Goutnor

Goutnor

colchicine

Manufacturer:

Noripharma

Distributor:

Pahang Pharmacy
Full Prescribing Info
Contents
Colchicine.
Description
0.5 mg: Each tablet contains Colchicine 0.5mg.
0.6 mg: Each tablet contains Colchicine 0.6mg.
Action
Pharmacology: Pharmacodynamics: Colchicine acts against the inflammatory response to urate crystals, by possibly inhibiting 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.
Pharmacokinetics: Peak plasma concentrations of colchicines are reached within 2 hours of oral administration. Colchicine is partially deacetylated in the liver and unchanged drug and its metabolites are excreted in the bile and undergo intestinal reabsorption. Colchicine is found in high concentration in leucocytes, kidneys and the liver and spleen. Most of the drug is excreted in the faeces but 10% to 20% is excreted in the urine and this proportion rises in patients with liver disorders.
Indications/Uses
For the treatment of acute gout, and for the prophylaxis of recurrent gout and to prevent acute attacks during initial therapy with allopurinol and uricosuric drugs.
Dosage/Direction for Use
For oral administration.
0.5 mg: For treatment of acute gout: 1mg initially then 0.5mg every 2-3 hours until pain is relieved or diarrhoea or vomiting or until a total dose of 6mg is reached.
Do not repeat the course of treatment within 3 days.
For prophylaxis: 0.5mg two or three times daily.
0.6 mg: Patients vary widely in their ability to tolerate the drug.
Dosage should be varied according to body weight or individual reaction to colchicine toxicity.
Acute gout: 1-2 tablets every 2 hours until the pain is relieved or until nausea, vomiting and diarrhea occurs. The usual amount of colchicine required in a course of therapy may range from 4-8 mg.
Pain and swelling usually abate within 12 hours and are usually gone within 48-72 hours.
Prophylaxis: Depending on the severity and patient's response and tolerance, the dosage varies from 1 tablet daily 1-4 times weekly to 1 tablet daily.
Pseudogout: To relieve acute attack, 1-2 tablets every 2 hours until the pain is relieved or until nausea, vomiting and diarrhea occurs.
Prophylaxis: Depending on the severity and patient's response and tolerance, up to 2 tablets daily.
Overdosage
Overdosage may cause burning feeling in stomach, throat or skin; vomiting; convulsions; diarrhoea, fever, muscle weakness; pulmonary edema; respiratory depression or renal failure. Colchicine should be withdrawn or the dose reduced if adverse gastro-intestinal effects occur. For treatment in acute poisoning, the stomach should be emptied by aspiration and lavage. A purgative such as sodium sulphate 30 gm in 250 ml of water, should be given. Demulcent drinks may be given freely. Morphine sulphate, 10 mg, intramuscularly may be given to relieve abdominal cramps. Atropine has also been given.
Contraindications
The use of colchicine is contraindicated in: pregnancy and lactation, people who are hypersensitive to colchicines, children under 2 years of age, blood dyscrasias, uric acid kidney stones.
Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.
Special Precautions
Colchicine should be given with care to elderly and debilitated patients who may be particularly susceptible to cumulative toxicity; and to those with cardiac, renal, hepatic or gastrointestinal disease.
Use In Pregnancy & Lactation
It is contraindicated during pregnancy and lactation.
Side Effects
Common side effects include nausea, vomiting, diarrhea and abdominal pain. Larger doses may cause profuse diarrhea, gastrointestinal haemorrhage, muscle weakness, skin rashes, renal and hepatic damage. Dehydration and hypotension may follow. Alopecia, peripheral neuritis and bone marrow depression with agranulocytosis and aplastic anaemia may occur after prolonged treatment. Rarely, peripheral neuritis, myopathy, rhabdomyolysis may occur.
Drug Interactions
Potential risk of severe drug interactions, including death, in certain patients treated with colchicines and concomitant P-glycoprotein or strong CYP3A4 inhibitors such as Clarithromycin, Cyclosporin, Erythromycin, Calcium Channel Antagonists (e.g. Verapamil and Diltiazem), Telithromycin, Ketoconazole, Itraconazole, HIV protease inhibitors and Nefazodone.
P-glycoprotein or strong CYP3A4 inhibitors are not to be used in patients with renal or hepatic impairment who are taking colchicines.
A dose reduction or interruption of colchicine treatment should be considered in patients with normal renal and hepatic function if treatment with a P-glycoprotein or strong CYP3A4 inhibitors is required.
Avoid consuming grapefruit and grapefruit juice while using colchicines.
Thiazide diuretics may cause a rise in serum uric acid and this may interfere with the activity of colchicine. Colchicine may impair the absorption of vitamin B12. Requirement for B12 may be increased.
Concomitant use with tolbutamide may lead to colchicine toxicity.
Storage
Store below 30°C. Protect from light.
ATC Classification
M04AC01 - colchicine ; Belongs to the class of preparations with no effect on uric acid metabolism. Used in the treatment of gout.
Presentation/Packing
Tab 0.5 mg (a white to off white round shaped tablet with 'C' engraved on one side) x 100 x 10's. 0.6 mg (a white to off white round shaped tablet with breaking line on one side) x 100 x 10's.
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