Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Tiofarma B.V., Benjamin Franklinstraat 5-10, 3261 LW Oud-Beijerland, Netherlands
Adults:
Adults and paediatric patients:
2 to 3 times daily 0.5 mg, possibly preceded by an initial dose of 1 mg. Treatment should end until the acute attack resolves, or earlier in the event of gastrointestinal symptoms and no improvement after 2 to 3 days.
No more than 6 mg should be taken as a course of treatment. After completion of a course, another course should not be started for at least 3 days (72 hours).
If diarrhoea or vomiting occurs, Colchicine Tiofarma Tablets should be discontinued immediately as these may be the first signs of an intoxication.
0.5–1 mg per day (to be taken in the evening).
Colchicine Tiofarma Tablets should not be used in children and adolescents.
Concomitant treatment of colchicine with several drugs, mostly inhibitors of cytochrome P450 3A4 (CYP3A4)/P-glycoprotein have been shown to increase the risk for colchicine toxicity. If a patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or with a P-glycoprotein inhibitor, the maximum recommended dosage of oral colchicine should be reduced and should be carefully monitored for adverse effects of colchicine.
In patients with mild and moderate renal impairment, the dose is 0.5 mg per day and should be carefully monitored for adverse effects of colchicine. For severe renal impairment, see section 4.3 contraindications.
In patients with mild and moderate hepatic impairment, the dose is 0.5 mg per day and should be carefully monitored for adverse effects of colchicine. For severe hepatic impairment, see section 4.3 contraindications.
The dose may be given as a single dose or doses higher than 1 mg/day may be divided and given twice daily.
Colchicine dosage should be increased in a stepwise fashion up to a maximum of 3 mg/day to control disease in patients who do not clinically respond to the standard dosage. Any increase of the daily dose should be monitored closely for adverse effects. Careful monitoring is needed in the presence of impaired renal or liver function. For these patients, the starting dose should be reduced by 50% (e.g. ≤1 mg/day).
1 to 3 mg per day.
For paediatric use, colchicine should only be prescribed under the supervision of a medical specialist with the necessary knowledge and experience.
A starting dose should be administered orally based on age:
In children with amyloid nephropathy, higher daily doses up to 2 mg/day might be needed.
When 0.25mg doses are required, e.g. to control disease in patients who do not clinically respond to the standard dosage, the 0.5 mg and 1 mg tablet are not appropriate.
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, gastro-intestinal or cardiac disease and patients at extremes of age. Following colchicine overdose, all patients, even in the absence of early symptoms should be referred for immediate medical assessment.
Symptoms of acute overdosage may be delayed (3 hours on average): nausea, vomiting, abdominal pain, hemorrhagic gastroenteritis, volume depletion, electrolyte abnormalities, leukocytosis, hypotension in severe cases. The second phase with life threatening complications develops 24 to 72 hours after drug administration: multisystem organ dysfunction, acute renal failure, confusion, coma, ascending peripheral motor and sensory neuropathy, myocardial depression, pancytopenia, dysrhythmias, respiratory failure, consumption coagulopathy. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery may be accompanied by rebound leukocytosis and reversible alopecia starting about one week after the initial ingestion.
No antidote is available.
Elimination of toxins by gastric lavage within one hour of acute poisoning. Consider oral activate charcoals 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 of presentation.
Haemodialysis has no efficacy (high apparent distribution volume).
Close clinical and biological monitoring in hospital environment.
Symptomatic and supportive treatment: control of respiration, maintenance of blood pressure and circulation, correction of fluid and electrolytes imbalance.
The lethal dose varies strongly (7–65 mg in one dose), but for adults it is generally about 20 mg.
5 years.
Shelf life after first opening of the tablet container is 6 months.
Store below 25°C. Store in the original package in order to protect from light.
Colchicine Tiofarma 500 microgram Tablets are available in:
Blisters:
Containers:
Not all pack sizes may be marketed.
No special requirements.
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