Instruction for use: Neuromidin

Active substance: Ipidacrine

ATX Code

N07AA Anticholinesterase drugs

Pharmacological group

M-, n-holinomimetiki, incl. Anticholinesterase agents

The nosological classification (ICD-10)

F09 Organic or symptomatic mental disorder, unspecified

Organic defeat of the central nervous system, Organic Psychology, Endogenous psychosis, Psycho-organic syndrome, Psycho-organic senile syndrome, Psycho-organic syndrome in old age, Psychotic disorder in organic diseases of the central nervous system, The psycho-organic syndrome, Vascular psychosis, The age-old pseudomelanchia, Exogenous-organic psychosis, Endogenous psychosis, Pseudomelanchia senile

G12.2 Disease of the motor neuron

Tropical spastic paraparesis, Amyotrophic lateral sclerosis, Bulbar Pallas, Bulbar palsy, Amyotrophic lateral sclerosis, Diseases of motor neurons, Amyotrophic lateral sclerosis, Low-Gehrig's disease, Charcot's disease, Amyotrophic amyotrophic sclerosis, Sclerosis lateral primary, Progressive pseudobulbar palsy, Progressive bulbar palsy, Primary lateral sclerosis

G37.9 Demyelinating disease of central nervous system, unspecified

Chronic inflammatory demyelinating polyneuropathy, Demyelinating disease

G58 Other mononeuropathies

Mononeuropathies

G61 Inflammatory polyneuropathy

G62.9 Polyneuropathy, unspecified

Neuropathic pain, Peripheral Neuropathy,Polyneuropathy, Polyneuropathy chronic recurrent, Affection of peripheral nerves, Radiation Neuropathy, Neuropathic pain

G70 Myasthenia gravis and other disorders of the neuromuscular synapse

Myasthenic syndrome, Myasthenic syndromes, Myasthenia gravis, Myasthenic syndrome, Severe myasthenia gravis (Myasthenia gravis)

G92 Toxic encephalopathy

Alcohol encephalopathy, Toxic brain damage, Toxic damage to the central nervous system, Encephalopathy in chronic alcoholism, Brain Injury Toxic, Encephalopathy against alcoholism, Acute lead encephalopathy

G96.9 Disorder of central nervous system, unspecified

Toxic damage to the central nervous system, CNS depression, Violation of the functions of the central nervous system, Functional deficiency of the nervous system, Traumatic injury of the central nervous system, Hereditary disease of the central nervous system, Hereditary diseases of the nervous system

K59.8.0 * Atony of the intestine

Atony of the duodenum, Atony of the gastrointestinal tract, Atony of the intestine, Atony of the intestine after operations, Atony of the intestine after childbirth, Atony of the musculature of the gastrointestinal tract, Sluggish peristalsis of the large intestine, Sluggish peristalsis of the colon, Hypotension of the duodenum, Hypotension of the intestine, Hypotension of the large intestine, Hypotonia of the large intestine, Constipation of various etiologies, due to hypotension of the gastrointestinal tract and flaccid peristalsis of the large intestine, Violation of the promotion of intestinal contents, Postoperative atony of the stomach, Postoperative intestinal atony

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves, Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis, Post-traumatic neuralgia, Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

Composition

Tablets 1 table.

active substance:

Ipidakrine hydrochloride monohydrate 20 mg

(In terms of ipidacrine hydrochloride)

Auxiliary substances: lactose monohydrate - 65 mg; Potato starch - 14 mg; Calcium stearate - 1 mg

Solution for intramuscular and subcutaneous administration 1 ml

active substance:

Ipidakrine hydrochloride monohydrate (in terms of ipidacrine hydrochloride) 5 mg

15 mg

Auxiliary substances: hydrochloric acid concentrated - up to pH 3; Water for injection - up to 1 ml

Description of dosage form

Tablets: round, flat-cylindrical, with a bevel, white.

Solution: clear, colorless liquid.

pharmachologic effect

Pharmacological action - anticholinesterase.

Pharmacodynamics

Neuromidin ® has a direct stimulating effect on impulse conduction on nerve fibers, interneuronal and neuromuscular synapses of the central nervous system and peripheral nervous system. The pharmacological action of Neuromidin® is based on a combination of two mechanisms of action: blockade of the potassium channels of the membrane of neurons and muscle cells; Reversible inhibition of cholinesterase in synapses.

Neuromidin ® enhances the effect on the smooth muscles of not only acetylcholine, but also adrenaline, serotonin, histamine and oxytocin.

Neuromidin® has the following pharmacological effects:

- improves and stimulates the impulse in the nervous system and neuromuscular transmission;

- 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 progressive course of dementia.

At preclinical study, Neuromidin® did not have teratogenic, embryotoxic, mutagenic, carcinogenic and immunotoxic effects, did not affect the endocrine system.

Pharmacokinetics

After intake, in / m and s / to the introduction quickly absorbed. Cmax in the blood plasma is achieved after 1 hour after ingestion and after 25-30 minutes after IM or SC administration. Binding to blood plasma proteins - 40-50% of the active substance. Rapidly enters the tissue, the half-distribution period is 40 minutes. Metabolised in the liver. It is excreted through the kidneys (mainly by tubular secretion and only 1/3 by glomerular filtration) and extrarenally (through the gastrointestinal tract). T1 / 2 Neuromidin for 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 CNS lesions, accompanied by motor and / or cognitive impairment);

Atony of the intestine (treatment and prevention) (in addition to tablets).

Contraindications

Hypersensitivity to any of the components of the drug;

epilepsy;

Extrapyramidal diseases 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 in the stage of exacerbation;

Pregnancy (the drug raises the tone of the uterus);

Lactation period;

Children under 18 years of age (no systematic data on the application).

With caution: with peptic ulcer of stomach and duodenum, thyrotoxicosis, SSS, as well as patients with obstructive diseases of the respiratory system in the history or in acute respiratory diseases.

Additionally for tablets

With caution: with lactase deficiency, lactose intolerance, lactose / isomaltose malabsorption syndrome, because The composition of the drug includes lactose.

Side effects

Caused by excitation of m-cholinergic receptors: drooling, increased sweating, palpitations, nausea, diarrhea, jaundice, bradycardia, epigastric pain, increased secretion of bronchial secretions, bronchospasm, convulsions. Salivation and bradycardia can be reduced by m-holinoblokatorami (atropine, etc.). Increase in the tone of the uterus, skin allergic reactions.

Rarely (after applying higher doses), dizziness, headache, chest pain, vomiting, general weakness, drowsiness, skin reactions (itching, rash) were observed. In these cases, reduce the dose or briefly (for 1-2 days) interrupt the reception of the drug. These side effects are observed in less than 10% of patients.

Interaction

Neuromidin® enhances sedation in combination with CNS depressants.

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 Neuromidin® is used simultaneously with other cholinergic agents.

The risk of bradycardia increases if β-blockers were used before starting treatment with Neuromidin.

Neuromidin® can be used in combination with nootropic drugs.

Alcohol increases the side effects of the drug.

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

Dosing and Administration

Inside, SC or in / m. Doses and duration of treatment are determined individually, depending on the severity of the disease.

Pills

Diseases of the peripheral nervous system:

- mono- and polyneuropathy, polyradiculopathy, myasthenia gravis and myasthenic syndrome of different etiology - 10-20 mg (0.5-1 table) 1-3 times a day. The course of treatment is from 1 to 2 months. If necessary, the course of treatment can be repeated several times with a break between courses in 1-2 months;

- to prevent myasthenic crises, with severe disorders of neuromuscular conduction, 1-2 ml (15-30 mg) of Neuromidin® 1.5% injection is briefly parenterally injected, then the treatment is continued with Neuromidin® tablets, the dose can be increased to 20-40 Mg (1-2 tablets) 5 times a day.

Diseases of the central nervous system: bulbar paralysis and paresis, the recovery period of organic lesions of the CNS (traumatic, vascular and other genesis), accompanied by motor and / or cognitive impairment - 10-20 mg (0.5-1 table) 2-3 times in day. The course of treatment from 2 to 6 months. If necessary, repeat treatment.

Treatment and prevention of intestinal atony - 20 mg (1 table) 2-3 times a day for 1-2 weeks.

Solution for w / m and s / to the introduction

Diseases of the peripheral nervous system:

- mono- and polyneuropathies of different genesis - p / k or in / m 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 - SC or IM 15-30 mg 1-3 times a day with a further transition to the tablet form. 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 - SC or IM 5-15 mg 1-2 times a day 10-15 days; If possible, switch to a tablet form;

- Rehabilitation for organic lesions of the central nervous system - IM 10-15 mg 1-2 times a day, the course - up to 15 days, then, if possible, go to the tablet form.

If the next dose was not taken on time, then it is not taken in addition.

The maximum daily dose is 200 mg.

Overdose

Symptoms: decreased appetite, bronchospasm, lacrimation, increased sweating, narrowing of the pupils, nystagmus, increased peristalsis of the gastrointestinal tract, spontaneous defecation and urination, vomiting, jaundice, bradycardia, intracardiac conduction disturbance, arrhythmias, lowering blood pressure, anxiety, anxiety, Ataxia, convulsions, coma, speech disorders, drowsiness, general weakness.

Treatment: apply symptomatic therapy, prescribe m-holinoblokatory (atropine, cyclodol, metacin, etc.).

special instructions

There are no systematic data on the use of Neuromidine ® in children.

For the duration of treatment should be excluded alcohol (increases the side effects of the drug).

Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. During treatment should refrain from driving the car, as well as practicing potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Form of issue

Tablets, 20 mg. For 10 tab. In a planar cell packaging made of PVC film and aluminum foil. Five contour packs in a pack of cardboard.

Solution for intramuscular and subcutaneous administration, 5 mg / ml and 15 mg / ml. 1 ml of the drug in neutral glass ampoules (type I). At 5 amp. In a contoured cell pack of PVC film. 2 contour squares in a pack of cardboard.

For the drug produced at JSC "SOFARMA", Bulgaria: 10 amp. In a contoured cell pack of PVC film. 1 contour pack in a pack of cardboard.

Terms of leave from pharmacies

On prescription.

storage conditions

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

Keep out of the reach of children.

Shelf life

Solution for intramuscular and subcutaneous injection of 5 mg / ml - 3 years.

Solution for intramuscular and subcutaneous administration of 15 mg / ml - 3 years.

Tablets 20 mg - 5 years.

Do not use after the expiry date printed on the package.