Aksamon - instructions for use, dose, side effects, contraindications

Active substanceIpidacrinIpidacrin

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Dosage form: & nbspsolution for intramuscular and subcutaneous administration

Composition:

Per 1 ml:

for a drug with a concentration of 5 mg / ml:

active substance: ipidakrine hydrochloride monohydrate (in terms of anhydrous) 5 mg;

Excipients: 0.1M hydrochloric acid solution to pH 3.00, water for injections up to 1 ml.

for a drug with a concentration of 15 mg / ml:

active substance: ipidacrine hydrochloride monohydrate (in terms of anhydrous) 15 mg;

Excipients: 0.1 M hydrochloric acid solution to pH 3.00, water for injection up to 1 ml.

Description:Transparent colorless liquid.

Pharmacotherapeutic group:Cholinesterase inhibitor

ATX: & nbsp

N.07.A.A Anticholinesterase drugs

Pharmacodynamics:

Aksamon® is a reversible inhibitor of cholinesterase, directly stimulates impulse conduction in the neuromuscular synapse and in the central nervous system (CNS) due to 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® 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:

With subcutaneous and intramuscular injection quickly absorbed. The maximum concentration in the blood is reached after 25-30 minutes after administration. Binding to blood plasma proteins - 40-50%. The drug quickly enters the tissues. Metabolised in the liver.The drug is excreted through the kidneys (mainly by tubular secretion and only 1/3 by glomerular filtration) and extrarenally (through the gastrointestinal tract). The half-life of the drug Aksamon® with parenteral administration is 2-3 hours. After parenteral administration, 34.8% of the dose is excreted unchanged in the urine.

Indications:

- Diseases of the peripheral nervous system: mono- and polyneuropathy, polyradiculopathy, 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.

Contraindications:

Hypersensitivity to any of the components of the drug, epilepsy, extrapyramidal disorders with hyperkinesia, angina pectoris, pronounced bradycardia, bronchial asthma, mechanical obstruction of the intestine or urinary tract, vestibular disorders, peptic ulcer of the stomach or duodenum at the stage of exacerbation, children under 18 years of age (there are no systematized data on the use in children).

Carefully:

When stomach ulcer and duodenum, thyrotoxicosis, diseases of cardio-vascular system, obstructive diseases respiratory system in anamnesis or in acute respiratory diseases.

Pregnancy and lactation:

The use of the drug increases the tone of the uterus and can lead to premature birth, so ipidacrin contraindicated during pregnancy.

Data on the use of the drug in the period of breastfeeding are absent.

Dosing and Administration:

Subcutaneously or intramuscularly.

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, polyradiculopathies: subcutaneously or intramuscularly 5-15 mg 1-2 times a day, the course 10-15 days (in severe cases - up to 30 days); further treatment is continued with the tablet form of the drug;

- myasthenia gravis and myasthenic syndrome: subcutaneously or intramuscularly 15-30 mg 1-3 times a 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.

Diseases of the central nervous system:

- bulbar paralysis and paresis: subcutaneously or intramuscularly 5-15 mg 1-2 times a day, course 10-15 days; further, if possible, switch to the tablet form;

- recovery period of organic CNS lesions accompanied by motor disturbancesand: intramuscularly 10-15 mg 1-2 times a 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 a day for 1-2 weeks.

Side effects:

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 / 10000 appointments), very rare (<1/10000 assignments) and an unidentified frequency (the frequency can not be calculated from the available data).

Disorders of the psyche:

infrequent - drowsiness.

Impaired nervous system:

infrequent - dizziness, headache, convulsions;

unidentified frequency - tremor.

Disorders from the side of the organ of vision:

unknown frequency - miosis.

Heart Disease:

frequent - palpitations, bradycardia;

unidentified frequency - pain behind the sternum.

Disturbances from the respiratory system, chest and mediastinal organs:

infrequent - increased secretion of bronchial secretions.

Disturbances from the gastrointestinal tract:

frequent - drooling, nausea;

infrequent - vomiting;

rare - diarrhea, pain in epigastrium.

Disorders from the liver and bile ducts:

unknown frequency - jaundice.

Disturbances from the skin and subcutaneous tissues:

infrequent - itching, rash.

General disorders and disorders at the site of administration:

frequent - increased sweating;

infrequent - general weakness;

unidentified frequency - hypothermia.

Salivation and bradycardia can be reduced by m-holinoblokatorami (atropine, cyclodol, metacin, etc.).

In case of an itch or rash, stop taking the medication. In other cases, reduce the dose or For a short time (1-2 days), stop taking the drug.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptoms: decreased appetite, bronchospasm, lacrimation, sweating, pupillary constriction, nystagmus, increasing motility of the gastrointestinal tract, spontaneous defecation and urination, vomiting, jaundice, bradycardia, impaired intracardiac conduction, arrhythmias, blood pressure, anxiety, worry, agitation, a feeling fear, ataxia, convulsions, coma, speech disorders, drowsiness and general weakness.

Treatment: use of m-holinoblokatorov (atropine, cyclodol, metacin, etc.), symptomatic therapy.

Interaction:

Aksamon ® 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 Aksamon is used® simultaneously with other cholinergic agents.

The risk of bradycardia increases if prior to the commencement of treatment with the Aksamon® drug, β-adrenoceptor blockers.

Relieves the depressing effect on neuromuscular transmission and conduction of excitation along the peripheral nerveslocal anesthetics, aminoglycosides, potassium chloride.

Aksamon® can be used in combination with nootropic drugs.

Alcohol increases the side effects of the drug.

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

During treatment should refrain from driving, other vehicles and mechanisms, as well as from practicing potentially dangerous activities that require increased concentration and speed psychomotor reactions.

Form release / dosage:Solution for intramuscular and subcutaneous administration, 5 mg / ml or 15 mg / ml.

Packaging:

1 ml of the drug in ampoules with a dot or ring of fracture from colorless glass.

5 ampoules are placed in a contour mesh package made of a polyvinyl chloride film.

Two contour squares are placed in a pack of cardboard. In each pack insert instruction for use.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002247

Date of registration:25.09.2013

Expiration Date:25.09.2018

The owner of the registration certificate:PIK-PHARMA, LLC PIK-PHARMA, LLC Russia

Manufacturer: & nbsp

ELLARA, LTD. Russia

Representation: & nbspPIK-PHARMA LLC PIK-PHARMA LLC Russia

Information update date: & nbsp03.07.2017

Illustrated instructions

Instructions

Axamon® (Axamon®)