Pharmacodynamics. Vasodilator (coronarolytic), sedative, hypnotic. has a mild antianginal effect. helps to reduce the excitability of the central nervous system, has a calming effect and facilitates the onset of natural sleep.
Ethyl ester of α-bromisovaleric acid, which is part of the preparation, has an antispasmodic, coronary artery disease and sedative effect; in high doses, it also causes a mild hypnotic effect.
Guaifenesin has an anxiolytic (anti-anxiety) effect.
Doxylamine hydrogen succinate is an H1 receptor blocker and exhibits sedative, hypnogenic and antiallergic effects.
Pharmacokinetics. Guaifenesin is rapidly (after 30 minutes) absorbed in the gastrointestinal tract. Mainly penetrates into tissues containing acidic mucopolysaccharides. After oral administration, Cmax is reached after 1-2 hours, and the therapeutic concentration is maintained for 6 hours. T½ guaifenesin is about 1 hour. It is excreted in sputum and excreted by the kidneys in the form of metabolites, as well as unchanged. Cmax of doxylamine hydrogen succinate in blood plasma is achieved on average 2 hours (Tmax) after taking the preparation.
T½ of doxylamine from blood plasma averages 10 hours.
Doxylamine hydrogen succinate is partially metabolized in the liver by demethylation and N-acetylation. T½ can increase significantly in the elderly and in patients with renal or hepatic impairment. Various metabolites formed during the breakdown of the molecule are not quantitatively significant, since 60% of the dose is determined in urine in the form of unchanged doxylamine.
Mild spasms of the coronary vessels; neurocirculatory dystonia - in complex therapy; neurosis with increased irritability; increased excitability; mild insomnia; dermatosis, accompanied by itching.
The dosage and duration of the course of treatment is determined by the doctor individually for each patient. adults, as a rule, are prescribed 1 tablet of the preparation 2-3 times a day before meals. for mild insomnia, 1-2 tablets are prescribed 30 minutes before bedtime.
Hypersensitivity to preparation components or antihistamines. severe renal and liver dysfunction, hepatic porphyria. history of glaucoma or family history. urethroprostatic disorders with a risk of urinary retention. severe heart failure. depression and other disorders accompanied by depression of the central nervous system.
In some cases, the following side effects may occur:
These phenomena are eliminated when the dose is reduced or the preparation is stopped.
With prolonged use of the preparation in high doses, the development of bromism is possible.
Diarrhea, constipation, dry mouth, poor accommodation, palpitations.
Daytime sleepiness: if this effect develops, it is necessary to reduce the dose.
There are rare reports of the formation of calculi in the bladder or in the kidneys in patients taking high doses of guaifenesin for a long time.
In the event of unwanted side reactions, you should seek the advice of your doctor.
While taking the preparation, you must avoid drinking alcohol.
It should be used with caution in elderly patients because of the risk of dizziness.
Sleep apnea syndrome (an increase in the number and duration of respiratory arrests) may worsen during treatment.
In some cases, a change in the color of urine is possible.
The preparation should be used with caution in such categories of patients with:
Use during pregnancy and lactation. The preparation is not prescribed during pregnancy and lactation.
Children. There is no experience with children, therefore, the preparation is not used in pediatric practice.
The ability to influence the reaction rate when driving or working with other mechanisms. For the period of treatment, one should refrain from driving or from working with other mechanisms, requiring the speed of psychomotor reactions.
With simultaneous use with other preparations that depress the central nervous system, mutual enhancement of the action is possible, as well as the enhancement of the action of ethanol. the effect of the preparation increases with alcohol intake.
It should be borne in mind that in the case of a combination of the preparation with:
atropine and atropine-like preparations (imipramine antidepressants, anticholinergic antiparkinsonian preparations, atropine antispasmodic preparations, disopyramide, phenothiazine neuroleptics), side effects such as urinary retention, constipation, dry mouth are possible;
antidepressants, morphine derivatives (pain relievers and preparations used to treat coughs), antipsychotics; barbiturates, benzodiazepines, antihypertensive agents of central action, it is possible to increase the depression of the central nervous system.
Drowsiness, weakness, dizziness, vertigo, gastrointestinal disorders and signs of anticholinergic effects are possible: agitation, dilated pupils, accommodation paralysis, dry mouth, redness of the face and neck, hyperthermia, sinus tachycardia. the use of the preparation in very high doses can cause symptoms such as agitation, confusion and respiratory depression.
Treatment: discontinuation of the preparation, gastric lavage and symptomatic therapy. There is no specific antidote.
In its original packaging at a temperature not exceeding 25 ° C.
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