Description

Naltrexone Hydrochloride Film-Coated Tablets (50 mg)

Healthy Inc is a specialized global supplier and exporter of advanced psychiatric, addiction medicine, and central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically optimized Naltrexone Hydrochloride Film-Coated Tablets (50 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Pure Mu-Opioid Receptor Antagonist” is a massive-volume, highly lucrative export to drug rehabilitation centers, psychiatric hospitals, outpatient addiction clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for the long-term management of Opioid Use Disorder (OUD) and Alcohol Dependence.

Product Overview

This highly advanced formulation utilizes a profound, pure opioid antagonist that fundamentally rewires the addicted brain. It physically blocks the neurological “reward” pathways, destroying the euphoric high of substance abuse and extinguishing crippling physiological cravings.

The “Receptor Blockade & Craving Severance” Specialist:

• Mechanism 1 (The Absolute Opioid Shield): Naltrexone possesses an incredibly high binding affinity for the mu-opioid receptors in the brain. It binds to these receptors tighter than heroin, fentanyl, or morphine, but it does not activate them. If a patient on Naltrexone relapses and injects heroin, the Naltrexone acts as an impenetrable physical shield. The opioid cannot attach to the receptor, and the patient feels absolutely zero euphoria or sedation, completely breaking the cycle of behavioral reinforcement.
• Mechanism 2 (The Alcohol Reward Disconnect): When a person drinks alcohol, the brain releases endogenous endorphins that bind to opioid receptors, triggering the release of dopamine (the “buzz”). Naltrexone aggressively blocks these receptors. When the patient drinks, the dopamine release is severely blunted. They no longer feel the euphoric reward of alcohol, which radically reduces cravings and binge-drinking episodes (often utilized in the globally recognized “Sinclair Method”).
• The “Precipitated Withdrawal” Reality (CRITICAL): Naltrexone is an antagonist. If a patient takes this tablet while still having opioids in their system, the Naltrexone will violently rip the opioids off the brain’s receptors. This triggers “Precipitated Withdrawal”—an immediate, agonizing, and terrifying state of acute opioid withdrawal. Patients MUST be completely detoxified and opioid-free for a minimum of 7 to 10 days before starting this therapy.

Product Composition & Strength

We supply this product as a Precision-Blended, Taste-Masked Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the hydrochloride salt.

*Pack Sizes: 10×10 Blisters or Bottles of 30/100 (Optimized specifically for strictly monitored, 30-day outpatient rehabilitation dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Psychiatric Distributors, and Hospital Procurement Boards.

Manufacturing Authority

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

• Intensive Taste-Masking & Rapid-Dissolution Engineering: Addiction therapy patients frequently struggle with compliance and may attempt to hold the pill in their mouth to spit it out later. Naltrexone API is intensely bitter. Our facilities utilize advanced high-shear wet granulation paired with a heavy-gauge, premium polymer film-coating. This creates a perfectly smooth, tasteless tablet that slips down the throat easily, while the internal superdisintegrants guarantee that the tablet shatters and absorbs instantly once it reaches the stomach acid, ensuring the receptor blockade is fully engaged.

Therapeutic Indications (Human Use)

Indicated for the comprehensive, long-term pharmacological management of substance use disorders:

• Opioid Dependence: Blockade of the pharmacological effects of exogenously administered opioids as an adjunct to the maintenance of the opioid-free state in detoxified, formerly opioid-dependent individuals.
• Alcohol Dependence: Treatment of alcohol dependence, as a component of a comprehensive management program that includes psychosocial support, to reduce relapse rates and alcohol cravings.

Dosage & Administration

Recommended Dosage (Strictly as per Addiction Medicine Guidelines):

• Standard Adult Dosing: 50 mg taken orally once daily.
• The Detoxification Prerequisite: The patient MUST be opioid-free (including Tramadol, Codeine, and Methadone) for a minimum of 7 to 10 days before initiating therapy. A “Naloxone Challenge Test” is often performed by the physician to confirm the absence of opioids before the first dose is given.
• Administration: Can be taken with or without food. Taking with food or antacids may help minimize the transient nausea frequently experienced during the first week of therapy.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING / CRITICAL ALERT (Fatal Overdose Vulnerability): When a patient stops taking Naltrexone, their neurological tolerance to opioids drops to absolute zero. If they relapse and attempt to take their “historical” or “usual” dose of heroin or fentanyl, it will cause immediate, fatal respiratory depression. The patient must be heavily counseled on this extreme risk of fatal overdose upon discontinuation.
• Hepatotoxicity: Naltrexone can cause dose-related hepatocellular injury. It is contraindicated in patients with acute hepatitis or liver failure. Liver function tests (AST/ALT) must be monitored periodically.
• Emergency Pain Management Crisis: Because Naltrexone completely blocks opioid receptors, standard emergency painkillers (like Morphine or Fentanyl) will not work if the patient is in a severe accident. Patients must carry a medical alert card. Emergency pain must be managed with regional anesthesia or heavy non-opioid multimodal analgesia (e.g., Ketamine, NSAIDs).
• Severe Depression & Suicidality: Patients in addiction recovery are highly vulnerable to depression. They must be closely monitored for sudden onset of severe depression or suicidal ideation during therapy.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Rehabilitation Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Psychiatric and Addiction-Medicine Formulations. Whether you are looking for a reliable Government Tender Supplier for state-sponsored rehab programs in the CIS or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.