Dormirel

Inside. By 1/2-1 table. a day, washed down with a small amount of liquid, 15-30 minutes before bedtime.

If the treatment is ineffective, the dose can be increased to 2 tablets on the doctor's recommendation.

The duration of treatment is from 2 to 5 days, if insomnia persists, you should consult a doctor.

Special patient groups

Renal and hepatic insufficiency. Due to the data on an increase in the plasma concentration and a decrease in the plasma clearance of doxylamine, a dose adjustment is recommended.

Age older than 65 years. H blockers₁- histamine receptors should be used with caution in this group of patients due to possible dizziness and delayed reactions with the risk of falling (for example, when waking up at night after taking sleeping pills). Due to the data on an increase in plasma concentration, a decrease in plasma clearance and an increase in the half-life, a dose adjustment is recommended.

Inside, with 100-150 ml of liquid (water) for 30 minutes-1 hour before the desired time of sleep.

If the doctor does not prescribe otherwise, then a single dose of the drug Valocordin^®- Doxylamine for patients over 18 years of age is 22 drops (corresponds to 25 mg of doxylamine succinate). If the therapy is not effective enough, the dose can be increased to a maximum of 44 drops (50 mg). Do not exceed the maximum daily dose.

After taking the drug Valocordin^®- Doxylamine it is necessary to ensure sufficient sleep duration, which will avoid disrupting psychomotor reactions in the morning.

In acute sleep disorders, if possible, you should limit yourself to a single application. To check the need to continue treatment with regular sleep disorders, it is recommended to proceed to a gradual dose reduction no later than 14 days after the start of daily use.

Usually, the duration of treatment is 2-5 days, the maximum duration of treatment with doxylamine is 14 days.

Special patient groups

Patients with renal and / or hepatic insufficiency, as well as patients over 65 years of age may be more susceptible to the effects of doxylamine, and therefore a reduction in its dose is recommended.

Inside, drinking a small amount of liquid, 15-30 minutes before bedtime, 1/2-1 table.

If the treatment is ineffective, the dose can be increased to 2 tablets on the doctor's recommendation.

The duration of treatment is from 2 to 5 days, if insomnia persists, you should consult a doctor.

Special patient groups

Renal and hepatic insufficiency. Due to the data on an increase in the concentration in the blood plasma and a decrease in the plasma clearance of doxylamine, a dose adjustment is recommended.

Age older than 65 years. H blockers₁- histamine receptors should be used with caution in this group of patients due to possible dizziness and delayed reactions with the risk of falls (for example, when waking up at night after taking sleeping pills). Due to data on an increase in plasma concentration, a decrease in plasma clearance, and an increase in T_1/2 it is recommended to adjust the dose in the direction of reduction.

hypersensitivity to doxylamine and other components of the drug or other antihistamines,

angle-closure glaucoma or family history of angle-closure glaucoma,

diseases of the urethra and prostate, accompanied by a violation of the outflow of urine,

congenital galactosemia, glucose-galactose malabsorption, lactase deficiency,

children and adolescents (up to 15 years).

With caution: cases of apnea in the anamnesis (due to the fact that doxylamine succinate can aggravate the syndrome of night apnea-sudden respiratory arrest during sleep), age over 65 years (due to possible dizziness and delayed reactions with the risk of falling (for example, when waking up at night after taking sleeping pills), as well as due to a possible increase in T_1/2, renal and hepatic insufficiency (T_1/2 may increase).

hypersensitivity to doxylamine, any component of the drug, as well as other antihistamines,

acute asthmatic attack,

angle-closure glaucoma,

congenital long QT syndrome,

pheochromocytoma,

prostatic hyperplasia in violation of the outflow of urine,

acute poisoning with alcohol and sleeping pills, narcotic analgesics, neuroleptics, tranquilizers, antidepressants, lithium preparations,

epilepsy,

simultaneous administration of MAO inhibitors,

bronchial asthma or other respiratory diseases that are characterized by hypersensitivity of the respiratory tract (do not use Valocordin^®- Doxylamine, because it contains peppermint oil, which can cause bronchospasm if inhaled),

breastfeeding period,

age up to 18 years.

With caution: pregnancy, liver failure, alcoholism, heart failure, hypertension, a history of bronchospasm, chronic shortness of breath, gastro-esophageal reflux, pylorostenosis, achalasia of the cardia, age over 65 years (the possibility of dizziness, the risk of loss of balance and falling during night awakenings, as well as in connection with a possible increase in T_1/2 of doxylamine).

Valokordin^®- Doxylamine should be used with extreme caution in patients with local cortical damage and a history of seizures, since even small doses of the drug can provoke severe seizures of epilepsy. EEG is recommended. Anticonvulsant therapy should not be interrupted during the use of the drug Valocordin^®- Doxylamine.

hypersensitivity to doxylamine and other components of the drug or other antihistamines,

angle-closure glaucoma or family history of angle-closure glaucoma,

diseases of the urethra and prostate, accompanied by a violation of the outflow of urine,

lactose intolerance, lactase deficiency, glucose-galactose malabsorption,

children and adolescents under 15 years of age.

With caution: cases of apnea in the anamnesis (due to the fact that doxylamine can aggravate the syndrome of night apnea (sudden respiratory arrest during sleep), age over 65 years (due to possible dizziness and delayed reactions with the risk of falls (for example, when waking up at night after taking sleeping pills), as well as due to a possible increase in T_1/2), renal and hepatic insufficiency (T_1/2 may increase).

From the gastrointestinal tract: constipation, dry mouth.

From the CCC side: the feeling of a heartbeat.

On the part of the visual organ: visual disturbances and accommodation, blurred vision.

From the kidneys and urinary tract: urinary retention.

From the nervous system: daytime sleepiness (in this case, the dose of the drug should be reduced), confusion, hallucinations.

On the part of laboratory parameters: increase in the level of CFC.

From the musculoskeletal system: rhabdomyolysis.

If any of these side effects worsen or any other side effects are observed that are not listed in the description, you should inform your doctor.

The frequency of potential adverse reactions is classified as follows: very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (up to <1/10000), and the frequency is unknown (cannot be estimated from available data).

From the blood and lymphatic system: in exceptional cases, when treated with H blockers₁- histamine receptors have been reported to develop leukopenia, thrombocytopenia, hemolytic anemia, very rarely-cases of aplastic anemia and agranulocytosis have been reported.

From the endocrine system: in patients with pheochromocytoma, the use of H blockers₁-histamine receptors may cause an increased release of catecholamines.

Mental disorders: adverse reactions that depend on individual susceptibility and the dose taken include a decrease in the rate of psychomotor reactions, a decrease in concentration, depression, in addition, paradoxical reactions may occur — anxiety, agitation, anxiety, insomnia, nightmares, confusion, hallucinations, tremor. After prolonged daily use, abrupt discontinuation of therapy can lead to rebound insomnia.

Drug addiction. Like other sleeping pills, doxylamine can cause physical and mental dependence. The risk of addiction increases with an increase in the dose and duration of treatment, as well as in patients with alcohol and drug addiction (including in the anamnesis).

Ricochet insomnia. Even after short courses of doxylamine, its withdrawal can lead to a relapse of insomnia. Therefore, the treatment should be discontinued, gradually reducing the dose.

Anterograde amnesia. Even in therapeutic doses, doxylamine can cause anterograde amnesia, especially within the first hour after taking it. The risk increases with increasing dose, but can be reduced by continuous sleep of sufficient duration (7-8 hours).

From the nervous system: dizziness, drowsiness, headache, rarely-possible convulsions.

On the part of the visual organ: accommodation disorders, increased IOP.

On the part of the organ of hearing and balance: noise in the ears.

From the CCC side: tachycardia, arrhythmia, decreased or increased blood pressure, decompensated heart failure. In several cases, changes were detected on the ECG.

Respiratory, thoracic, and mediastinal disorders: thickening of bronchial secretions, bronchial obstruction, bronchospasm, which can lead to impaired lung function.

From the gastrointestinal tract: autonomous adverse reactions such as dry mouth and constipation, nausea, vomiting, diarrhea, decreased or increased appetite, epigastric pain, very rarely — life-threatening paralytic intestinal obstruction.

From the liver and biliary tract: against the background of antihistamine therapy, liver function disorders (cholestatic jaundice) have been reported.

From the skin and subcutaneous tissue: skin allergic reactions, photosensitization, violation of thermoregulation.

From the musculoskeletal system and connective tissue: muscle weakness.

From the kidneys and urinary tract: violation of urination.

General disorders and disorders at the injection site: nasal congestion, fatigue, lethargy.

Development of addiction: regular use can lead to a decrease in effectiveness (addiction).

Careful individual selection of the daily dose allows you to reduce the frequency and severity of adverse reactions. The risk of adverse reactions is higher in older patients, which may increase their risk of falls.

From the gastrointestinal tract: constipation, dry mouth.

From the CCC side: the feeling of a heartbeat.

On the part of the visual organ: visual disturbances and accommodation, blurred vision.

From the nervous system: daytime sleepiness (in this case, the dose of the drug should be reduced), confusion, hallucinations.

From the kidneys and urinary tract: urinary retention.

On the part of laboratory parameters: increase in the level of CFC.

From the musculoskeletal system: rhabdomyolysis.

If any of the adverse reactions listed in the description worsen or any other adverse events that are not listed in the description appear, you should inform your doctor.

Symptoms: daytime drowsiness, agitation, pupil dilation (mydriasis), impaired accommodation, dry mouth, redness of the face and neck (hyperemia), fever (hyperthermia), sinus tachycardia, disorder of consciousness, hallucinations, decreased mood, anxiety, impaired coordination of movements, tremor( tremor), involuntary movements (athetosis), convulsions( epileptic syndrome), coma. Involuntary movements are sometimes harbingers of convulsions, which may indicate a severe degree of poisoning. Even in the absence of seizures, severe doxylamine poisoning can cause the development of rhabdomyolysis, which is often accompanied by acute renal failure. In such cases, standard therapy with constant monitoring of the level of CK is indicated. If you experience symptoms of poisoning, you should immediately consult a doctor.

Treatment: symptomatic (including the appointment of m-cholinomimetics) as a first aid — the appointment of activated charcoal (in the amount of 50 g-for adults and 1 g/kg - for children).

Symptoms: daytime drowsiness, dilated pupils, paresis of accommodation, dry mouth, redness of the skin of the face and neck, fever, sinus tachycardia, disorder of consciousness, hallucinations, decreased mood, increased anxiety, impaired coordination of movements, tremor, involuntary movements, convulsive syndrome, coma.

Involuntary movements are sometimes harbingers of convulsions, which may indicate a severe degree of poisoning. Even in the absence of seizures, doxylamine poisoning can cause the development of rhabdomyolysis, which is often accompanied by the development of severe renal failure. In such cases, standard therapy with constant monitoring of the activity of CK is indicated.

There is a report of a case where as a result of the patient taking 500 mg of doxylamine (due to persistent insomnia), acute pancreatitis and acute renal failure developed.

Treatment: if symptoms of poisoning appear, you should immediately consult a doctor. Symptomatic (including m-cholinomimetics and anticonvulsant drugs) and maintenance therapy (including ventilator). As a first aid, the use of activated charcoal is indicated (adults-50 g, children with an accidental overdose-1 g/kg). When ingesting a large amount of the drug-the appointment of gastric lavage or the induction of vomiting. Analeptics are contraindicated, because of the possible decrease in the convulsive threshold caused by taking the drug Valocordin^®- Doxylamine, increases the risk of convulsive syndrome. With arterial hypotension, alpha - and beta-adrenostimulants are not prescribed, in t.tsch. epinephrine( epinephrine), due to the possibility of a paradoxical increase in the severity of hypotension. It is advisable to prescribe norepinephrine (norepinephrine). It is necessary to avoid the use of drugs with beta-adrenostimulating effect, as they can increase vasodilation. In case of severe poisoning (loss of consciousness, cardiac arrhythmia) or the occurrence of anticholinergic syndrome (with ECG monitoring), an antidote — physostigmine salicylate can be used. With repeated epileptic seizures, anticonvulsants are prescribed. Due to the increased risk of respiratory depression, their appointment is possible only in cases where it is possible to conduct a ventilator. The effectiveness of hemodialysis, hemofiltration, and peritoneal dialysis in doxylamine overdose has not been studied, but these methods are unlikely to be effective due to the large V_d the drug. The effectiveness of forced diuresis has not been established.

Symptoms: daytime drowsiness, agitation, pupil dilation (mydriasis), accommodation disorders, dry mouth, redness of the face and neck (hyperemia), fever (hyperthermia), sinus tachycardia, disorder of consciousness, hallucinations, decreased mood, anxiety, impaired coordination of movements, tremors (tremor), involuntary movements (athetosis), convulsions (epileptic syndrome), coma.

Involuntary movements are sometimes harbingers of convulsions, which may indicate a severe degree of poisoning. Even in the absence of seizures, severe doxylamine poisoning can cause the development of rhabdomyolysis, which is often accompanied by acute renal failure.

Treatment: symptomatic (including m-cholinomimetics), as a first aid agent, the appointment of activated charcoal is indicated (in an amount of 50 g - for adults and 1 g/kg - for children). In the case of severe poisoning, standard therapy with constant monitoring of the level of CK is indicated.

If symptoms of poisoning appear, you should immediately consult a doctor.

Blocker H₁- histamine receptors from the group of ethanolamines. The drug has a sedative, sedative and m-anticholinergic action. Reduces the time of falling asleep, increases the duration and quality of sleep, while not changing the sleep phase. Duration of action — 6-8 hours.

Blocker H₁- histamine receptors from the group of ethanolamines. The drug has a sedative, sedatives, antihistamines and m-anticholinergic action. Reduces the time of falling asleep, increases the duration and quality of sleep, without changing the sleep phase.

The action begins within 30 minutes after taking doxylamine, its duration is 3-6 hours.

Blocker H₁- histamine receptors from the group of ethanolamines. Has a sedative, antihistamine, sedative and m-anticholinergic action.

Reduces the time of falling asleep, increases the duration and quality of sleep, does not change the sleep phase. Duration of action — 6-8 hours.

C_max in plasma, on average, it is reached in 2 hours after oral administration. T_1/2 - about 10 h. Absorption is high, it is metabolized in the liver. It penetrates through the blood-tissue barriers (including BBB). It is excreted by 60% by the kidneys in unchanged form, partially-through the gastrointestinal tract.

Special patient groups

In patients over 65 years of age, as well as in hepatic and renal insufficiency._1/2 it can be extended. When repeated courses of treatment, a stable concentration of the drug and its metabolites in the blood plasma is achieved later and at a higher level.

Doxylamine is rapidly and almost completely absorbed after oral administration. C_max in the blood serum, it is detected 2-2. 4 hours after administration at a dose of 25 mg and is 99 ng/ml.

Doxylamine is mainly metabolized in the liver. The main metabolites are N-desmethyl doxylamine, N,N-didesmethyl doxylamine, and their N-acetyl conjugates. It penetrates well through histohematic barriers, including BBB. T_1/2 ranges from 10.1 to 12 hours. The main part of the dose (about 60%) is excreted unchanged in the urine, partially through the intestine.

After oral administration, doxylamine is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in the blood plasma, on average, it is determined 2 hours after oral administration.

It is metabolized in the liver. It penetrates well through histohematic barriers, including the BBB. It is excreted by 60% by the kidneys in an unchanged form, partially-through the gastrointestinal tract._1/2 doxylamine is about 10 hours.

Special patient groups

In patients over 65 years of age, as well as in hepatic and renal insufficiency._1/2 it can be extended. When repeated courses of treatment, a stable concentration of the drug and its metabolites in the blood plasma is achieved later and at a higher level.

When taking Dormirel at the same time^® with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussive drugs), neuroleptics, anxiolytics, sedatives₁- antihistamines, central antihypertensive drugs, thalidomide, baclofen, pisotifen increases the depressing effect on the central nervous system.

When taken simultaneously with m-holinoblokiruyuschimi agents (atropine, imipramine antidepressants, antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine neuroleptics) increases the risk of side effects such as urinary retention, constipation, dry mouth.

Since alcohol increases the sedative effect of most H antagonists₁- histamine receptors, including the drug Dormirel^®, it is necessary to avoid its simultaneous use with alcoholic beverages and medicines containing alcohol.

With simultaneous use of the drug Valocordin^®- Doxylamine with antidepressants, barbiturates, benzodiazepines, anxiolytics, sedatives, narcotic analgesics, codeine-containing analgesics and antitussive drugs, neuroleptics, other H blockers₁- histamine receptors, central antihypertensive drugs (including clonidine and alpha-methyldopa), thalidomide, baclofen, pisotifen increases the depressing effect on the central nervous system.

The use of doxylamine leads to a significant increase in the activity of CYP2B, as well as a moderate induction of CYP3A and CYP2A. It is impossible to exclude the possibility of interaction with drugs that are metabolized with the participation of these enzymes, for example, antiarrhythmic agents, protease inhibitors, neuroleptics, beta-blockers, immunosuppressants and antiepileptic drugs.

Since ethanol increases the sedative effect of most H blockers₁- histamine receptors it is necessary to avoid the simultaneous use of the drug Valocordin^®- Doxylamine and drugs containing ethanol, as well as the use of alcoholic beverages.

When used concomitantly with drugs with m-choline-blocking activity (atropine and atropine-containing antispasmodics, tricyclic antidepressants, MAO inhibitors, antiparkinsonian drugs, disopyramide, phenothiazine neuroleptics), the anticholinergic effect of doxylamine succinate may be unpredictably increased and prolonged, while increasing the risk of such adverse reactions as urinary retention, constipation, paralytic intestinal obstruction, dry mouth, increased IOP. In addition, the combined use of doxylamine with MAO inhibitors can cause the development of arterial hypotension, central nervous system depression and respiratory function

Taking antihistamines can mask the initial signs of damage to the inner ear (ringing in the ears, dizziness, confusion) caused by the simultaneous use of ototoxic drugs (such as aminoglycosides, salicylates, diuretics).

During treatment with doxylamine succinate, the results of skin tests may be false negative.

Patients who take doxylamine succinate should not eliminate arterial hypotension with epinephrine (epinephrine) (a paradoxical increase in the severity of hypotension is possible). In cases of shock, norepinephrine (norepinephrine) should be used.

When used concomitantly with photosensitizing drugs, an additive photosensitizing effect may be observed.

When taking Dormirel at the same time^® with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussive drugs), neuroleptics, anxiolytics, sedatives₁- antihistamines, central antihypertensive drugs, thalidomide, baclofen, pisotifen increases the depressing effect on the central nervous system.

When taken simultaneously with m-holinoblokiruyuschimi agents (atropine, imipramine antidepressants, antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine neuroleptics) increases the risk of side effects such as urinary retention, constipation, dry mouth.

Since alcohol increases the sedative effect of most H antagonists₁- histamine receptors, including the drug Dormirel^®, it is necessary to avoid its simultaneous use with alcoholic beverages and medicines containing alcohol.