Paglyuferal®-3 (Pagluferalum-3)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBrominated + Calcium gluconate + Caffeine + Papaverine + PhenobarbitalBrominated + Calcium gluconate + Caffeine + Papaverine + Phenobarbital
Dosage form: & nbsp

pills.

Composition:

Composition per one tablet

Phenobarbital - 0.05 g

Brominated 0.15 g

Caffeine-benzoate sodium -0.01 g

Papaverine hydrochloride - 0.02 g

Calcium gluconate 0.25 g

Auxiliary substances:

Potato starch - 0.095 g

Calcium stearate - 0.005 g

Description:

a white-colored tablet with a facet and a risk in the middle.

Pharmacotherapeutic group:protivoznilepticheskoe means.
ATX: & nbsp

N.03.A.X   Other antiepileptic drugs

Pharmacodynamics:

Combined antiepileptic drug.

Phenobarbital interacts with the "barbiturate" region of the benzodiazepine-GABA-receptor complex, thereby increasing the sensitivity of GABA receptors to G AMK, leading to the opening of neuronal channels for chloride ions, to increase their entry into the cell. Reduces the excitability of neurons of the spleptogenic 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 the internal organs and vessels.

Calcium gluconate - Replenishes the deficiency of calcium ions, necessary for the implementation of 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 period of zero-elimination 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-zvecephalic barrier and the placenta. Communication with blood proteins (albumins) is 25-36%. Metabolism in the liver is exposed to 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. Fri and compounds are subsequently demethylated in monomethylxanthines. and then into methylated uric acids. The period of zero-elimination 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% of kidney, the remainder is removed with bowel contents (actively allocated wall of the terminal segment 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, adrenal hypofunction, hyperthyroidism, depressed. bronchoobstructive diseases, active alcoholism, pregnancy, lactation. This dosage form is not used in children under 3 years of age.

Carefully:

FROM caution: 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: 7-9 years - 1 tablet 2 times a day. 10-14 years - 1.5 tablets 2 times a day.

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

Side effects:

Dizziness, general weakness, ataxia, dysarthria, nystagmus, paradoxical reaction (especially in elderly and weakened patients - agitation), hallucinations, sleep disturbances, nausea, vomiting, constipation or diarrhea, increased activity of hepatic transaminases. agranulocytosis, megaloblastic anemia, thrombocytopenia, decrease or increase arterial 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 with combination with amitriptyline. nor a house. diazepam, chlordiaazepoxide.

Reduces the effectiveness of oral contraceptives and salicylates.

Reduces the blood levels of indirect anticoagulants, glucocorticosteroids, griseofulvin, doxycycline.estrogen and other medicines, 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 hypercadicuria. reduction of glomerular filtration or with nephrolithiasis in the history of the appointment of the drug should be controlled by the content of calcium in the urine, which is due to the presence of calcium gluconate in the drug. During treatment should refrain from performing work requiring quickness of psychomotor reactions (including driving). Against therapy, alcohol is not recommended.

Effect on the ability to drive transp. cf. and fur:not described
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 the instruction for use is placed in a pack of cardboard.
Storage conditions:

List B. In a dry, protected from light and inaccessible to children at a temperature of no higher than 25 ° C.

Shelf life:

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

Terms of leave from pharmacies:On prescription
Registration number:LSR-001795/07
Date of registration:30.07.2007
The owner of the registration certificate:MOSCOW PHARMACEUTICAL FACTORY, CJSC MOSCOW PHARMACEUTICAL FACTORY, CJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp24.08.2011
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