Instructions for use Sonobarboval drops 5 ml
Composition
active ingredients: ethyl ester of α-bromoisovaleric acid, solution of menthol in menthyl ester of isovaleric acid (validol), doxylamine hydrogen succinate.
1 ml of solution contains: ethyl ester of α-bromoisovaleric acid in terms of 100% substance – 18 mg; solution of menthol in menthyl ester of isovaleric acid (validol) – 80 mg; doxylamine hydrogen succinate in terms of 100% dry substance – 16.875 mg.
excipients: sodium acetate trihydrate; ethanol 96%; purified water.
Dosage form
Oral drops, solution.
Main physicochemical properties: clear colorless liquid with a specific aromatic odor.
Pharmacotherapeutic group
Hypnotics and sedatives. Combinations of hypnotics and sedatives, excluding barbiturates. ATX code N05СХ.
Pharmacological properties
Pharmacodynamics
A combined drug, the therapeutic efficacy of which is due to the pharmacological properties of the components that make up its composition.
α-Bromoisovaleric acid ethyl ester is a bromo derivative of a-isovaleric acid - one of the active components of valerian roots and rhizomes. The inclusion of bromine ions in the molecule of isovaleric acid ethyl ester contributes to the enhancement of sedative and hypnotic effects. It has sedative, tranquilizing and antispasmodic properties characteristic of valerian preparations. The mechanism of sedative action of valerian preparations is associated with a regulatory effect on the functions of the cerebral cortex: potentiation of GABA-ergic transmission by facilitating the release of GABA and inhibiting its reuptake, agonistic effect on adenosine and benzodiazepine receptors.
Doxylamine is a hypnotic, sedative, antihistamine drug. A blocker of H1-histamine receptors of the ethanolamine group with pronounced sedative and M-cholinolytic effects. It facilitates falling asleep, increases the duration and improves the quality of sleep, does not change the physiological phases of sleep.
A solution of menthol in the menthyl ester of isovaleric acid (validol) exhibits a moderate sedative and reflex coronary dilator effect, which is largely due to reflex reactions associated with irritation of sensitive nerve endings. Irritation of mucous membrane receptors is accompanied by stimulation of the formation and release of enkephalins, endorphins, and other endogenous physiologically active compounds.
Pharmacokinetics
Pharmacokinetic studies of α-bromoisovaleric acid ethyl ester and a solution of menthol in isovaleric acid menthyl ester have not been conducted.
Doxylamine is well absorbed from the gastrointestinal tract after oral administration. The maximum concentration in blood plasma (Cmax) is reached on average 1 hour (tmax) after oral administration. Penetrates through histohematological barriers (including blood-brain barrier) and is distributed to tissues and organs. It is partially metabolized in the liver by demethylation and N-acetylation with the formation of inactive metabolites.
The half-life (t1/2) is on average 10 hours. It is excreted by the kidneys (60% unchanged) and partially through the intestines.
Indication
Treatment of insomnia on the background of somatoform autonomic dysfunction; neurotic disorders accompanied by insomnia.
Contraindication
Increased individual sensitivity to the components of the drug and antihistamines;
acute angle-closure glaucoma, including a personal or family history;
urethroprostatic disorders with the risk of urinary retention;
severe arterial hypotension;
acute myocardial infarction.
Interaction with other medicinal products and other types of interactions
Concomitant use with drugs that have a depressant effect on the central nervous system (other sedatives; morphine derivatives; analgesics; drugs used to treat cough, for substitution therapy; neuroleptics; barbiturates; tranquilizers; antidepressants; benzodiazepines; other hypnotics; drugs for anesthesia (sodium oxybutyrate); anxiolytics, except benzodiazepines; sedative antihistamines; non-benzodiazepine sedatives; others: baclofen, thalidomide), with opioid analgesics, centrally acting antihypertensives and alcohol increases the depression of the central nervous system.
Impaired reaction speed can pose a danger when driving or operating other mechanisms.
Simultaneous use with central nervous system stimulants (caffeine, cordiamine, etc.) mutually weakens the effects of each of the drugs.
Atropine and atropine-like drugs (iminopramine antidepressants, most atropine-like H1-antihistamines, anticholinergic antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazines, clozapine) increase the risk of developing anticholinergic side effects.
Application features
If insomnia persists for longer than 5 days while taking the drug, the patient should consult a doctor regarding further use of the drug.
Like all hypnotics or sedatives, doxylamine succinate may exacerbate sleep apnea syndrome (increased number and duration of breathing stops).
The risk of abuse and drug dependence is low. However, cases of abuse and drug dependence have been reported. Signs of abuse or drug dependence should be monitored closely. Duration of treatment should not exceed 5 days. It is not recommended to use the drug in patients with a history of substance use disorders.
Doxylamine succinate remains in the body for approximately 5 half-lives (see Pharmacokinetics).
When taking the drug, especially in elderly patients, caution should be exercised due to the risk of cognitive impairment, sedation, slow reaction and/or vertigo/dizziness, for example, when waking up at night. Also, in the morning after taking the drug in the evening, sudden movements should be avoided, as slow reaction and dizziness are possible.
The half-life may be significantly longer in the elderly or in those suffering from renal or hepatic insufficiency.
With repeated administration, the drug or its metabolites reach steady state much later and at higher levels. The efficacy and safety of the drug can only be assessed after steady state is reached.
Dose adjustment may be necessary (see section "Method of administration and dosage").
In elderly patients, in cases of renal or hepatic insufficiency, an increase in plasma concentration and a decrease in plasma clearance are observed. It is recommended to reduce the dose of the drug.
This medicine contains 73% ethanol (alcohol), i.e. 0.262 g/dose, which is equivalent to 5.4 ml of beer or 2.3 ml of wine per dose (calculated per dose of 12 drops). Harmful for patients suffering from alcoholism. Caution should be exercised when using in patients with liver or kidney disease, or epilepsy. Alcohol intake should be avoided during treatment.
Use during pregnancy or breastfeeding
The drug is not prescribed during pregnancy due to the presence of bromine in the composition. It is not recommended to use the drug during lactation.
The ability to influence the reaction speed when driving or working with other mechanisms
The drug affects the speed of psychomotor reactions, so you should refrain from driving or working with other mechanisms.
During the next day after taking the drug, the possibility of developing daytime drowsiness, decreased concentration, and impaired accommodation should be taken into account.
In cases of insufficient sleep duration, the risk of impaired reaction speed increases (see section "Method of administration and dosage").
Method of administration and doses
The dose of the drug is set individually, taking into account the severity and duration of insomnia.
The drug is taken once orally with a small amount of water (1/2 glass) 15–30 minutes before bedtime.
The recommended single dose of the drug for adult patients is 12 drops, which corresponds to 7.5 mg of doxylamine. If necessary, the dose can be increased. The maximum single dose is 24 drops (15 mg of doxylamine). 1 ml of solution corresponds to 27 drops.
Elderly patients and patients with renal or hepatic insufficiency are recommended to reduce the dose.
To prevent the development of daytime drowsiness, it should be taken into account that after taking the drug, the possibility of sleeping for at least 7 hours should be ensured.
The duration of taking the drug is 2–5 days.
Children
The drug is not recommended for use in children under 18 years of age, as safety and efficacy have not been established.
Overdose
It is only possible when taking the drug in very high doses.
Symptoms: headache, nausea, cardiac disorders, hypersensitivity reactions to the components of the drug, agitation, delirium, hallucinations, impaired coordination of movements, athetosis, tremor, dilated pupils, accommodation paralysis, dry mouth, redness of the face and neck, hyperthermia, sinus tachycardia, central nervous system depression, ataxia, decreased blood pressure, convulsions, coma.
Acute doxylamine poisoning sometimes causes rhabdomyolysis, which may be complicated by acute renal failure.
Manifestations of chronic bromine poisoning (bromism) include: depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, and impaired coordination of movements. Symptomatic therapy is prescribed to eliminate these manifestations.
Long-term use of the drug is sometimes accompanied by increased psychodynamic activity.
Treatment is symptomatic.
Side effects
The drug is usually well tolerated by patients. The following side effects may develop:
from the nervous system: daytime drowsiness, dizziness, inhibition, decreased concentration, hallucinations, confusion, exacerbation of sleep apnea syndrome, increased psychodynamic activity;
from the digestive system: abdominal discomfort, nausea, dry mouth, constipation;
from the immune system: allergic reactions, including skin rashes, itching, urticaria, angioedema;
on the part of the organs of vision: accommodation disorder, blurred vision, visual defect, lacrimation;
Urinary system: urinary retention.
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, purpura.
Cases of abuse and drug dependence have been reported.
H1-antihistamine drugs cause sedation, cognitive impairment, and psychomotor impairment.
Expiration date
3 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
5 ml per bottle. 1 bottle per pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Address
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
