Gouter

Gouter

colchicine

Manufacturer:

Unicure

Distributor:

Bell-Kenz Pharma

Marketer:

Ambica
Concise Prescribing Info
Contents
Colchicine
Indications/Uses
Relief of acute gout & for prophylaxis of acute attacks, particularly during 1st few mth of treatment w/ allopurinol or uricosurics. Several other conditions including amyloidosis, Behcet's syndrome, familial Mediterranean fever, ITP, pericarditis, primary biliary cirrhosis & pyoderma gangrenosum.
Dosage/Direction for Use
Acute attacks of gout Initially 1 mg, then 0.5 mg every 2-3 hr until pain relief is obtained or GI adverse effects occur. Max: 10 mg. 2nd course at 3-day interval: Initially 0.5-1.2 mg, then 0.5 or 0.6 mg every 1-2 hr or 1-1.2 mg every 2 hr until pain is relieved or GI adverse effects occur. Max: 6 mg. Short-term prophylaxis of gout 0.5 or 0.6 mg once daily to tid.
Administration
Should be taken with food.
Contraindications
Blood dyscrasias. Severe renal (including haemodialysis patients), & hepatic impairment (except in familial Mediterranean fever). Concomitant use w/ P-gp inhibitors or strong CYP3A4 inhibitors in patients w/ renal or hepatic impairment. Pregnancy & lactation.
Special Precautions
Old & debilitated patients who may be particularly susceptible to cumulative toxicity. Patients w/ cardiac, hepatic, renal or GI disease. Mild to moderate renal impairment.
Adverse Reactions
Diarrhea, nausea, vomiting, & abdominal pain. Bone marrow depression w/ agranulocytosis, thrombocytopenia, & aplastic anaemia in prolonged treatment & local reactions eg, thrombophlebitis & neuritis. Extravasation may cause tissue necrosis.
Drug Interactions
Increased risk of myopathy & rhabdomyolysis w/ statins, fibrates, digoxin, ciclosporin. Increased plasma conc w/ cimetidine & tolbutamide. May cause reversible malabsorption of vit B12. Concomitant use w/ phenylbutazone may increase risk of leucopenia, thrombocytopenia or bone marrow depression. NSAIDs may increase risk of GI ulceration or haemorrhage. Reduced efficacy of prophylactic gout therapy w/ cytolytic antineoplastic agents. Increased risk of toxicity w/ CYP3A4 or P-gp inhibitors eg, macrolides (eg, clarithromycin, erythromycin), HIV PIs (eg, ritonavir, atazanavir), Ca2+ channel blockers (eg, verapamil, diltiazem), ketoconazole, itraconazole, voriconazole, ciclosporin, disulfiram. Increased plasma conc w/ grapefruit juice. Increased blood uric acid levels & risk of GI toxicity w/ alcohol. May cause false +ve results in urine tests for erythrocytes or Hb levels. May interfere w/ urinary determination of 17-hydroxycorticosteroids using Reddy, Jenkins & Thorn procedures.
MIMS Class
Hyperuricemia & Gout Preparations
ATC Classification
M04AC01 - colchicine ; Belongs to the class of preparations with no effect on uric acid metabolism. Used in the treatment of gout.
Presentation/Packing
Form
Gouter tab 500 mcg
Packing/Price
100's
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