Zidovudine Tablets IP/ USP

1. Product Introduction

Zidovudine (AZT) is a nucleoside reverse transcriptase inhibitor used as part of combination antiretroviral therapy for HIV-1 infection. The supplied product information describes 300 mg film-coated tablets in IP and USP variants, including the brand name Cirozy 300 for the USP version.

Healthy Life Pharma Pvt. Ltd. is named as manufacturer and Healthy Inc as exporter in the supplied brief. Site-specific manufacturing certifications and export arrangements require documentary confirmation.

2. Product Specifications

Dosage form: Film-coated tablet. Therapeutic class: Antiviral / Anti-HIV / NRTI. SKU: Zidovudine Tablets 300 mg.

The general marketing text also mentions 100 mg, BP compliance, 36-month shelf life and HDPE/blister packaging; these details are not confirmed for the two supplied 300 mg labels.

3. Manufacturing Technology

Manufacturing of zidovudine tablets requires validated dispensing, blending, compression and film-coating operations, with appropriate controls for cross-contamination, tablet uniformity and environmental conditions. Packaging should be selected using stability evidence.

Claims of dedicated ARV lines, specific coating materials, WHO-GMP status and factory location should be confirmed against current records rather than assumed from promotional descriptions.

4. Quality Assurance

• Identity and assay testing using validated analytical procedures.
• Content uniformity, dissolution and relevant tablet physical-quality tests.
• Related substances and degradation-product monitoring.
• Stability studies to establish expiry, storage conditions and packaging suitability.
• Batch release against the approved finished-product specification.

IP/USP designation in the supplied composition does not independently verify a released batch or full finished-product compliance.

5. Therapeutic Uses and Mechanism

Zidovudine is an NRTI that inhibits HIV reverse transcriptase after intracellular activation, helping suppress viral replication when used with other antiretroviral medicines.

• HIV-1 infection: used in an appropriate combination antiretroviral regimen.
• Prevention of perinatal HIV transmission: zidovudine may have a role in selected maternal or infant protocols under specialist guidance.
• Post-exposure prophylaxis: regimen selection follows current local guidance; zidovudine is not generally the preferred contemporary adult PEP option.

It does not cure HIV and must not be used as monotherapy for routine HIV treatment.

6. Export and Regulatory Support

For procurement, request the current manufacturing licence, applicable GMP certificate, approved product artwork, certificate of analysis, stability data and country-specific registration documentation.

CTD/ACTD, FSC, COPP, WHO-GMP status, Global Fund/PEPFAR eligibility, export destinations and FOB/CIF arrangements must be verified before publication as firm commitments.

7. Frequently Asked Questions

Q: Is zidovudine the same as AZT?
A: Yes. AZT is another name for zidovudine.

Q: What variants are listed?
A: Zidovudine IP 300 mg and Cirozy 300 / Zidovudine USP 300 mg, both film-coated.

Q: Can zidovudine be used alone for HIV?
A: No. HIV treatment requires a clinician-selected combination regimen.

Q: Does zidovudine need blood monitoring?
A: Yes. Clinicians monitor blood counts because anemia and neutropenia can occur.

8. Dosage and Administration

For adults receiving a zidovudine-containing regimen, 300 mg twice daily is a commonly used oral dose, but the prescribed regimen depends on the indication, renal function, clinical condition, concomitant medicines and local treatment guidelines. Pediatric, pregnancy and prevention protocols differ.

Use only on prescription as part of a clinician-selected regimen. Tablets may generally be taken with or without food; follow the approved pack insert. Do not stop or change antiretroviral therapy without medical advice.

9. Side Effects and Precautions

• Bone marrow suppression: anemia and neutropenia can be serious; baseline and follow-up complete blood counts are important.
• Other adverse effects may include nausea, headache, fatigue and muscle symptoms.
• Rare serious risks include lactic acidosis, severe hepatomegaly with steatosis and myopathy.
• Assess relevant drug interactions and adjust treatment for significant renal impairment as clinically indicated.
• Pregnancy and perinatal use require specialist evaluation; do not infer that this specific tablet is appropriate for all prevention protocols.

10. Storage Instructions

Keep in the original packaging and protect from excessive moisture and light as directed on the approved label. Confirm the temperature limit and shelf life against the product-specific stability data; the marketing description mentions below 30°C and 36 months, but these are not independently established for both 300 mg variants.

Keep out of reach of children.