Colchicine Tablets USP 1mg Technical Specification:
| Product Name: | Colchicine Tablets USP 1mg |
| Brand Name: | Generics |
| Strength: | (0.6mg), (1mg) |
| Dosage Form: | Tablet (Film-coated) |
| Route of Administration: | Via oral Route |
| Packing: | 30s, 60s, 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: | Antigout Drugs |
| Indication: | Colchicine is a medicine for treating inflammation and pain. It can be used to: treat flare-ups (attacks) of gout. prevent increased flare-ups of gout when you first start on a medicine like allopurinol – taken to manage your condition long term. |
| Storage: | USP Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Colchicine Tablets USP 0.6mg
- Colchicine Tablets USP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Colchicine Tablets USP 0.6mg
Each Film-coated tablet contains:
Colchicine USP…………………0.6mg
Excipients……………………q.s.
Colurs: Iron Oxide Red
- Colchicine Tablets USP 1mg
Each Film-coated tablet contains:
Colchicine USP…………..……1mg
Excipients……………………q.s.
Colurs: Sunset Yellow
THERAPEUTIC INDICATIONS:
Colchicine is a medicine for treating inflammation and pain. It can be used to: treat flare-ups (attacks) of gout. prevent increased flare-ups of gout when you first start on a medicine like allopurinol – taken to manage your condition long term.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
DISPENSE IN TIGHT LIGHT-RESISTANT CONTAINER.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: USP Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Colchicine Tablets USP 0.6mg
B. Colchicine Tablets USP 1mg
B. Colchicine Tablets USP 1mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Colchicine Tablets USP 0.6mg
Each Film-coated tablet contains:
Colchicine USP…………………0.6mg
Excipients……………………q.s.
Colurs: Iron Oxide Red
b) Colchicine Tablets USP 1mg
Each Film-coated tablet contains:
Colchicine USP…………..……1mg
Excipients……………………q.s.
Colurs: Sunset Yellow
Each Film-coated tablet contains:
Colchicine USP…………………0.6mg
Excipients……………………q.s.
Colurs: Iron Oxide Red
b) Colchicine Tablets USP 1mg
Each Film-coated tablet contains:
Colchicine USP…………..……1mg
Excipients……………………q.s.
Colurs: Sunset Yellow
THERAPEUTIC INDICATIONS:
Colchicine is a medicine for treating inflammation and pain. It can be used to: treat flare-ups (attacks) of gout. prevent increased flare-ups of gout when you first start on a medicine like allopurinol – taken to manage your condition long term.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
DISPENSE IN TIGHT LIGHT-RESISTANT CONTAINER. KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
DISPENSE IN TIGHT LIGHT-RESISTANT CONTAINER. KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: USP Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Dosage: As directed by the Physician.
