Paglyuferal -1 - instructions for use, dose, side effects, contraindications

Active substanceBrominated + Calcium gluconate + Caffeine + Papaverine + PhenobarbitalBrominated + Calcium gluconate + Caffeine + Papaverine + Phenobarbital

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Paglyuferal®-1

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MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Paglyuferal®-2

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MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Paglyuferal®-3

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MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Dosage form: & nbsppills.

Composition:

active substances: phenobarbital 25 mg, bromizoval 100 mg, sodium caffeine-benzoate 7.5 mg, papaverine hydrochloride 15 mg, calcium gluconate 250 mg; Excipients: potato starch, calcium stearate.

Description:

Tablets of white color with a facet and risk in the middle.

Pharmacotherapeutic group:antiepileptic agent.

ATX: & nbsp

N.03.A.X Other antiepileptic drugs

Pharmacodynamics:

Combined antiepileptic drug.

Phenobarbital interacts with the "barbiturate" site of the benzodiazepine-GABA receptor complex, thereby increasing the sensitivity of GABA receptors to GABA, leading to the opening of neuronal channels for chloride ions, which leads to an increase in their entry into the cell. Reduces the excitability of neurons in the epileptogenic focus and the spread of nerve impulses.It shows antagonism against a number of excitatory mediators (glutamate, etc.). Suppresses the sensory areas of the cerebral cortex, reduces motor activity, depresses the cerebral functions, including the respiratory center. Reduces the tone of the smooth muscles of the gastrointestinal tract. Has anticonvulsant, sedative, hypnotic and antispasmodic effect.

Caffeine - increases the reflex excitability of the spinal cord, excites the respiratory and vasomotor centers, stimulates metabolic processes in organs and tissues, including in muscle tissue and the central nervous system.

Papaverine hydrochloride - antispasmodic, has an antihypertensive effect. Reduces the tone and relaxes the smooth muscles of internal organs and vessels.

Calcium gluconate - replenishes the deficiency of calcium ions necessary for the process of transmission of nerve impulses.

Bromizov has sedative and moderate sleeping pills.

Pharmacokinetics:

Phenobarbital: absorbed slowly, completely. The maximum concentration in the blood plasma is determined after 1-2 hours, the connection with plasma proteins is 50%.Metabolized in the liver, induces microsomal liver enzymes CYP3A4, CYP3A5, CYP3A7 (the rate of enzymatic reactions increases 10-12 times). Cumulated in the body. The half-life is 2-4 days. It is excreted by the kidneys in the form of glucuronide, about 25% - unchanged. Penetrates into breast milk and through the placental barrier.

Caffeine: absorption is good, occurs throughout the intestine. The maximum concentration in the blood plasma is reached in 50-75 minutes. Rapidly distributed in all organs and tissues, it penetrates the hemato-encephalic barrier and the placenta. Communication with blood proteins (albumins) is 25-36%. Metabolism in the liver is more than 90%, in children of the first years of life up to - 10-15%. In adults, about 80% of the dose of caffeine is metabolized to paraxanthin, about 10% to theobromine and about 4% to theophylline. These compounds are subsequently demethylated into monomethylxanthines, and then into methylated uric acids. The half-life in adults is 3.9-5.3 hours (sometimes up to 10 hours). The excretion of caffeine and its metabolites is carried out by the kidneys.

Papaverine: bioavailability on the average - 54%. The connection with plasma proteins is 90%. It is well distributed, it penetrates through the histogematic bergers. Metabolised in the liver.The elimination half-life is 0.5-2 hours (may extend up to 24 hours). It is excreted by the kidneys in the form of metabolites.

Calcium gluconate: approximately 1 / 5-1 / 3 of the part is absorbed in the small intestine. About 20% is excreted by the kidneys, the rest is removed from the intestinal contents (actively allocated by the wall of the terminal section of the gastrointestinal tract).

Indications:Epilepsy.

Contraindications:

Hypersensitivity to any component of the formulation, expressed hepatic and / or renal insufficiency, drug dependency (including history), hyperkinesis, myasthenia gravis, severe anemia, porphyria, diabetes mellitus, hypofunction of the adrenal gland, hyperthyroidism, depressed, broncho-obstructive disease, active alcoholism, pregnancy, lactation. This dosage form is not used in children under 3 years of age.

Carefully:

in weakened patients (high risk of paradoxical arousal, depression and confusion even with conventional doses).

Pregnancy and lactation:contraindicated

Dosing and Administration:

Inside after eating.

Children: 3-4 years - 1 tablet 2 times a day, 5-6 years - 1.5 tablets 2 times a day, 7-9 years - 2 tablets 2 times a day, 10-14 years - 3 tablets 2 times a day.

Children from 14 years and adults: 4 tablets 2 times a day.

Side effects:

Dizziness, general weakness, ataxia, dysarthria, nystagmus, paradoxical reaction (especially in elderly and weakened patients - excitement), hallucinations, sleep disorders, nausea, vomiting, constipation or diarrhea, increased activity of hepatic transaminases, agranulocytosis, megaloblastic anemia, thrombocytopenia, decrease or increased blood pressure, tachycardia, arrhythmia (including extrasystole), atrioventricular blockade, allergic reactions, with prolonged use - drug dependence.

Overdose:

Symptoms: increased severity of side effects. Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

Interaction:

Phenytoin and valproate increase the content of phenobarbital in the blood serum.

The effect of phenobarbital decreases with simultaneous administration with reserpine, increases when combined with amitriptyline, nialamide, diazepam, chlordiaazepoxide.

Reduces the effectiveness of oral contraceptives and salicylates.

Reduces the blood in the blood of indirect anticoagulants, glucocorticosteroids, griseofulvin, doxycycline, estrogens and other drugs metabolized in the liver along the oxidation pathway (speeds up their metabolism).

Strengthens the effect of alcohol, neuroleptics, narcotic analgesics, muscle relaxants sedatives and hypnotics.

Acetazolamide, alkalinizing urine, reduces the reabsorption of phenobarbital in the kidneys and weakens its effect.

Reduces antibacterial activity of antibiotics and sulfonamides, antifungal action of griseofulvin.

Special instructions:

Patients with minor hypercalciuria, reduced glomerular filtration, or with nephrolithiasis in the history of the drug should be administered under the control of calcium in the urine, which is due to the presence of calcium gluconate in the drug. Against therapy, alcohol is not recommended.

Effect on the ability to drive transp. cf. and fur:During treatment should refrain from performing work requiring quickness of psychomotor reactions (including driving).

Form release / dosage:Pills.

Packaging:For 10 tablets in a contour mesh package or 10 pieces in a contour non-jawed package. Two contour packs together with instructions for use in a pack of cardboard. 40 tablets in cans of orange glass. Each bank along with Instructions for use are placed in a packet from the card.

Storage conditions:

List B. In a dry, protected from light and out of reach of children at a temperature above 25 ° C.

Shelf life:

Shelf life. 2 years. Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001884/07

Date of registration:02.08.2007

The owner of the registration certificate:MOSCOW PHARMACEUTICAL FACTORY, CJSC MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Manufacturer: & nbsp

MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia

Information update date: & nbsp24.08.2011

Illustrated instructions

Instructions

Paglyuferal®-1 (Pagluferalum®-1)