Benzonal (Benzonal)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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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: & nbsp
    pills
    Composition:
    Active substance:
    benzobarbital (benzonale) - 100.00 mg
    Excipients:
    potato starch - 14.12 mg,
    povidone - 1.20 mg, (low molecular weight polyvinylpyrrolidone medical)
    methylcellulose -1.74 mg,
    stearic acid 0.94 mg.
    Description:Tablets of white color are round, flat-cylindrical with a facet and a risk.
    Pharmacotherapeutic group:Antiepileptic remedy
    ATX: & nbsp

    N.03.A.A   Barbiturates and their derivatives

    Pharmacodynamics:

    Benzobarbital refers to derivatives of barbituric acid, which is the basis of many sleeping pills, narcotic and anticonvulsants. Preparations of this group have anesthetic, hypnotic, sedative and anticonvulsant effects. Barbiturates bind to barbiturate receptors. This in turn potentiates the effects of GABA (gamma-aminobutyric acid) and enhances the flow of chloride ions through the neuron membrane, leading to its partial hyperpolarization and a decrease in permeability.Since the barbiturate receptor is located near the receptors for benzodiazepines and GABA, barbiturates enhance the interaction of these compounds with their receptors. Barbiturates cause a general depression of the functions of the central nervous system.

    Benzobarbital - an antiepileptic agent, practically does not have a hypnotic effect. Pharmacological action is due to the metabolite - phenobarbital, which 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+ (sodium ion), reduces the spread of impulses from the focus of epileptic activity. The effect occurs after 20-60 minutes after oral administration. Benzobarbital is the inducer of microsomal enzymes of the liver, reduces the concentration of bilirubin in the blood serum.

    Pharmacokinetics:

    Suction: Benzobarbital is rapidly absorbed in the stomach. The maximum concentration in the blood is reached in 1-3 hours after administration. Steady concentration in the blood is established on day 3.The therapeutic concentration in the blood plasma is 15-45 mg / l.

    Distribution: the connection with plasma proteins is weak. Evenly distributed in various organs and tissues. Creates high concentrations in the brain, liver and kidneys. Penetrates through the histohematological barriers and into breast milk.

    Metabolism: Benzobarbital in the body is rapidly metabolized by microsomal enzymes of the liver, releasing phenobarbital, which has an antiepileptic effect.

    Excretion: the elimination half-life (T1) is 3-4 days. It is excreted by the kidneys, both in unmodified form and in the form of metabolites.

    Indications:

    Convulsive syndrome, epilepsy of various genesis, all kinds of seizures.

    - Partial seizures

    - Secondary generalized seizures

    - Tonic-clonic seizures

    - Myoclonic seizures

    - Seizures in the Lennox-Gastaut syndrome

    - Infantile spasms

    Contraindications:

    Severe violations of kidney and / or liver function, chronic heart failure II-IV functional class for NYHA, porphyria, anemia, bronchial asthma, respiratory failure, diabetes mellitus, thyrotoxicosis, adrenal insufficiency, hyperkinesis,depressive states (with suicidal attempts), hypersensitivity to benzobarbital.

    Children under 7 years.

    Pregnancy and lactation:

    Due to penetration through the placental barrier and into breast milk, the drug should not be used during pregnancy and lactation. For the duration of treatment, breastfeeding should be discontinued.

    Dosing and Administration:

    Inside, after eating, 3 times a day. Dosing regimen is individual and is prescribed by a doctor. Treatment begins with a single dose of a single dose. After 2-3 days gradually increase the dose to achieve a clinical effect (reduced frequency or complete cessation of seizures). The course of treatment is continuous and long, at least 2 years.

    Single dose - 100 - 150 - 200 mg; the highest single dose of 300 mg, the highest daily dose - 800 mg.

    For children 7-10 years, single dose - 50-100 mg, daily - 150-300 mg; 11-14 years single-dose - 100 mg, daily - 300-400 mg; the highest single dose for older children is 150 mg; the highest daily intake is 450 mg.

    For children younger than 7 years, tablets with a dosage of 100 mg are not used.

    Side effects:

    From the central nervous system: drowsiness, lethargy, slowing of mental reactions, inhibition, headache, ataxia, nystagmus,speech difficulties (in these cases, dose adjustment or caffeine administration is required).

    On the part of the hematopoiesis system: thrombocytopenia, anemia.

    From the cardiovascular system: lowering of arterial pressure, thrombophlebitis.

    Other: addiction, drug dependence, withdrawal syndrome, worsening of appetite, allergic reactions, bronchospasm.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Symptoms: suppression of the functions of the central nervous system (drowsiness, impaired vision, ataxia, dysarthria, nystagmus), including coma, respiratory center depression, lowering of blood pressure, impaired renal function, headache, severe weakness, increased or decreased body temperature,dilation of pupils, tachy- or bradycardia, cyanosis, hemorrhages in places of pressure, pulmonary edema. In chronic intoxication - irritability, weakening the capacity for critical evaluation, sleep disturbances, confusion.

    Treatment: gastric lavage, the reception of activated charcoal, symptomatic and resuscitative therapy aimed at restoring and maintaining the function of the respiratory and cardiovascular system, the central nervous system, the liver, and the kidneys.

    Interaction:

    Enhances the effect of narcotic analgesics, drugs for general anesthesia, neuroleptics, tranquilizers, tricyclic antidepressants, ethanol, hypnotics, reduces - paracetamol, anticoagulants, tetracyclines, griseofulvin, glucocorticosteroids, mineralocorticoids, cardiac glycosides, quinidine, vitamin D, xanthines.

    Special instructions:

    - Barbiturates are characterized by a withdrawal syndrome - the resumption or weighting of seizures when discontinuing medication. When switching to treatment with Benzonal, patients who had previously taken other barbiturates may have a sleep disorder, which is eliminated by the appointment of phenobarbital (50-100 mg) or other hypnotic medicines for the night. Currently, treatment of epileptic patients begins with other antiepileptic drugs (valproic acid, carbamazepine and others) with less pronounced side effects. Benzobarbital prescribe, if these funds are not effective, more often as part of combination therapy.

    - Caution should be used in patients who abuse drugs or have a history of drug dependence; with violations of liver function, acute or persistent pain, impaired renal function, respiratory diseases accompanied by dyspnea or airway obstruction, especially with asthmatic status.

    - With prolonged use, liver damage is possible.

    - Patients who are hypersensitive to one of the barbiturates may have an increased sensitivity to other barbiturates.

    - Do not use benzobarbital simultaneously with griseofulvin. With simultaneous application it is necessary to monitor the concentrations of hydantoin derivatives in the blood plasma.

    - Perhaps the development of drug dependence. Weak intoxication with barbiturates, acute or chronic, resembles alcoholic intoxication. Symptoms include inhibition, discoordination, difficulty in thinking, poor memory, speech and understanding slowing, violation of criticism, stalling of sexual aggressive impulses,narrowing the range of attention, emotional lability and sharpening of the main personality traits, which in the future can lead to the development of suicidal behavior. During the treatment period, do not drink alcohol.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, the speed of psychomotor reactions slows down. 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:10 tablets per contour cell packaging made of polyvinyl chloride film and foil of aluminum or flexible packaging on the basis of aluminum foil. 1, 2 or 5 contour squares with instructions for use in a pack of cardboard.
    Storage conditions:
    In accordance with the rules for storage of potent substances.
    In the dark 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 the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001531
    Date of registration:12.08.2011 / 27.10.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.01.2017
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