Corvalol Reneval, drops 25 ml

Pharmacotherapeutic group:
sedative.

ATX code: N05CM

Pharmacological properties

Pharmacodynamics
Combined drug, has sedative and antispasmodic effects, facilitates the onset of natural sleep.
Ethylbromisovalerianate has sedative and antispasmodic effect caused by irritation, mainly of receptors in the oral cavity and nasopharynx, 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 central vasomotor centers and a direct local spasmolytic effect on smooth muscles.
Phenobarbital has sedative (in small doses), hypnotic, muscle relaxant and antispasmodic effect, helps to reduce agitation of the central nervous system (CNS) and facilitates sleep, increases sedative effects of other components.

Pearmint oil has a reflex vasodilatory, antispasmodic, mild choleretic, antiseptic action. The mechanism of action is related to the ability to irritate the “cold” receptors of the oral mucosa and reflexively dilate mainly vessels of the heart and brain. It eliminates the phenomena of flatulence by irritating the mucosal receptors of the gastrointestinal tract (GIT), increasing intestinal peristalsis.

Pharmacokinetics
There are no data on the pharmacokinetics of ethylbromisovalerianate and peppermint components.
Phenobarbital is slowly, completely absorbed when taken orally. Maximal concentration in blood plasma is determined after 1-2 hours. Its binding to plasma proteins is 50%, in newborns – 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 the breast milk and through the placental barrier.

Indications

As a symptomatic (sedative and vasodilator) in functional disorders of the cardiovascular system, in neurosis-like states, accompanied by increased irritability, failure to fall asleep, tachycardia, excited states with pronounced vegetative manifestations; as an antispasmodic agent – in intestinal spasms.

Active ingredient

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

Composition

Active ingredients:
Ethyl bromisovalerianate (ethyl ester of alpha-bromisovalerian
acid) – 2000 mg
Phenobarbital – 1826 mg
Peppermint leaf oil
(peppermint oil) – 142 mg
Excipients:
ethanol (ethyl alcohol) 95% – 79 ml
sodium hydroxide
solution of 1 M – to pH 8.0-8.5
purified water – to 100 ml

.

How to take, the dosage

The dose is set individually. Orally, before meals, pre-dissolved in a small amount (30-50 ml) of water. Single dose for adults is 30 drops, if necessary (e.g., tachycardia) single dose can be increased up to 40-50 drops. Frequency of intake for adults is 2-3 times a day. In children from 3 years of age, 1 drop per year of a child’s life is used per day. Necessity of repeated dose is determined by a doctor depending on clinical picture of the disease. Duration of drug administration shall be determined by the physician individually.

Interaction

Drugs depressing CNS increase the effect of the drug.

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

The drug increases the toxicity of methotrexate.

The action of the drug increases with the use of valproic acid drugs.

Special Instructions

In 1 drop of the drug contains 0.022 g of absolute ethyl alcohol.
The maximum single dose of the preparation (50 drops) contains 1.1 g of absolute ethyl alcohol; the maximum daily dose (150 drops) contains 3.3 g of absolute ethyl alcohol.

Impact on ability to drive vehicles, mechanisms

The drug contains at least 70 vol.% of ethanol and phenobarbital, therefore, while taking Corvalol, it is necessary to refrain from driving vehicles and carrying out other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Synopsis

A clear colorless liquid with a characteristic odor.

Contraindications

Hypersensitivity to the components of the drug; expressed renal and/or hepatic dysfunction; alcoholism; craniocerebral trauma, brain disease; pregnancy, breastfeeding period; children under 3 years of age.

With caution

Children from 3 years of age.

Disordered liver function, kidney function.

Side effects

Sleepiness, dizziness, slow heart rate, decreased ability to concentrate, allergic reactions. Gastrointestinal disorders may occur. These phenomena disappear after reducing the dose of the drug or after discontinuation of the drug.
With long-term use of the drug it is possible to develop drug addiction, addiction, withdrawal syndrome, as well as bromine accumulation in the body and the development of bromine phenomena (depressed mood, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, movement coordination disorders).
If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: central nervous system (CNS) depression, nystagmus, ataxia, decreased blood pressure, agitation, dizziness, weakness, chronic bromine intoxication (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, movement coordination disorders).
Treatment: discontinuation of the drug, gastric lavage and symptomatic therapy, with CNS depression – caffeine, nikethamide.

Pregnancy use

Administration of Corvalol Reneval during pregnancy and during breastfeeding is contraindicated because the drug contains phenobarbital, which penetrates through the placenta and has teratogenic effect, has an adverse effect on the formation and further functioning of the central nervous system of the fetus and the newborn, penetrates into the breast milk, possible development of physical dependence in the newborn. If it is necessary to use during breastfeeding, discontinuation of breastfeeding should be considered.