Instructions Barboval hard capsules blister No. 30
Composition
active ingredients: ethyl ester of α-bromoisovaleric acid, solution of menthol in menthyl ester of isovaleric acid, phenobarbital;
1 capsule contains: ethyl ester of α-bromoisovaleric acid – 10 mg, solution of menthol in menthyl ester of isovaleric acid – 46 mg, phenobarbital – 9.8 mg;
Excipients: castor oil, lactose monohydrate (200), microcrystalline cellulose 102, crospovidone, calcium stearate, colloidal anhydrous silicon dioxide.
Dosage form
The capsules are hard.
Main physicochemical properties: hard gelatin capsules No. 0, blue cap, white body with or without a butterfly image. Capsule contents – homogeneous white or almost white powder.
Pharmacotherapeutic group
Hypnotics and sedatives. Combined barbiturate preparations. ATX code N05C B02.
Pharmacological properties
Pharmacodynamics
Barboval is a combined drug, the therapeutic effect of which is due to the pharmacological properties of the components that make up its composition.
Ethyl ester of α-bromosovaleric acid has a reflex, sedative and antispasmodic effect, which is due to a decrease in reflex excitability in the central nervous system and an increase in inhibition processes in neurons of the cortex and subcortical structures of the brain, as well as a decrease in the activity of central vasomotor centers and a local direct antispasmodic effect on smooth muscles.
Phenobarbital inhibits the activating effect of the centers of the reticular formation of the medulla oblongata on the cerebral cortex, thereby reducing the flow of excitatory influences on the cerebral cortex and subcortical structures. The reduction of activating influences produces, depending on the dose, a sedative, tranquilizing and hypnotic effect. Barboval reduces the excitatory effects on the vasomotor centers, coronary and peripheral vessels, reducing overall blood pressure, eliminating and preventing vascular spasms, especially cardiac ones.
Menthol in the menthyl ester of isovaleric acid has a calming effect on the central nervous system, slows down the peristalsis of the stomach and intestines, reduces flatulence, and also has a moderate reflex vasodilator and antispasmodic effect.
Pharmacokinetics
Not studied.
Indication
Neuroses accompanied by increased excitability, insomnia; hysteria; as part of the complex treatment of mild attacks of angina pectoris, arterial hypertension in the initial stage; tachycardia of functional genesis; with stomach and intestinal spasms, flatulence.
Contraindication
Hypersensitivity to any component of the drug, hepatic and renal failure, hepatic porphyria, severe arterial hypotension, acute myocardial infarction, severe heart failure, diabetes mellitus, depression, myasthenia gravis, alcoholism, drug and medication addiction, respiratory diseases with shortness of breath, obstructive syndrome.
Interaction with other medicinal products and other types of interactions
Simultaneous use with neuroleptics and tranquilizers potentiates, and with central nervous system stimulants weakens the effect of each component of the drug. Barboval, which contains barbituric acid derivatives, enhances the effect of local anesthetics, analgesics and hypnotics. Alcohol enhances the effects of the drug and may increase its toxicity. The effect of the drug is enhanced against the background of the use of valproic acid preparations. The presence of phenobarbital in Barboval can induce liver enzymes, which makes its simultaneous use with medications that are metabolized in the liver undesirable (with coumarin derivatives - indirect anticoagulants, griseofulvin, glucocorticoids, oral contraceptives, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral hypoglycemic, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive drugs), since their effectiveness will decrease as a result of a higher level of metabolism.
MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.
The risk of kidney damage increases with the simultaneous use of phenobarbital with gold preparations.
With prolonged simultaneous use of phenobarbital with nonsteroidal anti-inflammatory drugs, there is a risk of stomach ulcers and bleeding.
Concomitant use of phenobarbital with zidovudine increases the toxicity of both drugs.
The drug increases the toxicity of methotrexate. Alcoholic beverages should be avoided while taking the drug.
Application features
The presence of phenobarbital in the composition of the drug may lead to the risk of developing Stevens-Johnson and Lyell syndrome, which is most likely in the first weeks of treatment. Long-term use is not recommended due to the risk of developing drug dependence, possible accumulation of bromine in the body and the development of bromine poisoning. In cases where pain in the heart area does not go away after taking the drug, you should consult a doctor to exclude acute coronary syndrome. The drug should be prescribed with caution in decompensated heart failure, arterial hypotension, hyperkinesias, hyperthyroidism, adrenal hypofunction, acute and constant pain, acute drug intoxication.
Castor oil, which is part of the drug, can cause stomach upset and diarrhea.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug may cause drowsiness and dizziness, therefore, during treatment, patients are not recommended to work with dangerous mechanisms and drive vehicles.
Use during pregnancy or breastfeeding
The drug should not be used by women during pregnancy or breastfeeding.
Method of administration and doses
Barboval is taken orally. Usually, adults should take 1-2 capsules 2-3 times a day for 10-15 days. It is better to take the drug 20-30 minutes before meals. After a break of 10-15 days, the course of treatment can be repeated. The maximum daily dose is 6 capsules.
Children
There is no experience with the use of the drug in the treatment of children, therefore the drug is not used in pediatric practice.
Overdose
With prolonged or frequent use, cumulation of the drug may occur, leading to clinical manifestations of overdose, namely:
Central nervous system depression, which is eliminated by the use of CNS stimulants (caffeine, cordiamine); nystagmus, ataxia, decreased blood pressure, abnormalities in the blood formula.
Manifestations of chronic bromine poisoning include: depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, and impaired coordination of movements. Symptomatic therapy is prescribed to eliminate these manifestations.
Continuous long-term use of the drug may cause addiction, drug dependence, withdrawal syndrome, and sudden cessation of use - withdrawal syndrome. Long-term use of the drug is sometimes accompanied by increased psychodynamic activity instead of the expected sedation.
Symptoms of overdose: respiratory depression, up to its cessation; central nervous system depression, up to coma; cardiovascular depression, including rhythm disturbances, decreased blood pressure, up to a collapse-like state; nausea, weakness, decreased body temperature, decreased diuresis.
Treatment is symptomatic.
Adverse reactions
The drug is usually well tolerated.
The following adverse reactions may develop:
from the digestive system: constipation, feeling of heaviness in the epigastric region, with prolonged use - impaired liver function, nausea, vomiting; from the nervous system: weakness, ataxia, impaired coordination of movements, nystagmus, hallucinations, paradoxical excitation, decreased concentration of attention, fatigue, slow reactions, headache, cognitive disorders, confusion, drowsiness, mild dizziness; from the blood-forming organs: anemia, thrombocytopenia, agranulocytosis; from the cardiovascular system: arterial hypotension, bradycardia; from the immune system: hypersensitivity reactions, including angioedema, allergic reactions, including skin rash, itching, urticaria); from the skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis; Musculoskeletal system: with prolonged use of drugs containing phenobarbital, there is a risk of osteogenesis disorders; other: difficulty breathing.
Prolonged use of bromine-containing drugs can lead to bromine poisoning, which is characterized by the following symptoms: central nervous system depression, depressed mood, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne, or purpura.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister. 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
