Daruvir 600 Mg Tablets

उत्पाद विवरण

1. Technical Specifications

2. Product Description

Daruvir-R Tablet is a fixed-dose combination of Darunavir (600 mg) and Ritonavir (100 mg).

• Darunavir is a protease inhibitor that prevents HIV protease enzyme from cleaving viral polyproteins, leading to production of immature, non-infectious viral particles.

• Ritonavir acts as a pharmacokinetic enhancer (booster) by inhibiting CYP3A4 metabolism, thereby increasing plasma concentration and efficacy of Darunavir.

It is indicated for the treatment of HIV-1 infection in adults and adolescents, usually in combination with other antiretroviral agents.

3. Product Highlights

4. Therapeutic Uses

• HIV-1 Infection (in combination with other antiretrovirals):

  • First-line therapy in treatment-experienced patients.

  • Option for treatment-nave patients depending on regimen chosen.

• Helps in reducing viral load and increasing CD4 cell counts, improving immune function.

5. Side Effects

Common:

• Nausea, vomiting, diarrhea

• Abdominal pain

• Headache, dizziness

• Rash, itching

• Fatigue

Serious / Severe:

• Severe skin reactions (Stevens-Johnson syndrome, TEN rare)

• Hepatotoxicity (jaundice, elevated liver enzymes)

• Hyperglycemia, insulin resistance

• Lipid abnormalities (high cholesterol, triglycerides)

• Pancreatitis (rare)

• Cardiac conduction abnormalities (PR interval prolongation)

6. Precautions

• Drug Interactions: Avoid concomitant use with drugs highly dependent on CYP3A4 (e.g., simvastatin, lovastatin, rifampicin, midazolam).

• Liver Function: Monitor regularly; contraindicated in severe hepatic impairment.

• Allergy: Contraindicated in patients with known hypersensitivity to sulfonamides (Darunavir has a sulfonamide moiety).

• Pregnancy & Breastfeeding: Use with caution; breastfeeding not recommended in HIV-positive mothers.

• Metabolic Monitoring: Monitor blood glucose and lipid profile during long-term therapy.

• Adherence: Must be taken consistently with food for optimal absorption and to prevent resistance.