Donormil indications for use. Donormil

Donormil is a hypnotic that belongs to the class of ethanolamines and belongs to the group of blockers of cholinergic receptors and histamine H1 receptors. Latin name "Donormyl". Produced by the French company Bristol-Myers Squibb.

Pharmacology includes sedative and hypnotic effects.

The mechanism of action of Donormil is based on its ability to influence individual areas of the brain that are primarily responsible for the process of nervous excitability. A similar principle of operation is observed in antiallergic drugs, which are absorbed into the blood within a quarter of an hour and removed from the body by excretion in the urine.

The active substance of the drug, doxylamine succinate, is well absorbed by the gastrointestinal tract and within 1 hour after administration the maximum level of the concentrated mass in the blood plasma is observed. The half-life is 10-11 hours. The main volume of doxylamine succinate (more than 55-60%) is excreted unchanged through excretion through the urinary system.

Today there are no analogues of Donormil (generics) in Moscow pharmacies.

Indications for use

Donormil can be prescribed in many cases where the main goal is to normalize sleep, as it is effective:

• shortens the process of falling asleep;
• increases the quality and duration of sleep, without disturbing its phases;
• fights primary insomnia, as well as rare types of sleep disorders.

The drug in question can also be taken for the following indications:

• state of anxiety;
• increased excitability;
• stress and depression of various etiologies.

Release form

Donormil is available in three tablet forms, where two forms are combined into one form, since they have only a quantitative difference.

1. Film-coated tablets, weight 15 mg. The color is white, the shape is rectangular, there is a double-sided line. Packaging – tube with a polyethylene cap, sealed in a cardboard box. Quantity: 15 pcs. or 30 pcs.
2. Effervescent tablets, film-coated, weight 15 mg. The color is white, the shape is in the form of a cylinder with beveled edges, there is a one-sided mark. Packaging – tube with a polyethylene cap, sealed in a cardboard box. Quantity: 2 tubes in a box of 10 pcs.

Instructions for use

• The film-coated tablet is taken orally after meals before bedtime, 15-20 minutes, and should be washed down with a small amount of liquid.
• The effervescent tablet should be pre-dissolved in water (1 tablet per 100 ml) and taken 15-20 minutes before bedtime.

Donormil is prescribed to patients over 15 years of age, with the recommended daily dose of the drug up to 1 tablet per day, and a single dose can be divided in half.

The average duration of treatment is 2-7 days, the interval is determined by the patient’s well-being. Some cases require increasing the dosage as prescribed by the attending physician.

Donormil should be used with caution in a special group of patients:

• For patients with renal and hepatic insufficiency, the drug requires a dose adjustment downward due to a slow metabolism.
• For patients over 60 years of age, this drug is recommended to be taken in a minimum dosage due to possible manifestations of negative symptoms: dizziness, risk of falling.

Features of use during pregnancy and breastfeeding

Based on research by many scientists, taking Donormil in pregnant women is quite possible, subject to strict medical supervision. Particular attention should be paid to the third trimester of pregnancy, since the atropine-like and sedative properties of the drug have the same effect on the fetus.

Contraindications

• hypersensitivity to the active substance doxylamine succinate or other additional components of the drug;
• the presence of a disease of the eyeball, characterized by increased intraocular pressure (angle-closure glaucoma);
• the presence of a disease of the urethra, prostate gland, which is accompanied by a disorder of the urinary system;
• impaired metabolism, in which galactose is converted into glucose, deficiency and poor absorption of galactose and glucose from food;
• children under 15 years of age.

Side effects

Taking Donormil can cause a number of characteristic symptoms:

• lethargy;
• feeling of slight dizziness;
• slight impairment of the ability to navigate in space.

From the gastrointestinal tract:

• dry mouth;
• constipation;
• stool retention.

From the cardiovascular system:

• cardiopalmus.

From the organs of vision:

• impairment of the eye's ability to simultaneously clearly see objects located at different distances (impaired accommodation).

From the genitourinary organs:

• urinary retention;
• urinary disturbance.

From the side of the central nervous system:

• fatigue;
• drowsiness during daylight hours.

If your condition worsens and the above side effects worsen, you should immediately visit your doctor.

Combination with alcohol

Simultaneous use of Donormil with alcohol, as well as with any alcohol-containing medications, is strictly contraindicated due to the activation and enhancement of the sedative effect. In addition, this combination sharply reduces the ability to control complex mechanisms and also causes inhibition of mental reactions.

Overdose

Oversaturation of the body with the drug Donormil is possible after any excess of the dose prescribed by the doctor, since the body’s sensitivity to the drug is always individual. In this case, symptoms may be as follows:

• state of overexcitation;
• motor coordination disorder (ataxia);
• hallucinations;
• spatial disorientation;
• convulsive sensations;
• nausea, vomiting;
• increased body temperature;
• comatose states.

The manufacturer warns of a possible overdose of this drug, which can be fatal. However, to date, medicine does not know of a single similar case. As a consequence of deep intoxication with the drug, there can be a profound disruption of the normal functioning of the brain, which leads to lifelong disability in psychiatry.

If side effects develop, immediate assistance from a specialist is required.

Interaction with other drugs

The inhibitory effect on the central nervous system is enhanced when Donormil is used simultaneously with the following medications:

• sedative antidepressants;
• morphine derivatives;
• sedative H1-antihistamines.

Negative side effects increase when the drug Donormil is taken simultaneously with drugs from the M-anticholinergic group (atropine, disopyramide and others).

Price

In Moscow pharmacies, the price for a package of Donormil containing 30 tablets varies from 150 to 180 rubles.

Storage conditions and shelf life

The drug must be kept away from places accessible to children at a temperature range of 15-25°C. The shelf life of effervescent tablets is no more than 4 years, film-coated tablets are 5 years after the release date indicated on the package.

Video about the drug Donormil:

Today, thanks to a fast and very active life, more than 20% of all people have sleep problems. As a result, your health worsens, it becomes harder to work, and accidents occur when driving and operating machinery.

To prevent this, patients turn to their doctor for help. He recommends using sleeping pills.

"Donormil" This is precisely the kind of medicine that applies. It helps reduce the period of falling asleep and increase the duration of sleep itself. The first mentions of its use date back to 1948.

Product of a French pharmaceutical company "Donormil" is a worthy competitor to other drugs with hypnotic properties.

Instructions for use

Composition and release form

The main active ingredient of the drug "Donormil" is doxylamine succinate at a dose of 15 mg. One package contains 20 effervescent tablets or 30 film-coated tablets.

Pharmacological group

"Donormil" refers to drugs that are characterized by:

1. Sedative action (relaxes the body).
2. Sleeping pills action (helps to fall asleep faster, improves sleep quality, the frequency of awakenings at night is significantly reduced, the duration of sleep increases). In this case, there is no effect on sleep phases.

Pharmacodynamics and pharmacokinetics

The main active ingredient that is part of the drug "Donormil", is a histamine H1 receptor blocker and belongs to the class of ethinolamines. D

the effect of the drug lasts no more than 8 ocloc'k. The maximum concentration of a substance in blood plasma is determined after 60 minutes after the reception. The half-life from the body is at the level 10 hours.

The main part of the drug is excreted by the kidneys, and only 40% through the gastrointestinal tract. Doxylamine succinate has the ability to penetrate histohematic barriers and the blood-brain barrier is no exception.

In elderly patients and people with impaired liver or kidney function, the half-life may be significantly longer than in healthy people.

When using the drug "Donormil" with repeated courses of treatment, a later achievement of stable concentrations of the drug and metabolites in plasma is observed.

Indications

The main indication for the use of the drug is various sleep disorders.

These also include:

1. Insomnia,
2. Long period of falling asleep,
3. Presence of anxiety in sleep in the form of nightmares.

Contraindications

Since the drug has been very well studied, there are many contraindications for its use:

Side effect

Side effects when correct When selecting the dose of the drug, problems occur very rarely.

However, it is worth noting that patients complained of:

1. Feeling dry mouth.
2. Violation defecation and the development of constipation.
3. Increased frequency heartbeat.
4. Delay urination.
5. Feeling drowsiness during the day.

To avoid this, it is necessary to reduce the dose of the drug.

Drug interactions

Donormil should be used with caution with the following medications:

1. Drugs, that affect urination.
2. Antidepressants.
3. Alcohol. Since consuming alcohol-containing solutions with histamine H1 receptor antagonists increases the sedative effect of the latter, suppression of consciousness and complete relaxation of the body are possible. There is a high probability of overdose and poisoning. Their joint reception is strictly prohibited.
4. Barbiturates.
5. Derivatives morphine.
6. Neuroleptics.

When using Donormil together with m-cholinergic blockers, the risk of developing side effects such as defecation disorders, a feeling of dry mouth, and urinary retention increases significantly.

special instructions

Since there can be several reasons for insomnia, you first need to determine why it occurs. This is done because there are forms of sleep disorders in which the use of the drug "Donormil" inappropriate. Doxylamine succinate is no different from other sleeping pills and can provoke an increase in attacks and duration of sleep apnea.

Patients who have a rare congenital galactose intolerance should note that one tablet "Donormil" contains 100 mg of lactose monohydrate.

When taking this medicine, it is possible drowsiness during the day, therefore driving cars and other mechanisms that require quick reactions is prohibited.

Dosing

This medicinal product is intended only for internal reception. Effervescent tablets
must first be dissolved in half a glass of water, and regular ones should simply be washed down with liquid.

Treatment "Donormil" start with half a tablet half an hour before bedtime. Over time, the dose is increased to a whole tablet, and, on the recommendation of a doctor, to 30 mg of doxylamine.

The course of treatment is mainly no more than 5 days. If your sleep does not improve during this time, you should contact your doctor. If adverse reactions occur, the use of the drug is discontinued.

Peculiarities of dosage in patients with renal and hepatic impairment

During your appointment "Donormil" its concentration in plasma increases, and plasma clearance decreases. Due to these facts, it is recommended to reduce the dose of the drug.

Prescription of Donormil for elderly patients

Because using this medicine may cause dizziness and slow reaction, as well as the possibility of falling, which is very dangerous at that age.

Therefore, the prescription of H1-histamine receptor blockers is carried out with caution and the smallest therapeutic doses of the drug are recommended "Donormil".

Overdose

During inattentive reading of the instructions or failure to follow the doctor’s recommendations, the following symptoms of an overdose of the drug “Donormil” were recorded:

1. Nausea and gagging.
2. Hyperemia facial skin.
3. Feeling dry mouth.
4. Appearance hallucinations and seizures.
5. Feeling worries, anxiety.
6. Tremor and uncontrolled movements.
7. In particular in severe cases - coma.

First of all, you need to carry out the following activities:

1. Call ambulance.
2. Rinse stomach. To do this, you need to drink enough water and induce vomiting.
3. Use adsorbent for internal use (activated carbon, Sorbex, Atoxyl)

During clinical studies, the dose of Donormil that could cause the death of a patient was not established. It follows from this that it is impossible to die from this drug. To date, no case of deliberate overdose with a fatal outcome has been identified; a person faces only very severe intoxication.

Ask your doctor about your situation

Drug price

In different pharmacies of the country the price may differ, but its average indicators are at the level 220 – 250 rubles per package.

Sleeping pill

Drug: DONORMYL

Active substance: doxylamine
ATX code: R06AA09
KFG: Sleeping pill
Reg. number: P N008683/02
Registration date: 07.10.05
Owner reg. cred.: BRISTOL-MYERS SQUIBB (France) distribution in the Russian Federation AVENTIS PHARMA (Russia)

DOSAGE FORM, COMPOSITION AND PACKAGING

Effervescent tablets white, cylindrical, flat, with beveled edges and a notch on one side; slight surface roughness is allowed; When dissolved in water, the release of gas bubbles is observed.

Excipients: sodium bicarbonate, anhydrous citric acid, anhydrous sodium hydrogen phosphate, anhydrous sodium sulfate, sodium benzoate, macrogol 6000.

10 pieces. - polypropylene tubes (2) - cardboard boxes.

DESCRIPTION OF THE ACTIVE SUBSTANCE.
The scientific information provided is general and cannot be used to make a decision about the possibility of using a particular drug.

PHARMACHOLOGIC EFFECT

Histamine H1 receptor blocker from the ethanolamine group. Has a sedative, hypnotic effect. Reduces the time to fall asleep, increases the duration and quality of sleep, does not change sleep phases. Has an antiallergic effect. Has m-anticholinergic activity.

The severity of the sedative effect is comparable to barbiturates. Duration of action - 6-8 hours.

PHARMACOKINETICS

After oral administration, Cmax in blood plasma is achieved after 2-3 hours. T1/2 is about 10 hours.

INDICATIONS

Sleep disorders, insomnia. Allergic reactions, skin itching. As a component of combination medications used for colds and coughs.

DOSING REGIME

Taken orally. Adults with insomnia and sleep disorders - 15-25 mg 15-30 minutes before bedtime. For allergic reactions - in doses of up to 25 mg every 4-6 hours.

Children aged 6-12 years - 6.25-12.5 mg if necessary - every 4-6 hours.

Maximum daily dose for adults - 150 mg.

SIDE EFFECT

Maybe: lethargy, drowsiness, dry mouth, accommodation disturbances, constipation, urination problems.

CONTRAINDICATIONS

Angle-closure glaucoma, benign prostatic hyperplasia, urinary retention, lactation period, children under 6 years of age (as an antihistamine), children and adolescents up to 15 years of age (as a sedative-hypnotic), hypersensitivity to doxylamine.

PREGNANCY AND LACTATION

Contraindicated during lactation.

SPECIAL INSTRUCTIONS

Use with caution for lung diseases.

Impact on the ability to drive vehicles and operate machinery

When treated with doxylamine (mainly when used in the daytime - for allergic reactions, itching, as part of combination drugs for the treatment of colds), it is necessary to avoid driving vehicles, as well as other activities that require rapid psychomotor reactions.

DRUG INTERACTIONS

When used simultaneously with antidepressants, barbiturates, benzodiazepines, clonidine, opioid analgesics, neuroleptics, and tranquilizers, the inhibitory effect of doxylamine on the central nervous system is enhanced.

When used simultaneously with atropine and atropine-like drugs, imipramine, antiparkinsonian drugs with anticholinergic effects, disopyramide, phenothiazine derivatives, the risk of developing anticholinergic side effects (dry mouth, constipation, urinary retention) increases.

When used simultaneously with ethanol, the sedative effect of doxylamine increases.

Drug Donormil is an antagonist of H1-histamine receptors of the ethanolamine group with an M-anticholinergic effect. Has sedative and hypnotic effects.
Reduces the time required to fall asleep; increases sleep duration, improving its quality. Does not affect sleep phases. Duration of action is from 6 to 8 hours.
Rapidly absorbed from the gastrointestinal tract, penetrates the blood-brain barrier and other histohematic barriers. Metabolism donormila occurs in the liver, metabolic products are excreted in the urine (60%) and through the intestines.

Indications for use

Sleep disorders of various etiologies, including difficulty falling asleep (insomnia).

Mode of application

Donormil take half or a whole tablet per day 15 minutes before bedtime. The effervescent tablet is dissolved in water (100 ml). The coated tablets are taken with a small amount of water. If the drug is ineffective, after consulting a doctor, you can increase the dosage to 2 tablets. If insomnia does not cure within 2-5 days, it is necessary to change the method of therapy.

Side effects

. Daytime sleepiness;
. Urinary retention;
. Dry mouth;
. Violation of accommodation (paresis);
. Constipation.

Contraindications

. Individual intolerance to doxylamine or other components of the drug;
. Angle-closure glaucoma;
. Prostate adenoma and hyperplasia (symptoms of urinary retention);
. Children under 15 years old.

Pregnancy

Donormil should not be used by nursing mothers (passes into breast milk). During pregnancy, use with caution under the supervision of a physician.

Interaction with other drugs

There is a potentiation of the inhibitory effect on the central nervous system when taken donormila with other sedatives (benzodiazepines, barbiturates, opioid analgesics, clonidine, antipsychotics, anxiolytics). The simultaneous use of apomorphine reduces its emetic effect. Such side effects of donormil, such as dry mouth and urinary retention, may increase when taking M-anticholinergics together.

Overdose

Signs of a drug overdose are: anxiety, daytime drowsiness, decreased mood, impaired coordination of movements (tremor, athetosis), mydriasis, facial hyperemia, increased body temperature, convulsive readiness and convulsions, epileptiform seizures, coma.
If such symptoms develop, the help of a doctor is required. Overdose is treated with symptomatic drugs (M-cholinomimetics).

Release form

Donormil Available in the form of effervescent tablets (15 mg each) 10 pcs. in a tube (2 tubes in a cardboard box). Film-coated tablets are available in 15 or 30 pieces. in tube and cardboard packaging.

Effervescent tablets are flat, beveled, cylindrical tablets with a notch on one side.
Film-coated tablets are white, rectangular in shape, scored on both sides. The fracture of the tablet is also white.

Storage conditions

Donormil store at a temperature not exceeding 25°C out of reach of children. The shelf life of the drug, subject to storage conditions, is 4 years (for effervescent tablets) and 5 years (coated tablets). Dispensed according to doctor's prescription.

Synonyms

Doxylamine

Compound

Active ingredient: doxylamine succinate.

Auxiliary components of the effervescent tablet: sodium bicarbonate, anhydrous citric acid, anhydrous sodium hydrogen phosphate, sodium benzoate, anhydrous sodium sulfate, macrogol 6000.

Auxiliary components of the film-coated tablet: lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, hypromellose, dispersed dye Sepispers AP 7001 (contains titanium dioxide, hypromellose, propylene glycol and purified water), macrogol 6000, purified water.

Additionally

When consumed donormila Do not take alcohol or medications containing it (increased sedation). It should be borne in mind that the ability to control complex mechanisms and the ability to quickly react mentally when taking Donormil is significantly reduced.
An auxiliary component donormila is sodium chloride (484 mg in 1 tablet), which should be taken into account if it is necessary to limit salt intake (low-salt diet).

Main settings

Name:	DONORMIL
ATX code:	R06AA09 -

The description is valid on 25.03.2018

• Latin name: Donormyl
• ATX code: N05CM
• Active substance: Doxylamine
• Manufacturer: Bristol-Myers Squibb, France. Distribution - Aventis Pharma CJSC, Russia

Compound

1 film-coated tablet contains the active substance ( ) in a volume of 15 mg; Excipients: magnesium stearate , lactose monohydrate , MCC , croscarmellose sodium . Film shell composition: macrogol 6000 , hypromellose , Seapers AR 7001 .

Release form

Effervescent tablets (2 tubes in a pack, 10 pieces in a tube), film-coated tablets (1 tube in a pack, 30 pcs in a tube).

pharmachologic effect

The medicine has a hypnotic and sedative effect.

Pharmacodynamics and pharmacokinetics

Sleeping pill Donormyl contains an active substance that is a blocker histamine H1 receptors class ethanolamines. Sleeping pills reduce the time it takes to fall asleep and increase the duration of sleep. Duration of action – up to 8 hours. In blood plasma, the maximum concentration is reached 1 hour after consumption, and the half-life from plasma averages 10 hours. 60% is excreted unchanged through the kidneys, part of the drug is excreted through the gastrointestinal tract.

Indications for use

What can Donormil tablets be mainly used for? This medicine has the following indications for use: and sleep disorder .

Contraindications for Donormil

The contraindications are as follows:

• hypersensitivity to one of the components of the drug;
• congenital galactosemia , glucose-galactose malabsorption , lactase deficiency ;
• diseases of the prostate and urethra which are accompanied by difficulty urinating.

The drug should be used with extreme caution persons over 65 years old, pregnant women And breastfeeding. Contraindications also apply drivers, because the medicine causes drowsiness and may affect your ability to drive. This insomnia medication should not be taken by children and teenagers under 16 years of age.

Side effects of Donormil

The drug Donormil has the following side effects:

• dry mouth , ;
• palpitations ;
• (in this case it is necessary to reduce the dose of the medicine consumed);
• urinary retention .

If these side effects worsen or new ones appear, you should immediately inform your doctor.

Instructions for use of Donormil (Method and dosage)

This drug should be taken orally, preferably 15-30 minutes before bedtime. Recommended dose is 7.5-15 mg per day (0.5 or 1 tablet per day). If necessary, the dose can be increased to 30 mg (2 tablets per day). Course duration is 2-5 days. If insomnia continues for more than 5 days, you should consult a specialist about the further use of sleep tablets.

Instructions for Donormil for special groups of patients:

• Patients over 65 years of age are advised to prescribe this medicine with caution, as it may slow reaction And . In this case, the dose should be reduced;
• patients with hepatic or a reduced dose is also recommended.

Donormil overdose

Overdose symptoms: drowsiness , pupil dilation , dry mouth , excitation , disturbance of accommodation , redness of the neck rut And faces , disorder of consciousness , decreased mood , spasm , .

Treatment: symptomatic, used for first aid (50 g for adults).

To date lethal dose Donormil has not been established, so in case of an overdose the patient does not face death. At the moment, not a single case of fatal overdose has been recorded in medicine; only extremely severe overdose is possible. It is impossible to take a lethal dose of sleeping pills by accident.

Interaction

In case of simultaneous use of Donormil with other sedatives, barbiturates , anxiolytics , antipsychotics , central antihypertensive drugs , baclofen , thalidomode , pizotifen the effect on the central nervous system (CNS) increases. In case of simultaneous use of the drug with m-anticholinergic drugs (antiparkinsonian drugs , disopyramide , imipramine antidepressants etc.) side effects such as constipation , urinary retention And dry mouth .

Terms of sale

In most countries, Donormil can be purchased at pharmacies without a prescription. In Russia, this drug is available only by prescription.

Storage conditions

The drug must be stored out of the reach of children and at a temperature of 15-25 °C.

Best before date

This drug can be stored for 3 years if storage conditions are met.

Donormil's analogs

Level 4 ATX code matches:

Analogues of the drug in terms of the composition of active ingredients and release form include the following drugs: sonnix . The price of analogues, depending on the form of release (depending on the number of tablets) ranges from 13 to 41 UAH.

The price of sleeping pills without a prescription, which is not an analogue of this drug, varies from 20 to 85 UAH.

Alcohol and Donormil

Alcohol enhances the sedative effect of Donormil, so it is not recommended to use this medicine simultaneously with alcoholic drinks and medications. When using the drug with alcohol, doctors' reviews are as follows: even in small doses, ethyl alcohol can enhance the effect of the drug, which will lead to an overdose.

Reviews for Donormil

Various forums give Donormil an average rating of 3.5 on a 5-point scale. Reviews of sleeping pills basically boil down to the following: the pills help for a week, then their effect wears off. When consumed irregularly in small doses, the drug works without complaints or side effects.

Reviews from doctors about Donormil: when used correctly as prescribed by the treating doctor, there will be positive dynamics in improving sleep without side effects.

There is no information about the drug Donormil on Wikipedia.

Price for Donormil, where to buy

The average price for sleep tablets in Ukraine for this drug is 53 UAH.

The price in Moscow for this medicine varies depending on the number of tablets in the package from 220 to 250 rubles.

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