Colchicine 500 mcg 100 tablets

Colchicine 

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.