Corvalol, tablets 50 pcs

Phenobarbital, Ethyl ester of alpha-bromisovaleric acid, Sodium hydroxide, Peppermint oil

Indications

As a symptomatic (sedative and vasodilator) agent for functional disorders of the cardiovascular system, for neurosis-like conditions accompanied by increased irritability, for difficulty falling asleep, tachycardia, a state of agitation with pronounced vegetative manifestations; as an antispasmodic – for intestinal spasms.

Pharmacological effect

Pharmacotherapeutic group: sedative.

ATX code: N05СМ.

Pharmacological properties

Pharmacodynamics

A combined drug that has a sedative and antispasmodic effect, facilitating the onset of natural sleep.

Ethyl bromizovalerianate has a sedative and antispasmodic effect due to irritation, mainly of the receptors of the oral cavity and nasopharynx, a decrease in reflex excitability in the central parts of the nervous system and increased inhibition in the neurons of the cortex and subcortical structures of the brain, as well as a decrease in the activity of the central vasomotor centers and a direct local antispasmodic effect on smooth muscles.

Phenobarbital has a sedative (in small doses), hypnotic, muscle relaxant and antispasmodic effects, helps reduce excitation of the central nervous system (CNS) and facilitates the onset of sleep, enhances the sedative effect of other components.

Peppermint oil has a reflex vasodilating, antispasmodic, mild choleretic, antiseptic effect. The mechanism of action is associated with the ability to irritate the “cold” receptors of the oral mucosa and reflexively dilate mainly the vessels of the heart and brain. Eliminates flatulence by irritating receptors in the mucous membrane of the gastrointestinal tract (GIT), enhancing intestinal motility.

Pharmacokinetics

Data on the pharmacokinetics of ethyl bromoisovalerate and peppermint components are not available.

When taken orally, phenobarbital is absorbed slowly and completely. Maximum. the concentration in the blood plasma is determined after 1-2 hours, the connection with plasma proteins is 50%, in newborns – 30-40%. Metabolized in the liver, induces microsomal liver enzymes with isoenzymes CYP3A4, CYP3A5, CYP3A7 (the rate of enzymatic reactions increases 10-12 times). Cumulates in the body. The 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.

Special instructions

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

You should not drink alcohol while using the drug.

Impact on the ability to drive vehicles and machinery

The drug contains phenobarbital, therefore patients taking Corvalol are advised to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with complex mechanisms).

Active ingredient

Phenobarbital, Alpha-bromoisovaleric acid ethyl ester, Sodium hydroxide, Peppermint oil

Composition

Active ingredients: ethyl bromizovalerianate – 8.20 mg, phenobarbital – 7.50 mg, peppermint leaf oil – 0.58 mg.

Excipients: betadex (beta-cyclodextrin) – 55.55 mg, potato starch – 37.57 mg, lactose monohydrate – 83.70 mg, magnesium aluminum metasilicate – 3.50 mg, talc – 2.00 mg, magnesium stearate – 1.40 mg.

Pregnancy

The use of the drug Corvalol during pregnancy is contraindicated, since the drug contains phenobarbital, which penetrates the placenta and has a teratogenic effect, has a negative effect on the formation and further functioning of the central nervous system of the fetus and newborn; penetrates into breast milk, the development of physical dependence in the newborn is possible. If it is necessary to use it during breastfeeding, the issue of stopping breastfeeding should be decided.

Contraindications

Hypersensitivity to the components of the drug; severe renal and/or liver dysfunction; pregnancy; breastfeeding period; children under 18 years of age (efficacy and safety have not been established); galactose intolerance, lactase deficiency.

With caution:

Impaired liver and/or kidney function.

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

Side Effects

Drowsiness, dizziness, slow heart rate. decreased ability to concentrate, allergic reactions

Gastrointestinal disturbances may occur.

These phenomena disappear when the dose of the drug is reduced or the drug is stopped.

With long-term use of the drug, drug dependence, addiction, withdrawal syndrome may occur, as well as the accumulation of bromine in the body and the development of bromism phenomena (depressive mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements).

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

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

Phenobarbital (an inducer of microsomal oxidation) may reduce the effectiveness of drugs metabolized in the liver (including coumarin derivatives, griseofulvin, glucocorticosteroids, oral contraceptives); enhances the effect of local anesthetic, analgesic and hypnotic drugs.

The drug increases the toxicity of methotrexate.

The effect of the drug is enhanced by the use of valproic acid preparations.

Overdose

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

Treatment: discontinuation of the drug, gastric lavage and symptomatic therapy, if the central nervous system is depressed – caffeine, niketamide.

Storage conditions

Store the drug in its original packaging. At a temperature not higher than 25 o C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after expiration date.

Manufacturer

Pharmstandard-Leksredstva, Russia