DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Ribavirin (Ribavirin) - Indications and Dosage



Ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).


CHC Monoinfection

The recommended dose of ribavirin tablet is provided in Table 5. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

The daily dose of ribavirin tablet is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 5).

In the pivotal clinical trials, patients were instructed to take ribavirin tablets with food; therefore, patients are advised to take ribavirin tablets with food.

Table 5 Peginterferon alfa-2a and Ribavirin Tablets Dosing Recommendations


Peginterferon alfa-2a Dose

Ribavirin Tablets Dose


Genotypes non-1 showed no increased response to treatment beyond 24 weeks (see Table 2). Data on genotypes 5 and 6 are insufficient for dosing recommendations.

Genotype 1, 4 180 mcg <75 kg = 1000 mg 
≥75 kg = 1200 mg
48 weeks 
48 weeks
Genotype 2, 3 180 mcg 800 mg 24 weeks

CHC with HIV Coinfection

The recommended dose for hepatitis C in HCV/HIV coinfected patients is peginterferon alfa-2a 180 mcg sc once weekly and ribavirin tablets 800 mg po daily for a total of 48 weeks, regardless of genotype.

Dose Modifications

If severe adverse reactions or laboratory abnormalities develop during combination ribavirin tablets/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, ribavirin tablets/peginterferon alfa-2a therapy should be discontinued.

Ribavirin tablets should be administered with caution to patients with pre-existing cardiac disease (see Table 6). Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped (see WARNINGS).

Table 6 Ribavirin Tablets Dosage Modification Guidelines

Laboratory Values

Reduce Only Ribavirin 
Tablets Dose to 600 mg/day 1  

Discontinue Ribavirin 
Tablets if:

Hemoglobin in patients with 
no cardiac disease
<10 g/dL <8.5 g/dL
Hemoglobin in patients with 
history of stable cardiac 
≥2 g/dL decrease in
 hemoglobin during any 4
 week period treatment
<12 g/dL despite 4 weeks at 
reduced dose

1 One 200 mg tablet in the morning and two 200 mg tablets in the evening.

Once ribavirin tablet has been withheld due to either a laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin tablets at 600 mg daily and further increase the dose to 800 mg daily depending upon the physician's judgment. However, it is not recommended that ribavirin tablets be increased to its original assigned dose (1000 mg to 1200 mg).

Renal Impairment

Ribavirin tablets should not be used in patients with creatinine clearance <50 mL/min (see WARNINGS and CLINICAL PHARMACOLOGY: Special Populations).


Ribavirin Tablets, 200 mg are light pink to pink, round, biconvex, beveled, film-coated tablets debossed with the logo of ‘ZC19’ on one side, other side plain.

Ribavirin Tablets, 400 mg are light pink to pink, capsule shaped, biconvex, film-coated tablets debossed with 'ZD' and '07' on one side and plain on other side.

Ribavirin Tablets, 500 mg are light pink to pink, modified capsule shaped, biconvex, film-coated tablets debossed with 'ZC56' on one side and plain on the other side.

Ribavirin Tablets, 600 mg are light pink to pink, modified capsule shaped, biconvex, film-coated tablets debossed with 'ZD' and '08' on one side and plain on other side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0782-1 200 mg 30 Tablets in a Blister Pack LIGHT PINK TO PINK 68382-260

Storage Conditions

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Keep bottle tightly closed.

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017