Axamon® tablets


Registration number:  Р №003550/01

Trade name: Axamon®. 

International non-patented name (INN): ipidacrine.

Drug form: tablets.

Description: white flat cylindric tablets with a bevel.

Composition per one tablet:

drug substance – ipidacrine hydrochloride monohydrate (Axamon®) 20 mg (adjusted to ipidacrine hydrochloride); 

excipients - ludipress (lactose monohydrate 93 %, povidone 3,5 %, crosspovidone 3,5 %) 65 mg, carboxymethyl starch sodium 14 mg, calcium stearate 1 mg.

Pharmakotherapeutic group: choline estherase inhibitor.

АТХ Code: N07AA.


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Pharmacological properties

Pharmacodynamics. The drug is a reversible choline estherase inhibitor. Due to a block of potassium canals of cells and a suppression of a choline estherase activity it stimulates a neuro-muscular transmission and a conductivity of impulses in nervous system. It has a М- and N-choline receptors agonistic action. In increases acetyl choline, serotonine, histamine and oxytocine action on smooth muscles and increase a contractability of smooth muscle organs (including GIT and bronchi), decelerates heart rate, increases a secretion of salivary glands, a contractive activity of myometrium, a skeletal musculature tone. It has a stimulative effect on CNS (with some sedative effects), promotes a learning and memory improvements.

Pharmacokinetics. The drug is quickly absorbed from gastrointestinal tract. A maximal concentration in plasma is reached after one hour. 40-55 % of an active substance is binded with plasma proteins. A half-life is near 40 minutes. The drug is metabolized in liver. Excreted by kidneys (mainly by a tubular secretion, only 1/3 of the drug is excreted by a glomerular filtration) and extrarenally (through the GIT).

Indications

• peripheral nervous system diseases (neuritis, polyneuritis, polyneuropathy, polyradiculpathyз; myasthenia and myasthenic syndrome of a different etiology);

• a rehabilitation period after organic affections of central nervous system, with a motoric disturbances including bulbary paralysises and paresises;

• combined therapy of demyelinizing diseases;

• senile demention, Alzheimer's disease, encephalopathys of  different cuases.

Contraindications

Hypersensitivity to any components of the drug, epilepsy, extrapyramid affections with hyperkinesises, angina pectoris, prominent bradyarrhythmia, bronchial asthma, mechanical  intestinal or urinary ways obstruction, vestibulary disturbances, exacerbated gastric or duodenic ulcer, galactose intolerability, lactase deficiency aor glucose and galastose malabsorption, pregnancy and lactation, child age under 18 years.

Use with caution: remission of gastric or duodenic ulcer, thyreotoxicosis, intracardiac conductivity disturbances; history of obstructive diseases of the respiratory system, acute diseases of respiratory ways.

Method of use and dosages

The drug is used orally. Doses and duration of the treatment are adjusted individually in dependence on severity of a disease.

Peripheral nervous system diseases, myasthenia, myasthenic syndrome: 10-20 mg 1-3 times a day. Duration of the treatment – from one to three months. If it is necessary – a treatment course can be repeated (with interrupts between cources of 1-2 months).

Alzheimer's disease, encephalopathys, a rehabilitation period after organic affections of central nervous system, with a motoric disturbances including bulbary paralysises and paresises: daily dose is adjusted individually, most often 10-20 mg 2-3 times a day.

Demyelinizing diseases of nervous system: a dose can be increased to 20-40 mg 5-6 times a day. A maximum daily dose 200 mg.

If one taking of the drug has been missed, on the next time the normal dose is used.

Side effects

Due to an M-cholinergic receptors excitation salivation, increased perspiration, nausea, diarrhea, jaundice, bradyarrhythmia, epigastric pain, increase a bronchial secretion, bronchospasm, convulsions, an uterus tone increase are possible. A salivation and bradyarhythmia can be stopped by M-cholinergic receptors antagonists: atropine, trihexiphenyl (cyclodol), metocinium iodide (metacin) etc. More rarely, after a higher dosages use, dizziness, ataxia, headache, vomiting, common weakness, sleepiness, skin reactions (prupitus and rash) were observed. In these cases a dose has to be decreased or treatment has to be interrupted for a short time (1-2 days).

Over-dosage

Symptoms: appetite decrease, bronchospasm, lacrimation, increased perspiration, miosis, nystagm, an increase of gastrointestinal peristaltics, spontaneous defecation and urination, vomiting, jaundice, bradyarrhythmia, intracardiac conductivity affection, arrhythmias, arterial blood pressure decrease, anxiety, agitation, fear, convulsions, coma, speech affections, somnolence, common weakness.

Treatment: gastric lavage, use of M-cholinergic receptors antagonists: atropine, trihexiphenyl (cyclodol), metocinium iodide (metacin) etc., symptomatic treatment.

Interaction with other medicines

Increases a sedative effect in combination with medicines, suppressing central nervous system. An effect and side effects are increased in combined use with other choline esterase inhibitors and M-cholinoreceptors agonists. Patients with a myasthenia have an increased risk of cholinergic crisis development, if ipidacrine is used concomitantly with other cholinergic medicines. A risk of the bradyarrythmia increases if before the treatment beta-adrenergic receptor antagonists were used. The drug decreases a suppressing action on neuro-muscular transmission of local anesthetics, amine glycozides and alcohol. An alcohol increases side effects of the drug.

Precautions

It is recommended during the treatment to avoid driving a car and  performing potentially dangerous activities, where an increased concentration of attention and psyco-motoric reactions rate are needed.

Drug form. 20 mg tablets.

10 tablets in a blister from PVC film and Al foil.

50 tablets in dark glass bottles with threaded neck, sealed with plactic threaded seals, or in plastic sealed cans. A free space in cans is filled by a cotton whool. A can of 5 blisters are placed into a carton box with an instruction.

Shelf life

3 years. Do not use after the expiry date.

Keeping conditions

A list. Keep in protected from direct light place at temperature not higher than 25 °С. Keep out of the reach of children.

Selling conditions

By prescription.

Manufacturer

PIQ-PHARMA LLC., 129010 Moscow, Spassky blind alley, 2/1.

Manufactured by:

FSME «Central scientific constructor bureau» (FSME «CSCB»), 109240, Moskow, ул. Goncharnaya st., 20

or

CAS «Obninsk chemical pharmaceutical company» (CAS «OCPC»),

249036 Kaluzhskaya region, Obninsk, Koroleva st. 4

PIQ-PHARMA PRO Ltd, 188663 Leningradskaya region, Vsevolozhsky district, Kuzmolovsky, Workshop # 92.

 

Claims have to be sent to

PIQPHARMA LLC. Phone/fax: +7 495 925 57 00.