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Ribavirin (Rebetol)

Trade Name : REBETOL

Merck Sharp & Dohme Corp.

LIQUID

Strength 40 mg/mL

RIBAVIRIN Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ribavirin (Rebetol) which is also known as REBETOL and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 40 mg/mL per ml. Read more

Ribavirin (Rebetol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: EMBRYO-FETAL TOXICITY, HEMOLYTIC ANEMIA, and MONOTHERAPY NOT RECOMMENDED
  • See full prescribing information for complete boxed warning.
  • Significant teratogenic and embryocidal effects have been demonstrated in all animal species exposed to ribavirin. Therefore, REBETOL therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking REBETOL therapy. (, , , , )
  • The hemolytic anemia associated with REBETOL therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. (, , )
  • REBETOL monotherapy is not effective for the treatment of chronic hepatitis C. ()
  • REBETOL (ribavirin) in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease n
  • The following points should be considered when initiating REBETOL combination therapy with PegIntron or INTRON A:
  • REBETOL is a nucleoside analogue indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age or older with compensated liver disease. ()
  • u00a0
  • REBETOL is administered according to body weight. (, , )
  • Dose reduction or discontinuation is recommended in patients experiencing certain adverse reactions or renal dysfunction. (, , )
  • REBETOL Capsules 200 mg
  • REBETOL Oral Solution 40 mg per mL
  • REBETOL Capsules 200 mg ()
  • REBETOL Oral Solution 40 mg per mL ()
  • REBETOL combination therapy is contraindicated in:
  • Pregnancy and men whose female partners are pregnant (, , , )
  • Known hypersensitivity reactions such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin or any component of the product ()
  • Autoimmune hepatitis ()
  • Hemoglobinopathies ()
  • Creatinine clearance less than 50 mL/min (, )
  • Coadministration with didanosine (, )
  • Patients exhibiting the following conditions should be closely monitored and may require dose reduction or discontinuation of therapy:
  • The following serious adverse drug reactions are discussed in other sections of the labeling:
  • Hemolytic anemia occurred in more than 10% of adult patients receiving REBETOL/PegIntron or INTRON A combination therapy. ()
  • Most common adverse reactions (40% or greater) in adult patients receiving REBETOL/PegIntron or INTRON A combination therapy are injection site reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia and anxiety/emotional lability/irritability. () Most common adverse reactions (greater than 25%) in pediatric patients receiving REBETOL/PegIntron therapy are: pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, and vomiting. ()
  • Nucleoside analogues: Closely monitor for toxicities. Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities. ()
  • No data
  • Pediatrics: Safety and efficacy in patients less than 3 years old have not been established. ()
  • Organ transplant recipients: Safety and efficacy not studied. ()
  • Co-infected patients: Safety and efficacy with HIV or HBV co-infection have not been established. ()
  • There is limited experience with overdosage. Acute ingestion of up to 20 g of REBETOL capsules, INTRON A ingestion of up to 120 million units, and subcutaneous doses of INTRON A up to 10 times the recommended doses have been reported. Primary effects that have been observed are increased incidence and severity of the adverse reactions related to the therapeutic use of INTRON A and REBETOL. However, hepatic enzyme abnormalities, renal failure, hemorrhage, and myocardial infarction have been reported with administration of single subcutaneous doses of INTRON A that exceed dosing recommendations.
  • There is no specific antidote for INTRON A or REBETOL overdose, and hemodialysis and peritoneal dialysis are not effective for treatment of overdose of these agents.
  • REBETOL (ribavirin), is a synthetic nucleoside analogue (purine analogue). The chemical name of ribavirin is 1-u03b2-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxamide and has the following structural formula (see ).
  • Ribavirin is a white, crystalline powder. It is freely soluble in water and slightly soluble in anhydrous alcohol. The empirical formula is CHNO and the molecular weight is 244.21.
  • REBETOL capsules consist of a white powder in a white, opaque, gelatin capsule. Each capsule contains 200 mg ribavirin and the inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.
  • REBETOL oral solution is a clear, colorless to pale or light-yellow bubble gum-flavored liquid. Each milliliter of the solution contains 40 mg of ribavirin and the inactive ingredients sucrose, glycerin, sorbitol, propylene glycol, sodium citrate, citric acid, sodium benzoate, natural and artificial flavor for bubble gum #15864, and water.
  • No data
  • No data
  • Clinical Study 1 evaluated PegIntron monotherapy. See PegIntron labeling for information about this trial.
  • REBETOL 200 mg Capsules are white, opaque capsules with REBETOL, 200 mg, and the Schering Corporation logo imprinted on the capsule shell; the capsules are packaged in a bottle containing 56 capsules (NDC 0085-1351-05), 70 capsules (NDC 0085-1385-07), and 84 capsules (NDC 0085-1194-03). The bottle of REBETOL Capsules should be stored at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].
  • REBETOL Oral Solution 40 mg per mL is a clear, colorless to pale or light-yellow bubble gum-flavored liquid and it is packaged in 4-oz amber glass bottles (100 mL/bottle) with child-resistant closures (NDC 0085-1318-01). REBETOL Oral Solution should be stored between 2-8u00b0C (36-46u00b0F) or at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • REBETOL Oral Solution manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofn n Whitehouse Station, NJ 08889, USA
  • Manufactured by:Famar Montru00e9al Inc.Pointe-Claire, Quebec H9R 1B4, Canada
  • REBETOL Capsules manufactured by:Merck Sharp & Dohme Corp., a subsidiary ofn n Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • Copyright u00a9 2003-2020 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • Trademarks depicted herein are the property of their respective owners.
  • uspi-mk8908-mtl-2001r034
  • No data
  • PRINCIPAL DISPLAY PANEL - 56 Capsule Label
  • NDCn- 1351
  • REBETOLn (Ribavirin USP)n- 200 mg Capsules
  • Rx only
  • Each capsule contains:
  • 56 capsules
  • ATTENTION PHARMACIST:Each patient is required toreceive a Medication Guide.
  • PRINCIPAL DISPLAY PANEL - 70 Capsule Label
  • NDCn- 1385
  • REBETOLn (Ribavirin USP)n- 200 mg Capsules
  • Rx only
  • Each capsule contains:
  • 70 capsules
  • ATTENTION PHARMACIST:Each patient is required toreceive a Medication Guide.
  • PRINCIPAL DISPLAY PANEL - 84 Capsule Label
  • NDCn- 1194
  • REBETOLn (Ribavirin USP)n- 200 mg Capsules
  • Rx only
  • Each capsule contains:
  • 84 capsules
  • ATTENTION PHARMACIST:Each patient is required toreceive a Medication Guide.
  • NDC 0085-1318-01
  • 100 mL
  • REBETOLn- (Ribavirin USP)n- Oral Solution
  • 40mg
  • ATTENTION PHARMACIST:Must be dispensed in originalpackaging with the enclosedMedication Guide.
  • Rx only
  • BUBBLE GUMFLAVOR

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