Expiration date: 08/2025
The composition and form of issue:
Tablets, film-coated. 1 tablet contains:
dry extract from seeds of Colchicum autumnale 15, 6 mg
(in terms of the colchicine — 0, 5 mg)
excipients: lactose monohydrate corn starch microcrystalline copovidone acid steuerpolitische magnesium stearate, shellac, gum Arabic, povidone K25 magnesium oxide macrogol 6000 sucrose talc titanium oxide sodium carmellose amaranth E123 kostelny Carmine And sodium sulfate white and Carnauba wax
blistere in 20 PCs. in cardboard box 1 blister or in blister, 25 PCs in a carton carton 2 blisters.
Feature:
Deep red round shiny tablet, coated.
Pharmacological action:
Reduces the migration of leukocytes to focus of inflammation and inhibits phagocytosis of microcrystals of uric acid salts. Has antimitotic effect inhibits (partially or fully) cell division at the stage of anaphase and metaphase, prevents degranulation of neutrophils. Reduces the formation of amyloid fibrils, and prevents the development of amyloidosis.
Pharmacokinetics:
Quickly and rapidly absorbed from the gastrointestinal tract. Cmax in blood plasma after administration at a dose of 1 mg is 4, and 2 ng/ml and is reached after 70 min. T1/2 — 9, 3 h. Quickly penetrates the tissues, the volume of 473 l. In the high concentrations found in the liver, kidney, spleen, white blood cells and the gastrointestinal tract. Metabolized by the liver and excreted mainly in the bile through the intestines and about 23% through the kidneys. Once inside the enterohepatic circulation is detected after 4-6 h.
Description pharmacological action:
Effective for relief of acute attacks of gout: the first 12 hours of therapy significantly improves the condition of 75% of the patients (80% of patients causes side effects from the gastrointestinal tract before clinical improvement or simultaneously with it). Reduces the probability of recurrent acute attacks 3/4 patients with a daily intake of a daily dose of 1-2 mg. Prevents acute attacks in patients with familial Mediterranean fever (lowers the activity of dopamine-beta-hydroxylase). Increases life expectancy of patients with primary AL-amyloidosis. Has a positive effect on the skin in systemic sclerosis (reduced, reducing dryness).
Indications:
Gout (acute attack, prevention of gouty attack), periodic disease (familial Mediterranean fever).
Contraindications:
Hypersensitivity, liver and/or kidney failure, severe mielodepressiya, pregnancy, breast-feeding.
Application of pregnancy and breast-feeding:
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Side effects:
From the digestive tract: diarrhea, nausea, vomiting, stomach pain.
From the cardiovascular system and blood (hematopoiesis, hemostasis): rarely — leukopenia, agranulocytosis, aplastic anemia.
Other: in some cases, myo - and neuropathy, alopecia.
Drug interactions:
When used together with cyclosporine (especially in patients with impaired renal function) increased risk of myopathy with NSAIDs and other drugs, causing mielodepressiu — the risk of leukopenia and thrombocytopenia. Compatible with allopurinol and uricosuric drugs of action. Enhances the effect of inhibitory and sympathomimetic agents. Gives the absorption of cyanocobalamin. Protivopodagricescuu activity lower cytostatics (increase the concentration of uric acid) and urine sakikawa drugs, — increased urine alkalizing agents.
Method of application and dose:
Inside. Pills proglatyvayut is not liquid, squeezed enough liquid. During an acute attack of gout first take 2 table. (1 mg in terms of colchicine), 0, 5-1, 5 mg every 1-2 h until relief of pain (total dose per day should not exceed 8 mg). Reappointment scheme treatment of acute attack of gout can be conducted not earlier than 3 days. For the prevention of acute gout attacks in the first few months of treatment urikozuricescie means — for 0, 5-1, 5 mg daily or every other day for 3 months.
Overdose:
Symptoms: acute intoxication observed in adults after administration of doses of about 20 mg (in terms of colchicine) in children, 5 mg (equivalent colchicine) chronic intoxication in patients with gout after receiving a total dose of 10 mg and above in a few days.
The defeat exposed organs with a high rate of proliferation (because colchicine has antimitotic activity). After ingestion of toxic dose 2-6 h to develop a burning sensation and sore throat and mouth, urge to vomit, difficulty swallowing, nausea, thirst, vomiting, urination and defecation, tenesmus, and colic (usually with a sunken stomach) hypokalemia, hyponatremia and metabolic acidosis (due to Muco-watery and/or hemorrhagic diarrhea). Often, patients complain at the same time on the neuralgia, chest tightness and pain in the precordial region. With the further development of intoxication observed pale, low body temperature, cyanosis and dyspnoea. May develop tachycardia and hypotension up to the collapse. Neurological disorders are manifested in the form of lower sensitivity, spasms and symptoms of paralysis. The deadly outcome is possible in the first 3 days due to cardiovascular failure and respiratory paralysis.
Treatment: gastric lavage, symptomatic treatment aimed at stabilizing the function of the cardiovascular system (in/in drip introduction of plasma substitutes or isotonic sodium chloride solution with added glucose and electrolytes, digoxin, for maintenance of myocardial contractility) under control of ECG indication — oxygen therapy and artificial respiration. As a protective measure it is possible to conduct antibiotic treatment (carbenicillin, etc.), at elevated pressure of the cerebrospinal fluid — the introduction of dexamethasone (according to indications — lumbar puncture), for cramps in the stomach, atropine, papaverine, etc. (should not be used opiates). Necessary to monitor the function of organs, increased risk (liver, kidneys, bone marrow).
1-2 weeks after the treatment of possible intoxication full, sometimes permanent alopecia in some cases — violation of the kidney, lung and liver, rarely — blindness.
Precautions:
Treatment should be under close clinical and haematological control. When expressed adverse reactions from the gastrointestinal tract should reduce the dose of the drug. By reducing the number of leukocytes less 3?109 /l, and platelets below 1?106 /l reception should cease to normalize blood picture.
With caution should appoint patients of an older age, with cachexia, severe disorders of gastrointestinal function and diseases of the cardiovascular system.
