Description

Disulfiram Tablets (200mg / 250mg / 500mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Disulfiram Tablets in India. Disulfiram is a pioneering drug used in the Management of Chronic Alcoholism. It functions as a deterrent agent (aversion therapy) by creating an acute sensitivity to ethanol. It is prescribed to support motivated patients in maintaining sobriety by enforcing an immediate and unpleasant physical reaction if alcohol is consumed.

We offer Contract Manufacturing (Third Party) services for this specialized psychiatric medication. Disulfiram is typically formulated as a standard oral tablet or a Dispersible Tablet (to prevent “cheeking” or hiding the pill). Our WHO-GMP certified facility in Mumbai ensures precise dosing and stability. Healthy Inc manages the export logistics, supplying addiction treatment centers, psychiatric clinics, and rehabilitation facilities across Europe, Russia, and the Americas.

2. Product Specifications

3. Manufacturing Technology

Ensuring compliance in addiction therapy.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Dispersible Technology: We can manufacture Disulfiram as a Dispersible Tablet. This allows the medication to be dissolved in water before administration, ensuring the patient actually swallows the full dose—a critical feature in supervised addiction treatment programs.

  • Precise Granulation: Disulfiram has poor flow properties. We use wet granulation techniques with specific binders to ensure hard, durable tablets that do not crumble in the bottle but disintegrate rapidly when taken.

  • Safety Protocols: Since the drug is potent, our manufacturing suites use dedicated dust extraction systems to protect workers and prevent cross-contamination with other products.

• The Exporter: Healthy Inc

  • Patient Education Packs: We can provide packaging with clear warnings and “Do Not Drink” symbols, which is vital for patient safety.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation impurities (Diethyldithiocarbamate) to ensure efficacy.

5. Why Use Disulfiram?

The “chemical fence” against relapse.

• Mechanism: Disulfiram inhibits the enzyme Aldehyde Dehydrogenase. Normally, the liver breaks alcohol down into Acetaldehyde (toxic) and then quickly into Acetate (harmless). Disulfiram blocks the second step, causing Acetaldehyde to build up in the blood to 5-10 times the normal level.

• The Reaction (DER): If a patient drinks alcohol while on Disulfiram, they experience the Disulfiram-Ethanol Reaction: flushing, throbbing headache, respiratory difficulty, nausea, copious vomiting, sweating, thirst, and chest pain. This severe reaction creates a psychological barrier (fear) that helps prevent impulsive drinking.

• Key Indication:

  • Chronic Alcoholism: Maintenance of enforced sobriety in patients who want to quit.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Disulfiram Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Antabuse?

  A: Antabuse is the brand name (Teva/Odyssey). We manufacture the Generic Equivalent (Disulfiram).

• Q: Can I drink a little bit?

  A: ABSOLUTELY NOT. Even small amounts of alcohol (in sauces, vinegar, cough syrup, or aftershave) can trigger a severe reaction.

• Q: How long does it stay in the system?

  A: Up to 14 days. You cannot drink alcohol for at least 2 weeks after stopping the medication.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Induction: 500mg once daily for 1-2 weeks.

• Maintenance: 250mg (range 125mg–500mg) once daily.

• Administration: Can be crushed or mixed with liquid. Best taken in the morning. WARNING: Never administer until the patient has abstained from alcohol for at least 12 hours.

9. Side Effects and Precautions

• The Reaction: Warning: The alcohol reaction can be life-threatening (heart failure, respiratory arrest) in vulnerable patients.

• Hepatotoxicity: Rare but severe liver failure. Monitor Liver Function Tests (LFTs) at baseline and regularly.

• CNS: Drowsiness, fatigue, metallic taste, or garlic-like aftertaste.

• Contraindications: Cardiac disease, psychosis, and consumption of alcohol.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.