Instructions for Corvalcaps soft capsules blister No. 27
Composition
active ingredients: ethyl ester of alpha-bromoisovaleric acid, phenobarbital;
1 capsule contains 20 mg of alpha-bromoisovaleric acid ethyl ester, 18.26 mg of phenobarbital;
excipients: peppermint oil; sodium acetate trihydrate; purified water; polyethylene glycol 200;
gelatin capsule shell: gelatin, sorbitol liquid, partially dehydrated (E 420), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216).
Dosage form
Soft capsules.
Main physicochemical properties: soft gelatin capsules of oval shape, with a seam, from light yellow to light brownish yellow, filled with a transparent colorless viscous liquid with a characteristic odor.
Pharmacotherapeutic group
Hypnotics and sedatives. Combined barbiturate preparations. 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 alpha-bromizovaleric acid exhibits a reflex sedative and antispasmodic effect, caused by 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, a sedative or hypnotic effect.
Corvalcaps reduces excitatory effects on vasomotor centers, coronary and peripheral vessels, lowering overall blood pressure, relieving and preventing vascular spasms, especially cardiac ones.
Pharmacokinetics
The drug's effect develops in 15-45 minutes and lasts for 3-6 hours. In patients who have previously taken barbituric acid drugs, 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 Corvalcaps is reduced, so their half-life is prolonged, which requires a dose reduction and lengthening of 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 active substances or to any other component of the drug, acute hepatic porphyria, severe liver and kidney dysfunction, diabetes mellitus, depression, myasthenia gravis. Drugs containing phenobarbital are contraindicated in alcoholism, drug and drug addiction (including a history); in respiratory diseases with shortness of breath, obstructive syndrome; severe arterial hypotension, in acute myocardial infarction; in depressive disorders with a tendency of the patient to suicidal behavior.
Interaction with other medicinal products and other types of interactions
When using the drug with other drugs that depress the central nervous system, a mutual enhancement of the effect (sedative-hypnotic effect) is possible, which may be accompanied by respiratory depression. Alcohol enhances the effect of the drug and may increase its toxicity.
Medicines containing valproic acid enhance the effects of barbiturates.
Phenobarbital induces liver enzymes and, accordingly, can accelerate the metabolism of some drugs that are metabolized by liver enzymes (for example, coumarin derivatives, antibiotics and sulfonamides). Phenobarbital enhances the effect of analgesics, anesthetics, anesthetics, neuroleptics, tranquilizers; reduces the effect of paracetamol, indirect anticoagulants, metronidazole, tricyclic antidepressants, salicylates, digitoxin.
Possible effect on the concentration of phenytoin in the blood, as well as carbamazepine and clonazepam. MAO inhibitors prolong the effect of phenobarbital. Rifampicin may reduce the effect of phenobarbital. When used with gold preparations, the risk of kidney damage increases. With prolonged simultaneous use with non-steroidal 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. Undesirable interaction of Corvalcaps (containing phenobarbital) with lamotrigine, thyroid hormones, doxycycline, chloramphenicol, antifungals (azole group), griseofulvin, glucocorticoids, oral contraceptives due to the possibility of weakening the effect of the above drugs.
The drug increases the toxicity of methotrexate.
Application features
Life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with the use of phenobarbital.
Patients should be advised of their signs and symptoms and monitored closely for skin reactions. The highest risk of Stevens-Johnson syndrome or toxic epidermal necrolysis occurs during the first weeks of treatment.
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. The best prognosis in treatment is associated with early discontinuation of the suspected drug.
If a patient develops Stevens-Johnson syndrome or toxic epidermal necrolysis while using Corvalcaps, the drug should never be used in these patients again.
If the pain in the heart area does not go away after taking it, you should consult a doctor to rule out acute coronary syndrome. Use with caution in hyperkinesias, hyperthyroidism, adrenal hypofunction, uncompensated heart failure, severe arterial hypotension and constant pain, acute drug intoxication.
Long-term use of Corvalcaps is not recommended due to the risk of developing drug dependence, possible accumulation of bromine in the body, and the development of bromine poisoning.
The medicine contains sorbitol, so if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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, therefore the drug should not be taken by patients who work with mechanisms and drivers.
Use during pregnancy or breastfeeding
Do not use the medicine during pregnancy or 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 the drug 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
Symptoms.
Acute (mild to moderate) barbiturate poisoning: dizziness, fatigue, deep sleep from which the patient cannot be awakened.
Hypersensitivity reactions may occur: angioedema, urticaria, itching, rash.
Acute severe poisoning: central nervous system (CNS) depression, up to coma; respiratory system depression, up to respiratory arrest; cardiovascular system depression, up to a collapse-like state, including decreased blood pressure, rapid heartbeat, arrhythmia; bradycardia, vascular collapse, decreased or absent reflexes, nystagmus, headache, nausea, weakness, decreased body temperature, slowed pulse, decreased diuresis.
If poisoning is left untreated, death can occur as a result of vascular insufficiency, respiratory paralysis, or pulmonary edema.
Treatment.
Cases of acute poisoning with Corvalcaps 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. It is necessary to stabilize breathing and blood circulation. Respiratory failure is overcome by artificial respiration, shock should be stopped by infusion of plasma and plasma substitutes. If a lot of time has passed since the intake, it is necessary to wash the stomach (10 g of activated charcoal powder and sodium sulfate should be introduced 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 significant amount of table salt solution with the simultaneous administration of saluretics.
If hypersensitivity reactions occur, prescribe desensitizing medications.
Adverse reactions
Musculoskeletal: With prolonged use of drugs containing phenobarbital, there is a risk of impaired osteogenesis and the development of rickets (if the drug is used in children). 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 has not been identified.
On the part of the digestive tract: nausea, vomiting, constipation, feeling of heaviness in the epigastric region, with prolonged use - impaired liver function.
From the side of the hematopoietic system: agranulocytosis, megaloblastic anemia, thrombocytopenia, anemia.
From the cardiovascular system: arterial hypotension, bradycardia.
On the part of the immune system: allergic reactions, including angioedema.
Other: difficulty breathing, facial swelling, rash, itching.
Skin and mucous membranes: Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, rhinitis, conjunctivitis, acne, purpura, lacrimation.
Prolonged use of bromine-containing drugs can lead to bromine poisoning, which is characterized by the following symptoms: central nervous system (CNS) depression, depression, confusion, ataxia, apathy, depressed mood, conjunctivitis, rhinitis, acne, or purpura.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
9 capsules in a blister, 3 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "Kyiv Vitamin Plant".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
