COLCHICINE
Strength0.5 mg
Formoral.solid
1-1.5 mg daily in 1-2 divided doses; increase in steps of 0.5 mg if attacks continue, to a maximum of 3 mg daily - continuous, lifelong prophylaxis - not just during attacks
(EULAR/PReS 2024 age-band starting doses (not weight-based): under 5 years, up to 0.5 mg/day; 5-10 years, 0.5-1 mg/day; over 10 years, 1-1.5 mg/day (same as adult). Maximum 2 mg/day in children versus 3 mg/day in adults. Titrate under specialist guidance)
| Under 5 years: | Up to 0.5 mg daily |
|---|---|
| 5 to 10 years: | 0.5 to 1 mg daily |
| Over 10 years: | 1 to 1.5 mg daily, as for an adult. Maximum 2 mg daily in a child. |
Colchicine 500 microgram tablets SmPC sections 4.1 and 4.2, Paediatric population - Familial Mediterranean fever (eMC product 100968): "Colchicine is indicated in Familial Mediterranean Fever for prophylaxis of attacks and prevention of amyloidosis", with starting doses "0.5 mg / day in children less than 5 years of age (1 tablet); 1 mg / day in children from 5 to 10 years of age (2 tablets); 1.5 mg / day in children over 10 years (3 tablets)" and "increased in a stepwise fashion (e.g., 0.25mg/step) up to a maximum of 2mg/day (four tablets a day)". This label carries the familial Mediterranean fever indication for children only and states no adult regimen; the adult 1 to 1.5 mg daily rising to 3 mg is from the EULAR/PReS 2024 recommendations, which are not held in this corpus.
Colchicine is the mainstay of FMF: daily continuous dosing prevents both attacks and the amyloidosis that untreated FMF can cause, unlike its short 3-day course use in gout. EULAR/PReS 2024 states colchicine should be continued through conception, pregnancy, and lactation - stopping risks a flare and amyloidosis, and current evidence does not show the fetal risk that older general drug-labelling contraindications assume for colchicine's other indications
- Narrow therapeutic index - diarrhoea or vomiting is an early sign of toxicity; do not exceed the recommended dose.
- Reduce dose in renal or hepatic impairment; avoid combining with strong CYP3A4 or P-glycoprotein inhibitors (e.g. clarithromycin, ciclosporin) - risk of life-threatening toxicity.
- Do not stop colchicine in pregnancy without discussing with the treating specialist - see rationale.
- During an acute attack, keep the dose unchanged; do not increase colchicine to control attack pain.
- Numbers for the dose reductions: in mild to moderate renal or hepatic impairment an adult goes to 0.5 mg a day and a child's dose halves. A strong CYP3A4 or P-gp inhibitor needs a four-fold reduction and a moderate CYP3A4 inhibitor a two-fold one - and in renal or hepatic impairment those combinations are contraindicated outright, not merely reduced.
| Egyptian brand | Manufacturer | Indicative price |
|---|---|---|
| COLCHICINE 500 MCG 100 TABS. | EL NASR | 190.00 EGP (1.90/unit) |
| COLMEDITEN 0.5 MG 100 TABS. | KAHIRA | 190.00 EGP (1.90/unit) |
| GOURYST 0.5 MG 100 TABS. | PHAROPHARMA | 190.00 EGP (1.90/unit) |