1. Product Description
Brand Name: Fabiflu 400mg
Generic Name: Favipiravir
Manufacturer: Glenmark Pharmaceuticals (India)
Dosage Form: Film-coated tablets
Packaging: Blister strips (varies by pack size)
Approval Status: Emergency use authorization for COVID-19 in India
2. Composition
Component | Details |
---|---|
Active Ingredient | Favipiravir 400mg |
Inactive Ingredients | Microcrystalline cellulose, Povidone, Croscarmellose sodium, Magnesium stearate, Film coating agents |
3. Therapeutic Uses
Primary Indication:
-
Treatment of mild to moderate COVID-19 in adults (as per emergency approvals)
Mechanism of Action:
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Inhibits RNA-dependent RNA polymerase (RdRp), blocking viral replication of SARS-CoV-2 and other RNA viruses.
Recommended For:
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Patients with SpO₂ ≥ 94% (not for severe/critical COVID-19)
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Early-stage infection (within 3-5 days of symptom onset)
4. Dosage & Administration
Standard COVID-19 Treatment Course:
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Day 1 (Loading Dose): 1800mg (4.5 tablets of 400mg) twice daily
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Days 2-10 (Maintenance): 800mg (2 tablets of 400mg) twice daily
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Total Duration: 10-14 days (or as prescribed)
Administration Guidelines:
✔ Swallow whole with water (do not crush/chew)
✔ Can be taken with or without food
✔ Maintain consistent 12-hour intervals between doses
5. Contraindications
❌ Pregnancy (teratogenic risk – causes fetal abnormalities)
❌ Severe liver/kidney impairment
❌ History of gout or hyperuricemia (may increase uric acid)
❌ Hypersensitivity to favipiravir
6. Side Effects
Common | Less Common | Serious (Seek Medical Help) |
---|---|---|
Nausea | Diarrhea | Severe liver damage (jaundice) |
Headache | Elevated uric acid | Allergic reactions (rash, swelling) |
Stomach pain | Increased ALT/AST (LFT abnormalities) | Neuropsychiatric symptoms (hallucinations) |
7. Storage Conditions
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Temperature: Below 30°C
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Humidity: Keep in a dry place
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Packaging: Retain in original blister strips until use
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Shelf Life: Typically 24 months (check packaging)
Disposal:
-
Do not flush. Return unused tablets to pharmacies for safe disposal.
8. Drug Interactions
⚠ Pyrazinamide/Theophylline: May alter drug levels
⚠ Repaglinide: Potential hypoglycemia risk
⚠ Alcohol: May worsen liver effects
9. Special Precautions
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Pregnancy Test Required before prescribing to women of childbearing age.
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Contraception Mandatory during and 1 week post-treatment.
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Monitoring Needed:
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Liver function tests (LFTs)
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Uric acid levels
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Clinical symptom progression
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10. Manufacturer & Regulatory Notes
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Approved Under: Emergency use in India, Russia, Japan (as Avigan)
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Not FDA-Approved for COVID-19 in the USA
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Prescription-Only – Self-medication is unsafe.
Key Takeaways
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Fabiflu 400mg is an antiviral for early COVID-19 management.
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Strictly avoid in pregnancy (risk category: X).
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Early initiation (within 72 hours of symptoms) improves outcomes.
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