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Friday, October 28, 2016

Bevacizumab

Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: Immunoglobulin G 1 (human-mouse monoclonal rhuMAb-VEGF γ-chain anti-human vascular endothelial growth factor), disulfide with human-mouse monoclonal rhuMAb-VEGF light chain, dimer
Molecular Formula: C₆₆₃₈H₁₀₁₆₀N₁₇₂₀O₂₁₀₈S₄₄
CAS Number: 216974-75-3
Brands: Avastin

GI Perforations

GI perforation reported in 0.3–2.4% of patients receiving bevacizumab; may be fatal.^a If GI perforation occurs, discontinue bevacizumab permanently.^a (See GI Perforations under Cautions.)

Wound Healing Complications

Increased incidence of surgical and wound healing complications; may be serious and fatal.^a Discontinue bevacizumab if wound dehiscence occurs.^a (See Wound Healing Complications under Cautions.)

Appropriate interval between discontinuance of bevacizumab and subsequent elective surgery required to decrease risk of wound dehiscence not established.^a However, manufacturer recommends discontinuing therapy ≥28 days prior to elective surgery and resuming therapy only after surgical incision has fully healed.^a

Do not initiate therapy until ≥28 days following major surgery and after surgical incision has fully healed.^a

Hemorrhage

Severe, sometimes fatal hemorrhagic events (e.g., hemoptysis, epistaxis, GI hemorrhage, CNS hemorrhage, vaginal hemorrhage) reported.^a Do not administer to patients with serious hemorrhage or recent hemoptysis.^a (See Hemorrhage under Cautions.)

Introduction

Antineoplastic agent; a recombinant humanized monoclonal antibody.¹ ² ³ ⁴ ⁵

Uses for Bevacizumab

Colorectal Cancer

Used in combination with IV fluorouracil-based chemotherapy for the first-line treatment of metastatic cancer of the colon or rectum.¹ ² ³ ⁴ ⁹ Analysis of pooled data suggests that use of bevacizumab in combination with fluorouracil and leucovorin is associated with prolonged survival.²⁰

Has also been used in combination with oxaliplatin-containing regimens as first-line therapy for metastatic colorectal cancer†.³⁸

Used in combination with IV fluorouracil-based chemotherapy for the second-line treatment of previously treated metastatic cancer of the colon or rectum.¹ Interim analysis of data from one study indicated bevacizumab monotherapy† was associated with decreased survival compared with combination regimen consisting of fluorouracil, leucovorin, and oxaliplatin.¹

Under investigation for use as adjuvant therapy following surgery for early-stage (i.e., stage I or II) colon cancer†.²⁸

Non-small Cell Lung Cancer

Used in combination with carboplatin and paclitaxel for first-line treatment of unresectable, locally advanced, recurrent or metastatic nonsquamous NSCLC.¹ ¹⁰ ¹¹ ³³ ^d ^e

Some clinicians consider combination of bevacizumab, carboplatin, and paclitaxel as a regimen of choice in the initial treatment of advanced NSCLC for eligible patients (i.e., performance status of 0–2, nonsquamous histology, no history of hemoptysis, absence of CNS metastases, and no concomitant anticoagulant therapy).²⁷

Breast Cancer

Used in combination with paclitaxel for initial treatment of metastatic HER2-negative breast cancer.¹ Efficacy is based on prolonged progression-free survival; currently, no data available that demonstrate prolonged overall survival or amelioration of disease-related symptoms.¹ In December 2010, after reviewing data from 4 clinical studies, FDA recommended to remove this indication from bevacizumab’s approved labeling because of lack of benefit on overall survival and unfavorable risk-benefit ratio.⁵⁸ ⁵⁹ ⁶⁰ A public hearing was held on June 28–29, 2011.⁶¹ FDA’s final decision regarding approval status for this indication was pending at the time this drug monograph was finalized for publication.

Bevacizumab is not indicated for use in the treatment of breast cancer that has progressed following the use of an anthracycline and taxane regimen for metastatic disease.¹

Brain Tumors

Used as a single agent for treatment of glioblastoma in patients whose disease has progressed following previous therapy.^a Efficacy is based on increased objective response rate; currently, no data available that demonstrate prolonged overall survival or amelioration of disease-related symptoms.^a

Renal Cell Carcinoma

Used in combination with interferon alfa for treatment of metastatic renal cell carcinoma.^a

Ovarian Cancer

Under investigation for use in treatment of ovarian cancer†.²⁶

Prostate Cancer

Under investigation for use in treatment of prostate cancer†.²³ ²⁴

Neovascular Age-related Macular Degeneration

Has been used by intravitreal injection† in treatment of neovascular age-related macular degeneration†.³⁴

Bevacizumab Dosage and Administration

General

Use in combination with other chemotherapeutic agents.¹ (See Dosage under Dosage and Administration.)

Do not initiate therapy until ≥28 days following major surgery and after surgical incision has fully healed.¹ (See Wound Healing Complications under Cautions.)

Discontinue therapy ≥28 days prior to elective surgery; do not resume until surgical incision is fully healed.¹ (See Wound Healing Complications under Cautions.)

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹ Do not administer by rapid IV injection (e.g., IV push or bolus.¹

Dilution

Do not shake vial prior to dilution.¹

Withdraw appropriate dose of bevacizumab and dilute in 100 mL of 0.9% sodium chloride.¹ Do not administer or mix with dextrose solutions.¹

Rate of Administration

Administer initial dose over 90 minutes.¹ (See Infusion Reactions under Cautions.)

If well tolerated, administer second dose over 60 minutes.¹

If second dose is well tolerated, administer subsequent doses over 30 minutes.¹

Has been administered safely over shorter infusion times (0.5 mg/kg per minute).⁴³

Dosage

Consult respective manufacturers or published protocols for dosage, method of administration, and administration sequence of drugs in combination regimens.³

Adults

Colorectal Cancer

First-line Treatment of Metastatic Colorectal Cancer

5 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.¹

Use in combination with IV fluorouracil-based chemotherapy.¹ In clinical studies, bevacizumab was used in combination with the IFL regimen (irinotecan 125 mg/m², fluorouracil 500 mg/m², and leucovorin 20 mg/m², administered by IV injection once weekly for 4 out of every 6 weeks)¹ ⁴ or the 5-FU/LV regimen (leucovorin 500 mg/m² by IV infusion over 2 hours, then fluorouracil 500 mg/m² by slow IV injection [1 hour after initiation of leucovorin] given once weekly for the first 6 weeks out of every 8-week cycle).¹ ² ³

Second-line Treatment of Metastatic Colorectal Cancer

10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.¹

Use in combination with IV fluorouracil-based chemotherapy.¹ In clinical studies, bevacizumab was administered on day 1 of the treatment cycle prior to the FOLFOX4 regimen (oxaliplatin 85 mg/m² and leucovorin 200 mg/m² concurrently IV, then fluorouracil 400 mg/m² by direct IV injection, followed by fluorouracil 600 mg/m² by continuous IV infusion on day 1; and leucovorin 200 mg/m² IV, then fluorouracil 400 mg/m² by direct IV injection, followed by fluorouracil 600 mg/m² by continuous IV infusion on day 2; treatment cycles repeated every 2 weeks).¹

Non-small Cell Lung Cancer

IV

15 mg/kg every 3 weeks; continue until disease progression or unacceptable toxicity occurs.¹ ^e ^f

Use in combination with IV paclitaxel and carboplatin (PC regimen).¹ ^f In clinical studies, bevacizumab was administered 1 hour after the PC regimen (paclitaxel 200 mg/m² by IV infusion over 3 hours, then carboplatin [at dose required to obtain AUC of 6 mg/mL per minute] by IV infusion over 15–30 minutes beginning 60 minutes after completion of paclitaxel; treatment cycles repeated every 3 weeks).¹ ¹¹ ^d ^e ^f In these studies, patients received up to 6 cycles of bevacizumab in combination with the PC regimen, after which bevacizumab monotherapy (15 mg/kg every 3 weeks) was continued until disease progression or unacceptable toxicity occurred.¹ ¹¹ ^d ^e ^f A median of 7 treatment cycles (including cycles of bevacizumab monotherapy) was administered.¹¹

Breast Cancer

IV

10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.¹

Use in combination with IV paclitaxel (90 mg/m² IV once weekly for 3 out of 4 weeks).¹

Brain Tumors

Glioblastoma

10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.¹

Renal Cell Carcinoma

IV

10 mg/kg every 14 days; continue until disease progression or unacceptable toxicity occurs.¹

Use in combination with interferon alfa (9 million units sub-Q 3 times weekly).^a

Dosage Modification for Toxicity

Dosage reductions not recommended in any patient;¹ instead, temporarily or permanently discontinue therapy based on causality.¹

Discontinue therapy permanently if GI perforation (i.e., GI perforation, fistula formation in GI tract, intra-abdominal abscess), fistula formation involving an internal organ, wound dehiscence (requiring medical intervention), severe bleeding (requiring medical intervention), severe arterial thromboembolic event, nephrotic syndrome, hypertensive crisis, or hypertensive encephalopathy occurs.¹ ⁷

Discontinue therapy if reversible posterior leukoencephalopathy syndrome (RPLS) occurs.¹ ³¹ ³² ^a (See Reversible Posterior Leukoencephalopathy Syndrome [RPLS] under Cautions.) Risk of reinitiating therapy in patients previously experiencing RPLS not known.¹ ³²

Discontinue therapy temporarily in patients with evidence of moderate to severe proteinuria pending further evaluation, in patients with severe hypertension not controlled by medical management, or in patients with severe infusion reactions.¹ (See Cautions.)

Special Populations

No dosage adjustment required in geriatric patients.¹

Cautions for Bevacizumab

Contraindications

None.¹ ³

Warnings/Precautions

Warnings

Consider the usual cautions, precautions, and contraindications of any other antineoplastic agents included in the therapeutic regimen.³

GI Perforations

Potentially fatal GI perforation reported; generally manifested as abdominal pain, nausea, vomiting, constipation, and/or fever; usually occurs within the first 50 days following initiation of bevacizumab.¹ ³ ^a

GI perforation sometimes associated with or complicated by fistula formation (see Fistula Formation under Cautions) and/or intra-abdominal abscess.¹ ⁴ ^a

If GI perforation occurs, discontinue bevacizumab permanently.¹

Wound Healing Complications

Impaired wound healing, bleeding complications, and/or wound dehiscence, sometimes fatal, reported.¹ Discontinue bevacizumab in patients with wound healing complications requiring medical intervention.^a (See Boxed Warning.)

Do not initiate therapy until ≥28 days following major surgery and after surgical incision has fully healed.¹

Discontinue bevacizumab ≥28 days prior to elective surgery.¹ ^a Appropriate interval between discontinuance of bevacizumab and subsequent elective surgery not established, but consider long half-life of bevacizumab.¹ (See Half-life under Pharmacokinetics.) Manufacturer recommends resuming therapy only after surgical incision has fully healed.¹

Hemorrhage

Severe, sometimes fatal, hemorrhagic events (e.g., pulmonary hemorrhage, hemoptysis, hematemesis, epistaxis, severe GI hemorrhage, CNS hemorrhage, intracranial hemorrhage) reported.¹ (See Boxed Warning.)

Risk of severe pulmonary hemorrhage in patients with non-small cell lung cancer.^a Serious or fatal pulmonary hemorrhage reported in 31% of patients with squamous cell histology and in 4% of patients with non-squamous cell histology.^a

Risk of CNS hemorrhage in patients with CNS metastases.^a Intracranial hemorrhage reported in patients with glioblastoma.^a

Mild hemorrhagic events, most commonly grade 1 epistaxis, also reported.¹

Do not administer to patients with recent hemoptysis (≥½ teaspoon of red blood).¹ If severe hemorrhage (i.e., requiring medical intervention) occurs, discontinue therapy and manage aggressively.¹

Thromboembolism

Serious, sometimes fatal, arterial thromboembolic events (e.g., cerebral infarction, TIA, MI, angina) reported.¹ ⁷ ⁸ ¹⁶ ¹⁷ Increased risk in patients with a history of arterial thromboembolic events or patients ≥65 years of age.¹ ⁷ Weigh risks against benefits of therapy.¹⁷ Discontinue therapy permanently if severe arterial thromboembolic event occurs;¹ ⁷ safety of resuming therapy after resolution of an arterial thromboembolic event not studied.¹

Grade 3 or 4 venous thromboembolic events (e.g., DVT, intra-abdominal venous thrombosis) reported.¹ Increased risk of developing second thromboembolic event reported in patients with metastatic colorectal cancer receiving bevacizumab with chemotherapy despite use of full-dose warfarin therapy following an initial venous thromboembolic event.¹

Hypertension

Severe hypertension (grade 3 or 4) reported.¹ Complications include potentially fatal hypertensive encephalopathy and CNS hemorrhage.¹

Monitor BP every 2–3 weeks or more frequently if hypertension develops.¹ Hypertension may respond to antihypertensive therapy.¹ ⁶ Temporarily discontinue therapy in patients with severe hypertension not controlled with medical management.¹ If therapy is discontinued because of hypertension, monitor BP at regular intervals thereafter.¹ Discontinue therapy permanently if hypertensive crisis or hypertensive encephalopathy occurs.¹

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

RPLS (a brain-capillary leak syndrome) reported.¹ ²⁹ ³⁰ ³² May manifest with headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances; mild to severe hypertension also may occur.¹ ³² Manifestations occurred from 16 hours to 1 year after initiation of bevacizumab.¹ ³² Magnetic resonance imaging (MRI) is necessary to confirm diagnosis of RPLS.¹ ³²

Closely monitor and maintain strict control of BP during and following bevacizumab infusion.³⁰ If RPLS develops, discontinue bevacizumab and initiate treatment of hypertension as clinically indicated.¹ ³¹ ³² Symptoms usually lessen or resolve within days of drug discontinuance, but some patients have experienced ongoing neurologic sequelae.¹ ³² Risk of reinitiating bevacizumab in patients previously experiencing RPLS not known.¹ ³²

Neutropenia and Infection

Severe neutropenia, febrile neutropenia, and serious infection (including pneumonia, catheter infections, and wound infections), sometimes fatal, reported at higher incidence in patients receiving bevacizumab in combination with chemotherapy compared with those receiving chemotherapy alone.¹

Proteinuria

Increased incidence and severity of proteinuria reported.¹ Severity ranges from clinically silent to nephrotic syndrome.⁶ Proteinuria with findings of thrombotic microangiopathy on renal biopsy reported in patients receiving bevacizumab alone or in combination with other antineoplastic agents for various cancers.³⁷

Monitor patients for development or worsening of proteinuria with serial urinalysis.¹ Further assessment (e.g., 24-hour urine collection) recommended if ≥2+ urine dipstick reading occurs.^a Interrupt bevacizumab therapy for moderate proteinuria (≥2 g per 24 hours); resume therapy when proteinuria is <2 g per 24 hours.^a Safety of continuing or temporarily discontinuing therapy in patients with moderate to severe proteinuria not known.¹

Discontinue therapy in patients with nephrotic syndrome.¹ In clinical studies, proteinuria associated with nephrotic syndrome decreased in severity several months following discontinuance of bevacizumab in some patients but did not completely resolve.¹

Fistula Formation

GI tract fistula formation reported in patients with colorectal and other types of cancer (e.g., NSCLC) receiving bevacizumab.¹ ^g (See GI Perforations under Cautions.)

Non-GI fistula formation, sometimes fatal and usually occurring within first 6 months of treatment, reported.¹ Non-GI fistula sites include tracheo-esophageal, bronchopleural, biliary, vaginal, and bladder.¹ If fistula formation involving an internal organ occurs, discontinue bevacizumab permanently.¹

Infusion Reactions

Infusion reactions (e.g., hypertension, hypertensive crisis associated with neurologic manifestations, wheezing, oxygen desaturation, grade 3 hypersensitivity, chest pain, headache, rigor, diaphoresis) reported.¹

Infuse initial doses slowly, increasing rate of infusion as tolerated.¹ (See Rate of Administration under Dosage and Administration.)

If severe infusion reactions occur, interrupt infusion and administer appropriate medical therapy.¹ Adequate information on rechallenge not available.¹

Microangiopathic Hemolytic Anemia

Microangiopathic hemolytic anemia reported in patients with solid tumors receiving bevacizumab and sunitinib†;³⁵ ³⁶ cases were reversible within 3 weeks following discontinuance of both drugs without other interventions.³⁵ ³⁶ Use of bevacizumab in combination with sunitinib is not recommended.³⁵ ³⁶

Report cases of microangiopathic hemolytic anemia associated with bevacizumab therapy to the manufacturer or FDA.³⁵ ³⁶

Other Warnings/Precautions

Neutropenia and Infection

Severe neutropenia, febrile neutropenia, and serious infection (including pneumonia, catheter infections, and wound infections), sometimes fatal, reported.¹

Immunogenicity

Potential for immunogenicity.¹ Incidence of antibody formation not established.¹

CHF

CHF reported; higher risk in patients also receiving or who had previously received anthracyclines.¹

Safety of continuation or resumption of bevacizumab in patients who develop cardiac dysfunction not studied.¹

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether distributed into milk.¹ Discontinue nursing during treatment, taking into account the long half-life.¹ (See Half-life under Pharmacokinetics.)

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹ ³

Geriatric Use

No difference in overall survival relative to younger adults observed in patients receiving bevacizumab and chemotherapy for metastatic colorectal cancer.¹ ^a However, possible increased risk of asthenia, sepsis, deep thrombophlebitis, hypertension, hypotension, MI, CHF, diarrhea, constipation, anorexia, leukopenia, anemia, dehydration, hypokalemia, hyponatremia, nausea, vomiting, ileus, and fatigue.¹

Increased risk of proteinuria in patients ≥65 years of age receiving bevacizumab in combination with paclitaxel and carboplatin, compared with younger adults.¹ (See Proteinuria under Cautions.)

Insufficient experience in patients ≥65 years of age receiving bevacizumab in combination with paclitaxel for metastatic breast cancer to determine whether adverse effects differ from those in younger adults.¹

Possible increased incidence of arterial thromboembolic events, dyspepsia, GI hemorrhage, edema, epistaxis, increased cough, and voice alteration compared with younger adults.¹

Common Adverse Effects

Epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, exfoliative dermatitis.^a

Interactions for Bevacizumab

Specific Drugs

Drug	Interaction	Comments
Carboplatin	No effect on carboplatin exposure¹
Interferon alfa	No effect on interferon alfa exposure.¹ ^a
Irinotecan	No effect on pharmacokinetics of irinotecan or the active metabolite of irinotecan¹ ⁵ ^a
Paclitaxel	Possible decreased paclitaxel exposure after 4 treatment cycles of bevacizumab in combination with paclitaxel and carboplatin¹
Sunitinib	Possible microangiopathic hemolytic anemia³⁵ ³⁶ (see Microangiopathic Hemolytic Anemia under Cautions)	Use of bevacizumab in combination with sunitinib not recommended³⁵ ³⁶

Bevacizumab Pharmacokinetics

Absorption

Plasma Concentrations

Relationship between bevacizumab exposure and clinical outcome not studied.¹

Elimination

Metabolism

Metabolized by reticuloendothelial system.³

Elimination Route

Eliminated via reticuloendothelial system.³

Half-life

Approximately 20 days (range: 11–50 days).¹

Special Populations

Clearance varies by body weight, gender, and tumor burden.¹ Increased clearance observed in men and in patients with higher tumor burden; however, no evidence of reduced efficacy.¹

Stability

Storage

Parenteral

Injection Concentrate

2–8°C.¹ Do not freeze; protect from light.¹

Store diluted solution at 2–8°C for up to 8 hours.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

No incompatibilities with PVC or polyolefin bags.¹

Solution Compatibility

Compatible
Sodium chloride 0.9%
Incompatible
Dextrose solutions

Actions

Antineoplastic agent;¹ ³ ⁵ a recombinant humanized monoclonal IgG₁ antibody containing human framework regions and murine complementarity-determining regions.¹ ⁶

Binds to human vascular endothelial growth factor (VEGF) and prevents interaction of VEGF with its receptors (Flt-1, KDR) on the surface of endothelial cells.¹ This may result in inhibition of angiogenesis, thus reducing microvascular growth of tumors and inhibiting metastatic disease progression.¹ ² ³ ⁵

Advice to Patients

Importance of understanding potential risks associated with therapy, including severe hypertension, wound healing complications, and arterial thromboembolic events.¹ ^a

Importance of routine monitoring of BP; advise patients to inform clinician if BP is elevated.^a

Importance of immediately informing clinician if unusual bleeding, high fever, rigors, sudden worsening of neurological function, persistent or severe abdominal pain, severe constipation, or vomiting occurs.^a

Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed;¹ necessity for clinicians to advise women to avoid pregnancy during therapy and to use an effective method of contraception for ≥6 months after last dose of bevacizumab.³ Advise pregnant women of risk to the fetus and/or the potential risk for loss of the pregnancy.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease).¹

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Bevacizumab (Recombinant)
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, concentrate, for IV infusion	25 mg/mL (100 and 400 mg)	Avastin	Genentech

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 01/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Avastin 100MG/4ML Solution (GENENTECH): 4/$645.96 or 12/$1,850.05

Avastin 400MG/16ML Solution (GENENTECH): 16/$2,525.85 or 48/$7,374.16

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2012, Selected Revisions December 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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38. Saltz LB, Clarke S, Diaz-Rubio E et al. Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol. 2008; 26:2013-9. [PubMed 18421054]

39. Miles D, Chan A, Romieu G et al. Randomized, double-blind, placebo-controlled, phase III study of bevacizumab with docetaxel or docetaxel with placebo as first-line therapy for patients with locally recurrent or metastatic breast cancer (mBC): AVADO. Proc ASCO. 2008; Abstract LBA1011.

40. Escudier B, Pluzanska A, Koralewski P et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007; 370:2103-11.

41. Martin DF, Fine SL, protocol chairs. Comparison of age-related macular degeneration treatments trials: Lucentis-Avastin Trial (CATT). Last updated: 3/4/2008. National Eye Institute: Clinical Studies (database).

42. Scappaticci FA, Skillings JR, Holden SN et al. Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst. 2007; 99:1232-9. [PubMed 17686822]

43. Reidy DL, Chung KY, Timoney JP et al. Bevacizumab 5 mg/kg can be infused safely over 10 minutes. J Clin Oncol. 2007; 25:2691-5. [PubMed 17602073]

44. Genentech. Avastin (bevacizumab) prescribing information. South San Francisco, CA; 2008 Mar.

58. Food and Drug Administration. FDA drug safety communication: Avastin (bevacizumab): Process for removal of breast cancer indication begun. Rockville, MD; 2010 Dec 16. From FDA website.

59. Food and Drug Administration. Memorandum to the file BLA 125085 Avastin (bevacizumab): Regulatory decision to withdraw Avastin (bevacizumab) first-line metastatic breast cancer indication. Rockville, MD; 2010 Dec 15. From FDA website.

60. Woodcock J. Dear breast cancer community letter. Silver Spring, MD: Food and Drug Administration; 2010 Dec 16. From FDA website.

61. Food and Drug Administration. Avastin (bevacizumab) information. Rockville, MD; 2011 Jun 29. From FDA website.

64. Genentech. Avastin (bevacizumab) prescribing information. South San Francisco, CA; 2011 Feb.

a. Genentech. Avastin (bevacizumab) prescribing information. South San Francisco, CA; 2009 Jul.

d. Johnson DH, Fehrenbacher L, Novotny WF et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non–small-cell lung cancer. J Clin Oncol. 2004; 22:2184-91. [PubMed 15169807]

e. Genentech. Avastin dosing and administration in the first-line treatment of NSCLC. From Genentech website. Accessed 2007 Feb 7.

f. Genentech. Pivotal NSCLC trial overview. From Genentech website. Accessed 2007 Feb 7.

g. Barron H. Dear healthcare provider letter: important drug warning regarding Avastin (bevacizumab). South San Francisco, CA: Genentech, Inc; 2007 Apr. From FDA website.

h. Food and Drug Administration. Avastin (bevacizumab) [April 21, 2007: Genentech]. Medwatch alert. Rockville, MD; April 2007. From FDA website.

More Bevacizumab resources

Bevacizumab Side Effects (in more detail)
Bevacizumab Use in Pregnancy & Breastfeeding
Bevacizumab Drug Int

Robinul

Generic Name: glycopyrrolate (glye koe PIE roe late)

Brand Names: Cuvposa, Robinul, Robinul Forte

What is Robinul (glycopyrrolate)?

Glycopyrrolate reduces the secretions of certain organs in the body.

Glycopyrrolate helps to control conditions such as peptic ulcers that involve excessive stomach acid production.

Glycopyrrolate is also used to reduce drooling in children ages 3 to 16 who have certain medical conditions, such as cerebral palsy.

Glycopyrrolate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Robinul (glycopyrrolate)?

You should not use glycopyrrolate if you are allergic to it, or if you have bladder obstruction or other urination problems, a bowel obstruction called paralytic ileus, a blockage in your stomach or intestines, severe constipation, severe ulcerative colitis or toxic megacolon, glaucoma, myasthenia gravis, or if you also take potassium chloride.

Before you take glycopyrrolate, tell your doctor if you have kidney disease, heart disease, a heart rhythm disorder, a stomach disorder, a colostomy or ileostomy, a thyroid disorder, high blood pressure, vision problems, or numbness and tingling.

Take glycopyrrolate on an empty stomach, at least 1 hour before or 2 hours after a meal. This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of glycopyrrolate, such as dizziness and drowsiness. Avoid becoming overheated or dehydrated during exercise and in hot weather. Glycopyrrolate can decrease sweating and you may be more prone to heat stroke.

What should I discuss with my healthcare provider before taking Robinul (glycopyrrolate)?

You should not use glycopyrrolate if you are allergic to it, or if you have:

bladder obstruction or other urination problems;

a bowel obstruction called paralytic ileus;

a blockage in your digestive tract (stomach or intestines), severe constipation;

severe ulcerative colitis or toxic megacolon;

glaucoma;

myasthenia gravis; or

if you are also taking potassium chloride (Epiklor, K-Lor, K-Tab, Klor-Con, Micro-K, Rum-K, and others).

To make sure you can safely take glycopyrrolate, tell your doctor if you have any of these other conditions:

kidney disease;

heart disease or a heart rhythm disorder;

a stomach disorder such as hiatal hernia, reflux disease, or slow digestion;

a colostomy or ileostomy;

a thyroid disorder;

high blood pressure;

vision problems; or

a nerve disorder that causes numbness or tingling.

FDA pregnancy category C. It is not known whether glycopyrrolate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether glycopyrrolate 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. Glycopyrrolate should not be given to a child younger than 3 years old.

How should I take Robinul (glycopyrrolate)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take glycopyrrolate on an empty stomach, at least 1 hour before or 2 hours after a meal.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

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 weak or shallow breathing, feeling cold, jerky muscle movements, or seizure (convulsions).

What should I avoid while taking Robinul (glycopyrrolate)?

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of glycopyrrolate, such as dizziness and drowsiness. Avoid becoming overheated or dehydrated during exercise and in hot weather. Glycopyrrolate can decrease sweating and you may be more prone to heat stroke.

Robinul (glycopyrrolate) side effects

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

severe constipation, severe stomach pain and bloating;

diarrhea (especially if you have a colostomy or ileostomy);

feeling like you might pass out;

feeling very thirsty or hot, being unable to urinate, heavy sweating, weak pulse, or hot and dry skin; or

dry diapers, fussiness, or excessive crying in a child taking glycopyrrolate.

Less serious side effects may include:

dry mouth;

vomiting;

mild constipation;

stuffy nose, sinus pain; or

flushing (warmth, redness, or tingly feeling).

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 Robinul (glycopyrrolate)?

Many drugs can interact with glycopyrrolate. Below is just a partial list. Tell your doctor if you are using:

amantadine (Symmetrel);

atenolol (Tenormin, Tenoretic);

digoxin (Lanoxin, Lanoxicaps);

haloperidol (Haldol);

levodopa (Larodopa); or

metformin (Glucophage, Actoplus Met, Avandamet, Janumet, Kombiglyze, PrandiMet).

This list is not complete and other drugs may interact with glycopyrrolate. 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 Robinul resources

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

Robinul Prescribing Information (FDA)

Robinul Monograph (AHFS DI)

Robinul Advanced Consumer (Micromedex) - Includes Dosage Information

Robinul MedFacts Consumer Leaflet (Wolters Kluwer)

Glycopyrrolate Professional Patient Advice (Wolters Kluwer)

Cuvposa Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Cuvposa Prescribing Information (FDA)

Cuvposa Consumer Overview

Robinul Forte MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Robinul with other medications

Anesthesia
Peptic Ulcer

Where can I get more information?

Your pharmacist can provide more information about glycopyrrolate.

See also: Robinul side effects (in more detail)

Thursday, October 27, 2016

Doxylamine

Generic Name: doxylamine (dox IL a meen)

Brand Names: Aldex AN, Nytol Maximum Strength, Unisom

What is doxylamine?

Doxylamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Doxylamine is sometimes combined with other medicines to treat sneezing, itching, watery eyes, and runny nose caused by allergies or the common cold.

Doxylamine as a single drug (not part of a combination) is used as a short-term treatment for sleep problems (insomnia).

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

What is the most important information I should know about doxylamine?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Ask a doctor or pharmacist about taking this medication if you have glaucoma, kidney disease, an enlarged prostate, problems with urination, a stomach ulcer or obstruction, or a chronic lung disease such as bronchitis or emphysema.

If you miss a dose, take it as soon as you remember. It is best to take doxylamine only when you can devote several hours to sleep. If it is almost your normal waking hour, skip the missed dose and wait until you are ready for bed again. Do not use extra medicine to make up the missed dose.

There may be other drugs that can interact with doxylamine. 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.

Get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine.

What should I discuss with my health care provider before taking doxylamine?

Do not take this medication if you are allergic to doxylamine or other antihistamines.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

glaucoma;

kidney disease;

an enlarged prostate;

problems with urination;

stomach ulcer or digestive tract obstruction; or

bronchitis, emphysema or other chronic lung disease.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 12 years old without the advice of a doctor.

How should I take doxylamine?

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

The chewable tablet must be chewed thoroughly before you swallow it.

To treat insomnia, doxylamine is usually taken within 30 minutes of bedtime. Follow your doctor's instructions.

Talk with your doctor if your sleep problems do not improve after 2 weeks of treatment.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store doxylamine at room temperature away from moisture and heat.

See also: Doxylamine dosage (in more detail)

What happens if I miss a dose?

What happens if I overdose?

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

Overdose symptoms may include extreme drowsiness, loss of coordination, dry mouth, or seizure (convulsions).

What should I avoid while taking doxylamine?

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much antihistamine. Read the label of any other medicine you are using to see if it contains an antihistamine such as doxylamine, chlorpheniramine or diphenhydramine. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Avoid drinking alcohol while you are taking this medication. Alcohol can add to drowsiness caused by an antihistamine.

Doxylamine 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 any of these serious side effects:

fast, pounding, or uneven heartbeat;

confusion, hallucinations, unusual thoughts or behavior;

severe dizziness, anxiety, restless feeling, or nervousness;

urinating less than usual or not at all;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

Less serious side effects may include:

blurred vision;

dry mouth;

nausea, stomach pain, constipation;

dizziness, drowsiness;

problems with memory or concentration;

ringing in your ears;

restless or excitability (especially in children);

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.

Doxylamine Dosing Information

Usual Adult Dose for Nasal Congestion:

Doxylamine 5 mg oral tablet, chewable:
10 mg orally every 4 to 6 hours not to exceed 6 doses daily.

Usual Pediatric Dose for Nasal Congestion:

Doxylamine 5 mg oral tablet, chewable:
6 to 11 years old: 5 mg orally every 4 to 6 hours not to exceed 6 doses daily.
12 years or older: 10 mg orally every 4 to 6 hours not to exceed 6 doses daily.

What other drugs will affect doxylamine?

Cold or allergy medicine, narcotic pain medicine, other sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by doxylamine. Tell your doctor if you need to use any of these other medicines while you are taking doxylamine.

Tell your doctor about all other medications you use, especially:

a diuretic (water pill);

diphenhydramine (Benadryl) applied to the skin as a spray, cream, lotion, gel, or stick;

bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

medication to treat irritable bowel syndrome;

bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others); or

other antihistamines, or medicine to treat motion sickness.

This list is not complete and there may be other drugs that can interact with doxylamine. 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 doxylamine resources

Doxylamine Side Effects (in more detail)
Doxylamine Dosage
Doxylamine Use in Pregnancy & Breastfeeding
Drug Images
Doxylamine Drug Interactions
Doxylamine Support Group
8 Reviews for Doxylamine - Add your own review/rating

Doxylamine MedFacts Consumer Leaflet (Wolters Kluwer)

Aldex AN Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Doxylamine Succinate Monograph (AHFS DI)

Compare doxylamine with other medications

Allergies
Conjunctivitis, Allergic
Hay Fever
Insomnia
Nasal Congestion
Rhinorrhea
Upper Respiratory Tract Infection

Where can I get more information?

Your pharmacist can provide more information about doxylamine.

See also: doxylamine side effects (in more detail)

Declomycin

Pronunciation: DEM-e-kloe-SYE-kleen
Generic Name: Demeclocycline
Brand Name: Declomycin

Declomycin is used for:

Treating certain bacterial infections. It may be used in combination with other medicines to treat amoeba infections in the intestines. It may also be used for other conditions as determined by your doctor.

Declomycin is a tetracycline antibiotic. It works by interfering with the production of proteins needed by the bacteria to grow. Slowing the bacteria's growth allows the body's defense mechanisms (eg, white blood cells) to destroy the bacteria.

Do NOT use Declomycin if:

you are allergic to any ingredient in Declomycin or another tetracycline (eg, minocycline)

you are taking acitretin, isotretinoin, or a penicillin (eg, amoxicillin)

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

Before using Declomycin:

Some medical conditions may interact with Declomycin. 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 kidney or liver problems or diabetes

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

Acitretin, anticoagulants (eg, warfarin), digoxin, isotretinoin, methotrexate, or methoxyflurane because the risk of their side effects and toxic effects may be increased by Declomycin

Penicillins (eg, amoxicillin) or hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Declomycin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Declomycin 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 Declomycin:

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

Take Declomycin on an empty stomach at least 1 hour before or 2 hours after eating.

Do not take antacids containing aluminum, calcium, or magnesium; bismuth-containing products; iron; urinary alkalinizers (eg, sodium bicarbonate); zinc; or multivitamins with minerals within 2 hours before or 2 hours after taking Declomycin.

To clear up your infection completely, take Declomycin for the full course of treatment. Keep taking it even if you feel better in a few days.

Drink plenty of fluids with Declomycin to wash it down and avoid the risk of throat irritation.

To help prevent throat irritation, do not lie down immediately after taking Declomycin.

Do not use Declomycin if it is outdated or has been stored incorrectly.

If you miss a dose of Declomycin, 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 Declomycin.

Important safety information:

Declomycin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Declomycin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Be sure to use Declomycin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Declomycin only works against bacteria; it does not treat viral infections (eg, the common cold).

Long-term or repeated use of Declomycin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

Hormonal birth control (eg, birth control pills) may not work as well while you are using Declomycin. To prevent pregnancy, use an extra form of birth control (eg, condoms).

Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea, (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.

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

Do not use Declomycin for longer than prescribed without checking with your doctor.

Declomycin may interfere with certain lab test results. Be sure your doctor and laboratory personnel know you are using Declomycin.

Diabetes patients - Declomycin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Declomycin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Declomycin with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.

Declomycin is not recommended for use in CHILDREN younger than 8 years of age because permanent tooth discoloration (yellow-gray-brown) may occur.

PREGNANCY and BREAST-FEEDING: Declomycin has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Declomycin during pregnancy. Declomycin is found in breast milk. Do not breast-feed while taking Declomycin.

Possible side effects of Declomycin:

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:

Diarrhea; dizziness; headache; indigestion; loss of appetite; nausea; sensitivity to sunlight; throat irritation; vomiting.

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); bloody stools; blurred vision; dark urine; decreased or increased urination; fever, chills, or sore throat; increased thirst; muscle weakness; red, swollen, blistered, or peeling skin; severe diarrhea; severe or persistent headache; severe or persistent throat irritation; severe skin reaction to the sun; stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; vaginal irritation or discharge; vision changes; weakness; yellowing of the skin or eyes.

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: Declomycin 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.

Proper storage of Declomycin:

Store Declomycin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Declomycin out of the reach of children and away from pets.

General information:

If you have any questions about Declomycin, please talk with your doctor, pharmacist, or other health care provider.

Declomycin 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 Declomycin. 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

More Declomycin resources

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

Declomycin Monograph (AHFS DI)

Declomycin Concise Consumer Information (Cerner Multum)

Demeclocycline Prescribing Information (FDA)

Demeclocycline Professional Patient Advice (Wolters Kluwer)

Compare Declomycin with other medications

SIADH

DesOwen Lotion

Pronunciation: DES-oh-nide
Generic Name: Desonide
Brand Name: Examples include DesOwen and LoKara

DesOwen Lotion is used for:

Treating mild to moderate itching, redness, and swelling caused by certain skin conditions.

DesOwen Lotion is a topical corticosteroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation).

Do NOT use DesOwen Lotion if:

you are allergic to any ingredient in DesOwen Lotion

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

Before using DesOwen Lotion:

Some medical conditions may interact with DesOwen Lotion. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin

if you have measles, tuberculosis (TB), chicken pox, or shingles, a positive TB skin test, or if you have recently had a vaccination

if you are taking an oral corticosteroid (eg, prednisone)

Some MEDICINES MAY INTERACT with DesOwen Lotion. Because little, if any, of DesOwen Lotion is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if DesOwen Lotion 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 DesOwen Lotion:

Use DesOwen Lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Shake well before each use.

Apply a small amount of DesOwen Lotion to the affected area(s). Gently rub the medicine in until it is evenly distributed.

Wash your hands immediately after applying DesOwen Lotion, unless your hands are part of the treated area.

Do not cover the treated area(s) with bandages or other dressings unless advised to do so by your health care provider.

If you miss a dose of DesOwen Lotion, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use DesOwen Lotion.

Important safety information:

DesOwen Lotion is for external use only. Do not get it in your eyes, nose, or mouth. If you get it any of these areas, rinse right away with cool tap water.

Do NOT use more than the recommended dose or use for longer than 2 weeks without checking with your doctor.

If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.

Talk with your doctor before you use any other medicines or cleansers on your skin.

Do not apply DesOwen Lotion over large areas of the body, to open wounds, or to scraped, infected, or burned skin without first checking with your doctor.

Do not use DesOwen Lotion for other skin conditions at a later time.

Overuse of topical products may worsen your condition.

If DesOwen Lotion was prescribed to treat the diaper area, avoid using tight-fitting undergarments or plastic pants.

Check with your doctor before you receive any vaccine while you are using DesOwen Lotion.

DesOwen Lotion has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Tell your doctor or dentist that you take DesOwen Lotion before you receive any medical or dental care, emergency care, or surgery.

Contact your doctor if you have a cut or sore that does not heal.

Serious side effects may occur if too much of DesOwen Lotion is absorbed through the skin. This may be more likely to occur if you use DesOwen Lotion over a larger area of the body. It may also be more likely if you wrap or bandage the area after you apply DesOwen Lotion. The risk is greater in children. Do not use more than the prescribed dose. Contact your doctor right away if you develop unusual weight gain (especially in the face), muscle weakness, increased thirst or urination, confusion, unusual drowsiness, severe or persistent headache, or vision changes. Discuss any questions or concerns with your doctor.

DesOwen Lotion should be used with extreme caution in CHILDREN younger than 3 months old; safety and effectiveness in these children have not been confirmed.

Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use DesOwen Lotion.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using DesOwen Lotion while you are pregnant. It is not known if DesOwen Lotion is found in breast milk after topical use. If you are or will be breast-feeding while you use DesOwen Lotion, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of DesOwen Lotion:

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:

Mild, temporary stinging or burning when first applied.

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); acne-like rash; inflamed hair follicles; inflammation around the mouth; severe or persistent burning, irritation, redness, or swelling of the skin; thinning, softening, or discoloration of the skin.

See also: DesOwen 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 or other vision changes; muscle weakness; severe or persistent headache; symptoms of high blood sugar (eg, increased thirst or urination, confusion, unusual drowsiness); unusual weight gain, especially in the face.

Proper storage of DesOwen Lotion:

Store DesOwen Lotion between 36 and 86 degrees F (2 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep DesOwen Lotion out of the reach of children and away from pets.

General information:

If you have any questions about DesOwen Lotion, please talk with your doctor, pharmacist, or other health care provider.

DesOwen Lotion 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 DesOwen Lotion. 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

More DesOwen resources

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

Compare DesOwen with other medications

Atopic Dermatitis
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Blephamide

Generic Name: sulfacetamide and prednisolone ophthalmic (SUL fa SEET a mide and pred NIS oh lone off THAL mik)

Brand Names: Blephamide, Blephamide S.O.P., Ocu-Lone C

What is Blephamide (sulfacetamide and prednisolone ophthalmic)?

Sulfacetamide is an antibiotic. It is used to treat bacterial infections.

Prednisolone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Sulfacetamide and prednisolone ophthalmic is used to treat bacterial infections of the eyes.

Sulfacetamide and prednisolone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Blephamide (sulfacetamide and prednisolone ophthalmic)?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Who should not use Blephamide (sulfacetamide and prednisolone ophthalmic)?

Do not use sulfacetamide and prednisolone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

Do not use sulfacetamide and prednisolone ophthalmic if you have ever had an allergic reaction to a sulfa-based drug.

It is not known whether sulfacetamide and prednisolone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether sulfacetamide and prednisolone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I use Blephamide (sulfacetamide and prednisolone ophthalmic)?

Use sulfacetamide and prednisolone ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using your eyedrops or ointment.

To apply the eyedrops:

Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

To apply the ointment:

Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store sulfacetamide and prednisolone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using Blephamide (sulfacetamide and prednisolone ophthalmic)?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Use caution when driving, operating machinery, or performing other hazardous activities. Sulfacetamide and prednisolone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

Blephamide (sulfacetamide and prednisolone ophthalmic) side effects

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

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 Blephamide (sulfacetamide and prednisolone ophthalmic)?

Do not use this medication with other eyedrops that contain nitrates (e.g., silver nitrate).

Avoid other eye medications unless they are approved by your doctor.

Before using this medication, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others).

Drugs other than those listed here may also interact with sulfacetamide and prednisolone ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Blephamide resources

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

Blephamide Prescribing Information (FDA)

Blephamide Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Blephamide S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

Vasocidin Prescribing Information (FDA)

Vasocidin Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Blephamide with other medications

Blepharitis
Conjunctivitis, Bacterial
Keratitis
Keratoconjunctivitis
Uveitis

Where can I get more information?

Your pharmacist has additional information about sulfacetamide and prednisolone ophthalmic written for health professionals that you may read.

See also: Blephamide side effects (in more detail)