Disulfiram Tablets USP 500mg Technical Specification:
| Product Name: | Disulfiram Tablets USP 500mg |
| Brand Name: | Generics |
| Strength: | (250mg), (500mg) |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 90s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antidote |
| Indication: | Disulfiram Tablets USP are an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram Tablets are not a cure for alcoholism. |
| Storage: | Store at 20°C to 25°C. (See USP Controlled Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Disulfiram Tablets USP 250mg
- Disulfiram Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Disulfiram Tablets USP 250mg
Each uncoated tablet contains:
Disulfiram………………….250mg
Excipients……………………q.s.
Colour: Brilliant Blue FCF
- Disulfiram Tablets USP 500mg
Each uncoated tablet contains:
Disulfiram………………….500mg
Excipients……………………q.s.
Colour: Brilliant Blue FCF
THERAPEUTIC INDICATIONS:
Disulfiram Tablets are an aid in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage. Disulfiram Tablets are not a cure for alcoholism.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: Administration of this drug without the full knowledge of the patient may result in serious complications.
Warning: To the Physician: This is potent drug: indiscriminate use may result in serious undesirable reactions. Before administering this product, physicians should familiarize themselves with the enclosed literature.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C. (See USP Controlled Room Temperature)
Dispense in Tight, light-resistant container as defined in the USP.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Disulfiram Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Disulfiram………………….250mg
Excipients…………………...q.s.
Colour: Brilliant Blue FCF
b) Disulfiram Tablets USP 500mg
Each uncoated tablet contains:
Disulfiram………………….500mg
Excipients…………………...q.s.
Colour: Brilliant Blue FCF
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: Administration of this drug without the full knowledge of the patient may result in serious complications.
WARNING: To the Physician: This is potent drug: indiscriminate use may result in serious undesirable reactions. Before administering this product, physicians should familiarize themselves with the enclosed literature.
STORAGE & DOSAGE:
Dispense in Tight, light-resistant container as defined in the USP. Dosage: As directed by the Physician.
