Instructions Neuromidine solution for injection 0.5% ampoule 1 ml No. 10
Composition
active ingredient: ipidacrine hydrochloride;
Neuromidin® 5 mg/ml solution for injection: 1 ml of solution for injection (one ampoule) contains 5 mg of ipidacrine hydrochloride calculated on the anhydrous basis;
excipients: water for injections.
Neuromidin® 15 mg/ml solution for injection: 1 ml of solution for injection (one ampoule) contains 15 mg of ipidacrine hydrochloride calculated on the anhydrous basis;
excipients: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
Other agents acting on the nervous system. Parasympathomimetics. Anticholinesterase agents. ATX code N07AA.
Pharmacological properties
Pharmacodynamics.
Neuromidin® 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 Neuromidin® 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.
Neuromidin® enhances the effect on smooth muscles of not only acetylcholine, but also adrenaline, serotonin, histamine, and oxytocin.
Neuromidin® exhibits the following decisive pharmacological effects:
- improves 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.;
- specifically moderately stimulates the CNS with some manifestations of a sedative effect;
- 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.
Neuromidin® is rapidly absorbed after subcutaneous or intramuscular administration. The maximum concentration in the blood is reached after 25-30 minutes, 40-50% of the active substance binds to blood plasma proteins. Neuromidin® quickly enters the tissues; the half-life in the phase is 40 minutes. It is metabolized in the liver. The drug is excreted through 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 due to 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.
Interaction with other medicinal products and other types of interactions
Neuromidin® 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 Neuromidin® is used simultaneously with cholinergic drugs. The risk of developing bradycardia increases if β-blockers were used before starting treatment with Neuromidin®.
Neuromidin® 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
Neuromidin® increases uterine tone and can cause premature birth, so 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 engaging in 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.
Diseases of the peripheral nervous system:
Mono- and polyneuropathies of various genesis: subcutaneously or intramuscularly administer 5-15 mg 1-2 times a day, the course of treatment is 10-15 days (in severe cases up to 30 days); then treatment should be continued with the tablet form of the drug.
Myasthenia and myasthenic syndrome: subcutaneously or intramuscularly inject 5-30 mg 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 paralysis 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 Neuromidin® in children under 18 years of age, therefore the drug should not be used in children.
Overdose
Symptoms.
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, worry, anxiety, agitation, feelings of fear, ataxia, convulsions, coma, speech disorders, drowsiness, general weakness.
Treatment: symptomatic therapy should be applied, m-cholinoblockers should be used: atropine, cyclodol, metacin, etc.
Adverse reactions
Like all medicines, Neuromidin® can cause side effects, although not everybody gets them.
Cardiac disorders: increased heartbeat, decreased heart rate.
Nervous system disorders: when taking high doses - dizziness, headache, drowsiness, general weakness, convulsions.
Respiratory tract disorders: increased secretion of bronchial secretions, bronchospasm.
Gastrointestinal disorders: increased salivation, nausea; when using high doses - vomiting, diarrhea, jaundice, pain behind the sternum.
Skin and subcutaneous tissue disorders: increased sweating; allergic reactions, including rash, itching, urticaria, angioedema.
Reproductive system disorders: increased uterine tone.
Other: changes at the injection site.
In case of development of undesirable side effects, the dose should be reduced or the use of the drug should be interrupted for a short time (for 1-2 days). Salivation and a decrease in heart rate can be reduced by m-cholinoblockers (atropine, etc.).
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
1 ml of solution for injection (5 mg/ml or 15 mg/ml) in an ampoule.
10 ampoules in a contour blister pack in a cardboard box.
Vacation category
According to the recipe.
Producer
JSC "Olainfarm"/JSC "Olainfarm".
Location of the manufacturer and its business address
5 Rupnicu street, Olaine, LV-2114, Latvia.
