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Pilzona com июн 21, 2022 The theme of health 0 Comments

Medicinal products M04A C01 Colchicine

Active substance COLCHICINUM* (COLCHICIN*)

Pharmacological properties


Colchicine binds to microtubules at the stage of interphase cell division, inhibits the polymerization of microtubules and thus prevents the formation of a cytoskeletal structure, reduces mobility and degranulates intracellular lysosomes. So, colchicine simultaneously acts as a toxin and reduces the release of lysosomes, chemoattractants and lactic acid. By acting on leukocytes, colchicine inhibits the phagocytosis of uric acid crystals.It disrupts the cell membrane of leukocytes and reduces their mobilization, migration and adhesive ability. Colchicine reduces the invasion of new granulocytes and prevents cell division and migration. Colchicine does not affect the concentration of uric acid in the blood and tissues.

Pharmacokinetics. Suction.

Colchicine is rapidly and efficiently absorbed from the gastrointestinal tract. Approximately 60 minutes after taking 2 coated tablets (containing a total of 2 x 0.5 mg alkaloids, 2 x 0.38 mg colchicine), a peak plasma level of colchicine of 4.2 ng / ml was recorded. Distribution. The oral bioavailability of colchicine is 25-50%. In plasma, colchicine is weakly or moderately bound to proteins (30-50%) and, after reabsorption, is rapidly excreted from the blood plasma and distributed in various tissues.Colchicine is rapidly distributed in peripheral blood leukocytes, and its concentration in these cells after 72 hours may exceed the concentration in blood plasma (after 15 minutes, the concentration is 5 times higher than the concentration in blood plasma). It has been established that colchicine has a beneficial effect in the treatment of acute gout by acting on polymorphonuclear leukocytes. Colchicine accumulates predominantly in leukocytes, which justifies the beneficial effect of colchicine in gouty arthritis due to the inhibition of granulocyte migration to the area of ​​inflammation.

Metabolism and excretion.

Colchicine is partially acetylated in the liver and slowly metabolized in other tissues. Excretion of the drug and its metabolites mainly occurs with feces, only 10-20% is excreted in the urine. The percentage of excretion in the urine may be greater in patients with impaired liver function. Due to the high concentration of colchicine in tissues, only 10% of a single dose is excreted within 24 hours. Elimination of colchicine may continue for > 10 days after treatment. After taking colchicine at a dose of 1 mg, the half-life was 4.4 hours in patients with normal renal function and 18.8 hours in patients with renal dysfunction.

Indications and usage of Kolhikum-Dispert

Adults - treatment of acute attacks of gout; - prevention of gout attacks; – treatment of pericarditis and prevention of recurrent pericarditis; - Behçet's disease. Adults, children and adolescents for familial Mediterranean fever to prevent attacks and prevent amyloidosis.

Application Kolhikum-Dispert

Tablets should be swallowed whole with a sufficient amount of liquid, regardless of the meal. Treatment of acute gout attacks should begin as soon as possible (within the first 12 hours of the onset of a gout attack). The expected effect will come within 12 hours. First you should take 2 tablets (1 mg), then after 1 hour 1 tablet (0.5 mg). After this, the tablets should not be taken within 12 hours. If necessary, after 12 hours, you can repeat the reception. The maximum daily dose is 1 tablet (0.5 mg) every 8 hours until the symptoms subside. The course of treatment must be completed after symptom relief or after taking 12 tablets (6 mg). During the course of treatment, no more than 12 tablets (6 mg) should be taken.A second course of treatment is carried out no earlier than 3 days (72 hours) after the end of the previous course. Prevention of gout attacks: adults should take 1-2 tablets (0.5-1 mg) for no more than 6 months. The individual duration of treatment should be determined after assessing such factors as the frequency of exacerbations, the duration of the disease, and the presence and size of tophi.Treatment of familial Mediterranean fever. May be taken as a single dose or divided into multiple doses greater than 1 mg per day and taken twice daily. The dosage of colchicine should be increased in steps up to a maximum of 3 mg per day to control the course of the disease in the absence of a response to treatment at the standard dosage. Dose increases should be carefully monitored to avoid side effects. Careful monitoring is necessary in the presence of impaired renal or hepatic function.

For such patients, the initial dose should be reduced by 50%. Adults take 2-6 tablets (1-3 mg) per day. Most patients require 1-1.5 mg per day, but some patients may require doses of 2.0 mg or more.

Colchicine should only be taken by a doctor under the supervision of a healthcare professional in children. The recommended dose of colchicine for children is: - 1 tablet (0.5 mg) per day for children under 5 years of age; - 1-2 tablets (0.5-1 mg) per day for children aged 5 to 10 years; - 2-3 tablets (1-1.5 mg) per day for children over the age of 10 years.Children with amyloid nephropathy may require large daily doses of 3 to 4 tablets (1.5-2 mg) per day. Treatment of acute pericarditis and recurrent pericarditis. The recommended daily dose of colchicine for acute and recurrent pericarditis is 1-2 tablets (0.5 mg 1 mg) per day. In most clinical studies, the dose of colchicine used is 2 tablets (1 mg). Behçet's disease. The recommended dose of colchicine is 2-4 tablets (1-2 mg) per day. Impaired kidney function. Caution should be used in patients with mild renal impairment. For patients with moderate renal impairment, it is necessary to reduce the dose or increase the interval between doses.Such patients should be carefully monitored for side effects of colchicine. For information on the treatment of patients with severe renal impairment.

CONTRAINDICATIONS. Impaired liver function. Caution should be used in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for side effects of colchicine. For patients with severe liver dysfunction.Special groups of patients. The simultaneous use of colchicine with certain drugs, mainly inhibitors of cytochrome P450 3A4 (CYP3A4) / P-glycoprotein, increases the risk of colchicine toxicity. If the patient has received concomitant therapy with a moderate or potent CYP3A4 inhibitor or a P-glycoprotein inhibitor, the maximum recommended oral dose of colchicine should be reduced and the occurrence of side effects carefully monitored.


The drug is not recommended for use in children under 4 years of age due to insufficient data on the use. Contraindications hypersensitivity to colchicine or to the components of the drug. Patients with impaired renal or hepatic function should avoid the use of colchicine with P-glycoprotein inhibitors or strong inhibitors of CYP3A4 due to an increased risk of adverse effects of colchicine. Life-threatening and lethal toxicity of colchicine has been reported in these patients at therapeutic doses.The drug is contraindicated in patients who are on dialysis. Side effects with short-term and long-term use of frequent adverse reactions in patients who started taking colchicine, adverse reactions from the gastrointestinal tract, such as diarrhea, which usually appear within 24 hours. Typical symptoms are cramps, nausea, diarrhea, abdominal pain, and vomiting. In case of severe adverse reactions, the dose should be reduced as this may lead to greater toxicity.To reduce adverse reactions from the gastrointestinal tract during an acute attack of gout, the dose should be reduced. Depending on the frequency of occurrence of adverse reactions, they are divided into the following categories: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥ 1/10000, <1/1000), very rare (<1/10000), and also with an unknown frequency (cannot be estimated from the available data). The following are known side effects of colchicine, which are usually reversible after a temporary interruption of treatment.


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