Instructions for Corvalcaps Extra hard capsules blister No. 30
Composition
active ingredients: ethyl ester of alpha-bromisovaleric acid, phenobarbital;
1 capsule contains 18.4 mg of alpha-bromoisovaleric acid ethyl ester, 18.4 mg of phenobarbital;
excipients: peppermint oil, hop oil, cyclodextrin, magnesium stearate;
capsule shell: gelatin, titanium dioxide (E 171).
Dosage form
The capsules are hard.
Main physicochemical properties: hard gelatin capsules with a white body and cap. Capsule contents – granulated powder or pressed mass of white or almost white color.
Pharmacotherapeutic group
Hypnotics and sedatives. Combined barbiturate preparations. ATX code N05C B02.
Pharmacological properties
Pharmacodynamics
Corvalcaps Extra is a sedative and antispasmodic, the effect of which is determined by the components that make up its composition.
Ethyl ester of α-bromosovaleric acid exhibits reflex sedative and antispasmodic effects, which are due to irritation mainly of receptors of the oral cavity and nasopharynx, a decrease in reflex excitability in the central nervous system, an increase in inhibition phenomena in 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 muscles.
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 causes, depending on the dose, sedative, tranquilizing or hypnotic effects.
Corvalcaps Extra reduces excitatory effects on vasomotor centers, coronary and peripheral vessels, lowering overall blood pressure, relieving and preventing vascular spasms, especially cardiac ones.
Pharmacokinetics
When taken orally, the bioavailability of the components is high (approximately 60-80%). 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 people and patients with cirrhosis of the liver, the metabolism of Corvalcaps Extra is reduced, so their half-life of the drug is prolonged, which requires a dose reduction and an increase in the intervals between its administration.
Indication
neuroses with increased irritability; insomnia; in the complex therapy of hypertension and vegetative-vascular dystonia; mild coronary spasms, tachycardia; intestinal spasms (as an antispasmodic drug).
Contraindication
Hypersensitivity to the components of the drug, bromine; severe liver and/or kidney dysfunction; hepatic porphyria; severe heart failure.
Medicines containing phenobarbital are contraindicated in severe arterial hypotension, acute myocardial infarction, diabetes mellitus, depression, myasthenia gravis, alcoholism, drug and drug addiction, respiratory diseases with shortness of breath, obstructive syndrome.
Special safety measures.
Simultaneous consumption of alcoholic beverages should be avoided.
The presence of phenobarbital in the composition of the drug may lead to the risk of developing Stevens-Johnson and Lyell syndrome, which is most likely 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 exclude acute coronary syndrome. The drug should be prescribed with caution in cases of arterial hypotension, hyperkinesia, hyperthyroidism, adrenal hypofunction, acute and constant pain, acute drug intoxication.
Interaction with other medicinal products and other types of interactions
Centrally depressant drugs enhance the effect of Corvalcaps Extra. The presence of phenobarbital in the composition of the drug can induce liver enzymes, which makes it undesirable to use it simultaneously with drugs that are metabolized in the liver (including indirect anticoagulants, cardiac glycosides, antimicrobial, antiviral, antifungal, antiepileptic, anticonvulsant, psychotropic, oral hypoglycemic, hormonal, immunosuppressive, cytostatic, antiarrhythmic, antihypertensive drugs with coumarin derivatives, griseofulvin, glucocorticoids, oral contraceptives), since their effectiveness will decrease as a result of a higher level of metabolism. Corvalcaps Extra enhances the effect of local anesthetics, analgesics and hypnotics, which is associated with the content of barbituric acid derivatives.
When used simultaneously with valproic acid, its effect is enhanced.
When used simultaneously with methotrexate, the toxicity of the latter increases.
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 ulcers and bleeding.
Concomitant use of phenobarbital with zidovudine increases the toxicity of both drugs.
Ability to influence reaction speed when driving vehicles or other mechanisms
The medicine contains phenobarbital, which may cause impaired coordination and speed of psychomotor reactions, which should be taken into account when deciding whether to drive a vehicle or operate other mechanisms.
Use during pregnancy or breastfeeding
Corvalcaps Extra is not used during pregnancy and breastfeeding.
Method of administration and doses
The drug is taken orally, regardless of meals, 1 capsule 2-3 times a day, washed down with water. If necessary (pronounced tachycardia and spasm of coronary vessels), a single dose can be increased to 2 capsules.
The duration of use of Corvalcaps Extra is determined by the doctor depending on the clinical effect and tolerability of the drug.
Children
There is no experience with the use of the drug in 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 cause addiction, withdrawal syndrome, psychomotor agitation. Abrupt cessation of use of the drug can cause withdrawal syndrome.
Symptoms of overdose: central nervous system depression, confusion, dizziness, ataxia, drowsiness, almost to deep sleep. In severe cases of poisoning - respiratory failure, tachycardia, arrhythmias, decreased blood pressure, collapse, coma; nausea, weakness, decreased body temperature, decreased diuresis.
Treatment: symptomatic.
Adverse reactions
In some cases, the following side effects may occur:
from the digestive system: constipation, feeling of heaviness in the epigastric region, with prolonged use - impaired liver function, nausea, vomiting; from the nervous system: weakness, ataxia, impaired coordination of movements, nystagmus, hallucinations, paradoxical excitation, decreased concentration of attention, fatigue, slowed reactions, headache, cognitive disorders, confusion, drowsiness, mild dizziness; from the blood-forming organs: anemia, thrombocytopenia, agranulocytosis; from the cardiovascular system: arterial hypotension, bradycardia; from the immune system: hypersensitivity reactions, including angioedema, allergic reactions (including skin rash, itching, urticaria); from the skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis; Musculoskeletal system: with prolonged use of drugs containing phenobarbital, there is a risk of osteogenesis disorders; 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, confusion, ataxia, apathy, conjunctivitis, rhinitis, lacrimation, acne, or purpura.
These phenomena disappear when the dose is reduced or the drug is discontinued.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 capsules in a blister, 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
