1. Name Of The Medicinal Product
Colchicine Tablets BP 0.5mg
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Tablets
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of acute gout and for the prophylaxis of recurrent gout and to prevent acute attacks during the initial treatment with allopurinol or uricosuric drugs.
4.2 Posology And Method Of Administration
For oral administration.
For treatment of acute gout:
1 mg initially then 500 micrograms every 2-3 hours until pain is relieved or diarrhoea or vomiting occurs or until a total dose of 6 mg is reached.
Do not repeat the course of treatment within 3 days.
For prophylaxis:
500 micrograms two to three times daily.
4.3 Contraindications
History of hypersensitivity to colchicine. Blood dyscrasias.
4.4 Special Warnings And Precautions For Use
Colchicine should be given with care to elderly and debilitated patients and to those with cardiac, renal, hepatic or gastrointestinal disease.
Keep all medicines out of the reach of children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
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 and may induce muscle disorders when used in combination with ciclosporin.
Concomitant use with clarithromycin may lead to colchicine toxicity. Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (Pgp). Clarithromycin and other macrolides are known to inhibit CYP3A and Pgp. When clarithromycin and colchicine are administered together, inhibition of Pgp and/or CYP3A by clarithromycin may lead to increased exposure to colchicine. Patients should be monitored for clinical symptoms of colchicine toxicity.
Concomitant use with erythromycin or tolbutamide may also lead to colchicine toxicity.
4.6 Pregnancy And Lactation
Use of colchicine during pregnancy is not advised.
Chromosomal aberrations have been reported in some patients on prolonged colchicine therapy although a causal relationship is doubtful. Controlled studies in humans have not been performed. The data available do not establish specific teratogenic effects. It is not known whether colchicine is distributed into human milk and it should therefore be used with caution in nursing women.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
Common side effects include nausea, vomiting, diarrhoea and abdominal pain. Larger doses may cause profuse diarrhoea, 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.
4.9 Overdose
Symptoms of poisoning do not appear for at least several hours. Initial symptoms include nausea, vomiting and diarrhoea. The diarrhoea may be severe and blood-stained. Metabolic acidosis, dehydration, hypotension and shock may develop. 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. The patient may develop convulsions, delirium, muscle weakness, neuropathy and ascending paralysis of the CNS. Death may be due to respiratory depression, cardiovascular collapse or bone marrow depression. The fatal dose varies; 7 mg of colchicine has caused death, yet recovery has occurred after much larger doses.
In acute poisoning the stomach should be emptied by lavage. Treatment is primarily symptomatic and supportive with attention being given to the control of respiration, maintenance of blood pressure and the circulation, and correction of fluid and electrolyte balance. Haemodialysis or peritoneal dialysis may be of value when kidney function is compromised.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Although the precise mode of action of colchicine in the treatment of gout is unknown, it is considered to act against the inflammatory response to urate crystals, by possibly inhibiting the migration of granulocytes into the inflamed area.
5.2 Pharmacokinetic Properties
Colchicine is readily absorbed from the gastrointestinal tract and reaches peak plasma concentration within 2 hours. It is partially deacetylated in the liver and the unchanged drug and its metabolites are excreted in the bile and undergo intestinal reabsorption. Most of the drug is excreted in the faeces but 10-20% is excreted in the urine.
5.3 Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose
Purified Water
Stearic Acid
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Protect from light.
6.5 Nature And Contents Of Container
Amber coloured glass bottle with a tin plate cap fitted with a wax aluminium pulpboard liner.
Pack size: 20, 100.
6.6 Special Precautions For Disposal And Other Handling
None stated.
7. Marketing Authorisation Holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing Authorisation Number(S)
PL0014/5043R
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of First Authorisation: 9 February 1979
Date of Last Renewal: 28 April 2000
10. Date Of Revision Of The Text
January 2007
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