Kolkhikum-dispert
Producer: Solvay Pharmaceuticals, (Solvey Pharmasyyutikalz) GmbH Germany
Code of automatic telephone exchange: M04AC01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: dry extract from seeds of an autumn crocus of autumn 15,6 mg, (in terms of colchicine — 0,5 mg)
Excipients: lactoses monohydrate; MKTs; corn starch; коповидон; acid stearinpalmitinovy; magnesium stearate; shellac; arabic gum; K25 povidone; magnesium oxide; macrogoal 6000; sucrose; talc; titanium oxide; sodium of a karmelloz; E123 amaranth; cochineal carmine And; sodium sulfate; white and karnaubsky wax.
Pharmacological properties:
Antigouty effect of colchicine is connected with decrease in migration of leukocytes in the center of an inflammation and oppression of phagocytosis of microcrystals of salts of uric acid. Possesses also antimitotic action, suppresses (in whole or in part) cellular division in a stage of an anaphase and metaphase, prevents degranulation of neutrophils. Reducing formation of amyloid fibrilla, interferes with development of an amyloidosis.
It is highly effective for stopping of acute gout. In the first 12 h therapy the state significantly improves more than at 75% of patients. Can cause side reactions from a GIT of earlier clinical improvement in 80% or along with it.
In a daily dose of 1-2 mg at daily reception at 3/4 patients with gout reduces probability of development of repeated bad attacks.
Prevents the acute attacks at patients with family Mediterranean fever (dopamine - beta hydroxylases lowers activity).
Increases life expectancy of patients with primary AL amyloidosis. Exerts positive impact on skin (mitigation, dryness reduction) at a system scleroderma.
Pharmacokinetics. Colchicine is quickly and intensively soaked up from a GIT. Average Cmax in a blood plasma makes 4.2 ng/ml and is reached approximately in 70 min. after reception in a dose of 1 mg. T1/2 makes 9.3 h. Colchicine quickly gets into fabrics, has high Vd of 473 l. High concentration of colchicine are found in a liver, kidneys, a spleen, leukocytes and a GIT. Colchicine is metabolized in a liver and removed mainly with bile.
Enterogepatichesky circulation is found in 4 — 6 h after introduction inside. The greatest part of the entered dose is removed through intestines and about 23% - kidneys.
Indications to use:
— bad attacks of gout;
— periodic disease (family Mediterranean fever).
Route of administration and doses:
Inside. Tablets are swallowed entirely, without chewing, washing down with enough liquid.
At a bad attack of gout accept at first 2 таб. (1 mg of colchicine), and then on 0.5-1.5 mg (1-3 таб.) in each 1-2 h before easing of pain. The total dose of drug accepted in a day should not exceed 8 mg. Repeated appointment according to the scheme of treatment of a bad attack of gout can be carried out not earlier than in 3 days.
For prevention of bad attacks of gout in the first several months of treatment by uricosuric means accept 0.5-1.5 mg daily or every other day within (usually) 3 months.
Features of use:
Treatment needs to be carried out under careful hematologic and clinical control.
At emergence of the expressed side effects from a GIT it is necessary to reduce a dose or to cancel drug.
At decrease in quantity of leukocytes is lower 3000/mkl and thrombocytes below 100000/mkl reception is stopped before normalization of a picture of blood.
Influence on ability to driving of motor transport and to control of mechanisms: does not influence.
Side effects:
Diarrhea, nausea, vomiting and stomach aches, exceptional cases of a leukopenia (reduction of number of white blood cells). In certain cases after prolonged treatment the myopathy and a neuropathy was observed, is more rare — an agranulocytosis, hypoplastic anemia (change of number of uniform elements of blood), an alopecia (baldness).
Interaction with other medicines:
In combination with cyclosporine, especially at patients with disturbance of a day lily of kidneys, the probability of development of a myopathy increases.
Strengthens effect of deprimiruyushy and sympathomimetic means.
Breaks cyanocobalamine absorption.
NPVS and other drugs causing a miyelodepressiya increase risk of development of a leukopenia and thrombocytopenia.
Antigouty activity is reduced by cytostatics (increase concentration of uric acid) and the drugs acidifying urine. Alkalizing - strengthen effect.
Kolkhikum-Dispert it is possible to apply in a combination with Allopyrinolum and drugs of uricosuric action.
Contraindications:
— hypersensitivity;
— pregnancy;
— lactation period;
— liver failure;
— renal failure;
— the expressed oppression of a marrowy hemopoiesis;
With care it is necessary to appoint the patient of advanced age; with a cachexia; the GIT having heavy dysfunctions; having heavy dysfunctions of cardiovascular system.
Use at a renal failure
Protiovopokazano: renal failure.
Use at an abnormal liver function
Contraindicated: liver failure.
Overdose:
Acute intoxication was observed at adults after reception of a dose about 20 mg and children after reception have doses of 5 mg.
Chronic intoxication can be observed at the patients having gout after reception of a total dose of 10 mg or is higher within several days.
As colchicine has antimitotic activity, bodies of which the high speed of proliferation is characteristic are exposed to defeat more often.
Symptoms: approximately in 2-6 h after intake of a toxic dose burning and irritation in a throat and in a mouth, desires to vomiting and the complicated swallowing, nausea, thirst and vomiting, and after that — desires to an urination and defecation, tenesmus and gripes are noted (as a rule, at the exhausted patients).
Mucous and watery and/or hemorrhagic diarrhea can cause loss of liquid and electrolytes owing to what development of a hypopotassemia, hyponatremia and metabolic acidosis is possible. Often patients complain at the same time of constraint and pain in heart. Further pallor, decrease in body temperature, cyanosis and диспноэ is observed. Development of tachycardia and arterial hypotension (is possible up to a collapse).
Neurologic frustration are shown in the form of decrease in sensitivity, spasms and symptoms of paralysis. Death in the first three days owing to cardiovascular insufficiency and paralysis of breath is possible.
In 1-2 weeks after treatment of intoxication the long-term alopecia can be observed full, sometimes. Renal failures, lungs and a liver were in certain cases noted. There are messages on exceptional cases of a blindness.
Treatment can be only symptomatic, directed to stabilization of cardiovascular system. In/in kapelno enter plasma substitutes or isotonic solution of sodium of chloride with additive of glucose and electrolytes (mainly, potassium), carry out monitoring of an ECG.
For maintenance of contractility of a myocardium it is possible to appoint digoxin. If necessary — an antibioticotherapia. At supertension of cerebrospinal fluid dexamethasone is shown; there can be a need for carrying out a lumbar puncture. At spasms in a stomach appoint atropine, a papaverine or танналбин. It is not necessary to apply opiates.
There can be a need for use of an oxygenotherapy or for carrying out an artificial respiration.
Storage conditions:
In the dry, protected from light place, at a temperature not above 25 °C.
To store in the place, unavailable to children.
Issue conditions:
Without recipe
Packaging:
In the blister of 20 pieces; in a box the cardboard 1 blister or in the blister of 25 pieces; in a box cardboard 2 blisters.