Benzonal - instructions for use, dose, side effects, contraindications

Active substanceBenzobarbitalBenzobarbital

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Benzonal

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MOSCOW ENDOCRINE FACTORY, FSUE Russia

Benzonal

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TATHIMFARMPREPARATY, JSC Russia

Benzonal

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Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC

Benzonal

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UZOLE-SIBERIAN CHEMICAL PLANT, OJSC Russia

Dosage form: & nbsppills

Composition:

Composition per one tablet:

Active substance:

Benzobarbital (benzonale) - 100,000 mg;

Excipients:

Corn starch - 16,270 mg; calcium stearate - 1,380 mg; polysorbate-80 - 0.354 mg.

Description:Round flat cylindrical tablets of white color with a bevel.

Pharmacotherapeutic group:Antiepileptic agent. Barbiturates and their derivatives

ATX: & nbsp

N.03.A.A Barbiturates and their derivatives

Pharmacodynamics:

Antiepilepticheskoe means, serves as an inducer of enzymes, increases the activity of the monooxygenase enzyme system of the liver, practically does not have a hypnotic effect. Enhances inhibitory GABAergic effects in the central nervous system, especially in the thalamus, the ascending activating reticular formation of the brainstem at the level of intercalary neurons. Reducing the permeability of nerve fiber membranes for Na⁺, reduces the spread of impulses from the focus of epileptic activity. The effect occurs 20-60 minutes after oral administration.

Pharmacokinetics:

Rapidly metabolized in the body, releasing phenobarbital, which has antiepileptic effect. The connection with plasma proteins is weak. Creates high concentrations in the brain, liver, kidneys. Penetrates through the histohematological barriers and into breast milk. The elimination half-life is 3-4 days. It is excreted by the kidneys both in unchanged form and in the form of metabolites.

Indications:

Different forms of epilepsy. Treatment of non-convulsive and polymorphic epileptic seizures in combination with other antiepileptic drugs.

Contraindications:

Hypersensitivity to the components of the drug. Severe parenchymal lesions of the liver, kidney damage with impaired function, cardiac decompensation, diabetes mellitus, depressive conditions, chronic alcoholism, drug addiction, severe myasthenia gravis, porphyria, anemia, bronchial asthma, respiratory failure, hyperthyroidism, adrenal insufficiency, hyperkinesia, depressive states with suicidal attempts.

Pregnancy and lactation.

Pregnancy and lactation:

The drug is contraindicated during pregnancy.When pregnancy occurs, the patient should be informed of the potential threat to the fetus. Benzonal during pregnancy can lead to a disruption in the fetal development of the fetus. In children whose mothers took Benzonal in monotherapy and in combination with other anticonvulsants marked increase in the incidence of malformations, such as congenital neural tube defects, craniofacial deformities, malformations of the limbs and the cardiovascular system. It is shown that the intrauterine effect of Benzonal can have undesirable effects on mental and physical development. Neonates were cases of life-threatening bleeding associated with decreased levels of vitamin K and disorders in blood coagulation system in newborns exposed Benzonal in utero. Women of childbearing age must comply with contraception when using the drug. Benzonal excreted in breast milk in small amounts, but the use of the drug is not recommended during breastfeeding because of the development of possible side effects in a newborn.

Dosing and Administration:

Benzonal is taken orally after a meal. The dose is set by the doctor individually. The dose of the drug depends on the patient's age, nature and frequency of seizures. A single dose is 100-200 mg, the maximum daily dose is 800 mg. Most often, the drug is used for 100 mg 3 times a day. Treatment begins with a single dose of a single dose. After 2-3 days, the dose is raised to achieve a clinical effect (reduced frequency or complete absence of seizures). Treatment continues for a long time, not less than 1-3 years (even in the absence of seizures), applying one single dose per day. In case of resumption of seizures should return to the previous daily dose. The maximum dose: single dose - 300 mg, daily - 800 mg.

If the patient has previously used other anticonvulsants, the transition to Benzonal should be gradual: Benzonal first replace one dose, and then (after 3-5 days) the second and third doses of the drug.

Side effects:

Undesirable phenomena are distributed according to system-organ classes and frequency (very frequent (> 1/10), frequent (> 1/100, <1/10), infrequent (> 1/1000, <1/100) and rare (<1 / 1000)). The listed undesirable phenomena could be associated with the underlying disease and / or concomitant therapy.

From the respiratory system: bronchospasm;

from the cardiovascular system: lowering blood pressure;

from the nervous system: drowsiness, inhibition, headache, decrease appetite, lethargy, difficulty speaking, ataxia;

from the side of the psyche: slowing down of mental reactions;

on the part of the blood system: thrombocytopenia, anemia, thrombophlebitis;

from the digestive tract: diarrhea, constipation;

from the skin: allergic reactions (skin rash);

general disorders: with prolonged use, it is possible to develop drug dependence, with a sudden discontinuation of benzobarbital therapy - withdrawal syndrome, nystagmus.

With prolonged use of the drug manifestations of hypersensitivity syndrome to Benzonal and severe depression of the central nervous system are possible, which requires drug discontinuation.

Overdose:

Intoxication with the drug is manifested by depression of the functions of the central nervous system (drowsiness, impaired vision, ataxia, dysarthria, nystagmus), up to coma. There is a depression of the respiratory center, blood pressure decreases, and renal function is impaired.

Symptoms: headache, retardation, severe weakness, increase or decrease in body temperature, slowing and difficulty breathing, shortness of breath, agitation, narrowing of the pupils, tachy- or bradycardia, cyanosis, hemorrhages in places of pressure, confusion, pulmonary edema, coma. With chronic intoxication - irritability, weakened ability to critical evaluation, sleep disturbance, confusion.

Treatment: symptomatic and resuscitative therapy aimed at restoring and maintaining the function of the respiratory and cardiovascular system, liver, kidneys, central nervous system. These measures include intubation of the trachea in a coma, artificial ventilation in central hypoventilation, active antibiotic therapy and intravenous therapy with solutions of glucose and electrolytes, the use of cardiovascular drugs and glucocorticosteroids.

Interaction:

Benzonal enhances the effect of narcotic analgesics, general anesthetics, neuroleptics, tranquilizers, tricyclic antidepressants, ethanol, hypnotics, reduces the effect of paracetamol, anticoagulants, tetracyclines, griseofulvin,glucocorticosteroid preparations, mineralocorticoids, cardiac glycosides, quinidine, vitamin D, xanthines.

The drug is able to enhance the activity of the monooxygenase enzyme system of the liver, which should be taken into account when using simultaneously with other drugs because of the possible decrease in the effectiveness of the latter.

Special instructions:

The decision to treat patients with epilepsy with Benzonal is taken by the doctor, taking into account the course of the disease, the patient's condition and the effectiveness of the previous antiepileptic therapy. In patients who have previously taken barbiturates, sleep disturbance is possible with Benzonal treatment.

Antiepileptic drugs, including Benzonal, may increase the risk of suicidal thoughts or behavior. Therefore, patients receiving these drugs should be carefully monitored for the appearance or deterioration of depression, the appearance of suicidal thoughts or behavior.

During the treatment, alcoholic beverages are not allowed.

If the drug is suddenly discontinued, withdrawal may occur. There are reports of cases of the development of dependence in the use of Benzonal.Patients with drug dependence in history need to be closely monitored for signs of dependence on Benzonal.

Effect on the ability to drive transp. cf. and fur:

During benzobarbital treatment, it is necessary to refrain from potentially dangerous activities requiring an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets of 100 mg.

Packaging:

For 10 tablets in a contour non-cellular package of paper with a polymer coating.

For 10 tablets in a contour mesh box made of polyvinyl chloride film and foil of aluminum printed lacquered.

For 50 tablets in a polymer can with the first opening and a shock absorber or a can of polyethylene terephthalate for drugs with a screw cap or with the control of the first opening.

Each jar, 5 contour squares or 5 contour non-jawed packages with instructions for use are placed in a pack of cardboard.

100, 200, 500 contour non-jawed packages with an equal number of instructions for use are placed in a cardboard box (for hospitals).

Storage conditions:

List of potent substances.

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004557

Date of registration:27.11.2017

Expiration Date:27.11.2022

The owner of the registration certificate:UZOLE-SIBERIAN CHEMICAL PLANT, OJSC UZOLE-SIBERIAN CHEMICAL PLANT, OJSC Russia

Manufacturer: & nbsp

UZOLE-SIBERIAN CHEMICAL PLANT, OJSC Russia

Information update date: & nbsp09.01.2018

Illustrated instructions

Instructions

Benzonal (Benzonal)