Neuromidin^® (Tablets, Solution) Instructions for Use

ATC Code

N07AA (Anticholinesterase agents)

Active Substance

Ipidacrine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Cholinesterase inhibitor

Pharmacotherapeutic Group

Cholinesterase inhibitor

Pharmacological Action

It has a direct stimulating effect on the conduction of impulses along nerve fibers, interneuronal and neuromuscular synapses of the peripheral and central nervous systems.

The pharmacological action of ipidacrine is based on a combination of two mechanisms of action: blockade of potassium channels of the membrane of neurons and muscle cells; reversible inhibition of cholinesterase in synapses.

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

Ipidacrine has the following pharmacological effects: it improves and stimulates impulse conduction in the nervous system and neuromuscular transmission; it enhances the contractility of smooth muscle organs under the influence of agonists of acetylcholine, adrenaline, serotonin, histamine, and oxytocin receptors, with the exception of potassium chloride; it improves memory, inhibits the progressive development of dementia.

Pharmacokinetics

Absorption

After oral administration, it is rapidly absorbed from the gastrointestinal tract. C_max in blood plasma is reached after 1 hour.

Distribution

Binding to blood plasma proteins is 40-50%. Ipidacrine quickly enters tissues, the distribution half-life is 40 minutes.

Metabolism

Ipidacrine is metabolized in the liver.

Excretion

It is excreted by the kidneys, as well as extrarenally (through the gastrointestinal tract). Renal excretion occurs mainly through tubular secretion and only 1/3 of the dose is excreted by glomerular filtration.

Indications

• Diseases of the peripheral nervous system: mono- and polyneuropathy, polyradiculopathy, myasthenia gravis, myasthenic syndrome of various etiologies;
• Diseases of the central nervous system: bulbar paralysis and paresis; recovery period of organic lesions of the central nervous system, accompanied by motor and/or cognitive impairments;
• Treatment and prevention of intestinal atony.

ICD codes

Dosage Regimen

Tablets

Doses and duration of treatment are determined individually depending on the severity of the disease.

Diseases of the peripheral nervous system

For mono- and polyneuropathy, polyradiculopathy of various etiologies, myasthenia gravis and myasthenic syndrome – 10-20 mg 1-3 times/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 of 1-2 months between courses.

For preventing myasthenic crises, in severe neuromuscular conduction disorders, 15-30 mg of ipidacrine for injection is administered parenterally for a short period, then treatment is continued using Ipidacrine orally – the dose can be increased to 20-40 mg 5 times/day.

Diseases of the central nervous system

For bulbar paralysis and paresis, during the recovery period of organic lesions of the central nervous system (traumatic, vascular and other genesis), accompanied by motor and/or cognitive impairments – 10-20 mg 2-3 times/day. The course of treatment is from 2 to 6 months. If necessary, the course of treatment is repeated.

For treatment and prevention of intestinal atony – 20 mg 2-3 times/day for 1-2 weeks.

If the next dose was not taken on time, it should not be taken additionally.

The maximum daily dose is 200 mg.

Solution

Administered subcutaneously or intramuscularly. Doses and duration of treatment are determined individually depending on the severity of the disease.

Diseases of the peripheral nervous system

For mono- and polyneuropathy, polyradiculopathy of various etiologies – intramuscularly or subcutaneously 5-15 mg 1-2 times/day, course of treatment – 10-15 days (in severe cases up to 30 days); then treatment is continued with ipidacrine for oral administration.

For myasthenia gravis and myasthenic syndrome of various etiologies – intramuscularly or subcutaneously 15-30 mg 1-3 times/day, with a subsequent transition to oral administration. The total course of treatment is 1-2 months. If necessary, the course of treatment can be repeated several times with a break of 1-2 months between courses.

Diseases of the central nervous system

For bulbar paralysis and paresis, 5-15 mg 1-2 times/day is prescribed subcutaneously or intramuscularly for 10-15 days; if possible, switch to oral administration.

For rehabilitation in organic lesions of the central nervous system intramuscularly 10-15 mg 1-2 times/day, course – up to 15 days; then, if possible, switch to oral administration.

Adverse Reactions

Reactions due to stimulation of m-cholinergic receptors <10% – salivation, increased sweating, palpitations, nausea, diarrhea, jaundice, bradycardia, epigastric pain, increased bronchial secretion, bronchospasm, convulsions. Salivation and bradycardia can be reduced by m-cholinergic blockers (atropine and others).

When using the drug in high doses <10% – dizziness, headache, chest pain, vomiting, general weakness, drowsiness, skin allergic reactions (itching, rash). In these cases, the dose is reduced or the drug is temporarily (for 1-2 days) discontinued.

Other <10% – increased uterine tone, skin manifestations of allergic reactions.

Contraindications

• Hypersensitivity to ipidacrine and excipients of the drug used.
• Epilepsy;
• Vestibular disorders;
• Extrapyramidal diseases with hyperkinesis;
• Angina pectoris;
• Severe bradycardia;
• Bronchial asthma;
• Mechanical obstruction of the intestine or urinary tract;
• Peptic ulcer of the stomach or duodenum in the acute phase;
• Pregnancy (the drug increases uterine tone);
• Period of breastfeeding;
• Children and adolescents under 18 years of age (no systematic data on use).

Use with caution in peptic ulcer of the stomach and duodenum, thyrotoxicosis, diseases of the cardiovascular system, in patients with a history of obstructive respiratory diseases or with acute respiratory diseases, as well as in lactase deficiency, lactose intolerance, lactose/isomaltose malabsorption syndrome, because the drug used may contain lactose.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

It does not have a teratogenic or embryotoxic effect.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

During treatment, the patient should avoid alcohol consumption. Alcohol enhances the side effects of ipidacrine.

Effect on ability to drive vehicles and machinery

During treatment, the patient should refrain from driving vehicles, as well as engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

It enhances the sedative effect in combination with agents that depress the central nervous system.

The action of ipidacrine and side effects are enhanced when used concomitantly with other cholinesterase inhibitors and m-cholinomimetic agents.

In patients with myasthenia gravis, the risk of a cholinergic crisis increases with the simultaneous use of ipidacrine with other cholinergic agents.

The risk of bradycardia increases if beta-blockers were used before starting treatment with ipidacrine.

Ipidacrine can be used in combination with nootropic drugs.

Ipidacrine weakens the inhibitory effect on neuromuscular transmission and conduction of excitation along peripheral nerves of local anesthetics, aminoglycosides, and potassium chloride.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.