Instructions Ipidacord solution for injection 15 mg/ml ampoules 1 ml No. 10
Composition
active ingredient: ipidacrine hydrochloride;
Ipidaccord, solution for injection 5 mg/ml: 1 ml of solution for injection (one ampoule) contains ipidacrine hydrochloride monohydrate equivalent to 100% ipidacrine hydrochloride – 5 mg;
excipients: hydrochloric acid, water for injection;
Ipidaccord, solution for injection 15 mg/ml: 1 ml of solution for injection (one ampoule) contains ipidacrine hydrochloride monohydrate equivalent to 100% ipidacrine hydrochloride – 15 mg;
Excipients: hydrochloric acid, water for injection.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless solution.
Pharmacotherapeutic group
Other agents acting on the nervous system. Parasympathomimetics. Anticholinesterase agents. ATX code N07A A.
Pharmacological properties
Pharmacodynamics.
Ipidaccord, solution for injection, is a reversible cholinesterase inhibitor.
Ipidacord, solution for injection, has a direct stimulating effect on the conduction of impulses along nerve fibers, interneuronal and neuromuscular synapses of the peripheral and central nervous system.
The pharmacological action of Ipidacord, solution for injection, is based on a combination of two mechanisms of action:
– blockade of potassium channels in the membrane of neurons and muscle cells;
– reversible inhibition of cholinesterase in synapses.
Ipidaccord, solution for injection, enhances the effect on smooth muscles of not only acetylcholine, but also adrenaline, serotonin, histamine, and oxytocin.
Ipidacord, solution for injection, exhibits the following decisive pharmacological effects:
– restores and stimulates impulse conduction in the nervous system and neuromuscular transmission;
– enhances the contractility of smooth muscle organs under the influence of all antagonists of acetylcholine, adrenaline, serotonin, histamine and oxytocin receptors, with the exception of potassium chloride;
– improves memory, slows down the progressive development of dementia;
– restores impulse conduction in the peripheral nervous system, disrupted due to the influence of various factors, such as trauma, inflammation, the action of local anesthetics, some antibiotics, potassium chloride, toxins, etc.;
– moderately stimulates the central nervous system in combination with manifestations of certain sedative effects;
– exhibits an analgesic effect;
– exhibits antiarrhythmic effect.
The drug does not have teratogenic, embryotoxic, mutagenic and carcinogenic, as well as allergenic and immunotoxic effects, and does not affect the endocrine system.
Pharmacokinetics.
Ipidacord, solution for injection is rapidly absorbed after subcutaneous or intramuscular administration. Maximum blood concentration is achieved after
25–30 minutes, 40–50% of the active substance binds to blood plasma proteins. Ipidacord, solution for injection quickly enters the tissues; the half-life in the phase is
40 minutes. Metabolized in the liver. The drug is excreted by the kidneys, as well as extrarenal (through the gastrointestinal tract). The half-life with parenteral administration of the drug is 2–3 hours. Excretion occurs mainly by tubular secretion, and only 1/3 of the dose is excreted by glomerular filtration. With parenteral administration, 34.8% of the drug dose is excreted in the urine unchanged.
Indication
Diseases of the peripheral nervous system: mono- and polyneuropathy, polyradiculopathies, myasthenia and myasthenic syndrome of various etiologies.
Diseases of the central nervous system (CNS): bulbar palsies and paresis; recovery period of organic lesions of the CNS, which are accompanied by motor disorders.
Contraindication
- Hypersensitivity to ipidacrine.
- Epilepsy.
- Extrapyramidal disorders with hyperkinesis.
- Angina pectoris.
- Marked bradycardia.
- Bronchial asthma.
- Vestibular disorders.
- Mechanical obstruction of the intestines and urinary tract.
- Gastric or duodenal ulcer in the acute stage.
- Pregnancy.
- Breastfeeding period.
Interaction with other medicinal products and other types of interactions
Ipidacord, solution for injection enhances the sedative effect in combination with drugs that depress the central nervous system. The effect and side effects are enhanced when used together with other cholinesterase inhibitors and m-cholinomimetic drugs. In patients with myasthenia gravis, the risk of developing a "cholinergic" crisis increases if Ipidacord, solution for injection is used simultaneously with cholinergic drugs. The risk of developing bradycardia increases if β-blockers were used before starting treatment with Ipidacord, solution for injection.
Ipidacord, solution for injection can be used in combination with nootropic drugs.
Alcohol increases the side effects of the drug.
Application features
Use with caution in patients with a history of peptic ulcer of the stomach and duodenum, respiratory diseases, including acute respiratory diseases, cardiovascular diseases not associated with coronary pain, and thyrotoxicosis.
Use during pregnancy or breastfeeding
Ipidacord, solution for injection, increases uterine tone and may cause premature birth, therefore, the use of the drug is contraindicated during pregnancy.
The use of the drug is contraindicated during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
During the treatment period, it is necessary to refrain from driving a car, as well as from potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Method of administration and doses
The solution for injection is administered intramuscularly or subcutaneously. The dose and duration of treatment should be determined individually depending on the severity of the disease.
Peripheral nervous system diseases
Mono- and polyneuropathies of various genesis: administer 5–15 mg subcutaneously or intramuscularly
1–2 times a day, the course of treatment is 10–15 days (in severe cases up to 30 days); then the treatment should be continued with the tablet form of the drug.
Myasthenia and myasthenic syndrome: administer 5–30 mg subcutaneously or intramuscularly
1-3 times a day, with subsequent transition to tablet form. The total course of treatment is 1-2 months. If necessary, the treatment can be repeated several times with a break between courses of 1-2 months.
Central nervous system diseases
Bulbar palsies and paresis: subcutaneously and intramuscularly 5–15 mg 1–2 times a day, course of treatment – 10–15 days, if possible, switch to tablet form.
Recovery period for organic CNS lesions
Intramuscularly 10–15 mg 1–2 times a day, course of treatment up to 15 days, then 1–2 times a day if possible.
Children.
There are no systematic data on the use of the parenteral form of the drug Ipidacord, solution for injection in children (under 18 years of age), therefore the drug should not be used in children.
Overdose
Symptoms.
In case of severe overdose, a cholinergic crisis may develop, which is characterized by:
bronchospasm, lacrimation, increased sweating, constriction of the pupils, nystagmus, increased peristalsis of the gastrointestinal tract, spontaneous defecation and urination, vomiting, jaundice, bradycardia, intracardiac conduction disorders, arrhythmias, decreased blood pressure, anxiety, agitation, fear, ataxia, convulsions, coma, speech disorders, drowsiness, general weakness.
Treatment: symptomatic therapy should be applied, m-cholinoblockers should be used: atropine, cyclodol, metacin.
Adverse reactions
Like all medicines, Ipidacor, solution for injection, can cause side effects, although not everybody gets them.
Frequency of adverse reactions according to the MedDRA classification (Medical Dictionary of Regulatory Activities Terms):
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000) very rare (<1/10000); frequency unknown (cannot be estimated from the available data).
Cardiac: often - palpitations, bradycardia.
From the nervous system: infrequently - dizziness, headache, drowsiness (when taking high doses).
Respiratory, thoracic and mediastinal disorders: infrequently - increased bronchial secretion, bronchospasm.
From the gastrointestinal tract: often - increased salivation, nausea; infrequently - when using high doses - vomiting, rarely - diarrhea, epigastric pain.
Hepatic: frequency unknown – jaundice.
Skin and subcutaneous tissue disorders: common: increased sweating; uncommon: allergic reactions, including rash, itching, urticaria, angioedema.
From the reproductive system: increased uterine tone.
Musculoskeletal and connective tissue disorders: infrequently - muscle cramps (when using high doses).
Immune system disorders: frequency unknown - hypersensitivity reactions (including allergic dermatitis, anaphylactic shock, asthma, toxic epidermal necrolysis, erythema, urticaria, wheezing, laryngeal edema, injection site rash).
General disorders and administration site conditions: uncommon – weakness (when using high doses).
Anticholinergic agents such as atropine may reduce salivation and bradycardia.
In case of development of undesirable side effects, the dose should be reduced or the treatment should be discontinued for a short time (for
1–2 days) discontinue use of the drug.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Incompatibility.
The medicinal product should not be mixed with other solutions, except those specified in the "Method of administration and dosage" section.
Packaging
1 ml in an ampoule, 5 ampoules in a blister, 2 blisters in a pack or 100 ampoules in a pack.
Vacation category
According to the recipe.
Producer
Private Joint-Stock Company "Lekhim-Kharkiv".
Location of the manufacturer and address of its place of business.
Ukraine, 61115, Kharkiv region, Kharkiv city, Severyna Pototskoho street, building 36.
