Composition, form of production and packaging
Solution for w / m and s / to the introduction in the form of a transparent, colorless liquid.
1 ml
ipidakrine hydrochloride (in the form of monohydrate) 5 mg
Auxiliary substances: 0.1 M solution of hydrochloric acid - to pH 3.0, water d / u - up to 1 ml.
1 ml - ampoules of colorless glass (5) - packings of cellular outlines from polyvinylchloride film (2) - packs of cardboard.
Solution for w / m and s / to the introduction in the form of a transparent, colorless liquid.
1 ml
ipidakrine hydrochloride (in the form of monohydrate) 15 mg
Auxiliary substances: 0.1 M solution of hydrochloric acid - to pH 3.0, water d / u - up to 1 ml.
1 ml - ampoules of colorless glass (5) - packings of cellular outlines from polyvinylchloride film (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
The reversible inhibitor of cholinesterase directly stimulates the impulse in the neuromuscular synapse and in the central nervous system due to the blockade of the potassium channels of the membrane. Strengthens the effect on the smooth muscles of not only acetylcholine, but also adrenaline, serotonin, histamine and oxytocin. Aksamon В® has the following pharmacological effects:
- improves and stimulates impulse in the nervous system and neuromuscular transmission;
- improves conductivity in the peripheral nervous system, impaired due to injuries, inflammation, the effects of local anesthetics, certain antibiotics, potassium chloride, etc .;
- increases the contractility of smooth muscle organs under the influence of agonists acetylcholine, adrenaline, serotonin, histamine and oxytocin receptors, with the exception of potassium chloride;
- improves memory, inhibits the gradual development of dementia.
Does not have teratogenic, embryotoxic, mutagenic, carcinogenic and immunotoxic effects. Does not affect the endocrine system.
PHARMACOKINETICS
Suction and distribution
When n / k and / m introduction is rapidly absorbed. C max in the blood is reached after 25-30 minutes after administration.
Binding to blood plasma proteins - 40-50%. The drug quickly enters the tissues.
Metabolism and excretion
Metabolised in the liver. Removal of the drug is carried out through the kidneys (mainly by tubular secretion and only 1/3 by glomerular filtration) and extrarenally (through the gastrointestinal tract). T 1/2 of the drug Aksamon В® for parenteral administration is 2-3 hours. After parenteral administration, 34.8% of the drug dose is excreted unchanged in the urine.
INDICATIONS
- diseases of the peripheral nervous system: mono- and polyneuropathy, polyradiculopathies, myasthenia gravis and myasthenic syndrome of various etiologies;
- diseases of the central nervous system: bulbar paralysis and paresis, the recovery period of organic lesions of the CNS, accompanied by motor disorders;
atony of the intestine.
DOSING MODE
The drug is injected sc or v / m. Doses and duration of treatment are determined individually, depending on the severity of the disease.
Diseases of the peripheral nervous system
Mono- and polyneuropathies of various genesis, polyradiculopathy: SC or IM 5-15 mg 1-2 times / day, course 10-15 days (in severe cases - up to 30 days); further treatment continues with the tablet form of the drug.
Myasthenia gravis and myasthenic syndrome: sc or 15-30 mg 1-3 times / day with a further transition to the tablet form. The general course of treatment is 1-2 months. If necessary, treatment can be repeated several times with a break between courses in 1-2 months.
CNS diseases:
Bulbar paralysis and paresis: sc or to 5-15 mg 1-2 times / day, the course is 10-15 days; further, if possible, switch to a tablet form;
Restorative period of organic lesions of the CNS, accompanied by motor disorders: in / m 10-15 mg 1-2 times / day, course up to 15 days; further, if possible, switch to a tablet form.
Treatment and prevention of intestinal atony: the initial dose is 10-15 mg 1-2 times / day for 1-2 weeks.
SIDE EFFECT
The incidence of adverse reactions that may occur during the use of the drug is given in the following classification: very frequent (> 1/10 appointments), frequent (1 / 10-1 / 100 appointments), infrequent (1 / 100-1 / 1000 appointments), rare (1 / 1000-1 / 10,000 appointments), very rare (<1/10 000 assignments) and an unidentified frequency (the frequency can not be calculated from available data).
From the side of the psyche: infrequent - drowsiness.
From the nervous system: infrequent - dizziness, headache, convulsions; an unknown frequency is a tremor.
From the side of the organ of vision: an unknown frequency is miosis.
From the heart: frequent - palpitation, bradycardia; unknown frequency - pain behind the sternum.
From the respiratory system: infrequent - increased secretion of the bronchi.
From the digestive tract: frequent - salivation, nausea; infrequent - vomiting; rare - diarrhea, pain in epigastrium.
From the side of the liver and bile ducts: an unknown frequency - jaundice.
From the skin and subcutaneous tissues: infrequent - itching, rash.
General disorders and disorders at the injection site: frequent - increased sweating; infrequent - general weakness; unknown frequency - hypothermia.
Salivation and bradycardia can be reduced by m-holinoblokatorami (including atropine, cyclodol, metacin).
In case of an itch or rash, stop taking the medication. In other cases, reduce the dose or briefly (for 1-2 days) interrupt the reception of the drug.
CONTRAINDICATIONS
- epilepsy;
- extrapyramidal disorders with hyperkinesis;
- angina pectoris;
- pronounced bradycardia;
- bronchial asthma;
- mechanical obstruction of the intestine or urinary tract;
- Vestibular disorders;
- Stomach ulcer or duodenal ulcer in the stage of exacerbation;
- Children under 18 years of age (no systematic data on use in children);
- Hypersensitivity to any of the components of the drug.
With caution appoint at peptic ulcer of stomach and duodenum, thyrotoxicosis, diseases of the cardiovascular system, obstructive diseases of the respiratory system in the anamnesis or in acute respiratory diseases.
PREGNANCY AND LACTATION
The use of the drug raises the tone of the uterus and can lead to premature birth, so ipidakrin is contraindicated in pregnancy.
Data on the use of the drug in the period of breastfeeding are absent.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years of age (no systematic data on use in children
SPECIAL INSTRUCTIONS
Impact on the ability to drive vehicles and manage mechanisms
During treatment should refrain from driving, other vehicles and mechanisms, as well as from the employment of potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: decreased appetite, bronchospasm, lacrimation, increased sweating, narrowing of the pupils, nystagmus, increased peristalsis of the digestive tract, spontaneous defecation and urination, vomiting, jaundice, bradycardia, intracardiac conduction disturbance, arrhythmias, lowering blood pressure, anxiety, anxiety, agitation, ataxia, convulsions, coma, speech disorders, drowsiness and general weakness.
Treatment: use of m-holinoblokatorov (including atropine, cyclodol, metacin), symptomatic therapy.
DRUG INTERACTION
Aksamon В® enhances sedation in combination with drugs that depress the central nervous system.
Effects and side effects are enhanced when combined with other cholinesterase inhibitors and m-cholinomimetic agents. In patients with myasthenia gravis, the risk of developing a cholinergic crisis increases if Axamon В® is used simultaneously with other cholinergic agents.
The risk of developing a bradycardia increases, if before the beginning of treatment with the drug Aksamon В® beta-blockers were used.
Weaken the oppressive effect of local anesthetics, aminoglycosides, potassium chloride on neuromuscular transmission and conduction of excitation along the peripheral nerves.
Aksamon В® can be used in combination with nootropic drugs.
Ethanol increases the side effects of the drug.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light and inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 2 years.
