Colchicine 500 mcg 100 tablets
Composition
Each tablet contains
Colchicine - 500 mcg.
Excipients: corn starch, lactose monohydrate, talc powder, Avisel RN 101, Povidone K25.
Properties
Colchicine can interfere with the intracellular inflammatory complex present in neutrophils and monocytes, which promotes the activation of interleukin-1B. In addition, colchicine disrupts cytoskeletal functions by inhibiting the polymerization of B-tubulin in microtubules and prevents the activation, degranulation, migration of neutrophils, which are believed to affect some symptoms of gout.
Indications
Prevention and treatment of gout flares in adults. Familial Mediterranean fever (FMF) in adults and children aged 4 years and older. Colchicine is not an analgesic drug and should not be used to treat pain.
Directions for use
For gout flare-ups: prevention – 0.5, 1 mg 1 or 2 times a day for adults and adolescents over 16 years of age. Maximum dose 2 tablets (0.5 mg) or 1 tablet (1 mg) per day. Treatment of gout flare-ups: 1 mg (2 tablets) at the first signs of a gout flare-up, then 0.5 mg (1 tablet) an hour later.
FMF: adults and children over 12 years – 1-2 mg (2-4 tablets of 0.5 mg), children from 6 to 12 years old – 1-2 mg (2-4 tablets of 0.5 mg), children from 4 to 6 years old – 0.5-2 mg (1-4 tablets of 0.5 mg). Give the total dose divided into 1 or 2 doses per day. Increase or decrease the dose as directed and allow for increases of 0.5 mg/day, without exceeding the maximum recommended dose for administration. Colchicine tablets are administered orally, with or without food.
Contraindications
with caution in patients with renal or hepatic impairment. Life-threatening and fatal toxicity of colchicine has been reported in these patients when administered at therapeutic doses.
Precautions
fatal overdoses have been reported in children. Neuromuscular toxicity: myotoxicity, including rhabdomyolysis, may occur, especially in combination with other drugs known to cause this effect. In this case, temporary interruption or discontinuation of Colchicine should be considered.
Adverse reactions
for gout prophylaxis: diarrhea. For gout treatment: diarrhea (23%) and sore throat (3%). In FMF: most common (up to 20%) – abdominal pain, diarrhea, nausea and vomiting. These effects are usually mild, short-term and reversible.
Pregnancy, category C. Although not studied in the treatment of gout and data are limited, colchicine causes toxicity to embryo-fetal cells. Colchicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: colchicine is excreted in breast milk. Special caution should be exercised and breastfeeding should be discontinued when taking the drug, consult a doctor.
Drug interactions
With antibacterial agents: increased risk of colchicine development when taking clarithromycin or erythromycin. With cyclosporines: increased risk of nephrotoxicity and myotoxicity when taking colchicine with cyclosporine (increased plasma cyclosporine concentration).
Storage method
Store at a temperature not exceeding 30C in a dry place, inaccessible to children.
Packaging
Cardboard box of 100 tablets, 10 blisters of 10 tablets.