Ribacee
Generic Name
Ribavirin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
ribacee 200 mg capsule | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Ribavirin is an antiviral medication used in combination with pegylated interferon alpha, or with direct-acting antivirals, for the treatment of chronic hepatitis C virus (HCV) infection. It is not effective as monotherapy for HCV.
Uses & Indications
Dosage
Adults
Adults: Typically 800 mg to 1200 mg orally daily, in two divided doses, depending on body weight and HCV genotype, in combination with pegylated interferon alpha or direct-acting antivirals. For patients weighing less than 75 kg, 1000 mg/day; for patients weighing 75 kg or more, 1200 mg/day.
Elderly
Elderly: No specific dose adjustment solely based on age. Dosage should be adjusted based on renal function if impaired.
Renal_impairment
Renal impairment: For creatinine clearance <50 mL/min, dosage must be significantly reduced or contraindicated. Consult prescribing information for specific guidelines.
How to Take
Administer orally with food to enhance absorption and reduce nausea.
Mechanism of Action
Ribavirin is a guanosine analogue that inhibits viral RNA synthesis and mRNA capping by interfering with RNA polymerase. Its exact mechanism of action against HCV is complex and not fully understood, but it is believed to involve multiple pathways, including inhibition of inosine monophosphate dehydrogenase (IMPDH) and direct inhibition of HCV RNA polymerase.
Pharmacokinetics
Onset
Viral load reduction typically observed within the first 4 weeks of treatment.
Excretion
Primarily excreted renally as unchanged drug and metabolites. Approximately 60-70% of a dose is excreted in urine and 10% in feces.
Half life
Plasma half-life is approximately 120-200 hours (5-8 days), with an intracellular half-life in red blood cells of 16-20 days.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations reached in 1-2 hours. Bioavailability is approximately 45-65%.
Metabolism
Metabolized by reversible phosphorylation and cleavage to 1,2,4-triazole-3-carboxamide. Not extensively metabolized by the cytochrome P450 system.
Side Effects
Contraindications
- Pregnancy (Category X - teratogenic and embryotoxic)
- Severe anemia or hemoglobinopathies
- History of significant cardiac disease
- Autoimmune hepatitis
- Severe renal impairment (CrCl <30 mL/min)
- Hypersensitivity to ribavirin
Drug Interactions
Didanosine
Concomitant use with didanosine is not recommended due to increased risk of mitochondrial toxicity, which can lead to lactic acidosis and pancreatitis.
Azathioprine
Increased risk of myelosuppression (e.g., severe neutropenia) when co-administered with azathioprine, especially in patients with renal impairment.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is limited experience with overdose. Management should involve symptomatic and supportive care. Hemodialysis is not an effective means of removing ribavirin from the blood.
Pregnancy & Lactation
Pregnancy Category X. Contraindicated in pregnant women and in male partners of women who are pregnant or planning to become pregnant. Women of childbearing potential and their male partners must use two reliable forms of contraception during treatment and for 6 months post-treatment. It is not known if ribavirin is excreted in human milk, but due to potential serious adverse reactions in nursing infants, breastfeeding is not recommended.
Side Effects
Contraindications
- Pregnancy (Category X - teratogenic and embryotoxic)
- Severe anemia or hemoglobinopathies
- History of significant cardiac disease
- Autoimmune hepatitis
- Severe renal impairment (CrCl <30 mL/min)
- Hypersensitivity to ribavirin
Drug Interactions
Didanosine
Concomitant use with didanosine is not recommended due to increased risk of mitochondrial toxicity, which can lead to lactic acidosis and pancreatitis.
Azathioprine
Increased risk of myelosuppression (e.g., severe neutropenia) when co-administered with azathioprine, especially in patients with renal impairment.
Storage
Store below 30°C in a dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
There is limited experience with overdose. Management should involve symptomatic and supportive care. Hemodialysis is not an effective means of removing ribavirin from the blood.
Pregnancy & Lactation
Pregnancy Category X. Contraindicated in pregnant women and in male partners of women who are pregnant or planning to become pregnant. Women of childbearing potential and their male partners must use two reliable forms of contraception during treatment and for 6 months post-treatment. It is not known if ribavirin is excreted in human milk, but due to potential serious adverse reactions in nursing infants, breastfeeding is not recommended.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Refer to the packaging for the exact expiry date.
Availability
Available in pharmacies and hospitals
Approval Status
FDA approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Numerous clinical trials have established the efficacy and safety of ribavirin in combination with interferon alpha and, more recently, with various direct-acting antivirals for chronic HCV infection. Studies often focus on sustained virologic response (SVR) rates.
Lab Monitoring
- Complete Blood Count (CBC) with differential (baseline, 2 weeks, 4 weeks, then monthly)
- Renal function (creatinine, eGFR)
- Liver function tests (ALT, AST, bilirubin)
- Thyroid stimulating hormone (TSH)
- Pregnancy tests for women of childbearing potential (prior to initiation, monthly during treatment, and for 6 months post-treatment)
Doctor Notes
- Always prescribe as part of a combination regimen for HCV, never as monotherapy.
- Strict adherence to contraception guidelines for both male and female patients is crucial due to teratogenicity.
- Close monitoring of CBC, renal, and liver function is required throughout treatment.
Patient Guidelines
- Take with food as directed by your doctor.
- Do not miss doses; complete the full course of therapy.
- Women and male partners must use effective contraception during and for 6 months after treatment.
- Report any severe side effects, especially difficulty breathing, chest pain, or worsening depression.
- Stay well-hydrated.
Missed Dose Advice
If a dose is missed, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not double doses.
Driving Precautions
This medication may cause fatigue, dizziness, or blurred vision. Patients should exercise caution when driving or operating machinery until they know how Ribacee affects them.
Lifestyle Advice
- Avoid alcohol consumption.
- Maintain a healthy diet and lifestyle.
- Discuss any pre-existing conditions or new symptoms with your doctor.
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