DONORMYL PILL 15MG

pharmachologic effect

Histamine N blocker1-receptors from the group of ethanolamines. The drug has a sedative, sedative and m-holinoblokiruyuschee effect. It reduces the time of falling asleep, increases the duration and quality of sleep, while not changing the phase of sleep. Duration of action - 6-8 hours.

Pharmacokinetics

Suction and distribution

Cmaxis achieved on average 2 hours after ingestion. Absorption is high.

Metabolism and excretion

It penetrates through histohematogenous barriers (including BBB). Metabolized in the liver. T1/2 - about 10 hours. It is excreted by 60% by the kidneys unchanged, partially through the gastrointestinal tract.

Pharmacokinetics in special clinical situations

In patients older than 65 years, as well as with liver and kidney failure T1/2may lengthen.

By repeating the courses of treatment, a stable concentration of the drug and its metabolites in the blood plasma is reached later and at a higher level.

Indications

- transient sleep disturbances.

Dosing regimen

Inside On 1 / 2-1 tab. / Days, washing down with a small amount of liquid, 15-30 minutes before sleep. If the treatment is ineffective, according to the recommendation of the doctor, the dose may be increased to 2 tab.

Duration of treatment from 2 to 5 days; If insomnia persists, you should consult a doctor.

Patients with renal and hepatic impairment:in connection with the data on the increase in plasma concentration and a decrease in the plasma clearance of doxylamine, a dose downward adjustment is recommended.

Elderly patients over 65 years:histamine H blockers1-receptors should be carefully prescribed to this group of patients in connection with possible dizziness and delayed reactions with the danger of falling (for example, during night awakenings after taking sleeping pills). Due to data on increasing plasma concentrations, decreasing plasma clearance and increasing T1/2 recommended dose adjustment in the direction of reduction.

Side effect

Gastrointestinal:constipation, dry mouth.

Cardiovascular:feeling of heartbeat.

Special senses:blurred vision and accommodation, blurred vision.

Urogenital:urine retention.

Nervous system:daytime drowsiness (in this case, the dose of the drug should be reduced); confusion, hallucinations.

From the laboratory indicators: increase in level of KFK.

Musculoskeletal system: rhabdomyolysis

If any of the above side effects are exacerbated or other side effects appear, the patient should inform the doctor.

Contraindications

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

- angle-closure glaucoma or a family history of angle-closure glaucoma;

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

- congenital galactosemia, glucose-galactose malabsorption, lactase deficiency;

- children's and teenage age up to 15 years.

with caution:in patients with a history of apnea - due to the fact that doxylamine succinate may exacerbate the syndrome of sleep apnea (sudden respiratory arrest during sleep); patients older than 65 years - due to possible dizziness and delayed reactions with the danger of falls (for example, during night awakenings after taking sleeping pills), and also due to a possible increase in T1/2; in patients with renal and hepatic insufficiency (T1/2 may increase).

Use during pregnancy and lactation

Based on adequate and well-controlled studies, doxylamine can be used in pregnant women throughout the entire period of pregnancy. In the case of the appointment of this drug in late pregnancy, the atropine-like and sedative properties of doxylamine should be taken into account when monitoring the condition of the newborn.

It is not known whether doxylamine passes into breast milk. In connection with the possibility of the development of a sedative or aphrodisiac effect in a child, you should not breastfeed when using the drug.

Application for violations of the liver

Use with caution in patients with hepatic impairment (T1/2 may increase).

Application for violations of kidney function

Use with caution in patients with renal insufficiency (T1/2 may increase).

Use in children

Contraindicated in children and adolescents up to 15 years.

Use in elderly patients

with caution:patients older than 65 years - due to possible dizziness and slow reactions with the danger of falling (for example, during night awakenings after taking sleeping pills).

special instructions

It should be borne in mind that insomnia can be caused by a number of reasons for which there is no need to prescribe this drug.

The drug has a sedative effect, suppresses cognitive abilities and slows down psychomotor reactions. The first generation of histamine H blockers1-receptors can have m-anticholinergic, α-adrenergic blocking and antiserotoninovy ​​effects, which can cause dry mouth, constipation, urinary retention, disturbance of accommodation and vision.

Like all sleeping pills or sedatives, doxylamine succinate can exacerbate sleep apnea (sudden cessation of breathing during sleep) - increasing the number and duration of sleep apnea.

One pill of the drug contains 100 mg of lactose monohydrate, which should be taken into account in patients with rare congenital intolerance to galactose, lactase deficiency lapp or glucose-galactose malabsorption.

Influence on ability to drive vehicles and mechanisms

Due to the possible drowsiness in the daytime, driving a car, working with mechanisms and other activities that require quick mental and motor responses should be avoided.

Overdose

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

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

Treatment: symptomatic (m-cholinomimetics, etc.), as a means of first aid, the use of Activated carbon is shown (in the amount of 50 g for adults and 1 g / kg of body weight for children).

Drug interaction

While taking the drug Donormyl® with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussive drugs), neuroleptics, anxiolytics, histamine N blockers1-receptors with a sedative effect, central antihypertensive drugs, thalidomide, Baclofen, pizothiphene intensifies the inhibitory effect on the central nervous system.

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

Since ethanol enhances the sedative effect of most histamine N blockers1-receptors, including and drug Donormyl®, it is necessary to avoid its simultaneous use with alcoholic beverages and drugs containing ethanol.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature of 15-25 ° C. Shelf life - 3 years.

Pharmacy sales terms

The drug is available on prescription.