COLCHICINE KANAWATI 1 mg
Tablets

Guot Drugs

  • Chemical Composition

    Colchicine 1mg

  • Packing

    20Tablets

  • Medical Id

    T104

  • License Number

    44/2015

  • License date

    9/3/2015

Mechanism Of Action The anti-inflammatory effect of colchicine in acute gouty arthritis is selective for this disorder. Although its mode of action is not clearly understood, it is thought that colchicine causes the inhibition of the migration of granulocytes into the inflamed area. This reduces the release of lactic acid and proinflammatory enzymes that occurs during phagocytosis and breaks the cycle that leads to the inflammatory response
INDICATIONS Colchicine Kanawati tablets may be used for the treatment of acute gout and for short term prophylaxis during initial therapy with allopurinol and uricosuric drugs
CONTRAINDICATIONS The use of Colchicine Kanawati is contraindicated in pregnancy. Colchicine Kanawati should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion. Colchicine Kanawati should not be used in patients with severe renal impairment (creatinine clearance less than 10ml/minute). Colchicine Kanawati is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein or a strong CYP3A4 inhibitor.
Side EFFECTS Colchicine frequently causes nausea, vomiting and abdominal pain. Larger doses may cause profuse diarrhoea, gastrointestinal haemorrhage, skin rashes and renal and hepatic damage. Rarely peripheral neuritis, myopathy, rhabdomyolysis, alopecia, inhibition of spermatogenesis and, with prolonged treatment, bone marrow suppression with agranulocytosis, thrombocytopenia and aplastic anaemia occur.
WARNINGS Colchicine should be given with care to elderly and debilitated patients as there is a greater risk of cumulative toxicity. Care should also be exercised in those with cardiac, hepatic, gastrointestinal disease or if patients are breast-feeding. Colchicine should be avoided in patients with blood disorders. Reduce dose in patients with mild to moderate renal impairment. A reduction in colchicine dosage or interruption of colchicine treatment is recommended in patients with normal renal and hepatic function if treatment with a P-glycoprotein or a strong CYP3A4 inhibitor is required.
DRUG INTERACTIONS Antibacterials: increased risk of colchicine toxicity when given with clarithromycin or erythromycin, particularly in patients with pre-existing renal impairment. As CYP3A4 inhibitors, macrolides should not be used to treat patients with renal or hepatic impairment who are taking colchicine. P-glycoprotein or strong CYP3A4 inhibitors: Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein inhibitor (e.g. ciclosporin, verapamil or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketaconazole). A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with a P-glycoprotein or strong CYP3A4 inhibitor is required. Ciclosporin: Colchicine should be used with caution with ciclosporin due to the possible increased risk of nephrotoxicity and myotoxicity. Vitamins: the absorption of Vitamin B12 may be impaired by chronic administration or high doses of colchicine; requirement may be increased. Statins: Acute myopathy has been reported in patients given colchicine with statins. Patients should be advised to report muscle pain or weakness.
Pregnancy And lactations Do not use in pregnancy as there is a risk of foetal chromosome damage. Colchicine is distributed into breast milk. Colchicine may be used with caution during breast-feeding
Dosage And Administration Adults only: Gout: 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. Renal Impairment:For mild/moderate renal impairment (creatinine clearance 10-50 ml/minute), reduce dose or increase interval between doses. For use with allopurinol or uricosuric drugs:0.5 mg two to three times daily. Elderly: To be given with great care. Children: Not recommended.
OVERDOSE Colchicine has a narrow therapeutic window and is extremely toxic in overdose. Patients at particular risk of toxicity are those with renal or hepatic impairment, gastrointestinal or cardiac disease, and patients at extremes of age. There is often a delay of up to 6 hours before toxicity is apparent, and some features of toxicity may be delayed by 1 week or longer. All patients, even in the absence of early symptoms, should be referred for immediate medical assessment. Early features (up to 1 day after ingestion) include a feeling of burning and rawness in the mouth and throat, difficulty in swallowing, nausea, vomiting, abdominal pain and diarrhoea. Diarrhoea may be profuse, bloody and accompanied by tenesmus, and the patient may present with electrolyte disturbances and hypovolaemic shock. These symptoms, coupled with vascular damage, may lead to dehydration, hypotension and shock. Features after 1 to 7 days include confusion, decreased cardiac output, cardiac arrhythmias, renal and hepatic impairment, respiratory distress, hyperpyrexia and bone marrow depression. Consider oral activated charcoal in adults who have ingested more than 0.1 mg/kg bodyweight within 1 hour of presentation, and in children who have ingested any amount within 1 hour. Further doses of activated charcoal may enhance systemic elimination and may be considered in patients who have ingested more than 0.3 mg/kg. Management should include general symptomatic and supportive measures as indicated by the patient's clinical condition. Morphine sulphate 10mg, intramuscularly, may be given to relieve severe abdominal cramps.
Storage Conditions Store at room temperature, below 25°C Protect from light Keep out of reach of children