COMPOSITION: Each tablet contains 0,5 mg Colchicine.
PHARMACOLOGICAL CLASSIFICATION: A 3.3 Antigout preparations.
PHARMACOLOGICAL ACTION: Colchicine is an anti-inflammatory agent unique in its selective effectiveness against gout. An acute attack of gout apparently occurs as a result of an inflammatory reaction to crystals of mono-sodium urate that are deposited in the joint tissue from hyperuric body fluids. The inflammatory response involves local infiltration of granulocytes that phagocytize the urate crystals. In synovial tissues and in leukocytes associated with the inflammatory process, lactic acid production is high and this favours a local decrease in pH that fosters further uric acid deposition. Colchicine diminishes lactic acid production by leukocytes directly and by diminishing phagocytosis, and thereby interrupts the cycle of urate crystal deposition and inflammatory response that sustains the acute attack.
For relief of acute attacks of gout in cases of emergency.
Colchicine provides dramatic relief of acute attacks of gout and is an effective prophylactic agent against such attacks.
CONTRA-INDICATIONS: Its use is contra-indicated during pregnancy.
DOSAGE AND DIRECTIONS FOR USE: In acute gout the initial dose is 0,5 to 1 mg (1 to 2 tablets) by mouth, followed by 0,5 mg (1 tablet) every 2 hours until relief is obtained or gastro-intestinal symptoms occur. The total dose usually required to alleviate an attack is 4 to 10 mg, and the latter amount should not be exceeded. The course should not be repeated within 3 days. Dose adjustments of colchicine for prophylactic use may be necessary in patients with impaired renal function. Either a reduced dosage or an increased dosing interval has been suggested.
For prophylaxis of recurrent attacks oral doses may range from 0,5 mg (1 tablet) weekly to three times daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Colchicine frequently causes nausea, vomiting, abdominal pain and diarrhoea. The medicine should be withdrawn or the dose reduced if adverse gastro-intestinal effects occur. Burning of the skin and throat may also occur.
Bone marrow depression with agranulocytosis, thrombocytopenia and aplastic anaemia have occurred on prolonged treatment, as well as peripheral neuritis, myopathy, rashes and alopecia.
Colchicine should be given with care to old and debilitated patients and to those with cardiac, hepatic, renal or gastro-intestinal disease.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Symptoms of overdosage do not appear for at least several hours. The first symptoms are nausea, vomiting and diarrhoea. The diarrhoea may be severe and haemorrhagic, and can lead to metabolic acidosis, dehydration, hypotension and shock. A burning sensation of the throat, stomach and skin may also occur. Extensive vascular damage and acute renal toxicity with oliguria and haematuria have been reported. Bone marrow depression with leucopenia may be followed by rebound leucocytosis.
The patient may develop convulsions, delirium, muscle weakness, neuropathy and ascending paralysis of the central nervous system. Death may be due to respiratory depression, cardiovascular collapse or bone marrow depression.
In case of overdosage or acute poisoning patients should be carefully monitored for some time to take account of the delayed onset of symptoms. In acute poisoning the stomach should be emptied by lavage. Treatment is symptomatic and supportive. Respiration may require assistance. The circulation should be maintained and fluid and electrolyte imbalance corrected. Haemodialysis or peritoneal dialysis may be of value when kidney function is compromised.
IDENTIFICATION: Biconvex, white bisected tablet.
PRESENTATION: Securitainers of 50 tablets.
STORAGE INSTRUCTIONS: Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.
APPLICATION NUMBER: C822 (Act 101/1965).
NAME AND BUSINESS ADDRESS OF APPLICANT: Pharmacare Limited
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 11/09/1970.
A & S PRINTERS
Updated on this site: November 2000
Current: January 2004
Source: Community Pharmacy