Instructions Paraplexin solution for injection 15 mg/ml ampoule 1 ml No. 10
Composition
active ingredient: ipidacrine hydrochloride monohydrate;
1 ml of solution contains 5 mg or 15 mg of ipidacrine hydrochloride monohydrate calculated on the anhydrous basis;
excipient: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless liquid.
Pharmacotherapeutic group
. Agents acting on the nervous system. Parasympathomimetics. Anticholinesterase agents. ATX code N07A A.
Pharmacological properties
Pharmacodynamics.
Paraplexin® has a direct stimulating effect on impulse conduction along nerve fibers, interneuronal and neuromuscular synapses of the peripheral and central nervous systems.
The pharmacological action of Paraplexin® 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.
Paraplexin® enhances the effect on smooth muscles of not only acetylcholine, but also adrenaline, serotonin, histamine, and oxytocin.
Paraplexin® exhibits the following 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.
Paraplexin® 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. Paraplexin® quickly enters the tissues; the half-life is 40 minutes. It is 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 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
Paraplexin® 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 agents. In patients with myasthenia gravis, the risk of developing a cholinergic crisis increases if Paraplexin® is used simultaneously with cholinergic agents. The risk of developing bradycardia increases if β-blockers were used before starting treatment with Paraplexin®.
Paraplexin® 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
Paraplexin® 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.
The ability to influence the reaction speed when driving or working with 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 ipidacrine.
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.
Diseases of the central nervous system.
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, the course of treatment is up to 15 days, then 1-2 times a day if possible.
Children.
There are no systematic data on the use of parenteral ipidacrine hydrochloride 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 gastrointestinal peristalsis, 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, etc.
Adverse reactions
Cardiovascular system: increased heartbeat, decreased heart rate.
From the nervous system: when using high doses - dizziness, headache, drowsiness, general weakness, convulsions.
On the part of the respiratory system: increased secretion of bronchial secretions, bronchospasm.
On the part of the digestive system: 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.
From the reproductive system: 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 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. Do not freeze.
Keep out of reach of children.
Packaging
1 ml of solution in an ampoule, 5 ampoules in a blister. 2 blisters (10 ampoules) in a cardboard pack.
Vacation category
According to the recipe.
Producer
PJSC "Lekhim-Kharkiv".
Location of the manufacturer and its business address
Ukraine, 61115, Kharkiv region, Kharkiv, 17th Party Congress St., 36.
Applicant
LLC "Pharmaceutical Company "Salutaris".
Applicant's location
Ukraine, 01042, Kyiv, Druzhby Narodiv Boulevard, 9.
