Chrocee Capsule

Ribavirin 200mg

Composition
Chrocee® is a guanosine (ribonucleic) analog used to stop viral RNA synthesis and viral mRNA capping, thus, it is a nucleoside inhibitor. Chrocee® is a prodrug, which when metabolized resembles purine RNA nucleotides. In this form it interferes with RNA metabolism required for viral replication.


Indications
Chrocee® in combination with peginterferon alfa-2a is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

Dosage and administration
Adult dose:

Hepatitis C Virus Genotype Dose of Peginterferon alfa-2a Dose of Chrocee® Duration
Genotype 1, 4 180 mcg <75 kg = 1000 mg 48 weeks
≥75 kg = 1200 mg 48 weeks
Genotype 2, 3 180 mcg 800 mg 24 weeks

 

Pediatric dose:

Body Weight (kg) Chrocee® Daily Dose* Number of capsules
23 –33 400 mg/day 1 x 200 mg capsule A.M.
1 x 200 mg capsule P.M.
34 – 46 600 mg/day

1 x 200 mg capsule A.M.
2 x 200 mg capsule P.M.

47 – 59 800 mg/day

2 x 200 mg capsule A.M.
2 x 200 mg capsule P.M.

60 – 74 1000 mg/day

2 x 200 mg capsule A.M.
3 x 200 mg capsule P.M.

≥75 1200 mg/day

3 x 200 mg capsule A.M.
3 x 200 mg capsule P.M.

 

Use in pregnancy
Chrocee® may cause birth defects and/or death of the exposed fetus. Ribavirin has demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of Ribavirin. Ribavirin treatment should not be started until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.

Side effects
The most common adverse reactions (frequency greater than 40%) in adults receiving combination therapy are fatigue/asthenia, pyrexia, myalgia, and
headache.


Pharmacokinetics
Absorption: The pharmacokinetic properties of Sofomax® and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration of Sofomax®, it was absorbed with a peak plasma concentration observed at ~0.5–2 hour post-dose, regardless of dose level.

Precautions
Renal impairment patients: Dose should be reduced in patients with creatinine clearance less than or equal to 50 mL/min


Drug interactions
Nucleoside analogues: Closely monitor for toxicities. Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue Interferon, Ribavirin or both with orsening toxicities.
Azathioprine: Concomitant use of Azathioprine with Ribavirin has been reported to induce severe pancytopenia and may increase the risk
Azathioprine-related myelotoxicity.

Pharmaceutical precautione
Store in a cool (below 30° C) and dry place. Protect from light.

Presentation
Chrocee® 200 mg capsule: Each capsule contains Ribavirin BP 200 mg.

Package quantities
Chrocee® 200 mg capsule: Carton of 20 capsules in blister pack.