Colmacyn Tablets / Film-coated
Colchicine
0.5mg
Macleods Pharmaceuticals Ltd.
| Pack size | 30's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | INDIA |
| Agent | Pharma House Pharmaceuticals L.L.C. |
| Retail Price | 41.50 AED |
Indications
Colmacyn Tablets / Film-coated is used for:
Acute gout, Familial Mediterranean Fever, Behcet's disease, Gouty arthritis
Adult Dose
Gout
Treatment of acute gout flares (Colcrys): 1.2 mg PO at first sign of flare, then 0.6 mg 1 hr later; not to exceed 1.8 mg in 1-hr period
Prophylaxis (Colcrys, Mitigare): 0.6 mg PO once daily or q12hr; not to exceed 1.2 mg/day; after gout flare, wait 12 hr to continue prophylaxis
Familial Mediterranean Fever
Colcrys: 1.2-2.4 mg/day PO in single daily dose or divided q12hr; increased in 0.3 mg/day increments as necessary to control disease; decreased in 0.3 mg/day increments if intolerable side effects develop; not to exceed 2.4 mg/day
Hepatic impairment (gout)
Mild to moderate: Dosage adjustment not necessary; monitor patients for adverse effects
Severe: Dosage adjustment not necessary; do not repeat more frequently than every 2 weeks; consider alternative therapy if repeated courses are required
Hepatic impairment (familial Mediterranean fever)
Mild to moderate: Monitor patients for adverse effects
Severe: Consider dosage reduction; do not repeat more frequently than every 2 weeks
Child Dose
Gout
<16 years
Not recommended
>16 years
Treatment of acute gout flares: 1.2 mg PO at first sign of flare, then 0.6 mg 1 hr later; not to exceed 1.8 mg in 1-hr period
Prophylaxis: 0.6 mg PO once daily or q12hr; not to exceed 1.2 mg/day; after gout flare, wait 12 hr to continue prophylaxis
Familial Mediterranean Fever
<4 years: Safety and efficacy not established
4-6 years: 0.3-1.8 mg/day PO in single daily dose or divided q12hr
6-12 years: 0.9-1.8 mg/day PO in single daily dose or divided q12hr
>12 years: 1.2-2.4 mg/day PO in single daily dose or divided q12hr
Renal Dose
Renal impairment (gout)
Mild (CrCl 50-80 mL/min) and moderate (CrCl 30-50 mL/min): Dosage adjustment not necessary; monitor patients for adverse effects
Severe (CrCl <30 mL/min): Dosage adjustment not necessary; do not repeat more frequently than every 2 weeks
Hemodialysis: 0.6 mg once; do not repeat more frequently than every 2 weeks
Renal impairment (familial Mediterranean fever)
Mild (CrCl 50-80 mL/min) and moderate (CrCl 30-50 mL/min): Monitor patients for adverse effects; dosage adjustment may be required
Severe (CrCl <30 mL/min): 0.3 mg/day initially; dosage increases should be done with adequate monitoring for adverse effects
Hemodialysis: 0.3 mg PO once; dosage increases should be done with adequate monitoring for adverse effects
Administration
Should be taken with food.
Contra Indications
Hypersensitivity; blood dyscrasias, severe renal impairment, pregnancy, debilitated patients; SC/IM admin.
Precautions
Elderly; GI disease. Cardiac, renal and hepatic impairment; prolonged therapy not recommended; lactation.
Lactation: Drug enters breast milk; use with caution (American Academy of Pediatrics Committee states that drug is "compatible" with nursing)
Pregnancy-Lactation
Pregnancy
Available human data from published literature on colchicine use in pregnancy over several decades have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Lactation
Colchicine is present in human milk
No adverse events in breastfed infants in the published literature after administration of colchicine to lactating women
No data available on the effects of colchicine on milk production
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Infertility
Case reports and epidemiology studies in males on colchicine therapy indicate that infertility from colchicine is rare and may be reversible
Interactions
Reversible malabsorption of vitamin B12 may occur because of ileal mucosal function alteration. Response to CNS depressants and sympathomimetics may increase when used concurrently with colchicine. Increased risk of myopathy when used concurrently with simvastatin.
Potentially Fatal: With ciclosporin, increased risk of nephrotoxicity and myotoxicity. Risk of colchicine toxicity when used with macrolides.
Adverse Effects
Side effects of Colchicine :
>10%
Gastrointestinal (GI) effects (eg, diarrhea, nausea, cramping, abdominal pain, vomiting) (26-77%)
1-10%
Fatigue (1-4%), Gout (0-4%), Pharyngolaryngeal pain (2-3%), Headache (1-2%)
Mechanism of Action
Colchicine, a phenanthrene derivative, exerts its effect by reducing the inflammatory response to the deposited urate crystals and also by diminishing phagocytosis in joints. It inhibits lactic acid production by leucocytes, thereby interrupting urate deposition and inflammatory response that sustains the acute gout attack.
Note
Colmacyn 0.5mg Tablets / Film-coated manufactured by Macleods Pharmaceuticals Ltd.. Its generic name is Colchicine. Colmacyn is availble in United Arab Emirates.
Farmaco UAE drug index information on Colmacyn Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.