PHARMACOLOGICAL CLASSIFICATION: A 3.3 antigout preparations.
PHARMACOLOGICAL ACTION: Colchicine has a specific clinical effect in the treatment of acute gout.
For relief of acute attacks of gout in cases of emergency.
Acute and chronic gout.
CONTRA-INDICATIONS: Pregnancy. Colchicine should be given with care to old and feeble patients and to those with cardiac, renal or gastro-intestinal disease.
DOSAGE AND DIRECTIONS FOR USE: B.P. Dosage: 1 mg immediately followed by 0,5 mg, (½ tablet) 2 hourly until pain is relieved or vomiting and diarrhoea intervene.
(A maximum dosage of 6 mg daily).
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Colchicine may cause nausea, vomiting and abdominal pain. Larger doses may cause profuse diarrhoea, skin rashes and renal damage and dehydration and hypotension may follow. Blood disorders such as leucopenia and neutropenia may also occur. Alopecia may occur after prolonged treatment. Special Precaution: Do not exceed the prescribed dose.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Symptoms of poisoning set in only after an interval of 3 - 6 hours, even with large doses. At first there is a feeling of burning and rawness in the mouth and throat and difficulty in swallowing, followed by nausea, abdominal pain, vomiting and diarrhoea, colic and tenesmus, spasm of the bladder and prostration. Anuria, delirium, hypotension and convulsions may occur. Treatment of acute poisoning: The stomach should be emptied. A saline purgative should be given to promote peristalsis. The circulation should be maintained with infusions of plasma and electrolyte imbalance corrected. Respiration may require assistance. Morphine sulphate 10 mg I.M. may be given to relieve severe abdominal cramps.
IDENTIFICATION: Slightly biconvex, cylindrical, pink tablets with a breakline on one side. 018 is engraved on the side with the breakline and the logotype on the other side.
PRESENTATION: Blister packs of 60 tablets.
STORAGE INSTRUCTIONS: Store in a cool, dry place, below 25°C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.
REFERENCE NUMBER: C665 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT: CIPLA MEDPRO (PTY) LTD.
DATE OF PUBLICATION OF THIS PACKAGE INSERT: November 2006
CE115 - A0004
Updated on this site: December 2016
Original Source: Hospital Pharmacy