Barboval®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BARBOVAL® (BARBOVALUM®)

Composition:

Active substances: ethyl ether of α-bromo-isovaleric acid, menthol in menthyl ester of isovaleric acid, phenobarbital;

1 ml of solution contains ethyl ether of α-bromo-isovaleric acid, calculated as 100 % substance – 18 mg, menthol solution in menthyl ester of isovaleric acid (validol) – 80 mg, phenobarbital – 17 mg;

Excipients: sodium acetate trihydrate, ethanol (96 %), purified water.

Pharmaceutical form. Oral drops.

Main physicochemical properties: clear, colorless liquid with a characteristic aromatic odor.

Pharmacotherapeutic group. Hypnotics and sedatives. Barbiturates, combinations.

ATC code N05C B02.

Pharmacological Properties

Pharmacodynamics

Barbival® is a combined medicinal product, whose therapeutic effect is determined by the pharmacological properties of its constituent components.

Ethyl ether of α-bromoisovaleric acid exerts a reflex sedative and spasmolytic effect, caused by stimulation primarily of the oral and nasopharyngeal receptors, reduction of reflex excitability in central parts of the nervous system, enhancement of inhibitory processes in neurons of the cerebral cortex and subcortical brain structures, as well as reduction of activity in central vasomotor centers and direct local spasmolytic action on smooth muscle.

Phenobarbital suppresses the activating influence of the reticular formation centers in the midbrain and medulla oblongata on the cerebral cortex, thereby reducing excitatory impulses to the cerebral cortex and subcortical structures. This reduction in activating influences results, depending on the dose, in sedative, tranquilizing, and hypnotic effects. Barbival® reduces excitatory effects on vasomotor centers, coronary and peripheral blood vessels, thereby lowering overall arterial pressure and relieving or preventing vascular spasm, particularly in the heart vessels.

Menthol in menthyl ether of isovaleric acid exerts a calming effect on the central nervous system, slows gastric and intestinal peristalsis, reduces meteorism, and also produces a moderate reflex vasodilating and spasmolytic effect.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Neuroses accompanied by increased excitability and insomnia; hysteria; as part of complex treatment of mild angina attacks, early-stage arterial hypertension, functionally induced tachycardia, gastric and intestinal spasms, meteorism.

Contraindications.

Hypersensitivity to any component of the drug, hepatic and renal insufficiency, hepatic porphyria, severe heart failure, pronounced arterial hypotension, acute myocardial infarction, diabetes mellitus, depression, myasthenia, alcoholism, narcotic and drug dependence, respiratory disorders with dyspnea, obstructive syndrome.

Interaction with other medicinal products and other types of interactions.

Concomitant use with neuroleptics and tranquilizers potentiates, while use with central nervous system stimulants reduces, the effect of each component of the drug. Barbовалâ, containing barbituric acid derivatives in its composition, enhances the action of local anesthetics, analgesics, and hypnotics. Alcohol intensifies the drug's effects and may increase its toxicity. The drug's effect is enhanced when used concomitantly with valproic acid preparations. The presence of phenobarbital in Barbовалâ may induce liver enzymes, making its concomitant use undesirable with drugs metabolized in the liver (including coumarin derivatives, griseofulvin, glucocorticoids, oral contraceptives, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral hypoglycemic, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive agents, etc.), as their efficacy may be reduced due to increased metabolism.

MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.

Concomitant use of phenobarbital with gold-containing preparations increases the risk of kidney damage.

Long-term concomitant use of phenobarbital with nonsteroidal anti-inflammatory drugs increases the risk of gastric ulceration and bleeding.

Concomitant use of phenobarbital with zidovudine enhances the toxicity of both drugs.

The drug increases methotrexate toxicity.

Alcoholic beverages should be avoided during treatment with this drug.

Special precautions for use.

The presence of phenobarbital in the medicinal product may lead to a risk of developing Stevens-Johnson syndrome and Lyell's syndrome, which is most likely during the first weeks of treatment. Prolonged use is not recommended due to the risk of drug dependence, possible accumulation of bromine in the body, and bromine poisoning. In cases when chest pain does not subside after taking the drug, it is necessary to consult a physician to exclude acute coronary syndrome. The drug should be prescribed with caution in patients with arterial hypotension, hyperkinesias, hyperthyroidism, adrenal insufficiency, acute and persistent pain, and acute intoxication with medicinal products.

Use during pregnancy or breastfeeding.

The drug is contraindicated in women during pregnancy or breastfeeding.

Ability to affect reaction rate while driving or operating machinery.

The drug may cause drowsiness and dizziness; therefore, patients are advised not to operate dangerous machinery or drive vehicles during treatment.

Method of Administration and Dosage

Barbовал is taken orally with a small amount of liquid or on a piece of sugar placed under the tongue.

Dosage and duration of treatment are determined individually by a physician. The usual dose for adults is 10–15 drops 2–3 times daily for 10–15 days.

The medication should preferably be taken 20–30 minutes before meals.

After a break of 10–15 days, the treatment course may be repeated.

Children

There is no experience with the use of this medication in pediatric practice; therefore, the drug is not used in children.

Overdose

With prolonged or frequent use, drug accumulation may occur, leading to clinical manifestations of overdose, namely:

• Central nervous system depression, which can be counteracted by using CNS stimulants (e.g., caffeine, cordiamine, etc.);
• Nystagmus, ataxia, decreased arterial blood pressure, and abnormalities in blood formula.

Symptoms of chronic bromine poisoning include: depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, and impaired motor coordination. Symptomatic therapy is prescribed to manage these manifestations.

Prolonged continuous use of the drug may lead to habituation, drug dependence, and withdrawal syndrome; abrupt discontinuation may result in rebound symptoms. Long-term use may occasionally be associated with increased psychodynamic activity instead of the expected sedative effect.

Symptoms of overdose: respiratory depression, up to respiratory arrest; central nervous system depression, up to coma; cardiovascular depression, including arrhythmias and decreased arterial blood pressure, up to collapse-like state; nausea, weakness, hypothermia, and reduced diuresis.

Treatment: symptomatic.

Side effects.

The drug is usually well tolerated. Possible side effects include:

Gastrointestinal system: constipation, feeling of heaviness in the epigastric region, liver function disturbances with prolonged use, nausea, vomiting;

Nervous system: weakness, ataxia, impaired motor coordination, nystagmus, hallucinations, paradoxical excitement, decreased attention span, fatigue, slowed reaction time, headache, cognitive disturbances, confusion, drowsiness, mild dizziness;

Hematopoietic system: anemia, thrombocytopenia, agranulocytosis;

Cardiovascular system: arterial hypotension, bradycardia;

Immune system: hypersensitivity reactions, including angioneurotic edema, allergic reactions, such as skin rash, itching, urticaria;

Skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis;

Musculoskeletal system: prolonged use of preparations containing phenobarbital may pose a risk of impaired osteogenesis;

Other: difficulty breathing.

Prolonged use of drugs containing bromine may lead to bromism, characterized by the following symptoms: central nervous system depression, depressive mood, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne, or purpura.

Shelf life. 4 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

25 ml in a bottle. 1 bottle per carton.

Availability. Over-the-counter.

Manufacturer. JSC "Farmak".

Manufacturer's location and address of business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.