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:
A. Disulfiram Tablets USP 250mg
B. Disulfiram Tablets USP 500mg
B. Disulfiram Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Disulfiram Tablets USP 250mg
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
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:
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.
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.
Dispense in Tight, light-resistant container as defined in the USP. Dosage: As directed by the Physician.
