Ipidacrin (Tablets) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

ATC Code

N06DA05 (Ipidacrine)

Active Substance

Ipidacrine (Rec.INN registered by WHO)

Dosage Form

Ipidacrine

Tablets 20 mg: from 5 to 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical with a bevel.

Excipients: lactose monohydrate, potato starch, calcium stearate.

5 pcs. – contour cell packaging (from 1 to 10) – cardboard packs.
10 pcs. – contour cell packaging (from 1 to 10) – cardboard packs.
25 pcs. – contour cell packaging (1, 2, 3, 4 or 5) – cardboard packs.
20 pcs. – polyethylene jars (1) – cardboard packs.
40 pcs. – polyethylene jars (1) – cardboard packs.
50 pcs. – polyethylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

Cholinesterase inhibitor

Pharmacotherapeutic Group

Psychoanaleptics; agents for the treatment of dementia; anticholinesterase agents

Pharmacological Action

Cholinesterase inhibitor. Prevents enzymatic hydrolysis of acetylcholine and prolongs its action. Blocks potassium channels of membranes and promotes their depolarization. Stimulates synaptic transmission in neuromuscular endings, conduction of excitation in nerve fibers, enhances the effect on smooth muscles of acetylcholine and other mediators (including epinephrine, serotonin, histamine, oxytocin), restores neuromuscular transmission and conduction of excitation in the peripheral nervous system (due to disorders of various origins: trauma, inflammation, action of local anesthetics, antibiotics, toxins, potassium chloride). Increases tone and contractility of smooth muscles of internal organs, including the gastrointestinal tract and bronchi (up to bronchospasm), reduces heart rate, enhances secretion of salivary glands, contractile activity of the myometrium, tone of skeletal muscles.

It has a stimulating effect on the central nervous system in combination with individual manifestations of sedative action; promotes improvement of learning and memory.

Indications

Diseases of the peripheral nervous system (neuritis, polyneuritis, polyneuropathy, polyradiculopathy), bulbar paralysis and paresis.

In the recovery period for organic lesions of the central nervous system, accompanied by motor and/or cognitive impairments.

Myasthenia gravis, myasthenic syndrome.

Demyelinating diseases (as part of complex therapy).

Alzheimer’s disease, senile dementia of the Alzheimer’s type.

Functional disorders of the central nervous system (decreased memory, ability to concentrate, motivation, initiative, disorientation, emotional lability, etc.) in encephalopathy (of traumatic, vascular and other origin), cerebrovascular accident, traumatic brain injury, cerebral dysfunction with learning difficulties in children.

Weakness of labor activity.

Intestinal atony.

Intoxication with anticholinergic agents.

ICD codes

Dosage Regimen

Administer orally, subcutaneously, or intramuscularly.

For oral administration, initiate therapy with 10-20 mg taken 1-2 times daily.

Titrate the dose gradually based on individual tolerance and therapeutic response.

The maximum single oral dose is 50 mg.

The maximum total daily dose is 200 mg, regardless of the route of administration.

For subcutaneous or intramuscular injection, a single dose ranges from 5 mg to 30 mg.

The frequency of parenteral administration is typically 1-2 times per day.

For the treatment of myasthenia gravis, the total daily dose is typically 60-150 mg, divided into multiple administrations.

For dementia and cognitive disorders, the common maintenance dose is 20-40 mg taken 2-3 times daily.

For peripheral nervous system diseases, use 20 mg 2-3 times a day.

Adjust the dosing frequency and treatment duration according to the specific indication and clinical picture.

The duration of a standard treatment course is typically 1-2 months; repeat courses are possible after consultation with a physician.

Adverse Reactions

From the digestive system: anorexia, hypersalivation, nausea, vomiting, increased peristalsis, diarrhea, jaundice.

From the central nervous system: dizziness (after repeated application), ataxia.

Allergic reactions: skin rash, itching.

Other: manifestations of m-cholinomimetic action – bronchospasm, bradycardia.

Contraindications

Epilepsy, extrapyramidal disorders with hyperkinesis, angina pectoris, severe bradycardia, bronchial asthma, vestibular disorders, gastric ulcer and duodenal ulcer in the acute phase; mechanical obstruction of the intestine or urinary tract; pregnancy, lactation period, children and adolescents under 18 years of age; hypersensitivity to ipidacrine.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Special Precautions

Use with caution in gastric ulcer, thyrotoxicosis, diseases of the cardiovascular system. It is necessary to take into account the ability of ipidacrine to increase uterine tone.

During treatment, alcohol consumption should be avoided, as ethanol enhances the side effects of ipidacrine.

Effect on ability to drive vehicles and machinery

Should not be used in patients whose activities are associated with driving vehicles and work requiring high concentration of attention and speed of psychomotor reactions.

Drug Interactions

With simultaneous use, Ipidacrine enhances the sedative effect of drugs that have a depressant effect on the central nervous system, ethanol, the effect of other cholinesterase inhibitors and m-cholinomimetics.

In patients with myasthenia gravis, when using ipidacrine against the background of other cholinergic agents, the risk of developing a cholinergic crisis increases.

With simultaneous use with beta-blockers, bradycardia increases.

Ipidacrine weakens the effect of local anesthetics, antibiotics, potassium chloride.

Atropine and methocinium iodide reduce the severity of overdose symptoms.

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.