Description

Naloxone Hydrochloride Injection

Healthy Inc is a specialized global supplier and exporter of life-saving emergency antidotes. We provide high-purity Naloxone Hydrochloride Injection (400 mcg / 1 ml), manufactured in WHO–GMP certified sterile facilities. This “Overdose Reversal” agent is a mandatory export to emergency departments, ambulance services, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive antidote for opioid overdose and post-operative respiratory depression.

Product Overview

This formulation contains Naloxone Hydrochloride, a pure opioid antagonist with no agonist activity.

The “Reversal” Specialist:

• Mechanism (The Receptor Blocker): Naloxone acts as a competitive antagonist at the μ (mu), κ (kappa), and σ (sigma) opioid receptors in the CNS. It has a higher affinity for these receptors than most opioids (like Heroin, Morphine, or Fentanyl), effectively displacing the drug and immediately reversing life-threatening respiratory depression and sedation.
• Zero Agonist Activity: Unlike older antidotes, Naloxone does not produce respiratory depression or sedation itself. If administered to a patient who has not taken opioids, it has virtually no effect, making it extremely safe for empiric use in unconscious patients.
• Rapid Onset: IV administration reverses coma and apnea within 1 to 2 minutes.

Product Composition & Strength

We supply this product as a Sterile Solution in Glass Ampoules or Pre-filled Syringes.

*Pack Sizes: Tray of 10 Ampoules or Box of 10 Vials.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

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

• pH Stability: Naloxone is unstable in alkaline solutions. Our formulation is buffered to an optimal pH of 3.0–4.5 to ensure maximum potency throughout the 24-month shelf life.
• Sterile Integrity: Produced in Class 100 cleanrooms using aseptic filling techniques to ensure the product is pyrogen-free and safe for rapid intravenous bolus administration.

Therapeutic Indications (Human Use)

Indicated for the complete or partial reversal of opioid depression:

• Opioid Overdose: Emergency treatment of known or suspected overdose (Heroin, Fentanyl, Oxycodone, Methadone).
• Post-Operative Reversal: Reversal of opioid depression after surgery (to speed up recovery).
• Neonatal Asphyxia: Reversal of respiratory depression in newborns whose mothers received opioids during labor.
• Septic Shock: Adjunctive use to improve blood pressure (controversial/investigational).

Dosage & Administration

Recommended Dosage (Strictly as per Emergency Protocol):

• Route: Intravenous (IV), Intramuscular (IM), or Subcutaneous (SC).
• Adult Overdose: 0.4 mg to 2 mg IV. Repeat at 2-3 minute intervals if no response. If no response after 10 mg, question the diagnosis.
• Post-Op Reversal: Smaller doses (0.1 mg to 0.2 mg) titrated to avoid reversing analgesia (pain relief).
• Neonates: 0.01 mg/kg IV, IM, or SC.

Safety Warnings (CRITICAL):

• Acute Withdrawal: Rapid reversal in opioid-dependent patients causes severe withdrawal symptoms: body aches, diarrhea, tachycardia, fever, sweating, and aggression.
• Short Half-Life: Naloxone wears off in 30–80 minutes, which is shorter than most opioids. “Re-narcotization” (Return of Coma) can occur. Monitor the patient for at least 2 hours.
• Cardiac Stress: Sudden reversal can cause hypertension, tachycardia, and pulmonary edema in patients with pre-existing heart disease.

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 Sterile Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government 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.