Ipigrix solution for injection 15mg/ml 1ml ampoules No. 10

INSTRUCTIONS FOR MEDICAL ADMINISTRATION

1. NAME OF THE MEDICINE

IPIGRIX

2. GENERAL CHARACTERISTICS

International nonproprietary name: ipidacrin (ipidacrinum) Description Transparent, colorless liquid.

3. COMPOSITION OF THE MEDICINE

1 ml of solution contains: active substance: shdacrine hydrochloride (in terms of anhydrous substance) 5 mg < ) or 15 mg, excipients: 1 M hydrochloric acid solution to pH 2.8-4.0, water for injection up to 1 ml.

4. FORM OF RELEASE

Injection.

5. MEDICINE CLASSIFICATION CODE

Anticholinesterase drugs. ATX code: N07AA.

6. PHARMACOLOGICAL PROPERTIES Pharmacodynamics

A reversible cholinesterase inhibitor, prevents the enzymatic hydrolysis of acetylcholine and prolongs its action. Blocks membrane potassium channels and promotes their depolarization. Stimulates synaptic transmission in neuromuscular endings, conduction of excitation in nerve fibers, enhances the effect of acetylcholine and other mediators (epinephrine, serotonin, histamine, oxytocin) on smooth muscles, restores neuromuscular transmission and conduction of excitation in the peripheral nervous system (due to disorders of various origins: trauma, inflammation, the action of local anesthetics, antibiotics and toxins). Increases the tone and contractility of the smooth muscles of internal organs, including the gastrointestinal tract (GIT) and bronchi (up to bronchospasm), reduces the heart rate (HR), increases the secretion of the salivary glands, the contractile activity of the myometrium, and the tone of the skeletal muscles. It has a stimulating effect on the central nervous system (CNS) in combination with individual manifestations of sedation; helps improve learning and memory. Pharmacokinetics Absorption Ipidacrine is rapidly absorbed after parenteral administration. Potent concentration in plasma after subcutaneous or intramuscular administration for 25-30 minutes. About 40-55% of the active substance is bound to plasma. The therapeutic effect is manifested through parenteral administration. The duration of action of the drug is 3-5 hours. Distribution The drug penetrates the blood-brain barrier. Ipidacrine quickly enters the tissues, and at equilibrium only 2% of the drug is found in the plasma. Metabolism and excretion The drug is metabolized in the liver. Ipidacrine is excreted renal and extrarenally (by biotransformation in the liver), excretion in the urine predominates. The half-life of ipidacrine elimination is 0.7 hours. After parenteral administration of ipidacrine unchanged, 34.8% of the administered dose is excreted in the urine. This indicates rapid metabolism of the drug in the body.

7. INDICATIONS FOR USE

— Diseases of the peripheral nervous system (neuritis, polyneuritis, polyneuropathy, polyradiculoneuropathy); — myasthenia gravis and other myasthenic syndromes; — bulbar paralysis and paresis with organic lesions of the central nervous system, accompanied by motor disorders (recovery period); — demyelinating diseases of the central nervous system (as part of complex therapy); — memory disorders of various origins (Alzheimer’s disease and other forms of senile dementia); - intestinal atony.

8. METHOD OF APPLICATION AND DOSAGE

Doses and duration of treatment are determined individually depending on the severity of the disease. Ipidacrine solutions containing 5 mg/ml and 15 mg/ml are administered intramuscularly and subcutaneously. Diseases of the peripheral nervous system, demyelinating diseases of the central nervous system (as part of complex therapy): 5-15 mg of ipidacrine subcutaneously (1 ml of a solution containing 5 mg or 15 mg of ipidacrine in 1 ml) 1-2 times a day. The duration of treatment is 1-2 months. If necessary, the course of treatment can be repeated several times with an interval of 1-2 months. For acute mononeuritis, use 5 mg of ipidacrine (1 ml of solution containing 5 mg of ipidacrine in 1 ml) 1-2 times a day in combination with anti-inflammatory and decongestant drugs. The duration of the course of treatment is 10-15 days. For chronic neuritis and polyradiculoneuritis, if previous therapy did not provide a sufficient therapeutic effect, use 10 mg of ipidacrine (2 ml of a solution containing 5 mg of ipidacrine in 1 ml) 1-2 times a day. The duration of treatment is 20-30 days. If necessary, the course of treatment can be repeated 2-3 times with an interval of 2-4 weeks. For myelopolyradiculoneuritis with paresis of all extremities, use 15-20 mg of ipidacrine (1 ml of a solution containing 15 mg of ipidacrine in 1 ml or 4 ml of a solution containing 5 mg of ipidacrine in 1 ml) 2-3 times a day. The duration of treatment is 30-40 days.

The duration of treatment is 1-2 months. If necessary, the course of treatment can be repeated several times with an interval of 1-2 months. To prevent the development of myasthenic crisis in case of severe impairment of neuromuscular conduction, 15-30 mg of ipidacrine (1-2 ml of a solution containing 15 mg of ipidacrine in 1 ml) is administered for a short time. Boulevard paralysis and paresis due to organic lesions of the central nervous system, accompanied by motor disorders (recovery period): for head injuries in the acute period (3-5 days after injury), 1-2 ml of a solution containing 5 mg of ipidacrine in 1 ml is prescribed, 1-2 once a day. On days 5-6 after injury, the dose can be increased to 30-45 mg of ipidacrine (2-3 ml of a solution containing 15 mg of ipidacrine in 1 ml), 1-3 times a day. In some cases, in case of severe disorders of brain activity, ipidacrine is administered intravenously infusion along with 5% or 0.9% sodium chloride solution. The course of treatment is prescribed individually, usually lasting 30-40 days. Memory disorders of various origins (Alzheimer's disease and other forms of senile dementia): doses and duration of treatment are prescribed individually. The recommended dose at the beginning of treatment is 10 mg of ipidacrine (2 ml of solution containing 5 mg of ipidacrine in 1 ml) 2 times a day. Then the dose is gradually increased. The maximum dose can sometimes reach 120-200 mg per day and the duration of treatment is from 4 months to 1 year. Intestinal atony: use 10-20 mg of ipidacrine (2-4 ml of solution containing 5 mg of ipidacrine in 1 ml) 2-3 times a day. The duration of treatment is 1-3 weeks. 9. SIDE EFFECTS Ipidacrine is usually well tolerated. Side effects are mainly associated with stimulation of M-cholinergic receptors.

The following side effects are classified according to MedDRA organ system groups. To divide the frequency of occurrence, the following classification was used: often (>1/100 to <1/10), less often (>1/1000 to <1/100), rarely (>1/10,000 to <1/1000). Gastrointestinal disorders Common: hypersalivation, nausea. Less common: vomiting. Rarely: diarrhea, epigastric pain. Unknown: dyspepsia. Nervous system disorders

Less common: dizziness, headaches, drowsiness, muscle spasms, weakness. Cardiac dysfunction Often: palpitations, bradycardia. Eye damage Unknown: miosis.

Damage to the respiratory system, diseases of the chest and mediastinum Less common: increased bronchial secretion. Damage to the musculoskeletal and related systems Unknown: tremor. Damage to the skin and adjacent tissues Often: increased sweating. Less common: allergic reactions (itching, rashes), usually when used in large doses. General disorders and administration site reactions Not known: hypothermia, chest pain. Salivation and bradycardia can be reduced with the help of anticholinergic drugs (atropine and others). If side effects occur, you should reduce the dose or stop using the drug for a short time (for 1-2 days).

10. CONTRAINDICATIONS

Epilepsy, extrapyramidal disorders with hyperkinesis, angina pectoris, bradycardia, bronchial asthma, a tendency to vestibular disorders, peptic ulcer of the stomach and duodenum in the acute phase, intestinal or urinary tract obstruction, pregnancy, lactation, hypersensitivity to the components of the drug. The use of ipidacrine in children is contraindicated due to the lack of clinical studies on safety in this age group.

11. OVERDOSE

Symptoms: in case of severe overdose, a cholinergic crisis may develop (bronchospasm, lacrimation, increased sweating, constriction of the pupils, nystagmus, increased gastrointestinal motility, spontaneous defecation and urination, vomiting, jaundice, bradycardia, intracardiac conduction disturbances, arrhythmias, arterial hypotension, restlessness, anxiety, excitement, fear, ataxia, convulsions, coma, speech impairment, drowsiness, general weakness). Treatment: symptomatic therapy is carried out, m-anticholinergics are used (including atropine, cyclodol, metacin).

12. PRECAUTIONS

Use with caution in patients with gastric and duodenal ulcers, thyrotoxicosis, diseases of the cardiovascular system, acute respiratory tract diseases, as well as in patients with a history of respiratory system diseases. Pregnancy and breastfeeding. Ipidacrine increases uterine tone and can cause premature labor, so it should not be used during pregnancy. This drug should not be used while breastfeeding. fI

Impact on the ability to drive vehicles and maintain machinery. Ipidacrine may have a sedative effect, so caution should be exercised in those exposed to this effect.

13. INTERACTION WITH OTHER DRUGS Ipidacrine weakens the inhibitory effect on neuromuscular transmission and the conduction of excitation along peripheral nerves of local anesthetics, aminoglycosides and potassium chloride. The sedative effect of drugs that depress the central nervous system, including ethanol, as well as the effect of other cholinesterase inhibitors and m-cholinergic stimulants are enhanced by ipidacrine. Compared to other cholinergic drugs, ipidacrine increases the risk of cholinergic crisis in patients with myasthenia gravis. Beta-blockers increase the severity of bradycardia caused by ipidacrine. Cerebrolysin improves the mental activity of ipidacrine.

14. CONDITIONS AND STORAGE DURATION

Store at a temperature no higher than 25 C. Do not freeze! Keep out of the reach of children. Shelf life - 2 years. Do not use after the expiration date stated on the package.

15. HOLIDAY CONDITIONS

On prescription.

16. PACKAGING

1 ml in a colorless glass ampoule with two marking rings of yellow and red (solution for injection 5 mg/ml) or green and red (solution for injection 15 mg/ml) and with a line or break point. 5 ampoules in a cell package. 2 cell packs with instructions for use in a cardboard pack.

17. INFORMATION ABOUT THE MANUFACTURER (APPLICANT) Registration Certificate Holder

JSC Grindeks. St. Krustpils, 53, Riga, LV-1057, Latvia Phone: +371 67083 205 Fax: +371 67083 505 E-mail Manufacturer HBM Pharma s.r.o. St. Sklabinska 30, Martin 036 80, Slovakia

Ipigrix tablet 20 mg pack cont cell/pack card x50

Ipigrix tablet 20 mg x50 ATX code: N07AA (Anticholinesterase drugs) Active substance: ipidacrine Rec.INN registered by WHO

Dosage form IPIGRIX tab. 20 mg: 50 pcs

reg. No.: LP-003193 dated 09/11/15 - Valid

Release form, composition and packaging

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

1 tab. ipidacrine hydrochloride monohydrate 21.6 mg, which corresponds to the content of ipidacrine hydrochloride 20 mg

Excipients: sodium carboxymethyl starch - 14 mg, lactose monohydrate - 65 mg, potato starch - 12.6 mg, dried potato starch - 1.4 mg, calcium stearate - 1 mg.

25 pcs. — contour cell packaging (2) — cardboard packs.

Clinical and pharmacological group: Cholinesterase inhibitor

Pharmacotherapeutic group: Anticholinesterase agent

Open the description of the active components of the drug IPIGRIS

The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug.

pharmachologic effect

Indications

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

In the recovery period for organic lesions of the central nervous system, accompanied by motor disorders.

Myasthenia, 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.) with encephalopathy (traumatic, vascular and other origins), cerebrovascular accident, traumatic brain injury, cerebral dysfunction with learning disabilities children.

Weakness of labor.

Intestinal atony.

Intoxication with anticholinergic drugs.

ICD-10 codes

Dosage regimen

Inside, s/c, i/m. Single dose – 10-40 mg. The maximum dose is 200 mg/day. The frequency of administration and duration of treatment depend on the indications.

Side effect

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

From the side of the central nervous system: dizziness (after repeated use), ataxia.

Allergic reactions: skin rash, itching.

Other: manifestations of m-cholinergic stimulating effect - bronchospasm, bradycardia.

Contraindications for use

Epilepsy, extrapyramidal disorders with hyperkinesis, angina pectoris, severe bradycardia, bronchial asthma, tendency to vestibular disorders, pregnancy, lactation, hypersensitivity to ipidacrine.

Use during pregnancy and breastfeeding

Contraindicated during pregnancy and lactation.

special instructions

It should be used with caution for gastric ulcers, thyrotoxicosis, and diseases of the cardiovascular system. It is necessary to take into account the ability of ipidacrine to increase uterine tone.

Impact on the ability to drive vehicles and operate machinery

It should not be used in patients whose activities involve driving vehicles and work that requires high concentration and speed of psychomotor reactions.

Drug interactions

When used simultaneously, ipidacrine enhances the sedative effect of drugs that have a depressant effect on the central nervous system, ethanol, and the effect of other cholinesterase inhibitors and m-cholinomimetics.

In patients with myasthenia gravis, when using ipidacrine along with other cholinergic drugs, the risk of developing a cholinergic crisis increases.

When used simultaneously with beta-blockers, bradycardia increases.

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

Atropine and methocynium iodide reduce the severity of overdose symptoms.

Ipigrix