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COLCHICINE is a brand name for Colchicine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults • Colchicine is indicated for the treatment of acute gout. Important warning! Because of the narrow therapeutic range of colchicine, the recommended maximum dose must not be exceeded. Overdosing, including by ignoring interactions, can lead to a fatal, very painful and irreversible poisoning with a fatal…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Gout Acute gout attack 500 micrograms (2 ml) two to four (2-4) times daily until symptoms are relieved. The course of treatment should end when symptoms are relieved or when a total of 6,000 micrograms (24 ml) have been taken.
No more than 6,000 micrograms (24 ml) 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 should be discontinued immediately as these may be the first signs of an intoxication.
Prophylaxis of gout attack 500 micrograms – 1,000 micrograms per day (2 – 4 ml/day) to be taken in the evening. Paediatric population Colchicine should not be used in children and adolescents. Acute and Recurrent Pericarditis Adults The recommended dose is 500 micrograms/day (2 ml/day) for patients weighing ≤70 kg or in patients with intolerance to higher doses.
The recommended dose is 500 micrograms (2 ml) twice daily for patients with a body weight of >70 kg. Treatment duration is 6 months in recurrent pericarditis and 3 months in acute pericarditis. Paediatric population Colchicine should not be used in children and adolescents.
Familial Mediterranean Fever The dose may be given as a single dose or doses higher than 1,000 micrograms/day (4 ml/day) may be divided and given twice daily. Colchicine dosage should be increased in a stepwise fashion up to a maximum of 3,000 micrograms/day (12 ml/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. g. ≤ 1,000 micrograms/day, 4 ml). Adults 1,000 to 3,000 micrograms per day (4 to 12 ml per day).
Paediatric population 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: - 500 micrograms/day (2 ml/day) in children less than 5 years of age - 1,000 micrograms/day (4 ml/day) in children from 5 to 10 years of age - 1,500 micrograms/day (6 ml/day) in children over 10 years of age In children with amyloid nephropathy, higher daily doses up to 2,000 micrograms/day (8 ml/day) might be needed.
Adverse reactions are listed below by system organ class and in decreasing frequency.
Frequencies are defined as:
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (Cannot be estimated from the available data) Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug.
Table 2 - Frequency of adverse reactions Frequency System Organ Class Very common Common Uncommon Rare Very rare Not known Blood and lymphatic system disorders Bone marrow depression with agranulocytosis, aplastic anaemia, pancytopenia, neutropenia, thrombocytopenia, leukopenia Nervous system disorders Peripheral neuritis, neuropathy.
Gastrointestinal disorders Abdominal pain, nausea, vomiting and diarrhoea Hepatobiliary disorders Hepatotoxicity, transaminases increased Renal and urinary disorders Renal impairment Skin and subcutaneous tissue disorders Urticaria, maculopapular rash, erythema, edema Alopecia, rash Musculoskeletal and connective tissue disorders Myopathy, rhabdomyolysis, muscle weakness Reproductive system and breast disorders Amenorrhoea, dysmenorrhoea, oligospermia, azoospermia Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain Metabolism and nutrition disorders Vitamin B12 deficiency Paediatric population No long-term safety data are available in paediatric patients.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Colchicine is potentially toxic, so it is important not to exceed the dose prescribed by a medical specialist with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur.
Colchicine in patients with pre-existing blood dyscrasias, gastrointestinal disease, elevated aminotransferase, creatinine or troponin levels, severe liver disease, myopathy, bacterial or neoplastic pericarditis should not be used due to the risk of developing neuromuscular toxicity is increased.
If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, or prolonged bleeding, treatment with colchicine should be immediately discontinued and a full haematological investigation should be conducted.
Caution is advised in case of: • Liver or renal impairment • Cardiovascular disease • Gastrointestinal disorders • Elderly and debilitated patients • Patients with abnormalities in blood counts • Pregnant or lactating women Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia).
The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood count are essential. If skin abnormalities (petechiae) occur, blood counts should be checked immediately.
5). Co-administration with P-gp inhibitors and/or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine-induced toxicity including fatalities. 5) and patients should be carefully monitored for adverse effects of colchicine.
P-gp inhibitors and/or strong CYP3A4 inhibitors and renal/hepatic function For patients with an impaired renal or hepatic function, the combined use of colchicine and P-gp inhibitors and/or strong CYP3A4 inhibitors should be avoided whenever possible, as it may be difficult to forecast and control systemic exposure to colchicine.
1. • Patients with blood dyscrasias • Patients with severe renal impairment • Patients with severe hepatic impairment
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. 250 micrograms/step) up to a maximum of 2,000 micrograms/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. Concomitant treatment with other medicinal products 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.
g. ≤ 1,000 micrograms/day) in Familial Mediterranean Fever. The dose should be carefully monitored for adverse effects of colchicine. 4). 3 contraindications. g. ≤ 1,000 micrograms/day) in Familial Mediterranean Fever. The dose should be carefully monitored for adverse effects of colchicine.
4). 3 contraindications. Table 1 – Colchicine dosage instructions Indication Patient Group Dose (μg) Frequency Special Notes Adults 500 micrograms (2 mL) 2–4 times daily Maximum dose: 6,000 micrograms (24 mL) per course. Stop when symptoms resolve or max dose reached.
Wait ≥72 hrs before the next course. Discontinue if diarrhoea or vomiting occurs. Renal impairment 500 micrograms (2 mL) Once daily Avoid with strong CYP3A4/P-gp inhibitors Hepatic impairment 500 micrograms (2 mL) Once daily Avoid with strong CYP3A4/P-gp inhibitors Acute Gout Attack Children Not suitable for paediatric use Adults 500–1,000 micrograms (2–4 mL) Once daily (evening) — Renal impairment 500 micrograms (2 mL) Once daily Avoid with strong CYP3A4/P-gp inhibitors Hepatic impairment 500 micrograms (2 mL) Once daily Avoid with strong CYP3A4/P-gp inhibitors Prophylaxis of gout attack Children Not suitable for paediatric use Adults ≤70 kg or intolerant to high doses 500 micrograms (2 mL) Once daily Duration: 3 months Adults >70 kg 500 micrograms (2 mL) Twice daily Duration: 3 months Renal impairment 500 micrograms (2 mL) Once daily Avoid with strong CYP3A4/P-gp inhibitors Hepatic impairment 500 micrograms (2 mL) Once daily Avoid with strong CYP3A4/P-gp inhibitors Acute Pericarditis Children Not suitable for paediatric use Adults ≤70 kg or intolerant to high doses 500 micrograms (2 mL) Once daily Duration: 6 months Adults >70 kg 500 micrograms (2 mL) Twice daily Duration: 6 months Recurrent Pericarditis Renal 500 Once daily Avoid with strong CYP3A4/P-gp impairment micrograms (2 mL) inhibitors Hepatic […]
In those exceptional cases where continuation of colchicine when starting P-gp inhibitors and/or strong CYP3A4 inhibitors are considered a benefit, despite the potential risk of overdose, significant dose reductions of colchicine dose and careful clinical monitoring should be applied.
Long-term use of colchicine may be associated with vitamin B12 deficiency. In case colchicine is used for treatment of acute gout or for prophylaxis of a gout attack during initiation of urate-lowering therapy Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed.
6). 6). Paediatric population No long-term safety data are available in paediatric patients. The use of colchicine in children is primarily indicated for the indication FMF. Safety and effectiveness in paediatric patients have not been established in indications acute gout, prophylaxis of a gout attack and acute/recurrent pericarditis.
Other warnings Clinical trial data showed a trend for an increased risk of non-cardiovascular death in patients treated with colchicine. There is no clear association between colchicine therapy and non-cardiovascular death, nevertheless caution should be exercised in colchicine-treated patients with chronic coronary disease and with comorbidities that may underlie potential causes of mortality.
The potential benefits and risks should always be weighed, and the patients should be carefully monitored for any signs or symptoms of toxicity. This medicine contains sodium methyl parahydroxybenzoate. This medicine contains Sodium methyl parahydroxybenzoate as an excipient.
May cause allergic reactions (possibly delayed). This medicine Solution contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 1ml of solution, that is to say essentially 'sodium-free'.