Disulfiram Tablets

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. manufactures Disulfiram Tablets in India. Disulfiram is an alcohol-deterrent medicine used as one component of a comprehensive treatment program for selected patients with alcohol dependence who understand and consent to its use. It does not treat alcohol withdrawal and should not be administered to an intoxicated patient or without the patient's knowledge. Counseling, psychosocial support and appropriate medical follow-up remain important parts of treatment.

2. Product Specifications

3. Manufacturing Technology

• Dosage-Form Control: Granulation, compression and any dispersible-tablet characteristics are validated against the registered master formula and finished-product specification.
• Blend Uniformity: Controlled dispensing and blending support consistent active distribution throughout each batch.
• Tablet Performance: Hardness, friability, disintegration and dissolution are controlled using product-specific acceptance criteria.
• Safety & Cross-Contamination Control: Manufacturing uses appropriate containment, cleaning and dust-control procedures according to facility risk assessment and GMP requirements.

4. Quality Assurance

• Assay & Uniformity: Potency and dosage-unit uniformity are verified against approved pharmacopoeial/registered limits.
• Dissolution: Drug release is tested according to the applicable finished-product method rather than a universal percentage/time target.
• Related Substances: Relevant impurities and degradation products are monitored using validated analytical methods.
• Stability: Shelf life and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Disulfiram inhibits aldehyde dehydrogenase, which can cause acetaldehyde to accumulate when ethanol is consumed. The resulting disulfiram-ethanol reaction may include flushing, headache, nausea, vomiting, sweating, palpitations, hypotension and other symptoms. Severe reactions can include arrhythmias, cardiovascular collapse, respiratory depression, seizures or death.

• Alcohol Dependence: Disulfiram may support abstinence in appropriately selected, informed and motivated patients as part of a broader treatment program.
• Not Withdrawal Treatment: It does not manage acute alcohol withdrawal and should only be started after an appropriate period of abstinence specified by the registered label/clinician.
• Alcohol Exposure: Patients must avoid alcoholic beverages and should check medicines, foods, toiletries or topical products that may contain enough alcohol to trigger a reaction.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Safety Labeling: Market-specific warnings and patient information can be incorporated according to approved regulatory artwork.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Disulfiram Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Disulfiram tablet formulations in India.

Q: Is Disulfiram available under brand names?
A: Yes. Disulfiram has been marketed under different brands. A manufacturer's product should only be described as bioequivalent or interchangeable with a specific reference product when supported by the required regulatory evidence.

Q: Can alcohol be consumed while taking Disulfiram?
A: No. Ethanol can trigger a potentially serious disulfiram-ethanol reaction. Patients should follow the product label and clinician instructions about avoiding alcoholic beverages and alcohol-containing products.

Q: How long must alcohol be avoided after stopping?
A: The alcohol-sensitizing effect can persist after the last dose. Many labels warn that reactions may occur for up to about 14 days, but patients should follow the exact registered product instructions and clinician advice.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Dosing: Initial and maintenance doses should follow the registered prescribing information and clinician's assessment. A universal fixed induction/maintenance regimen should not be applied across all markets and patients.
• Before Starting: Disulfiram must not be administered while a patient is intoxicated. The minimum alcohol-free interval before the first dose should follow the registered label and clinician guidance.
• Administration: Crushing, dispersing or mixing a tablet is appropriate only if the specific dosage form and label permit it.
• Supervision: Treatment is most appropriate when the patient understands the risks, consents to therapy and has appropriate clinical and psychosocial follow-up.

9. Side Effects and Precautions

• Disulfiram-Ethanol Reaction: Can be severe or life-threatening; suspected severe reactions require urgent medical care.
• Hepatotoxicity: Serious hepatitis and liver failure have been reported. Baseline and follow-up liver assessment may be appropriate according to prescribing information and clinical circumstances; symptoms such as jaundice, dark urine, marked fatigue or persistent nausea require prompt evaluation.
• Neurologic / Psychiatric: Drowsiness, headache, peripheral neuropathy and, rarely, significant psychiatric or neurologic effects can occur.
• Contraindications / Cautions: Significant cardiovascular disease, psychosis, severe hepatic disease and relevant hypersensitivity may affect suitability; follow the registered label.
• Drug Interactions: Clinically important interactions can occur with medicines including metronidazole, warfarin, phenytoin and others. Medication review is important before and during treatment.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive light, heat and moisture.
• Keep in original packaging and out of reach of children.