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Ipidacrine (Tablets, Solution) Instructions for Use

ATC Code

N06DA05 (Ipidacrine)

Active Substance

Ipidacrine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Cholinesterase inhibitor

Pharmacotherapeutic Group

Psychoanaleptics; agents for the treatment of dementia; anticholinesterase agents

Pharmacological Action

Cholinesterase inhibitor. Prevents the enzymatic hydrolysis of acetylcholine and prolongs its action. Blocks potassium channels of membranes and promotes their depolarization. Stimulates synaptic transmission in neuromuscular junctions, 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 the tone and contractility of the smooth muscles of internal organs, including the gastrointestinal tract and bronchi (up to bronchospasm), decreases heart rate, enhances the secretion of salivary glands, the contractile activity of the myometrium, and the tone of skeletal muscles.

It has a stimulating effect on the central nervous system in combination with individual manifestations of a sedative effect; 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 (memory impairment, decreased ability to concentrate, motivation, initiative, disorientation, emotional lability, etc.) in encephalopathy (of traumatic, vascular and other origins), cerebrovascular accident, traumatic brain injury, cerebral dysfunction with learning difficulties in children.

Weakness of labor.

Intestinal atony.

Intoxication with anticholinergic agents.

ICD codes

ICD-10 code Indication
F00 Dementia in Alzheimer’s disease
F07 Personality and behavioral disorders due to disease, damage or dysfunction of the brain
F81 Specific developmental disorders of scholastic skills
G12.2 Motor neuron disease
G30 Alzheimer’s disease
G35 Multiple sclerosis
G36 Other form of acute disseminated demyelination
G37 Other demyelinating diseases of the central nervous system
G54 Lesions of nerve roots and plexuses
G60 Hereditary and idiopathic neuropathy
G61 Inflammatory polyneuropathy
G62.1 Alcoholic polyneuropathy
G63.2 Diabetic polyneuropathy
G70 Myasthenia gravis and other disorders of the neuromuscular junction
G93.4 Unspecified encephalopathy
I69 Sequelae of cerebrovascular diseases
K59.8 Other specified functional intestinal disorders
M54.1 Radiculopathy
M79.2 Neuralgia and neuritis, unspecified
O62 Abnormalities of forces of labor
T44.3 Other parasympatholytics [anticholinergics and antimuscarinics] and spasmolytics, not elsewhere classified
T90 Sequelae of injuries of head
ICD-11 code Indication
6A03.Z Developmental learning disorder, unspecified
6D80.Z Dementia due to Alzheimer’s disease, onset unknown or unspecified
6D8Z Dementia, unknown or unspecified cause
6E68 Secondary emotionally labile personality disorder
6E6Z Unspecified secondary mental or behavioral syndromes
8A20 Alzheimer’s disease
8A40.Z Multiple sclerosis, unspecified
8A41.Z Isolated demyelinating syndromes of the central nervous system, unspecified
8A42.Z Acute disseminated encephalomyelitis, unspecified
8A4Z Multiple sclerosis or other white matter disorders, unspecified
8B25.Z Sequelae of cerebrovascular disease, unspecified
8B60.Z Motor neuron disease, unspecified
8B6Y Other specified motor neuron diseases or related disorders
8B6Z Motor neuron diseases or related disorders, unspecified
8B93.Z Radiculopathy, unspecified
8B9Z Diseases of nerve roots or plexuses, unspecified
8C01.Z Inflammatory polyneuropathy, unspecified
8C03.0 Diabetic polyneuropathy
8C2Y Other specified hereditary neuropathy
8C4Z Disorders of nerve roots, plexuses or peripheral nerves, unspecified
8C6Z Myasthenia gravis or other specified diseases of the neuromuscular junction, unspecified
8D44.0 Alcoholic polyneuropathy
8E47 Encephalopathy, not elsewhere classified
8E4A.0 Paraneoplastic or autoimmune disorders of the central nervous system, including brain and spinal cord
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
8E63 Post-cardiopulmonary bypass encephalopathy
DB32.3 Acquired hypoganglionosis of the colon
DB32.Z Colonic motility disorders, unspecified
DD90.2 Functional heartburn
DD91.Y Other specified irritable bowel syndrome or functional bowel disorders
DD93.Y Other specified functional gastrointestinal disorders in infants, toddlers and school-age children
FB56 Specified soft tissue diseases, not elsewhere classified
JB02.Z Abnormalities of forces of labor, unspecified
NA0Z Head injury, unspecified
NE60 Poisoning by drugs, medicaments or biological substances, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally, subcutaneously, or intramuscularly.

For subcutaneous or intramuscular injection, use a single dose of 5 mg to 30 mg.

The maximum daily dose is 200 mg; do not exceed this limit.

For peripheral nervous system diseases (neuritis, polyneuropathy), use 10 mg to 40 mg orally three to four times daily.

For central nervous system disorders (Alzheimer’s disease, dementia, post-traumatic conditions), initiate therapy with 10 mg orally two to three times daily.

Gradually increase the dose based on tolerance and clinical response.

For myasthenia gravis and myasthenic syndromes, titrate the dose individually, monitoring for cholinergic effects.

For intestinal atony, administer 10 mg to 20 mg subcutaneously or intramuscularly.

For weakness of labor, use a 5 mg to 10 mg subcutaneous or intramuscular injection.

Adjust the frequency and duration of therapy according to the specific indication and patient response.

In elderly patients or those with hepatic/renal impairment, initiate treatment at the lower end of the dosing range.

Monitor for signs of cholinergic excess, particularly when increasing the dose.

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 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, cardiovascular diseases. The ability of ipidacrine to increase uterine tone should be taken into account.

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

Effect on ability to drive vehicles and operate machinery

Should not be used in patients whose activities involve driving vehicles and work requiring high concentration 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 methoctinium 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Ipidacrine Tablets 20 mg

Dosage Form, Packaging, and Composition

Tablets

1 tab.
Ipidacrine 20 mg

10 pcs. – blister packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
20 pcs. – blister packs – cardboard packs (20 pcs.) – By prescription
20 pcs. – blister packs (2 pcs.) – cardboard packs (40 pcs.) – By prescription
20 pcs. – blister packs (3 pcs.) – cardboard packs (60 pcs.) – By prescription
20 pcs. – blister packs (4 pcs.) – cardboard packs (80 pcs.) – By prescription
20 pcs. – blister packs (5 pcs.) – cardboard packs (100 pcs.) – By prescription
50 pcs. – blister packs – cardboard packs (50 pcs.) – By prescription
50 pcs. – blister packs (2 pcs.) – cardboard packs (100 pcs.) – By prescription
50 pcs. – blister packs (3 pcs.) – cardboard packs (150 pcs.) – By prescription
50 pcs. – blister packs (4 pcs.) – cardboard packs (200 pcs.) – By prescription
50 pcs. – blister packs (5 pcs.) – cardboard packs (250 pcs.) – By prescription

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

Bottle Rx Icon Ipidacrine Solution for intramuscular and subcutaneous administration 5 mg/1 ml: amp. 5, 10, 15 or 20 pcs.
Solution for intramuscular and subcutaneous administration 15 mg/1 ml: amp. 5, 10, 15 or 20 pcs.

Dosage Form, Packaging, and Composition

Solution for intramuscular and subcutaneous administration transparent, colorless.

1 ml
Ipidacrine hydrochloride monohydrate 5.4 mg
   Equivalent to ipidacrine hydrochloride content 5 mg

Excipients : 1M hydrochloric acid solution, water for injections.

1 ml – ampoules (5) – blister packs (1) – cardboard packs.
1 ml – ampoules (5) – blister packs (2) – cardboard packs.
1 ml – ampoules (5) – blister packs (3) – cardboard packs.
1 ml – ampoules (5) – blister packs (4) – cardboard packs.


Solution for intramuscular and subcutaneous administration transparent, colorless.

1 ml
Ipidacrine hydrochloride monohydrate 16.2 mg
   Equivalent to ipidacrine hydrochloride content 15 mg

Excipients : 1M hydrochloric acid solution, water for injections.

1 ml – ampoules (5) – blister packs (1) – cardboard packs.
1 ml – ampoules (5) – blister packs (2) – cardboard packs.
1 ml – ampoules (5) – blister packs (3) – cardboard packs.
1 ml – ampoules (5) – blister packs (4) – cardboard packs.

Marketing Authorization Holder

Rif LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

Bottle Rx Icon Ipidacrine Solution for intramuscular and subcutaneous administration 5 mg/ml
Solution for intramuscular and subcutaneous administration 15 mg/ml

Dosage Form, Packaging, and Composition

Solution for intramuscular and subcutaneous administration

1 ml
Ipidacrine 5 mg

1 ml – ampoules (10 pcs.) – cardboard packs – By prescription
1 ml – ampoules (5 pcs.) – cardboard packs – By prescription


Solution for intramuscular and subcutaneous administration

1 ml
Ipidacrine 15 mg

1 ml – ampoules (10 pcs.) – cardboard packs – By prescription
1 ml – ampoules (5 pcs.) – cardboard packs – By prescription

Marketing Authorization Holder

Pharmproekt, JSC (Russia)

Dosage Form

Bottle Rx Icon Ipidacrine Tablets 20 mg

Dosage Form, Packaging, and Composition

Tablets

1 tab.
Ipidacrine 20 mg

10 pcs. – blister packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – blister packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – blister packs (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – blister packs (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – blister packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
120 pcs. – jars – cardboard packs (120 pcs.) – By prescription
120 pcs. – bottles – cardboard packs (120 pcs.) – By prescription
14 pcs. – blister packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – blister packs (10 pcs.) – cardboard packs (140 pcs.) – By prescription
14 pcs. – blister packs (2 pcs.) – cardboard packs (28 pcs.) – By prescription
14 pcs. – blister packs (3 pcs.) – cardboard packs (42 pcs.) – By prescription
14 pcs. – blister packs (4 pcs.) – cardboard packs (56 pcs.) – By prescription
14 pcs. – blister packs (5 pcs.) – cardboard packs (70 pcs.) – By prescription
14 pcs. – blister packs (6 pcs.) – cardboard packs (84 pcs.) – By prescription
14 pcs. – blister packs (7 pcs.) – cardboard packs (98 pcs.) – By prescription
14 pcs. – blister packs (8 pcs.) – cardboard packs (112 pcs.) – By prescription
14 pcs. – blister packs (9 pcs.) – cardboard packs (126 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
30 pcs. – bottles – cardboard packs (30 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
60 pcs. – bottles – cardboard packs (60 pcs.) – By prescription
7 pcs. – blister packs – cardboard packs (7 pcs.) – By prescription
7 pcs. – blister packs (10 pcs.) – cardboard packs (70 pcs.) – By prescription
7 pcs. – blister packs (2 pcs.) – cardboard packs (14 pcs.) – By prescription
7 pcs. – blister packs (3 pcs.) – cardboard packs (21 pcs.) – By prescription
7 pcs. – blister packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
7 pcs. – blister packs (5 pcs.) – cardboard packs (35 pcs.) – By prescription
7 pcs. – blister packs (6 pcs.) – cardboard packs (42 pcs.) – By prescription
7 pcs. – blister packs (7 pcs.) – cardboard packs (49 pcs.) – By prescription
7 pcs. – blister packs (8 pcs.) – cardboard packs (56 pcs.) – By prescription
7 pcs. – blister packs (9 pcs.) – cardboard packs (63 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription
90 pcs. – bottles – cardboard packs (90 pcs.) – By prescription

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Forms

Bottle Rx Icon Ipidacrine-SZ Solution for intramuscular and subcutaneous administration 5 mg/ml
Solution for intramuscular and subcutaneous administration 15 mg/ml

Dosage Form, Packaging, and Composition

Solution for intramuscular and subcutaneous administration

1 ml
Ipidacrine hydrochloride 5 mg

1 ml – ampoules (10 pcs.) – carton packs – By prescription


Solution for intramuscular and subcutaneous administration

1 ml
Ipidacrine hydrochloride 15 mg

1 ml – ampoules (10 pcs.) – carton packs – By prescription

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