets, USP – 10 mg Blister Carton - 100 Tablets

Blister Carton - 100 tablets                         NDC 42858-002-10

CII                                                                  Rx Only

Package Label, Oxycodone Hydrochloride Tablets, USP – 15 mg– Bottle of 100 Tablets

Bottle of 100 tablets                                     NDC 42858-003-01

CII                                                                  Rx Only

Package Label, Oxycodone Hydrochloride Tablets, USP – 20 mg– Bottle of 100 Tablets

Bottle of 100 tablets                                     NDC 42858-004-01

CII                                                                  Rx Only

Package Label, Oxycodone Hydrochloride Tablets, USP – 30 mg– Bottle of 100 Tablets

Bottle of 100 tablets                                     NDC 42858-005-01

CII                                                                  Rx Only

Oxycodone HYDROCHLORIDE  Oxycodone hydrochloride  tablet

Difluprednate ophthalmic

Generic Name: difluprednate ophthalmic (DYE floo PRED nate off THAL mik)

Brand Names: Durezol

What is difluprednate ophthalmic?

Difluprednate is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Difluprednate ophthalmic (for the eye) is used to treat eye swelling caused by surgery.

Difluprednate ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about difluprednate ophthalmic?

You should not use this medication if you are allergic to difluprednate, or if you have any type of viral or fungal eye infection, ocular herpes, or an untreated infection in your eye or elsewhere, including chickenpox.

Before using difluprednate ophthalmic, tell your doctor if you are allergic to any drugs, or if you have herpes. You may need a dose adjustment or special tests to safely use difluprednate.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not stop using difluprednate suddenly without first talking to your doctor. Tell your doctor if your symptoms do not improve after 2 days of treatment with difluprednate ophthalmic.

Do not wear any contact lens that has not been approved by your doctor. Do not use difluprednate ophthalmic while you are wearing regular contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using difluprednate before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

What should I discuss with my healthcare provider before I receive difluprednate ophthalmic?

You should not use this medication if you are allergic to difluprednate, or if you have any type of infection, especially:

• 
  

  a fungal or bacterial eye infection;

  
  


• 
  

  any type of viral eye infection, such as ocular herpes; or

  
  


• 
  

  an untreated infection in your eye or elsewhere, including chickenpox.

  
  

Before using difluprednate ophthalmic, tell your doctor if you are allergic to any drugs, or if you have herpes. You may need a dose adjustment or special tests to safely use difluprednate.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether difluprednate ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use difluprednate ophthalmic?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Difluprednate ophthalmic is usually given 4 times per day beginning 24 hours after your surgery and continuing for 2 weeks. After the first 2 weeks, your dose may be decreased to 2 times per day for 1 week or longer. Follow your doctor's instructions.

Wash your hands before using the eye drops.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

  
  


• 
  

  Use the eye drops only in the eye you are having surgery on.

  
  


• 
  

  Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

  
  

Tell your doctor if your symptoms do not improve after 2 days of treatment with difluprednate ophthalmic. Do not stop using difluprednate suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

To be sure this medication is not causing harmful effects, your eyes may need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

Store this medication at room temperature away from heat, moisture, and light. Do not freeze. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of difluprednate is not likely to cause life-threatening symptoms.

What should I avoid after I receive difluprednate ophthalmic?

Do not wear any contact lens that has not been approved by your doctor.

Do not use difluprednate ophthalmic while you are wearing regular contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using difluprednate before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Difluprednate can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

Difluprednate ophthalmic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  pain behind your eyes, sudden vision changes, severe headache;

  
  


• 
  

  sudden eye irritation;

  
  


• 
  

  blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

  
  


• 
  

  signs of new eye infection, such as swelling, draining, or crusting of your eyes.

  
  

Less serious side effects may include mild burning, stinging, or itching of your eyes.

• 
  

  feeling like something is in your eye;

  
  


• 
  

  eyes being more sensitive to light;

  
  


• 
  

  eye pain, itching, or redness; or

  
  


• 
  

  itchy or watery eyes.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Difluprednate ophthalmic Dosing Information

Usual Adult Dose for Postoperative Ocular Inflammation:

Instill one drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response

What other drugs will affect difluprednate ophthalmic?

It is not likely that other drugs you take orally or inject will have an effect on difluprednate ophthalmic used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More difluprednate ophthalmic resources

• Difluprednate ophthalmic Side Effects (in more detail)
• Difluprednate ophthalmic Dosage
• Difluprednate ophthalmic Use in Pregnancy & Breastfeeding
• Difluprednate ophthalmic Support Group
• 0 Reviews for Difluprednate - Add your own review/rating

• Durezol Prescribing Information (FDA)


• Durezol Monograph (AHFS DI)


• Durezol Advanced Consumer (Micromedex) - Includes Dosage Information


• Durezol Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• Durezol Consumer Overview

Compare difluprednate ophthalmic with other medications

• Postoperative Ocular Inflammation

Where can I get more information?

• Your doctor or pharmacist can provide more information about difluprednate ophthalmic.

See also: difluprednate side effects (in more detail)

Roxanol

Generic Name: morphine (Oral route)

MOR-feen

Oral route(Capsule, Extended Release)

Kadian(R): Capsule contains morphine sulfate, an opioid agonist and Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Kadian(R) is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The 100-mg and 200-mg capsules are for use in opioid-tolerant patients only. Kadian(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule pellets due to the risk of rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Capsule, Extended Release, 24 HR)

Avinza(R): Capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. Avinza(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule beads due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in the rapid release and absorption of a potentially fatal dose of morphine .

Oral route(Solution)

Morphine oral solution is available in 10 mg/5 mL, 20 mg/5 mL and 100 mg/5 mL (20 mg/mL) concentrations. The 100 mg/5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Keep morphine oral solution out of the reach of children .

Oral route(Tablet, Extended Release)

MS Contin(R): 100 mg and 200 mg tablets are for use in opioid-tolerant patients only. MS Contin(R) tablets are a controlled-release formulation, should be swallowed whole and are not to be broken, chewed, dissolved, or crushed due to the risk of rapid release and absorption of a potentially fatal dose of morphine . Oramorph(R) SR: This is a sustained-release dosage form. Swallow the tablet whole; the tablet should not be broken in half, nor should it be crushed or chewed .

Commonly used brand name(s)

In the U.S.

• Avinza


• Kadian


• Kadian ER


• MS Contin


• MSIR


• Oramorph SR


• Roxanol


• Roxanol-T

Available Dosage Forms:

• Capsule, Extended Release


• Capsule, Extended Release, 24 HR


• Tablet, Extended Release


• Capsule


• Tablet


• Powder for Suspension, Extended Release


• Solution


• Capsule, Delayed Release


• Syrup

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For Roxanol

Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain.

When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using Roxanol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of morphine in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of morphine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving morphine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Naltrexone


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alfentanil


• Alprazolam


• Amobarbital


• Anileridine


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Cimetidine


• Clobazam


• Clonazepam


• Clorazepate


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Estazolam


• Ethchlorvynol


• Fentanyl


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Halazepam


• Hydrocodone


• Hydromorphone


• Ketazolam


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenobarbital


• Prazepam


• Prochlorperazine


• Promazine


• Promethazine


• Propoxyphene


• Quazepam


• Remifentanil


• Secobarbital


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiethylperazine


• Thiopental


• Thioridazine


• Triazolam


• Trifluoperazine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine


• Esmolol


• Gabapentin


• Rifampin


• Somatostatin


• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, or history of or


• Chronic obstructive pulmonary disease (COPD) or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Gallbladder disease or gallstones or


• Head injuries, history of or


• Heart disease or


• Hypothyroidism (an underactive thyroid) or


• Hypovolemia (low blood volume) or


• Kyphoscoliosis (curvature of the spine with breathing problems) or


• Pancreatitis (inflammation of the pancreas) or


• Problems with passing urine or


• Swallowing problems—Use with caution. May increase risk for more serious side effects.

• Asthma, severe or


• Breathing problems, severe (e.g., hypoxia) or


• Paralytic ileus (intestine stops working and may be blocked) or


• Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of morphine

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to Roxanol. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

You may take this medicine with or without food.

Morphine extended-release capsules and tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.

Swallow the extended-release capsules and tablets whole. Do not break, crush, dissolve, or chew them. Do not use extended-release tablets that are broken.

If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing.

While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about.

Morphine extended-release capsules or tablets work differently from the regular morphine oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release capsules):
  
  • For moderate to severe pain:
    
    • Patients switching from regular morphine forms:
      
      • Adults—The capsule is given once a day. The initial dose in milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
    • Patients who are not taking narcotic medicines:
      
      • Adults—At first, 30 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  


• For oral dosage form (extended-release tablets):
  
  • For moderate to severe pain:
    
    • Patients switching from regular morphine forms:
      
      • Adults—The tablet is given every 8 hours or every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. The total amount per day will be divided and given as 2 or 3 doses during the day. Your doctor may adjust your dose if needed.
      
      
      • Children—Use and dose must be determined by your doctor.
      
      
    
    
  
  


• For oral dosage form (solution):
  
  • For moderate to severe pain:
    
    • Adults—10 to 20 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets):
  
  • For moderate to severe pain:
    
    • Adults—15 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Morphine can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Flush the unused capsules, liquid, and tablets down the toilet.

Precautions While Using Roxanol

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Roxanol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Abdominal or stomach pain


• blurred vision


• bulging soft spot on the head of an infant


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in the ability to see colors, especially blue or yellow


• chest pain or discomfort


• chills


• confusion


• cough


• decreased urination


• difficulty with breathing


• difficulty with swallowing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fainting


• fast, pounding, or irregular heartbeat or pulse


• headache


• hives


• increased sweating


• insomnia


• itching


• loss of appetite


• nausea


• nervousness


• noisy breathing


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• severe constipation


• severe vomiting


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• skin rash


• slow or irregular heartbeat


• sweating


• swelling


• tightness in the chest


• trembling or shaking of the hands or feet


• trouble with breathing


• trouble with urinating


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• bluish lips or skin


• change in consciousness


• chest pain or discomfort


• cold, clammy skin


• convulsions


• decrease in the amount of urine


• decrease in the frequency of urination


• difficulty in passing urine (dribbling)


• extremely shallow or slow breathing


• fast, weak pulse


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• irregular, fast or slow, or shallow breathing


• lightheadedness


• loss of consciousness


• low blood pressure or pulse


• nervousness


• painful urination


• pale or blue lips, fingernails, or skin


• pale skin


• pinpoint red spots on the skin


• pounding in the ears


• shakiness and unsteady walk


• troubled breathing with exertion


• unconsciousness


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• very slow breathing


• very slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Bloody urine


• constricted, pinpoint, or small pupils (black part of the eye)


• dark-colored urine


• decreased awareness or responsiveness


• extreme drowsiness


• fever


• increased blood pressure


• increased thirst


• lower back or side pain


• muscle cramps or spasms


• muscle pain or stiffness


• no muscle tone or movement


• severe sleepiness


• swelling of the face, fingers, or lower legs


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cramps


• diarrhea


• difficulty having a bowel movement (stool)


• drowsiness


• false or unusual sense of well-being


• relaxed and calm feeling


• sleepiness or unusual drowsiness


• weight loss

Less common

• Absent, missed, or irregular menstrual periods


• acid or sour stomach


• agitation


• bad, unusual, or unpleasant (after) taste


• belching


• blurred or loss of vision


• change in taste


• decreased interest in sexual intercourse


• depression


• disturbed color perception


• double vision


• dry mouth


• face is warm or hot to touch


• fear


• floating feeling


• halos around lights


• heartburn


• inability to have or keep an erection


• indigestion


• loss in sexual ability, desire, drive, or performance


• muscle stiffness or tightness


• nervousness


• night blindness


• overbright appearance of lights


• problems with muscle control


• redness of the skin


• seeing double


• skin rash


• sleeplessness


• stomach discomfort, upset, or pain


• stopping of menstrual bleeding


• trouble sleeping


• tunnel vision


• unable to sleep


• uncontrolled eye movements


• upper abdominal or stomach pain


• weakness

Incidence not known

• Abnormal dreams


• belching


• burning while urinating


• change in vision


• change in walking and balance


• change or problem with discharge of semen


• clumsiness or unsteadiness


• confusion as to time, place, or person


• delusions


• dementia


• dry skin


• eye pain


• feeling of constant movement of self or surroundings


• general feeling of discomfort or illness


• hiccup


• holding false beliefs that cannot be changed by fact


• impaired vision


• indigestion


• loss of memory


• problems with memory


• seeing, hearing, or feeling things that are not there


• sensation of spinning


• thirst


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• unusual excitement, nervousness, or restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Roxanol side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Roxanol resources

• Roxanol Side Effects (in more detail)
• Roxanol Use in Pregnancy & Breastfeeding
• Roxanol Drug Interactions
• Roxanol Support Group
• 0 Reviews for Roxanol - Add your own review/rating

• Roxanol Concentrate MedFacts Consumer Leaflet (Wolters Kluwer)


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• Astramorph PF Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Avinza Consumer Overview


• Avinza Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Avinza Prescribing Information (FDA)


• Infumorph Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Kadian Consumer Overview


• Kadian Prescribing Information (FDA)


• Kadian Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• MS Contin Prescribing Information (FDA)


• MS Contin Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• MS Contin Consumer Overview


• Morphine Sulfate Monograph (AHFS DI)


• Oramorph SR Prescribing Information (FDA)


• RMS Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Roxanol with other medications

• Pain

Darby Topical Fluoride Bubble Gum

Generic Name: sodium fluoride

Dosage Form: aerosol, foam
Darby 2.72 % Topical Sodium Fluoride Foam Bubble Gum

Darby 2.72 % Topical Sodium Fluoride Foam

(1.23 % Fluoride Ions)

Bubble Gum

4.4 oz / 125 g

NDC 66467-3730-1

A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

130 applications

Medicinal ingredients:

Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)

Non-Medicinal ingredients: cocamidopropyl betaine, phosphoric acid, poloxamer 407, sucralose, tartaric acid, xylitol, purified water, bubble gum flavour

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx only


Made in USA

Distributed by:

Darby Dental Supply, LLC

Jericho, Ny11753

UPC 952-9104

Rev 00

DARBY  TOPICAL SODIUM FLUORIDE BUBBLE GUM sodium fluoride  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-3730 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) fluoride ion .0272 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66467-3730-1 125 g In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/10/2010

Labeler - Darby Dental Supply Co (825137818)

Revised: 11/2010Darby Dental Supply Co

More Darby Topical Fluoride Bubble Gum resources

• Darby Topical Fluoride Bubble Gum Use in Pregnancy & Breastfeeding
• Darby Topical Fluoride Bubble Gum Support Group
• 3 Reviews for Darby Topical Fluoride Bubble - Add your own review/rating

Compare Darby Topical Fluoride Bubble Gum with other medications

• Prevention of Dental Caries

Bovatec

Dosage Form: FOR ANIMAL USE ONLY
Bovatec®

Liquid 20

Type A Medicated Article

Brand of lasalocid

CATTLE: For improved feed efficiency and increased rate of weight gain when used in medicated feeds for cattle fed in confinement for slaughter. For increased rate of weight gain when used in medicated feeds for pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).

For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs.

SHEEP: For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva and E. intricata in sheep maintained in confinement.

Each pound contains 90.7 grams (20%) of lasalocid (as lasalocid sodium activity) in a carrier suitable for incorporation in liquid feed supplements.

IMPORTANT: Handling Information - Must be thoroughly mixed in feeds before use. When mixing and handling lasalocid liquid premix, use protective clothing and impervious gloves. Avoid contact with eyes. Operators should wash hands thoroughly with soap and water after handling.

MIXING DIRECTIONS

This product should be incorporated into liquid feed supplements:

(1)

Agitate Bovatec Liquid 20 before use.

(2)

Supplements with suspending agent(s) should be in a pH range of 4 - 8 and maintain physical stability for up to three months with a viscosity not less than 300 cps.

(3)

Conventional liquid supplements should be in a pH range of 4 - 8.

 

For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

 

For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(4)

The following is provided as a guide in determining the quantity of Bovatec Liquid 20 (Type A Medicated Article) to be added in preparing liquid feed supplements (LFS). Preparation of intermediate liquid premix is not recommended.

* 6.13 gm lasalocid per fluid ounce (Bovatec Liquid 20 specific gravity is 1.035)
LFS TO BE FED UNDILUTED As a Type C Medicated Feed - Hand-Fed or Top Dressed
Amount of LFS to be fed (lbs/head/day)	To achieve a lasalocid intake of (mg/head/day)	Bovatec Liquid 20 per ton LFS
		pounds	fluid ounces*
0.5	15	0.66	9.8
0.5	60	2.65	39.2
0.5	70	3.09	45.7
0.5	200	8.82	130.5
0.5	300	13.23	195.8
0.5	360	15.88	234.9
1.0	15	0.33	4.9
1.0	60	1.32	19.6
1.0	70	1.54	22.8
1.0	200	4.41	65.3
1.0	300	6.62	97.9
1.0	360	7.94	117.5
LFS TO BE DILUTED As a Type B Medicated Feed - Mixed into a Feed
Amount of LFS to be added to final feed (lbs/ton)	Lasalocid in final feed (grams/ton)	Bovatec Liquid 20 per Ton LFS
		pounds	fluid ounces*
100	10	2.21	32.6
100	25	5.51	81.6
100	30	6.62	97.9
150	10	1.47	21.8
150	25	3.68	54.4
150	30	4.41	65.3
200	10	1.10	16.3
200	25	2.76	40.8
200	30	3.31	48.9

DO NOT FEED UNDILUTED

USE DIRECTIONS

Species	Dose	Indications for use
Feedlot Cattle	10-30 grams lasalocid per ton of total ration (90% dry matter)	For improved feed efficiency in cattle being fed in confinement for slaughter, feed continuously to provide not less than 100 mg nor more than 360 mg per head per day.
	25-30 grams lasalocid per ton of total ration (90% dry matter)	For improved feed efficiency and increased rate of weight gain in cattle being fed in confinement for slaughter, feed continuously to provide not less than 250 mg nor more than 360 mg per head per day.
Pasture Cattle – slaughter, stocker, feeder cattle, and dairy and beef replacement heifers	60-300 mg lasalocid per head/day	For increased rate of weight gain. The drug must be contained in at least 1 pound of feed and fed continuously on a daily basis.
	60-300 mg lasalocid per head/day	For increased rate of weight gain, feed continuously on a free-choice basis. (Manufacture of Type C free-choice feeds from this product requires a Medicated Feed License Application approved by FDA.)
		Daily lasalocid intakes in excess of 200 mg per head per day have not been shown to be more effective than 200 mg lasalocid per head per day.
		NOTE: Coccidiosis may occur when young pasture cattle are comingled with adult cattle passing coccidial oocysts.
Cattle	1 mg lasalocid per 2.2 lbs body weight/day	For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs. Hand feed continuously to provide not more than 360 mg per day.
Sheep	20-30 grams lasalocid per ton of total ration (90% dry matter)	For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, and E. intricata in sheep maintained in confinement. Feed continuously to provide not less than 15 mg nor more than 70 mg per head per day depending on body weight.

CAUTION: Animal Safety - Do not allow horses or other equines access to premixes or supplements containing lasalocid, as ingestion may be fatal. The safety of lasalocid in unapproved species has not been established. Feeding undiluted or mixing errors resulting in excessive concentrations of lasalocid could be fatal to cattle and sheep.

Warning

A withdrawal period has not been established for this product in pre-ruminating calves.

Do not use in calves to be processed for veal.

DO NOT FEED UNDILUTED

Net Wt. 50 Lb. (22.68 kg)

NADA 96-298, Approved by FDA. Not for human use.

See side panel for use directions

Made in U.S.A.

Trademarks registered

by Alpharma Inc.

710347 0910

List No. 710127

Alpharma Inc.

Bridgewater, New Jersey 08807

PRINCIPAL DISPLAY PANEL - 50 lb Drum

List No. 710127

Control

Expires:

Bovatec®

Liquid 20

Type A Medicated Article

Brand of lasalocid

CATTLE: For improved feed efficiency and increased rate of weight gain when used in

medicated feeds for cattle fed in confinement for slaughter. For increased rate of weight

gain when used in medicated feeds for pasture cattle (slaughter, stocker, feeder cattle, and

dairy and beef replacement heifers).

For control of coccidiosis caused by Eimeria bovis and E. zuernii in cattle up to 800 lbs.

SHEEP: For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis

(E. ninakohlyakimovae), E. parva and E. intricata in sheep maintained in confinement.

Each pound contains 90.7 grams (20%) of lasalocid (as lasalocid sodium activity)

in a carrier suitable for incorporation in liquid feed supplements.

IMPORTANT: Handling Information - Must be thoroughly mixed in feeds before use.

When mixing and handling lasalocid liquid premix, use protective clothing and impervious

gloves. Avoid contact with eyes. Operators should wash

hands thoroughly with soap and water after handling.

DO NOT FEED UNDILUTED

Net Wt. 50 Lb. (22.68 kg)

NADA 96-298, Approved by FDA. Not for human use.

See side panel for use directions

Alpharma®

Alpharma Inc.

Bridgewater, New Jersey 08807

Take Time

Observe Label

Directions

Made in U.S.A.

Trademarks registered

by Alpharma Inc.

710347 0910

Bovatec 20  lasalocid sodium  liquid

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 46573-459 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Lasalocid Sodium (Lasalocid) Lasalocid Sodium 90.7 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Off-White to Yellow) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46573-459-06 22.68 kg In 1 DRUM None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA096298	01/01/2009

Labeler - Alpharma Inc. Animal Health (070954094)

Revised: 11/2009Alpharma Inc. Animal Health

Diphenhydramine/Pseudoephedrine Tablets

Pronunciation: DYE-fen-HYE-dra-meen/SOO-doe-e-FED-rin
Generic Name: Diphenhydramine/Pseudoephedrine
Brand Name: Benadryl-D

Diphenhydramine/Pseudoephedrine is used for:

Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Diphenhydramine/Pseudoephedrine is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by promoting sinus and nasal drainage, which relieves congestion and pressure.

Do NOT use Diphenhydramine/Pseudoephedrine if:

• you are allergic to any ingredient in Diphenhydramine/Pseudoephedrine


• you have severe high blood pressure, severe heart blood vessel disease, fast heartbeat, severe heart problems, narrow-angle glaucoma, or if you are unable to urinate


• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Diphenhydramine/Pseudoephedrine:

Some medical conditions may interact with Diphenhydramine/Pseudoephedrine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of lung or breathing problems (eg, asthma, emphysema); sleep apnea; trouble sleeping; blood problems (eg, porphyria); adrenal gland problems (eg, adrenal gland tumor); high blood pressure; fast, slow, or irregular heartbeat; heart problems; heart blood vessel problems; or stroke


• if you have a history of diabetes; glaucoma or increased pressure in the eye; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or thyroid problems

Some MEDICINES MAY INTERACT with Diphenhydramine/Pseudoephedrine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Diphenhydramine/Pseudoephedrine's side effects


• Beta-blockers (eg, propranolol) or bromocriptine because the risk of their side effects may be increased by Diphenhydramine/Pseudoephedrine


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Diphenhydramine/Pseudoephedrine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diphenhydramine/Pseudoephedrine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Diphenhydramine/Pseudoephedrine:

Use Diphenhydramine/Pseudoephedrine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Diphenhydramine/Pseudoephedrine by mouth with or without food.


• If you miss a dose of Diphenhydramine/Pseudoephedrine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Diphenhydramine/Pseudoephedrine.

Important safety information:

• Diphenhydramine/Pseudoephedrine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Diphenhydramine/Pseudoephedrine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Diphenhydramine/Pseudoephedrine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Diphenhydramine/Pseudoephedrine without checking with your doctor.


• Diphenhydramine/Pseudoephedrine has diphenhydramine and pseudoephedrine it. Before you start any new medicine, check the label to see if it has diphenhydramine or pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Diphenhydramine/Pseudoephedrine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Diphenhydramine/Pseudoephedrine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Diphenhydramine/Pseudoephedrine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Diphenhydramine/Pseudoephedrine for a few days before the tests.


• Tell your doctor or dentist that you take Diphenhydramine/Pseudoephedrine before you receive any medical or dental care, emergency care, or surgery.


• Use Diphenhydramine/Pseudoephedrine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Diphenhydramine/Pseudoephedrine in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Diphenhydramine/Pseudoephedrine should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diphenhydramine/Pseudoephedrine while you are pregnant. Do not take Diphenhydramine/Pseudoephedrine in the third trimester of pregnancy. Diphenhydramine/Pseudoephedrine is found in breast milk. Do not breast-feed while taking Diphenhydramine/Pseudoephedrine.

Possible side effects of Diphenhydramine/Pseudoephedrine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, and throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mood or mental changes; persistent trouble sleeping; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor; trouble urinating or inability to urinate; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Diphenhydramine/Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular breathing; unusually fast, slow, or irregular heartbeat.

Proper storage of Diphenhydramine/Pseudoephedrine:

Store Diphenhydramine/Pseudoephedrine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diphenhydramine/Pseudoephedrine out of the reach of children and away from pets.

General information:

• If you have any questions about Diphenhydramine/Pseudoephedrine, please talk with your doctor, pharmacist, or other health care provider.


• Diphenhydramine/Pseudoephedrine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Diphenhydramine/Pseudoephedrine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Diphenhydramine/Pseudoephedrine resources

• Diphenhydramine/Pseudoephedrine Side Effects (in more detail)
• Diphenhydramine/Pseudoephedrine Dosage
• Diphenhydramine/Pseudoephedrine Use in Pregnancy & Breastfeeding
• Diphenhydramine/Pseudoephedrine Drug Interactions
• Diphenhydramine/Pseudoephedrine Support Group
• 1 Review for Diphenhydramine/Pseudoephedrine - Add your own review/rating

Compare Diphenhydramine/Pseudoephedrine with other medications

• Hay Fever
• Nasal Congestion

Ridactate

Generic Name: calcium lactate (KAL see um LAK tate)

Brand Names: Ridactate

What is Ridactate (calcium lactate)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of your body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.

Calcium lactate is used to prevent and to treat calcium deficiencies.

Calcium lactate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ridactate (calcium lactate)?

Do not take calcium lactate or antacids that contain calcium without first asking your doctor if you also take other medicines. Calcium can make it harder for your body to absorb certain medicines. Calcium lactate works best if you take it with food.

What should I discuss with my healthcare provider before taking Ridactate (calcium lactate)?

Before taking this medication, tell your doctor if you have:

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  a history of kidney stones; or

  
  


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  a parathyroid gland disorder.

  
  

If you have any of these conditions, you may not be able to take calcium lactate, or you may need a dose adjustment or special tests during treatment.

Talk to your doctor before taking calcium lactate if you are pregnant. Talk to your doctor before taking calcium lactate if you are breast-feeding a baby.

How should I take Ridactate (calcium lactate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Calcium lactate works best if you take it with food. Take calcium lactate with a full glass of water. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, decreased appetite, constipation, confusion, delirium, stupor, and coma.

What should I avoid while taking Ridactate (calcium lactate)?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Ridactate (calcium lactate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

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  nausea or vomiting;

  
  


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  decreased appetite;

  
  


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  constipation;

  
  


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  dry mouth or increased thirst; or

  
  


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  increased urination.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ridactate (calcium lactate)?

Calcium lactate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

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  digoxin (Lanoxin, Lanoxicaps);

  
  


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  antacids or other calcium supplements;

  
  


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  calcitriol (Rocaltrol) or vitamin D supplements; or

  
  


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  doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with calcium lactate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Ridactate resources

• Ridactate Side Effects (in more detail)
• Ridactate Use in Pregnancy & Breastfeeding
• Ridactate Drug Interactions
• Ridactate Support Group
• 0 Reviews for Ridactate - Add your own review/rating

Compare Ridactate with other medications

• Hypocalcemia
• Hypoparathyroidism
• Osteomalacia
• Osteoporosis
• Pseudohypoparathyroidism

Where can I get more information?

• Your doctor or pharmacist can provide more information about calcium lactate.

See also: Ridactate side effects (in more detail)