Ribavirin is a nucleoside analog antiviral sold in the U.S. under 4 brand and generic names, for human adenovirus infections, west nile fever and respiratory syncytial virus infections. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Copegus (application NDA021511). Other ribavirin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Ribavirin tablets should be taken with food. Ribavirin tablets should be given in combination with PEGASYS ® ; it is important to note that ribavirin tablets should never be given as monotherapy. See PEGASYS ® Package Insert for all instructions regarding PEGASYS ® dosing and administration. CHC: Ribavirin tablets are administered according to body weight and genotype (2.1) CHC with HIV coinfection: 800 mg by mouth daily for a total of 48 weeks, regardless of genotype (2.2) Dose reduction or discontinuation is recommended in patients experiencing certain adverse reactions or renal impairment (2.3 , 2.4) 2.1 Chronic Hepatitis C Monoinfection Adult Patients The recommended dose of ribavirin tablets is provided in Table 1 . The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks. The daily dose of ribavirin tablets 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 1 ). Table 1 PEGASYS ® and Ribavirin Tablets Dosing Recommendations Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10 ). Data on genotypes 5 and 6 are insufficient for dosing recommendations. * See PEGASYS ® Package Insert for…
PEGASYS ® in combination with ribavirin causes a broad variety of serious adverse reactions [see Boxed Warning and Warnings and Precautions (5) ] . The most common serious or life-threatening adverse reactions induced or aggravated by ribavirin/PEGASYS ® include depression, suicide, relapse of drug abuse/overdose, and bacterial infections each occurring at a frequency of less than 1%. Hepatic decompensation occurred in 2% (10/574) CHC/HIV patients [see Warnings and Precautions (5.3) ] . The most common adverse reactions (frequency greater than 40%) in adults receiving combination therapy are fatigue/asthenia, pyrexia, myalgia, and headache. (6.1) The most common adverse reactions in pediatric subjects were similar to those seen in adults. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adult Patients In the pivotal registration trials NV15801 and NV15942, 886 patients received ribavirin for 48 weeks at doses of 1000/1200 mg based on body weight. In these…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | — | — | View → | |
| 2 | 64/100 | Prescription | Capsule | — | — | View → |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| E;81 | 200 mg | white | capsule | — |
| F;10 | 200 mg | pink | capsule | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Ribavirin tablets are contraindicated in: Women who are pregnant. Ribavirin tablets may cause fetal harm when administered to a pregnant woman. Ribavirin tablets are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.1) , Use in Specific Populations (8.1) , and Patient Counseling Information (17) ] . Men whose female partners are pregnant. Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials [see Drug Interactions (7.1) ] . Ribavirin tablets and PEGASYS ® combination therapy are contraindicated in patients with: Autoimmune hepatitis. Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before treatment [see Warnings and Precautions (5.3) ] . Hepatic decompensation (Child-Pugh score greater than or equal to 6) in cirrhotic CHC patients coinfected with HIV before treatment [see Warnings and Precautions (5.3) ] . Pregnant women and men whose female partners are pregnant (4 , 5.1 , 8.1 )…
Results from a pharmacokinetic sub-study demonstrated no pharmacokinetic interaction between PEGASYS ® (peginterferon alfa-2a) and ribavirin. Nucleoside analogues: Closely monitor for toxicities. Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities (7.1) Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity (7.3) 7.1 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine, and zidovudine. However, no pharmacokinetic (e.g., plasma concentrations or intracellular triphosphorylated active metabolite concentrations) or pharmacodynamic (e.g., loss of HIV/HCV virologic suppression) interaction was observed when ribavirin and lamivudine (n=18), stavudine (n=10), or zidovudine (n=6) were coadministered as part of a multi-drug regimen to HCV/HIV coinfected patients. In Study NR15961 among the CHC/HIV coinfected cirrhotic patients receiving NRTIs, cases of hepatic decompensation (some fatal) were observed [see Warnings and Precautions (5.3) ] . Patients receiving PEGASYS ® /ribavirin and NRTIs should be closely monitored for treatment-associated toxicities. Physicians should refer to prescribing…
| 3 | Not yet rated | Prescription | Tablet | — | — | View → |
| 4 | Not yet rated | Prescription | Solution | — | — | View → |