Drug Catalog - Product Detail
COLCHICINE CP 0.6mg 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00143-3018-01 | HIKMA | 100 | 0.6MG | CAPSULE |
PACKAGE FILES
Generic Name
COLCHICINE
Substance Name
COLCHICINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA204820
Description
11 DESCRIPTION Colchicine is an alkaloid obtained from the plant colchicum autumnale . The chemical name for colchicine is ( S)-N- (5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. The structural formula is represented below: Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether. Colchicine capsules are supplied for oral administration. Each capsule contains 0.6 mg colchicine, USP and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF, and may contain D&C Red No. 28, FD&C Red No. 40 and Quinoline Yellow. Structural Formula Image
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Colchicine capsules, 0.6 mg are No. 4 Dark Blue/Light Blue Hard Gelatin Capsules printed “West-ward 118” in white ink. NDC 0143-3018-30: Bottle of 30 Capsules NDC 0143-3018-01: Bottle of 100 Capsules NDC 0143-3018-10: Bottle of 1000 Capsules 16.2 Storage Store at 20° to 25°C (68° to 77°F), [See USP Controlled Room Temperature]. Protect from light and moisture.
Indications & Usage
1 INDICATIONS AND USAGE Colchicine capsules are indicated for prophylaxis of gout flares in adults. Limitations of use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes. Colchicine capsules are indicated for prophylaxis of gout flares in adults ( 1 ). Limitations of use: The safety and effectiveness of colchicine capsules for acute treatment of gout flares during prophylaxis has not been studied. Colchicine capsules are not an analgesic medication and should not be used to treat pain from other causes.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • 0.6 mg (one capsule) once or twice daily ( 2 ). Maximum dose 1.2 mg/day. Colchicine capsules are administered orally, without regard to meals ( 2 ). 2.1 Gout Prophylaxis For prophylaxis of gout flares, the recommended dosage of colchicine capsules is 0.6 mg once or twice daily. The maximum dose is 1.2 mg per day. Colchicine capsules are administered orally, without regard to meals.