Colchicum-dispersant® (Colchicum-dispert®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspcoated tablets
Composition:

1 tablet, coated, contains:

Active substance:

Autumn seedlings of autumn seeds extract [eq. 500 μg colchicine] [in the extract of 57-64% lactose, 28-32% cellulose microcrystalline] 15.6 mg;

Excipients:

Core

Copovidone 5.33 mg.

Corn starch 27.5 mg.

Lactose Monohydrate 41.6-43.9 mg.

Magnesium stearate 0.33 mg.

Palmitostearic acid 1.34 mg.

Talc 7.00 mg.

Microcrystalline cellulose 3.6-5.2 mg.

Shell

Acacia gum 0.3 mg.

Carnauba Wax 0.140 mg.

Carmellose sodium 0.273 mg.

Magnesium oxide 2.6 mg.

Macrogol 6000 1.093 mg.

Opalux AS 250000 [sucrose 0.7923 mg, Ponso 4R (E124) dye 0.22633 mg, quinoline yellow (E104) dye 0.09652 mg, titanium dioxide (E171) 0.07904 mg, povidone 0.0133 mg ] 1.2445 mg.

Povidone - To 25 2.186 mg.

Sucrose 86.1515 mg.

Talc 11, 975 mg.

Titanium dioxide (E171) 3.717 mg.

Shellac 0.32 mg.

Description:

Dark red round glossy tablets, covered with a shell.

Pharmacotherapeutic group:A remedy for treating gout
ATX: & nbsp
  • Colchicine
    • Pharmacodynamics:

    The antipodal action of colchicine is associated with a decrease in the migration of leukocytes to the focus of inflammation and the inhibition of phagocytosis of microcrystals of uric acid salts. It also has antimitotic action, suppresses (in whole or in part) cell division in the anaphase and metaphase stage, prevents degranulation of neutrophils.Reducing the formation of amyloid fibrils, prevents the development of amyloidosis.

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

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

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

    Increases the life expectancy of patients with primary ALamyloidosis.

    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 maximum concentration in blood plasma is 4.2 ng / ml and is reached approximately 70 minutes after taking 1 mg dose. The half-life is 9.3 hours. Colchicine quickly penetrates into the fabric, has a high volume of distribution of 473 liters.High concentrations of colchicine are found in the liver, kidneys, spleen, leukocytes and gastrointestinal tract. Colchicine metabolized in the liver and excreted mainly with bile.

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

    Indications:

    - ABOUTsevere attacks of gout;

    - periodic illness (familial Mediterranean fever).

    Contraindications:

    Hypersensitivity, pregnancy, lactation, hepatic and / or renal failure, severe oppression of bone marrow hematopoiesis.

    With extreme caution should be prescribed to patients of old age, as well as with cachexia, which has severe dysfunction of the gastrointestinal tract, cardiovascular system.

    Lactose intolerance, laccase deficiency, sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption. Children under 18 years.

    Carefully:

    Patients with diabetes mellitus (due to the content of sucrose and lactose in the formulation).

    Dosing and Administration:

    Inside.Tablets are swallowed whole, without chewing, squeezed with enough liquid.

    In an acute attack of gout, first take 2 tablets (1 mg colchicine), and then 0.5-1.5 mg every 1-2 hours until pain is relieved. The total dose of the drug taken per day should not exceed 8 mg. Re-appointment according to the scheme of treatment of an acute attack of gout can be carried out not earlier than in 3 days.

    To prevent acute attacks of gout in the first few months of treatment, uricosuric agents take 0.5-1.5 mg daily or every other day (usually) for 3 months.

    Side effects:

    Diarrhea, nausea, vomiting and stomach pain, rare cases of leukopenia (a decrease in the number of white blood cells). 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).

    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 be observed in patients suffering from gout, after taking a total dose of 10 mg or higher for several days.

    Because the colchicine has antimitotic activity, the organs are often affected, for which a high proliferation rate is characteristic.

    Symptomatology of intoxication. Approximately 2-6 hours after ingestion of a toxic dose, burning and perspiration in the throat and in the mouth, urges to vomit and difficulty swallowing, nausea, thirst and vomiting, and then - the urge to urinate and defecate, tenesmus and colic (as a rule , in depleted patients).

    Mucoid-watery and / or hemorrhagic diarrhea can lead to loss of fluid and electrolytes, resulting in the development of hypokalemia, hyponatremia and metabolic acidosis. Often, patients complain of both constriction and pain in the region of the heart. In the future, there is pallor, a decrease in body temperature, cyanosis and dyspnea. Possible development of tachycardia and arterial hypotension (right up to the collapse).

    Neurological disorders. manifested in the form of reduced sensitivity, seizures and symptoms of paralysis. Possible fatal outcome in the first three days due to cardiovascular failure and respiratory paralysis.

    After 1-2 weeks after the treatment of intoxication, a complete,sometimes long-term alopecia. In some cases violations of the kidneys, lungs and liver were noted. There are reports of rare cases of blindness.

    Treatment of intoxication. Treatment can only be symptomatic, which is aimed at stabilizing the cardiovascular system. Intravenously kalelno enter plasma substitutes or isotonic sodium chloride solution with the addition of glucose and electrolytes (mainly, potassium), conduct ECG monitoring.

    To maintain myocardial contractility, you can assign digoxin. If necessary, antibiotic therapy. With increased pressure of the cerebrospinal fluid, dexamethasone; there may be a need for a lumbar puncture. When spasms in the abdomen are prescribed atropine, papaverine or tannalbine. Do not use opiates.

    It may be necessary to use oxygen therapy or in artificial respiration.

    Interaction:

    In combination with cyclosporine, especially in patients with impaired renal function, the likelihood of developing myopathy increases.

    Strengthens the effect of the depressive and sympathomimetic agents.

    It interferes with the absorption of cyanocobalamin.

    Nonsterotid anti-inflammatory drugs and other drugs that cause myelodepression, increase the risk of developing leukopenia and thrombocytopenia.

    Anti-arterial activity reduces cytostatics (increase the concentration of uric acid) and urine acidifying drugs, alkalizing intensify the effect.

    Colchicum-Dyspert® can be used in combination with allopurinol and uricosuric agents.

    Special instructions:

    Treatment should be carried out under thorough hematological and clinical control.

    If there are significant side effects from the GI tract, you should reduce the dose or cancel the drug.

    With a decrease in the number of white blood cells below 3000 / μl and platelets below 100,000 / μl, the reception is stopped until the blood picture is normalized.

    Effect on the ability to drive transp. cf. and fur:

    Does not affect.

    Form release / dosage:
    Pills.
    Packaging:For 20 tablets in Al / PVC / PVDC blister, 1 blister with instructions for use in a cardboard box.
    Storage conditions:

    Store in a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    5 years. The expiration date is indicated on the package.The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N014955 / 01-2003
    Date of registration:13.04.2009 / 24.08.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Solvay PharmaceuticalsSolvay Pharmaceuticals Germany
    Manufacturer: & nbsp
    Representation: & nbspFARMAGATE, LLCFARMAGATE, LLC
    Information update date: & nbsp31.01.2018
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