Type: Tab.
Manufacturer/Distributor: Colchicine 0.6 mg
Square Pharmaceuticals Ltd.
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Colimax is a medicine used in the treatment and prevention of gout. It reduces inflammation which causes pain, swelling, and other symptoms of gout. Colimax can be taken with or without food. You should take it regularly and at the same time each day to get the maximum benefit from it. Keep taking it as recommended by your doctor and complete the dose even if you feel better. If you stop, your symptoms may get worse. Some common side effects of this medicine are nausea, vomiting, abdominal pain, and diarrhea. Talk to your doctor if any of these side effects do not go away with time. Your doctor may help with ways to reduce or prevent these symptoms. To make sure the medicine is safe for you, before taking this medicine, let your doctor know if you have any problems with your heart, kidneys or liver. Pregnant and breastfeeding mothers should consult with their doctors before taking the medicine.
Uses of Colimax
Side effects of Colimax
Common
How to use Colimax
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Colimax may be taken with or without food, but it is better to take it at a fixed time.
How Colimax works
Colimax reduces inflammation which causes pain, swelling and other symptoms of gout.
What if you forget to take Colimax?
If you miss a dose of Colimax, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
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Brief Description
Indication
Acute gout, Familial Mediterranean Fever, Behcet's disease, Gouty arthritis
Administration
Should be taken with food.
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
Contraindication
Hypersensitivity; blood dyscrasias, severe renal impairment, pregnancy, debilitated patients; SC/IM admin.
Mode 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.
Precaution
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)
Side Effect
>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%)
Pregnancy Category Note
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
Interaction
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.
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