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Lamivudine and Zidovudine Tablets original product packshot

Lamivudine & Zidovudine Tablets

Brand: Lamuzy Tablets

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

Usage: HIV-1 infection, in combination with other antiretroviral medicines

Therapeutic category: Antiretroviral / Anti-HIV (NRTI)

Manufacturer: Healthy Life Pharma Pvt. Ltd.

Exporter: Healthy Inc

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 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 Lamivudine and Zidovudine Tablets. This fixed-dose combination contains two nucleoside reverse transcriptase inhibitors (NRTIs) used as part of combination antiretroviral therapy for HIV-1 infection.

Lamivudine and zidovudine suppress viral replication but do not cure HIV. A complete regimen must include other appropriate antiretroviral agents selected by a qualified clinician. The suitability of zidovudine-containing regimens depends on current treatment guidelines and patient factors.

2. Product Specifications

Product / BrandComposition per tabletType
Lamuzy – Lamivudine and Zidovudine Tablets IPLamivudine IP 150 mg + Zidovudine IP 300 mgFilm-coated fixed-dose combination
Lamivudine Tablets IPLamivudine IP 100 mgFilm-coated; separate single-ingredient product
Lamivudine Tablets IPLamivudine IP 150 mgFilm-coated; separate single-ingredient product
Cirolam 150 – Lamivudine Tablets USPLamivudine USP 150 mgFilm-coated; separate single-ingredient product
Lamivudine + Zidovudine + Nevirapine Tablets IPLamivudine IP 150 mg + Zidovudine IP 300 mg + Nevirapine IP 200 mgFilm-coated; separate triple combination

Therapeutic class: Antiretroviral / NRTI combination. CAS: Lamivudine 134678-17-4; Zidovudine 30516-87-1. Packaging and shelf life: As per approved product artwork, stability data and registration dossier.

3. Manufacturing Technology

Production of fixed-dose antiretroviral tablets requires controlled blending, tablet compression, film coating and validated manufacturing processes. The process must demonstrate uniform distribution of both active ingredients and suitable stability. Specific coating systems, excipients and manufacturing equipment should be confirmed against the actual batch manufacturing record.

Export pack selection may include high-barrier blisters or suitable HDPE containers, subject to stability studies and destination-market requirements.

4. Quality Assurance

Product release testing should follow the applicable approved pharmacopoeial monograph and specifications, including identification, assay of both ingredients, content uniformity, dissolution, related substances and stability testing. A certificate of analysis should support each released batch. Bioequivalence must not be claimed unless demonstrated through appropriate studies.

5. Pharmacology and Clinical Use

Lamivudine and zidovudine are NRTIs. After intracellular phosphorylation, they inhibit HIV reverse transcriptase and terminate viral DNA synthesis.

HIV-1: The two-drug combination is used with other antiretroviral medicines, not alone as a complete HIV regimen. Zidovudine-containing combinations are not the preferred first-line option for many patients under contemporary guidelines.

Hepatitis B: Lamivudine also has anti-HBV activity, but this lamivudine/zidovudine fixed-dose combination is not a standard treatment for hepatitis B alone. In HIV/HBV coinfection, therapy must adequately treat both infections to avoid resistance and HBV flare.

6. Export and Regulatory Support

Potential B2B support may include CTD/ACTD dossiers, certificates of analysis, applicable manufacturing licenses, free-sale certificates or other documents where issued and available. WHO-GMP status, COPP, destination-market approval, supply capacity and export terms should be verified before making commercial or regulatory representations.

7. Frequently Asked Questions

Q: What is the Lamuzy composition?
A: Each film-coated tablet contains Lamivudine IP 150 mg and Zidovudine IP 300 mg.

Q: Is the triple combination the same product?
A: No. The formulation containing Nevirapine 200 mg is a distinct three-drug product and should have its own approved label.

Q: Is this medicine for hepatitis B?
A: This fixed-dose combination is principally an HIV antiretroviral product. Hepatitis B treatment requires a separate clinician-directed assessment.

Q: Can treatment be stopped when symptoms improve?
A: No. Antiretroviral treatment must be taken consistently as prescribed; interruptions can cause viral rebound and resistance.

8. Dosage and Administration

The appropriate dose and regimen depend on the approved product label, body weight, blood counts, renal function and other medicines. For eligible adults and adolescents, the 150 mg/300 mg fixed-dose tablet has historically been prescribed twice daily with additional antiretroviral agents; this is not a universal instruction. Dose adjustment may require separate components rather than the fixed-dose tablet. Take only as prescribed; do not self-treat HIV or hepatitis B.

9. Side Effects and Precautions

Important risks: Zidovudine can cause serious anemia, neutropenia and myopathy. NRTIs can rarely cause lactic acidosis and severe hepatomegaly with steatosis. Nausea, headache and fatigue may occur. Patients require appropriate blood-count and clinical monitoring.

HIV/HBV coinfection: Stopping lamivudine can precipitate a serious hepatitis B flare. Clinicians should assess HBV status and use an appropriate HBV-active regimen.

Drug interactions: Review other antiretrovirals and medicines that may increase bone marrow toxicity. Pregnancy, pediatric use, renal impairment and liver disease require individualized clinical evaluation.

10. Storage Instructions

Store according to the approved label, protected from moisture and excessive heat, in the original packaging. Confirm the precise storage temperature and shelf life using approved stability data. Keep out of reach of children.