Valokordin pills 7.544mg + 7.544mg, 20pcs

Composition

For 1 tablet

Active ingredients:

phenobarbital-7,544 mg

ethylbromisovalerianate-7,544 mg

Auxiliary substances:

peppermint leaf oil-0.529 mg;

common hop seed 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

Pharmacological action

A sedative.

ATX code: N05 SEE

Pharmacological properties:

Pharmacodynamics

A combined drug, the action of which is determined by the pharmacological properties of the components that make up its composition. It has a sedative and antispasmodic effect.

Phenobarbital has sedative (in low doses), hypnotic, muscle relaxant and antispasmodic effects. Helps reduce the arousal of the central nervous system and facilitates the onset of sleep, enhances the sedative effect of another Active ingredient.

Ethylbromisovalerianate has a sedative (similar to the valerian effect) and antispasmodic effect, mainly on oral and nasopharyngeal receptors, due to irritation, reduced reflex excitability in the central nervous system and increased inhibition in cortical neurons and subcortical structures of the brain, as well as a decrease in the activity of central vasomotor centers and direct local antispasmodic effect on smooth muscles.

Pharmacokinetics

Data on the pharmacokinetics of ethylbromisovalerianate are not available.

When taken orally, phenobarbital is absorbed slowly, completely. The maximum concentration in blood plasma is determined after 1-2 hours, the connection with plasma proteins is 50%, in newborns-30-40%. It is metabolized in the liver, induces microsomal liver enzymes by CYP3A4, CYP3A5, and CYP3A7 isoenzymes (the rate of enzymatic reactions increases 10-12 times). It accumulates in the body. The elimination half-life is 2-4 days. It is excreted by the kidneys in the form of glucuronide, about 25% – unchanged. Penetrates into breast milk and through the placental barrier.

Indications

As a symptomatic sedative for functional disorders of the cardiovascular system, neurosis-like conditions accompanied by increased irritability, sleep disturbance, tachycardia, a state of agitation with pronounced vegetative manifestations.

Use during pregnancy and lactation

Hypersensitivity to the components of the drug, acute hepatic porphyria, hereditary lactose intolerance, glucose-galactose malabsorption, age up to 18 years (efficacy and safety have not been established), severe renal and/or liver function disorders, pregnancy and lactation.

With caution

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

If you have one of these diseases/If you have any serious medical conditions, be sure to consult your doctor before taking the drug.

Contraindications

Hypersensitivity to the components of the drug, acute hepatic porphyria, hereditary lactose intolerance, glucose-galactose malabsorption, age up to 18 years (efficacy and safety have not been established), severe renal and/or liver function disorders, pregnancy and lactation.

With caution

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

If you have one of these diseases/If you have any serious medical conditions, be sure to consult your doctor before taking the drug.

Side effects

Drowsiness, dizziness, slowing of the heart rate, decreased ability to concentrate, allergic reactions. Gastrointestinal disorders may occur. These phenomena disappear with a decrease in the dose of the drug. With prolonged use of the drug, drug dependence, addiction, withdrawal syndrome, as well as bromine accumulation in the body and the development of bromism (depressive mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements) may develop.

Very rarely, hypersensitivity reactions may occur (shortness of breath, angioedema, severe adverse skin reactions).

There have been reports of reduced bone mineral density, osteopenia and osteoporosis, and fractures in patients who have been taking phenobarbital for a long time. The mechanism of the effect of phenobarbital on bone metabolism has not been identified.

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

Interaction

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

Ethanol enhances the effect of the drug.

Phenobarbital (an inducer of microsomal oxidation) can reduce the effectiveness of drugs that 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 effect of the drug is enhanced by the use of valproic acid.

If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Valocordin®.

How to take, course of use and dosage

Hypersensitivity to the components of the drug, acute hepatic porphyria, hereditary lactose intolerance, glucose-galactose malabsorption, age up to 18 years (efficacy and safety have not been established), severe renal and/or liver function disorders, pregnancy and lactation.

With caution

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

If you have one of these diseases/If you have any serious medical conditions, be sure to consult your doctor before taking the drug.

Overdose

. Symptoms:

Central nervous system depression, nystagmus, ataxia, decreased blood pressure, agitation, dizziness, weakness, chronic bromine intoxication (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements).

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. When the central nervous system is depressed-caffeine, niketamide.

There is no specific antidote.

Description

Round flat tablets with a chamfer of white or almost white color with inclusions with an embossed “V” marking on one side, smooth on the other side.

Special instructions

Before using the drug, you should consult your doctor.

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

If the drug is used in an uncontrolled manner, drug dependence may occur.

During the use of the drug, do not drink alcohol.

Influence on the ability to drive vehicles and mechanisms

When using the drug, you should avoid potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of reach of children.

Shelf

life is 2 years.

Do not use after the expiration date.

Active ingredient

Peppermint Leaf Oil, Phenobarbital, Hop Seed Oil, Ethylbromisovalerianate

Dosage form

Tablets