Instructions for Corvalol tablets blister No. 30
Composition
active ingredients: ethyl ester of a-bromoisovaleric acid, phenobarbital, peppermint oil;
1 tablet contains ethyl ester of a-bromoisovaleric acid in terms of 100% substance - 12.42 mg, phenobarbital in terms of 100% dry substance - 11.34 mg, peppermint oil - 0.88 mg;
excipients: lactose monohydrate, magnesium stearate, β-cyclodextrin, acesulfame potassium.
Dosage form
Pills.
Main physicochemical properties: white tablets with a biconvex surface.
Pharmacotherapeutic group
Sleeping pills and sedatives. Barbiturates in combination with other components.
ATX code N05C B02.
Pharmacological properties
Pharmacodynamics
Corvalol® is a sedative and antispasmodic drug, the effect of which is determined by the components that make up its composition.
Ethyl ester of α-bromizovaleric acid has a reflex sedative and antispasmodic effect, caused by irritation mainly of the receptors of the oral cavity and nasopharynx, a decrease in reflex excitability in the central nervous system and an increase in inhibition phenomena in the neurons of the cortex and subcortical structures of the brain, as well as a decrease in the activity of central vasomotor centers and a direct local antispasmodic effect on vascular smooth muscle.
Phenobarbital inhibits the activating effects of the centers of the reticular formation of the medulla oblongata on the cerebral cortex, thereby reducing the flow of excitatory effects on the cerebral cortex and subcortical structures. The reduction of activating effects produces, depending on the dose, a sedative, tranquilizing or hypnotic effect. Corvalol® reduces the excitatory effects on the vasomotor centers, coronary and peripheral vessels, reducing overall blood pressure, relieving and preventing vascular spasms, especially cardiac ones.
Peppermint oil contains a large number of essential oils, including approximately 50% menthol and 4–9% menthol esters. They are able to irritate the "cold" receptors of the oral cavity and reflexively dilate mainly the vessels of the heart and brain, relieving spasms of smooth muscles, causing a calming and mild choleretic effect. Peppermint oil has an antiseptic and antispasmodic effect, and has the ability to eliminate flatulence.
Pharmacokinetics
When taken sublingually, absorption begins already in the sublingual area, the bioavailability of the active substances is high (approximately 60–80%). The effect is manifested quickly (after 5–10 minutes). When taken orally, the effect develops after 15–45 minutes and lasts for 3–6 hours. In people who have previously taken barbituric acid preparations, the duration of action is reduced due to the accelerated metabolism of phenobarbital in the liver, where barbiturates cause enzyme induction. In elderly patients and patients with cirrhosis of the liver, the metabolism of Corvalol® is reduced, so their half-life is prolonged, which requires a dose reduction and an extension of the interval between doses of the drug.
Indication
Neuroses with increased irritability;
insomnia;
in the complex therapy of hypertension and vegetative-vascular dystonia;
mild coronary spasms, tachycardia;
intestinal spasms caused by neurovegetative disorders (as an antispasmodic drug).
Contraindication
Hypersensitivity to the components of the drug, bromine;
severe liver and/or kidney dysfunction;
hepatic porphyria;
severe heart failure;
severe arterial hypotension;
acute myocardial infarction;
diabetes;
depression;
myasthenia gravis;
alcoholism;
drug and medication addiction;
respiratory diseases with shortness of breath, obstructive syndrome.
Interaction with other medicinal products and other types of interactions
Drugs with a central depressant effect enhance the effect of Corvalol®.
The presence of phenobarbital in the composition of the drug may induce liver enzymes and, accordingly, may accelerate the metabolism of some drugs metabolized by these enzymes (including indirect anticoagulants, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral hypoglycemic, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive drugs, griseofulvin, glucocorticoids, oral contraceptives), since their effectiveness will decrease as a result of a higher level of metabolism.
Corvalol® enhances the effect of analgesics, local anesthetics and drugs that depress the central nervous system.
MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital.
The risk of kidney damage increases with the simultaneous use of phenobarbital with gold preparations.
With prolonged simultaneous use of phenobarbital with nonsteroidal anti-inflammatory drugs, there is a risk of stomach ulcer formation and bleeding.
Concomitant use of phenobarbital with zidovudine increases the toxicity of both drugs.
When used simultaneously with valproic acid, its effect is enhanced.
Alcohol enhances the effect of the drug and also increases its toxicity. Alcoholic beverages should be avoided while taking the drug.
Application features
The risk of developing Stevens-Johnson and Lyell syndrome is greatest in the first weeks of treatment. Long-term use is not recommended due to the risk of developing drug dependence, possible accumulation of bromine in the body and the development of bromine poisoning. In cases where pain in the heart area does not go away after taking the drug, you should consult a doctor to rule out acute coronary syndrome. It is prescribed with caution in hyperkinesia, hyperthyroidism, adrenal hypofunction, decompensated heart failure, acute and persistent pain, acute drug intoxication.
Simultaneous consumption of alcoholic beverages should be avoided.
The drug should be prescribed with caution in cases of arterial hypotension.
The drug contains lactose monohydrate, therefore, if you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Use during pregnancy or breastfeeding
Do not use during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug should not be taken by people who work with machinery, drivers of vehicles, etc.
Method of administration and doses
Corvalol® is prescribed sublingually (under the tongue) or orally for adults, 1 tablet 2–3 times a day.
If necessary (pronounced tachycardia and spasm of coronary vessels), a single dose can be increased to 3 tablets.
The duration of use of the drug is determined by the doctor depending on the clinical effect and tolerability of the drug.
Children
There is no experience in the treatment of children.
Overdose
Overdose is possible with frequent or long-term use of the drug, which is associated with the cumulation of its components. Long-term and constant use can lead to addiction, withdrawal syndrome, psychomotor agitation. Abrupt cessation of use of the drug can cause withdrawal syndrome.
Symptoms of overdose: respiratory depression, up to its cessation; central nervous system depression, confusion, dizziness, ataxia, drowsiness, up to coma; cardiovascular depression, including rhythm disturbances, tachycardia, decreased blood pressure, up to a collapse-like state; nausea, weakness, decreased body temperature, decreased diuresis.
Treatment: symptomatic.
Side effects
Corvalol® is generally well tolerated. In some cases, the following side effects may occur:
from the digestive tract: constipation, feeling of heaviness in the epigastric region, with prolonged use - impaired liver function, nausea, discomfort in the stomach and intestines;
from the nervous system: weakness, ataxia, impaired coordination of movements, nystagmus, hallucinations, paradoxical excitement, decreased concentration, fatigue, slowed reactions, headache, cognitive impairment, confusion, drowsiness, mild dizziness;
from the side of the hematopoietic organs: anemia, thrombocytopenia, agranulocytosis;
Immune system disorders: hypersensitivity reactions, including angioedema;
Cardiovascular system: hypotension, bradycardia; slowing of heart rate;
Skin and mucous membranes: allergic reactions, including skin rash, itching, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis;
other: difficulty breathing.
Prolonged use of bromine-containing drugs can lead to bromine poisoning, which is characterized by the following symptoms: central nervous system depression, depressed mood, depression, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne, or purpura.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister. 1, 3 or 5 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
