Instructions for Corvalol oral drops, 50 ml bottle
Composition
active ingredients: ethyl ester of a-bromoisovaleric acid, phenobarbital, peppermint oil;
1 ml of solution (26 drops) contains ethyl ester of a-bromizovaleric acid in terms of 100% substance - 20 mg, phenobarbital - 18.26 mg, mint oil (Mentha oil) - 1.42 mg;
other ingredients: stabilizer, ethanol 96%, purified water.
Dosage form
Oral drops.
Main physicochemical properties: colorless transparent liquid with a specific odor.
Pharmacotherapeutic group
Hypnotics and sedatives. Barbiturates in combination with other components. ATX code N05C B02.
Pharmacological properties
Pharmacodynamics.
Corvalol is a sedative and antispasmodic, 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, which is due to irritation mainly of the receptors of the oral cavity and nasopharynx, a decrease in reflex excitability in the central nervous system, an increase in inhibition phenomena in neurons. centers and a direct local antispasmodic effect on vascular smooth muscles.
Phenobarbital inhibits the activating effect 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 causes, depending on the dose, sedative, tranquilizing or hypnotic effects. Corvalol reduces the excitatory effect on vasomotor centers, coronary and peripheral vessels, reducing overall blood pressure, relieving and preventing vascular spasms, especially cardiac.
Peppermint oil contains a large number of essential oils, in particular about 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 antiseptic and antispasmodic effects, the ability to eliminate flatulence. Irritating the receptors of the mucous membrane of the stomach and intestines, it enhances intestinal peristalsis.
Pharmacokinetics.
When taken orally, absorption begins in the sublingual area, the bioavailability of the components is high (approximately 60-80%). The effect develops especially quickly (after 5-10 minutes) when kept in the mouth (sublingual absorption) or taken on a sugar lump. The effect develops after 15-45 minutes and lasts 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 the elderly and in patients with cirrhosis of the liver, the metabolism of Corvalol is reduced, so their half-life is prolonged, which requires the need to reduce the dose and extend the intervals 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;
- acute hepatic porphyria;
- medicines containing phenobarbital are contraindicated in severe arterial hypotension, acute myocardial infarction, diabetes mellitus, depression and depressive disorders with a tendency of the patient to suicidal behavior, myasthenia gravis, alcoholism, drug and medication addiction (with shortness of breath, obstructive syndrome).
Interaction with other medicinal products and other types of interactions
Centrally acting depressants enhance the effect of Corvalol, a mutual enhancement of the sedative-hypnotic effect is possible, which may be accompanied by respiratory depression. The effect of the drug is enhanced by the use of valproic acid preparations. Alcohol increases the effect of the product and may increase its toxicity.
Phenobarbital induces liver enzymes and, thus, can accelerate the metabolism of some drugs metabolized by liver enzymes (e.g., coumarin derivatives, antibiotics, sulfonamides, antivirals, oral hypoglycemics, hormonal, immunosuppressive, cytostatics, anticytostatics). Phenobarbital reduces the effect of paracetamol, indirect anticoagulants, metronidazole, tricyclic antidepressants, salicylates, cardiac glycosides (digoxin). Phenobarbital enhances the effect of analgesics, anesthetics, narcosis, neuroleptics, tranquilizers. Possible effect on the concentration of phenytoin in the blood, as well as carbamazepine and clonazepam.
Undesirable interaction of Corvalol (due to the content of phenobarbital) with antiepileptic drugs (lamotrigine), thyroid hormones, doxycycline, chloramphenicol, antifungals (azole group), griseofulvin, glucocorticoids through oral contraceptives.
Phenobarbital enhances the effects of analgesics and anesthetics.
Rifampicin may reduce the effect of phenobarbital. When used with gold preparations, the risk of kidney damage increases. With prolonged simultaneous use with nonsteroidal anti-inflammatory drugs, there is a risk of stomach ulcers and bleeding. Simultaneous use of drugs containing phenobarbital with zidovudine increases the toxicity of both drugs. The drug increases the toxicity of methotrexate.
Application features
During treatment with the drug, it is not recommended to engage in activities that require increased attention, rapid mental and motor reactions.
Simultaneous consumption of alcoholic beverages should be avoided.
The presence of phenobarbital in the composition of the drug may cause the development of Stevens-Johnson and Lyell syndrome, most likely in the first weeks of treatment.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis (e.g. progressive skin rash, often with blisters, and mucosal lesions) occur, treatment should be discontinued.
The best results in the treatment of Stevens-Johnson syndrome or toxic epidermal necrolysis have been observed with early diagnosis and immediate discontinuation of any suspected drug when these symptoms occur. The best prognosis for treatment is associated with early discontinuation of the suspected drug.
If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while using Corvalol, the drug should never be used in these patients again.
Long-term use of the drug is not recommended due to the risk of developing drug dependence, possible accumulation of bromine in the body, and the development of bromine poisoning.
If the pain in the heart area does not go away after taking the drug, you should consult a doctor to rule out acute coronary syndrome. Use with caution in severe arterial hypotension, hyperkinesia, hyperthyroidism, adrenal hypofunction, decompensated heart failure, acute and chronic pain syndrome, acute drug intoxication.
This medicine contains 56% by volume of ethanol (alcohol).
The minimum dose of the drug (15 drops) contains 254 mg of ethanol, which is equivalent to 6.4 ml of beer or 2.7 ml of wine. Harmful for patients suffering from alcoholism. It should be used with caution in patients with liver disease and epilepsy.
Use during pregnancy or breastfeeding
Do not use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Corvalol contains phenobarbital and ethanol, so it may cause impaired coordination, psychomotor speed, drowsiness and dizziness during treatment. In this regard, it is not recommended to engage in activities that require increased attention, including driving vehicles and working with other mechanisms.
Method of administration and doses
Corvalol is taken orally, regardless of meals, 2-3 times a day, 15-30 drops with water or on a piece of sugar. If necessary (pronounced tachycardia and spasm of coronary vessels), a single dosage can be increased to 40-50 drops.
The duration of use of the drug is determined by the doctor depending on the clinical effect and tolerability.
Children
There is no experience in the treatment of children, therefore the drug should not be used in pediatric practice.
Overdose
Symptoms.
Acute (mild to moderate) barbiturate poisoning: dizziness, fatigue, even deep sleep from which the patient cannot be awakened.
Hypersensitivity reactions may occur: angioedema, urticaria, itching, rash.
Acute severe poisoning: deep coma accompanied by tissue hypoxia, shallow breathing, initially rapid, then slow breathing, rapid heartbeat, cardiac arrhythmia, low blood pressure, bradycardia, vascular collapse, weakening or loss of reflexes, cardiac dysfunction, decreased body temperature, slowed pulse, decreased diuresis.
If poisoning is left untreated, death is possible due to vascular insufficiency, respiratory paralysis, or pulmonary edema.
Overdose is possible with frequent or prolonged use of the drug, which is associated with the cumulation of its components. Long-term and constant use can cause addiction, withdrawal syndrome, psychomotor agitation.
Prolonged use of bromine-containing drugs can lead to bromine poisoning, which is characterized by the following symptoms: a state of confusion, ataxia, apathy, depressed mood, conjunctivitis, colds, acne, or purpura.
Cases of acute poisoning should be treated in the same way as poisoning with other hypnotics and barbiturates, depending on the severity of the symptoms of poisoning. The patient should be transferred to the intensive care unit. Breathing and circulation need to be stabilized and normalized. Respiratory failure is overcome by artificial respiration, shock is stopped by infusion of plasma and plasma substitutes. If a long time has passed since the intake, it is necessary to wash the stomach (10 g of activated charcoal powder and sodium sulfate are administered into the stomach). In order to quickly remove the barbiturate from the body, forced diuresis with alkalis, as well as hemodialysis and/or hemoperfusion, can be performed.
Treatment of bromine poisoning: the elimination of bromine ions from the body can be accelerated by administering a large amount of table salt solution with the simultaneous administration of saluretics.
If hypersensitivity reactions occur, prescribe desensitizing medications.
Adverse reactions
Corvalol is usually well tolerated. In some cases, the following side effects may occur:
from the digestive system: nausea, vomiting, constipation, feeling of heaviness in the epigastric region, with prolonged use - impaired liver function;
from the nervous system: asthenia, weakness, ataxia, impaired coordination of movements, nystagmus, hallucinations, paradoxical excitation, fatigue, slowed reactions, headache, cognitive impairment, confusion, drowsiness, insomnia (in elderly patients), impaired concentration;
Immune system: hypersensitivity reactions, including angioedema, difficulty breathing, facial swelling;
Skin and mucous membranes: allergic reactions, including skin rashes, itching. Serious skin adverse reactions reported with the use of phenobarbital: Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), urticaria, rhinitis, conjunctivitis, acne, purpura, lacrimation;
from the blood system: megaloblastic anemia, anemia, thrombocytopenia, agranulocytosis;
Respiratory system: difficulty breathing;
Cardiovascular system: bradycardia, hypotension;
Musculoskeletal: With prolonged use of drugs containing phenobarbital, there is a risk of impaired osteogenesis. There have been reports of reduced bone mineral density, osteopenia, osteoporosis, and fractures in patients receiving long-term therapy with phenobarbital. The mechanism by which phenobarbital affects bone metabolism is unknown.
With prolonged use, manifestations of bromine poisoning may occur. Symptoms: central nervous system depression, depression, ataxia, apathy, rhinitis, conjunctivitis, acne or purpura, lacrimation, confusion.
These phenomena disappear when the dose is reduced or the drug is discontinued.
Expiration date
2 years and 6 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
25 ml or 50 ml in a bottle. 1 bottle in a pack.
Vacation category
Bottle of 25 ml - without a prescription.
50 ml bottle - by prescription.
Producer
JSC "Formak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
