Valokordin, tablets 7.544 mg+7.544 mg 20 pcs.

Sedative.

ATX code: N05CM

Pharmacological properties:

Pharmacodynamics

A combined drug whose action is due to the pharmacological properties of its constituent components. It has sedative and antispasmodic effect.

Phenobarbital has sedative (in low doses), hypnotic, muscle relaxant and antispasmodic action. It helps to decrease the excitation of the central nervous system and facilitates the onset of sleep, increases the sedative effect of the other active substance.

Ethylbromisovalerianate has sedative (similar to valerian effect) and antispasmodic effect, mainly on receptors in the oral cavity and nasopharynx, caused by irritation, reduction of reflex excitability in the central nervous system and increased inhibition in the cortex and subcortical structures of the brain, as well as reduced activity of the central vasomotor centers and direct local spasmolytic effect on smooth musculature.

Pharmacokinetics

There are no data on the pharmacokinetics of ethylbromisovalerianate.

Phenobarbital is slowly, completely absorbed when taken orally. Maximum concentration in blood plasma is determined after 1-2 hours, binding to plasma proteins – 50%, in infants – 30-40%. It is metabolized in liver, induces microsomal liver enzymes by CYP3A4, CYP3A5, CYP3A7 isoenzymes (enzymatic reaction rate increases by 10-12 times). It accumulates in the body. Period of half-life is 2 – 4 days. It is excreted by kidneys as glucuronide, about 25% – unchanged. It penetrates into breast milk and through the placental barrier.

Indications

Active ingredient

Composition

Per 1 tablet

The active ingredients:

Phenobarbital – 7.544 mg

Ethylbromisovalerianate – 7.544 mg

Excipients:

Peppermint leaf oil – 0.529 mg;

hop oil – 0.074 mg;

beta-cyclodextrin in terms of dry matter – 55.550 mg;

Potato starch – 13.589 mg;

Lactose monohydrate – 43.770 mg;

Microcrystalline cellulose type 101 – 10.500 mg;

Calcium stearate – 0.900 mg.

How to take, the dosage

Hypersensitivity to the components of the drug, acute hepatic porphyria, hereditary lactose intolerance, glucose-galactose malabsorption, age under 18 years (effectiveness and safety not established), severe renal and/or hepatic impairment, pregnancy and breast-feeding period.

With caution

Disorders of renal and/or hepatic function; simultaneous use with drugs that are metabolized in the liver (see section “Interaction with other medicinal products”).

If you have any of the following diseases/conditions, always consult your physician before taking this medication.

Interaction

Drugs that depress the central nervous system increase the effect of the drug.

Ethanol increases the effect of the drug.

Phenobarbital (inducer of microsomal oxidation) may decrease the effectiveness of drugs which are metabolized in the liver (including coumarin derivatives, lamotrigine, thyroid hormones, doxycycline, chloramphenicol, antifungal drugs (azole type), antibiotics, sulfonamides, griseofulvin, glucocorticosteroids and oral contraceptives).

The drug may increase the toxicity of methotrexate.

The action of the drug is increased with valproic acid.

Please talk to your doctor before using Valocordin® if you are using the above or other medicines (including over-the-counter medications).

Special Instructions

Physician should be consulted before using the drug.

There is no experience of using the drug in children under 18 years of age.

In case of uncontrolled use of the drug, drug addiction may occur.

Alcohol should not be consumed during the use of the drug.

Impact on ability to drive, operate machinery

When using the drug, avoid potentially hazardous activities requiring increased concentration and quick psychomotor reactions (including driving vehicles and operating moving machinery).

Synopsis

Contraindications

With caution

Disorders of renal and/or hepatic function; concomitant use with drugs that are metabolized in the liver (see section “Interaction with other medicinal products”).

If you have any of the following diseases/conditions, always consult your physician before taking this medication.

Side effects

Sleepiness, dizziness, slow heart rate, decreased ability to concentrate, allergic reactions. Gastrointestinal disorders may occur. The above-mentioned phenomena disappear after reducing the drug dose. With long-term use of the drug it is possible to develop drug dependence, addiction, “withdrawal” syndrome, as well as bromine accumulation in the body and development of bromism (depressed mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, movement coordination disorders).

Very rarely, hypersensitivity reactions may occur (dyspnea, Quincke’s edema, severe adverse skin reactions).

There have been reports of: reduced bone mineral density; development of osteopenia and osteoporosis; and fractures in patients who have taken phenobarbital for a long time. The mechanism of phenobarbital effect on bone tissue metabolism has not been identified.

If you experience side effects that are listed in the instructions for use; or if they worsen; or if you notice any other side effects not listed in the instructions, you should tell your doctor.

Overdose

Depression of the central nervous system, nystagmus, ataxia, decreased blood pressure, agitation, dizziness, weakness, chronic bromine intoxication (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, movement coordination disorders).

In severe cases – coma accompanied by tissue hypoxia, respiratory disorders, tachycardia, arrhythmia, vascular collapse, decreased peripheral reflexes.

Treatment: discontinuation of the drug, gastric lavage and symptomatic therapy. In case of depression of the central nervous system – caffeine, nikethamide.

There is no specific antidote.

Pregnancy use

Hypersensitivity to the components of the drug, acute hepatic porphyria, hereditary lactose intolerance, glucose-galactose malabsorption, age under 18 years (effectiveness and safety not established), severe renal and/or hepatic impairment, pregnancy and breast-feeding period.

With caution

Disorders of renal and/or hepatic function; simultaneous use with drugs that are metabolized in the liver (see section “Interaction with other medicinal products”).

If you have any of the following diseases/conditions, always consult your physician before taking this medication.