Description

Stavudine Capsules

Healthy Inc is a specialized global supplier and exporter of essential antiretroviral (ARV) therapeutics. We provide high-purity Stavudine Capsules (30 mg / 40 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Nucleoside Reverse Transcriptase Inhibitor (NRTI)” is a specialized, targeted export to infectious disease hospitals, legacy HIV/AIDS treatment centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical salvage intervention in combination antiretroviral therapy (cART) for patients exhibiting severe intolerance to first-line regimens.

Product Overview

This formulation contains Stavudine (d4T), a synthetic thymidine nucleoside analogue with potent activity against the Human Immunodeficiency Virus (HIV-1).

The “Viral DNA Chain Terminator” Specialist:

• Mechanism (Reverse Transcriptase Inhibition): Once absorbed, Stavudine enters the infected CD4 cell and is phosphorylated by cellular kinases into its active metabolite, stavudine triphosphate. This active form aggressively competes with the natural substrate (thymidine triphosphate) for binding to the HIV-1 reverse transcriptase enzyme. When incorporated into the growing viral DNA strand, it lacks the 3′-OH group necessary for DNA elongation, causing immediate chain termination and halting viral replication.
• Legacy & Salvage Role: While highly effective at suppressing viral load, its profound mitochondrial toxicity profile has relegated it to a second-line or salvage therapy. It is utilized exclusively when modern NRTI backbones (like Tenofovir Disoproxil Fumarate or Zidovudine) have failed due to specific viral resistance mutations or severe patient intolerance.
• High CNS Penetration: Unlike some modern ARVs, Stavudine crosses the blood-brain barrier effectively, achieving cerebrospinal fluid (CSF) concentrations comparable to plasma levels, which is clinically valuable in treating HIV-associated encephalopathy.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in highly secure, moisture-resistant high-density polyethylene (HDPE) bottles or Alu-Alu blister strips.

*Pack Sizes: 60-Capsule HDPE Bottles (the global standard for 30-day BID ARV dispensing) or 10×10 Alu-Alu Blisters.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and ARV Tender Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Assay Precision & Stability: Because ARV resistance develops rapidly if plasma levels drop, our manufacturing process utilizes advanced geometric blending to guarantee absolute content uniformity across every batch. Specialized packaging environments strictly control humidity to prevent API degradation over the 24-month shelf life.
• Pharmacovigilance Compliance: Manufactured strictly under international guidelines for legacy antiretrovirals, guaranteeing zero cross-contamination and the highest purity profile to avoid exacerbating the drug’s inherent mitochondrial toxicities.

Therapeutic Indications (Human Use)

Indicated for the treatment of HIV-1 infection:

• Combination Antiretroviral Therapy (cART): Must be used strictly in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients who have failed or exhibit severe toxicity to modern first-line NRTI backbones.

Dosage & Administration

Recommended Dosage (Strictly as per Infectious Disease Specialist):

• Administration: Taken orally, every 12 hours (twice daily), with or without food.
• Weight-Based Dosing (CRITICAL):
  – Adults weighing ≥ 60 kg: 40 mg every 12 hours.
  – Adults weighing < 60 kg: 30 mg every 12 hours.
• Renal Impairment: Because Stavudine is excreted primarily unchanged by the kidneys, the dosage and frequency must be drastically reduced in patients with impaired renal function (creatinine clearance < 50 mL/min).

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Lactic Acidosis & Severe Hepatomegaly): Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination. Female gender, obesity, and prolonged nucleoside exposure increase this risk.
• BLACK BOX WARNING (Fatal Pancreatitis): Fatal and nonfatal pancreatitis have occurred during therapy. Stavudine must be suspended immediately if clinical signs or laboratory abnormalities suggestive of pancreatitis occur.
• Peripheral Neuropathy & Lipoatrophy: Stavudine exhibits high mitochondrial toxicity. It is highly associated with severe, dose-limiting peripheral neuropathy (numbness, tingling, pain in hands/feet) and profound, irreversible lipoatrophy (severe loss of subcutaneous fat in the face, limbs, and buttocks).
• Zidovudine (AZT) Antagonism: Stavudine MUST NEVER be co-administered with Zidovudine (AZT), as they compete for the same intracellular phosphorylation pathways, resulting in total loss of antiviral efficacy.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Antiretroviral (ARV) Medicines, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for global health procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.