Colchicum-dispert 500mkg

indications for use

acute attacks of gout;

periodic illness (familial Mediterranean fever).

mode of application

Inside. The tablets are swallowed whole, without chewing, with a sufficient amount of liquid.

In an acute attack of gout, first take 2 tablets. (1 mg colchicine), and then 0.5-1.5 mg (1-3 tablets) every 1-2 hours until the pain subsides. The total dose of the drug taken per day should not exceed 8 mg. Re-appointment according to the treatment regimen for an acute gout attack can be carried out no earlier than 3 days later.

For the prevention of acute attacks of gout in the first few months of treatment with uricosuric agents, 0.5-1.5 mg are taken daily or every other day for (usually) 3 months.

composition of the medicine

Film-coated tablets are dark red, round, shiny.

1 tab.

dry extract of autumn crop seeds 15.6 mg,

? which corresponds to the content of the sum of alkaloids in terms of colchicine 500 mcg

Excipients: lactose monohydrate, microcrystalline cellulose, corn starch, copovidone, stearin (stearin palmitic acid), magnesium stearate, shellac, gum arabic, povidone K25, light magnesium oxide, macrogol 6000, sucrose oxide, talc, sodium, titanium ), cochineal carmine A, sodium sulfate, white wax, carnauba wax.

contraindication

hypersensitivity;

pregnancy;

lactation period;

liver failure;

renal failure;

pronounced suppression of bone marrow hematopoiesis;

Precautions should be taken in elderly patients; with cachexia; having severe gastrointestinal dysfunction; having severe dysfunction of the cardiovascular system

pharmachologic effect

[I] - Instructions for medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation on December 16, 2002.

The anti-gout effect of colchicine is associated with a decrease in the migration of leukocytes to the inflammatory focus and inhibition of the phagocytosis of microcrystals of uric acid salts. It also has an antimitotic effect, suppresses (fully or partially) cell division in the anaphase and metaphase stages, and prevents neutrophil degranulation. By reducing the formation of amyloid fibrils, it prevents the development of amyloidosis.

It is highly effective for the relief of acute gout. In the first 12 hours of therapy, the condition significantly improves in more than 75% of patients. In 80%, it can cause adverse reactions from the gastrointestinal tract before or simultaneously with clinical improvement.

In a daily dose of 1-2 mg with daily intake in 3/4 of patients with gout, it reduces the likelihood of developing repeated acute attacks.

Prevents acute attacks in patients with familial Mediterranean fever (reduces the activity of dopamine beta-hydroxylase).

Increases the life expectancy of patients with primary AL-amyloidosis. It has a positive effect on the skin (softening, reducing dryness) with systemic scleroderma

Pharmacokinetics

Colchicine is rapidly and intensively absorbed from the gastrointestinal tract. The average Cmax in blood plasma is 4.2 ng / ml and is reached approximately 70 minutes after taking a dose of 1 mg. T1 / 2 is 9.3 hours. Colchicine quickly penetrates into tissues, has a high Vd of 473 liters. High concentrations of colchicine are found in the liver, kidneys, spleen, leukocytes and gastrointestinal tract. Colchicine is metabolized in the liver and excreted mainly in the bile.

Enterohepatic circulation is detected 4-6 hours after oral administration. The largest part of the administered dose is excreted through the intestines and about 23% - by the kidneys.

Side effect

Diarrhea, nausea, vomiting and stomach pain, rare cases of leukopenia (decreased white blood cell count). In some cases, after long-term treatment, myopathy and neuropathy were observed, less often - agranulocytosis, hypoplastic anemia (change in the number of blood cells), alopecia (baldness).

Application during pregnancy and lactation

Contraindicated during pregnancy and lactation.

Application for violations of liver function

Contraindicated: liver failure.

Application for impaired renal function

Contraindicated: renal failure.

Use in elderly patients

With extreme caution should be prescribed to elderly patients.

special instructions

Treatment must be carried out under close hematological and clinical supervision.

If severe side effects from the gastrointestinal tract appear, the dose should be reduced or the drug should be discontinued.

With a decrease in the number of leukocytes below 3000 / μl and platelets below 100,000 / μl, the intake is stopped until the blood picture normalizes.

Influence on the ability to drive vehicles and control mechanisms: no effect.

Overdose

Acute intoxication was observed in adults after taking a dose of about 20 mg and in children after taking a dose of 5 mg.

Chronic intoxication can occur in patients with gout after taking a total dose of 10 mg or more for several days.

Since colchicine has antimitotic activity, organs with a high proliferation rate are more often affected.

Symptoms: approximately 2-6 hours after ingestion of a toxic dose, there is a burning sensation and perspiration in the throat and mouth, the urge to vomit and difficulty swallowing, nausea, thirst and vomiting, and after that - the urge to urinate and defecate, tenesmus and colic ( usually in emaciated patients).

Mucous-watery and / or hemorrhagic diarrhea can lead to loss of fluid and electrolytes, as a result of which hypokalemia, hyponatremia and metabolic acidosis may develop. Patients often complain of both oppression and pain in the heart area. In the future, there is pallor, a decrease in body temperature, cyanosis and dyspnea. Development of tachycardia and arterial hypotension (up to collapse) is possible.

Neurological disorders manifest themselves in the form of decreased sensation, seizures and paralysis symptoms. Death in the first three days is possible due to cardiovascular failure and respiratory paralysis.

1-2 weeks after the cure of intoxication, complete, sometimes long-term alopecia can be observed. In some cases, there were impaired renal, lung and liver function. There are reports of rare cases of blindness.

Treatment can only be symptomatic, aimed at stabilizing the cardiovascular system. Plasma substitutes or isotonic sodium chloride solution with the addition of glucose and electrolytes (mainly potassium) are injected intravenously, and the ECG is monitored.

Digoxin can be given to maintain myocardial contractility. If necessary, antibiotic therapy. With increased cerebrospinal fluid pressure, dexamethasone is indicated; lumbar puncture may be necessary. With spasms