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Lamivudine, Zidovudine & Nevirapine Tablets

Composition: Lamivudine IP 150 mg + Zidovudine IP 300 mg + Nevirapine IP 200 mg per film-coated tablet

Usage: HIV-1 treatment under specialist supervision

Category: HIV Antiviral Drugs

Therapeutic category: Antiretroviral / Triple Fixed-Dose Combination

Manufacturer: Healthy Life Pharma Pvt. Ltd. (certification subject to verification)

Exporter: Healthy Inc (status subject to verification)

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Lamivudine, Zidovudine & Nevirapine Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter of this triple fixed-dose antiretroviral combination. Each film-coated tablet contains lamivudine 150 mg, zidovudine 300 mg and nevirapine 200 mg. The combination has been used in treatment of HIV-1 infection under specialist supervision.

Contemporary HIV guidelines often prefer newer antiretroviral regimens. Use of a nevirapine/zidovudine-containing combination depends on local approval, patient suitability and the current treatment protocol. Manufacturing capability, certification and tender availability should be confirmed directly.

2. Product Specifications

ProductComposition per film-coated tabletClassification
Lamivudine + Zidovudine + Nevirapine Tablets IPLamivudine IP 150 mg + Zidovudine IP 300 mg + Nevirapine IP 200 mg; excipients q.s.Main triple fixed-dose combination
Lamivudine Tablets IPLamivudine IP 100 mgSeparate single-ingredient product
Lamivudine Tablets IPLamivudine IP 150 mgSeparate single-ingredient product
Cirolam 150Lamivudine USP 150 mgSeparate branded single-ingredient product
LamuzyLamivudine IP 150 mg + Zidovudine IP 300 mgSeparate dual fixed-dose combination

Therapeutic class: Antiretroviral, two NRTIs plus one NNRTI. CAS: Lamivudine 134678-17-4; Zidovudine 30516-87-1; Nevirapine 129618-40-2. Shelf life and packaging: Subject to approved stability data and product registration.

3. Manufacturing Technology

Triple-component tablet manufacture requires validated mixing, granulation or direct compression, content-uniformity controls, film coating and stability testing. Each active ingredient must remain within its approved specifications. Specific use of wet granulation, solubilizers, coating materials or particular equipment must be supported by the actual manufacturing record.

Packaging selection, including high-barrier blisters or HDPE bottles, depends on approved stability studies and destination-market requirements.

4. Quality Assurance

Quality control should assess identity, assay, content uniformity, dissolution of all three active ingredients, related substances, microbiological requirements where applicable, and stability. Batch-specific certificates of analysis should support release. Claims of bioequivalence, WHO prequalification, or particular assay limits require documented evidence and cannot be inferred from the composition alone.

5. Pharmacology and Clinical Use

Lamivudine and zidovudine are nucleoside reverse transcriptase inhibitors (NRTIs) that interfere with viral DNA synthesis. Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that inhibits HIV-1 reverse transcriptase through a different binding mechanism.

Indication: Treatment of HIV-1 infection as an appropriately selected complete antiretroviral regimen. This triple combination is not an approved standalone hepatitis B treatment. HIV/HBV coinfection needs an HBV-active regimen selected by the clinician. The combination does not cure HIV.

6. Export and Regulatory Support

Potential B2B documentation includes CTD/ACTD dossiers, certificate of analysis, manufacturing licenses, free-sale certificates and other documents where actually available. WHO-GMP certification, COPP, WHO prequalification, regulatory approvals, shelf life, shipping arrangements and export capacity must be independently verified before publication or tender submission.

7. Frequently Asked Questions

Q: What does each triple-combination tablet contain?
A: Lamivudine 150 mg, zidovudine 300 mg and nevirapine 200 mg.

Q: Is Lamuzy the same product?
A: No. Lamuzy contains only lamivudine and zidovudine; it does not contain nevirapine.

Q: Can a patient start directly on the triple tablet?
A: Nevirapine-containing regimens may require a lead-in period and close monitoring; a full-dose fixed combination is not suitable for automatically initiating therapy. Follow the approved label and specialist advice.

Q: Is it a first-line HIV medicine everywhere?
A: No. Many modern guidelines prefer other regimens. Local guidance and individual clinical factors determine suitability.

8. Dosage and Administration

Use only as directed by an HIV specialist and the locally approved prescribing information. Historically, the full-strength triple combination has been used twice daily in eligible adults after appropriate nevirapine lead-in. Nevirapine initiation commonly requires 200 mg once daily for the first 14 days to reduce rash risk; this full-strength fixed combination must not be used to deliver an unsuitable lead-in dose. Dosing depends on clinical history, liver function, blood counts, weight, interactions and treatment guidelines. Do not start, change or interrupt treatment without clinical advice.

9. Side Effects and Precautions

Nevirapine: Serious and potentially fatal liver injury and severe skin reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis, can occur, particularly early in treatment. Rash with fever, blistering, mouth sores, jaundice or other systemic symptoms needs urgent medical assessment.

Zidovudine: Can cause anemia, neutropenia and muscle toxicity; blood-count monitoring is important. NRTI class: Rare lactic acidosis and severe hepatomegaly with steatosis have been reported.

HBV coinfection: Stopping lamivudine may cause hepatitis B flare. Evaluate drug interactions, pregnancy, hepatic disease and existing antiretroviral resistance before prescribing. Regular clinical and laboratory monitoring is essential.

10. Storage Instructions

Store in the original, tightly closed packaging, protected from excessive heat and moisture, according to the approved product label. Confirm the exact temperature and expiry period from approved stability data. Keep out of reach of children.