Colchicina Seid

Colchicina Seid Liều dùng/Hướng dẫn sử dụng

colchicine

Nhà sản xuất:

Seid S.A

Nhà phân phối:

Nafarma
Thông tin kê toa chi tiết tiếng Anh
Dosage/Direction for Use
Colchicine has a narrow therapeutic window and is extremely toxic in the event of overdose. The dose indicated as follows must never be exceeded as it may prove fatal.
Oral use.
The recommended dose depends on the age of the patient, renal and hepatic function and the concomitant use of other medicinal products (see Precautions and Interactions).
Adults: Acute attack of gout: The recommended dose is 1 tablet (1 mg) at the first sign of an acute attack. If pain relief is not achieved, a second tablet (1 mg) may be administered one or two hours after the first dose. Doses higher than 2 mg in 24 hours must not be administered. Doses higher than 2 mg per day have demonstrated increased adverse effects with no benefit in terms of efficacy.
This dosage regimen may be administered for up to 4 consecutive days, with a total cumulative dose of 6 mg in 4 days. If necessary due to persistence of gout-related pain, the regimen described previously may be repeated after a three day treatment-free "wash-out" period.
Preventative treatment of gout attacks during initial therapy with allopurinol or uricosuric agents: The recommended dose for preventive treatment of gout attacks is 1 mg per day.
Periodic disease or familial Mediterranean fever: The recommended dose is 1 to 2 mg per day. This may be divided into two daily doses or taken as a single dose.
Treatment of chronic gout: The recommended dose for the treatment of chronic gout is 1 mg per day.
Children and adolescents under 18 years of age: Acute gout attack, prevention of gout attacks and chronic gout: There are insufficient data to establish recommendations in this age group.
Periodic disease or familial Mediterranean fever: The recommended dose in children over 12 years is 1 to 2 mg per day. This may be divided into two daily doses or taken as a single dose.
Although the presentation of this medicinal product does not allow for an appropriate dosage in children younger than 12 years, for information purposes the dose in children aged 4 to 6 years would be 0.3 to 1.8 mg per day and the dose in children aged 6 to 12 years would be 0.9 to 1.8 mg per day. These doses may be administered in a single dose or divided into two doses.
Renal failure: No dose adjustment is required in patients with mild renal failure (creatinine clearance 50-80 ml/min), although close monitoring is recommended due to the possible appearance of adverse effects (see Precautions and Pharmacology: Pharmacokinetics under Actions). Should these appear, dose reduction may be necessary.
The dose may need to reduced by half and/or the interval between doses may need to be increased in patients with moderate renal failure (creatinine clearance 30-50 ml/min).
The use of colchicine is contraindicated in patients with severe renal failure (creatinine clearance <30 ml/min) (see Contraindications).
Hepatic insufficiency: No dose adjustment is required in patients with mild or moderate hepatic insufficiency, although close monitoring is recommended due to the possible appearance of adverse effects (see Precautions and Pharmacology: Pharmacokinetics under Actions). Should these appear, dose reduction may be necessary.
Although a dose reduction is required in patients with severe hepatic insufficiency, the presentation of this medicinal product does not allow this; therefore the use of colchicine would be contraindicated in such patients (see Contraindications).
Elderly patients and special populations: Other alternative therapies should be used in elderly patients or in those with renal or hepatic disorders. If it is decided to administer colchicine in these patients, the cumulative dose must not exceed 3 mg in a four-day period instead of 6 mg in the adult population (see Dosage & Administration).