Colchicine STELLA 1 mg

Rx

Indications:

For treatment of acute gout and for short-term prophylaxis during initial therapy with allopurinol and uricosuric drugs.

Dosage:

Adults:

• 1 mg initially, followed by 0.5 mg every two to three hours until relief of pain is obtained or vomiting or diarrhoea occurs. A total dose of 6 mg should not be exceeded. The course should not be repeated within three days.
• For use with allopurinol or uricosuric drugs: 0.5 mg two to three times daily.
• For mild/moderate renal impairment (creatinine clearance 10 – 50 ml/minute), reduce dose or increase interval between doses.

Elderly: To be given with great care.

Children: To be given with great care.

Usage:

Colchicine STELLA 1 mg is administered orally.

• Hypersensitivity to colchicine or to any of the excipients.
• Pregnant women.
• Patients with renal or hepatic impairment who are talking a P-glycoprotein or a strong CYP3A4 inhibitor.
• Patients undergoing haemodialysis, patients with severe renal impairment (creatinine clearance less than 10 ml/minute).

• Common:
  Nausea, vomiting, abdominal pain; profuse diarrhea, gastrointestinal haemorrhage, rashes, renal damage (large doses).
• Uncommon:
  Peripheral neuritis, alopecia, blood dyscrasia (prolonged treatment), azoospermia (reversible).

• Colchicine should be given with care to elderly and debilitated patients; cardiac, hepatic, gastrointestinal disease.
• Avoid using Colchicine STELLA 1 mg in patients with blood disorders.
• Reduce dose in patients with mild to moderate renal impairment.
• A reduction in colchine dosage or interruption of colchine treatment us recommended in patients with normal renal and hepatic function if treatment with P-glycoprotein inhibitor or a strong CYP3A4 inhibitor is required.
• Colchicine STELLA 1 g contains lactose and sucrose (saccharose). Patients with rare hereditary problems of galactose intolerance, fructose intolerance, total lactase deficiency or glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
• Colchicine may be used with extreme caution during breast-feeding.
• Patients should be aware of how they react to Colchicine STELLA 1 mg before driving or operating machinery.