Description

Compound: Each tablet contains:

Colchicine – 500 mcg.

Auxiliary components: corn starch, lactose monohydrate, talc powder, Avisel PH 101, Povidone K25.

Properties: colchicine can be incorporated into the intracellular inflammatory complex present in neutrophils and monocytes, which promotes the activation of interleukin-1B. In addition, colchicine impairs cytoskeletal function by inhibiting B-tubulin polymerization in microtubules and prevents the activation, degranulation, and migration of neutrophils, which are thought to influence some of the symptoms of gout.

Indications: prevention and treatment of gout attacks in adults. Familial Mediterranean fever (FMF) in adults and children aged 4 years and older. Colchicine is not a pain reliever and should not be used to treat pain.

Mode of application: For attacks of gout: prophylaxis – 0.5, 1 mg 1 or 2 times a day for adults and adolescents over 16 years of age. The maximum dose is 2 tablets (0.5 mg) or 1 tablet (1 mg) per day. Treatment of attacks of gout: 1 mg (2 tablets) at the first sign of an exacerbation of gout, then 0.5 mg (1 tablet) an hour later. FMF: adults and children over 12 years old – 1-2 mg each (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, 0.5-2 mg (1-4 tablets of 0.5 mg). The total dose should be divided into 1 or 2 doses per day. Increase or decrease the dose as directed and increments of 0.5 mg/day are allowed without exceeding the maximum recommended intake. Colchicine tablets are taken by mouth with or without food.

Contraindications: with caution in patients with renal or hepatic insufficiency. In such patients, life-threatening and fatal toxicity of colchicine has been reported at therapeutic doses. Precautionary measures: Fatal overdoses have been reported in children. Neuromuscular toxicity: Myotoxicity, including rhabdomyolysis, may occur, especially when combined with other drugs known to cause this effect. In this case, temporary interruption or discontinuation of colchicine should be considered. Side effects: in the prevention of gout: diarrhea. In the treatment of gout: diarrhea (23%) and sore throat (3%). With FMF: most often (up to 20%) – abdominal pain, diarrhea, nausea and vomiting. These effects are usually mild, short-lived, and reversible. Pregnancy Category C. Although not studied in the treatment of gout and data are limited, colchicine causes fetal cell toxicity. Colchicine should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. Lactation: Colchicine is excreted in breast milk. You should be especially careful and stop breastfeeding while taking the drug, consult your doctor.

Drug interaction. With antibacterial agents: increased risk of side effects of colchicine when taking clarithromycin or erythromycin. With cyclosporins: increased risk of nephrotoxicity and myotoxicity when taking colchicine with cyclosporine (increased plasma concentrations of cyclosporine).

Storage method: Store at a temperature not exceeding 30C in a dry place out of the reach of children.