Donormil® (Donormyl® )

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDoxylamineDoxylamine
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  • Valocordin®-Doxylamine
    drops inwards 
    Crevel Moiselbach GmbH     Germany
  • Donormil®
    pills inwards 
    Bristol-Myers Squibb     France
    • Dosage form: & nbsp

    The tablets covered with a cover.

    Composition:

    One tablet, film-coated, contains:

    active substance: doxylamine succinate - 15 mg;

    Excipients: lactose monohydrate - 100 mg, croscarmellose sodium - 9 mg, microcrystalline cellulose - 15 mg, magnesium stearate - 2 mg;

    composition of film shell: macrogol 6000 - 1 mg, hypromellose - 2.30 mg, Sepipers AP 7001 (hypromellose 2-4%, titanium dioxide CI 77,391 25-31%; propylene glycol 30-40%; water up to 100%) - 0.70 mg.

    Description:

    Rectangular tablets are white with a notch on both sides of the tablet. The color at the break is white.

    Pharmacotherapeutic group:antagonist of H1-histamine receptors
    ATX: & nbsp

    A.06.A.A.09   Doxylamine

    Pharmacodynamics:

    Block H1-gistaminovyh receptors from the group of ethanolamines. The drug has a hypnotic, sedative and M-anticholinergic action. Reduces the time of falling asleep, increases the duration and quality of sleep, while not changing the phase of sleep. The duration of the action is 6-8 hours.

    Pharmacokinetics:

    Maximum concentration in plasma on average is achieved 2 hours after ingestion. Half-life time - about 10 hours. Absorption is high, metabolized in the liver. Well penetrates through the histohematological barriers (including BBB). It is excreted by 60% kidneys in unchanged form, in part - through GIT.

    Pharmacokinetics of the drug in specific patient groups

    In patients older than 65 years, as well as with hepatic and renal insufficiency, the half-life can increase. When the course of treatment is repeated, the stable concentration of the drug and its metabolites in the blood plasma is reached later and at a higher level.

    Indications:Transient sleep disturbances.
    Contraindications:

    hypersensitivity to doxylamine or other components of the drug;

    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 and adolescence (up to 15 years).

    Carefully:

    Patients with cases of apnea in history - due to the fact that doxylamine succinate can aggravate the syndrome of nocturnal sleep apnea (sudden stopping of breathing in sleep). Patients over 65 years of age - due to possible dizziness and delayed reactions with a risk of falling (for example, at night awakenings after taking sleeping pills), and also in connection with a possible increase half-life; patients with renal and hepatic insufficiency (half-life may increase).

    Pregnancy and lactation:

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

    It is not known whether the doxylamine in breast milk. In connection with the possibility of developing a sedative or stimulating effect in a child, breast-feeding with the use of the drug should not be.

    Dosing and Administration:

    The recommended dose is from 1/2 to 1 tablet per day. The tablet, covered with a shell, is taken orally, squeezed with a small amount of liquid. Take 15 minutes before bedtime. If the treatment is ineffective, the dose can be increased to 2 tablets on the recommendation of the doctor. Duration of treatment from 2 to 5 days; If insomnia persists, treatment should be reviewed.

    Side effects:

    From the gastrointestinal tract: constipation, dry mouth.

    From the side of cardio-vascular system: a feeling of palpitations.

    From the side of the organ of vision: violation of accommodation.

    From the side of the kidneys and urinary tract: retention of urine.

    From the nervous system: drowsiness during the day (in this case, the dose of the drug should be reduced).

    If any of these side effects are aggravated or you notice any other side effects not listed in the instructions, tell your doctor!

    Overdose:

    Symptoms: (hypertension), sinus tachycardia, frustration of consciousness, hallucinations, decreased mood, anxiety, impaired coordination of movements , trembling (tremor), involuntary movements (athetosis), seizure (epileptic syndrome), coma. Involuntary movements are sometimes harbingers of convulsions, which may indicate a severe degree of poisoning. Even in the absence of convulsions severe poisoning with doxylamine can cause the development of rhabdomyolysis, which is often accompanied by acute renal failure.In such cases, standard therapy with continuous level control creatine phosphokinase. When symptoms of poisoning appear, you should immediately consult a doctor.

    Treatment: symptomaticincluding M-cholinomimetics, etc.), the reception of activated carbon (50 g for adults and 1 g / kg for children) is shown as a first aid.

    Interaction:With simultaneous reception of the drug Donormil® with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussives), neuroleptics, anxiolytics, sedative H1-antigistamines, central antihypertensive drugs, thalidomide, baclofen, pisotifenum, the inhibitory effect on the central nervous system increases. With simultaneous administration with M-anticholinergic agents (atropine, imipramine antidepressants, antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine antipsychotics), the risk of such side effects as urinary retention, constipation, and dry mouth increases.

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

    Special instructions:It should be taken into account that insomnia can be caused by a number of reasons, in which there is no need to prescribe this medication. Like all sleeping pills or sedatives, doxylamine succinate can aggravate the nocturnal sleep apnea (sudden stopping of breathing in sleep), increasing the number and duration of apnea attacks.

    One tablet contains 100 mg lactose monohydrate, which should be taken into account in patients with a rare congenital galactose intolerance, deficiency of lactase Lappa, or glucose-galactose malabsorption.

    Effect on the ability to drive transp. cf. and fur:In connection with the possible drowsiness during the day, you should avoid driving, working with mechanisms and other activities that require rapid mental and motor reactions.
    Form release / dosage:Tablets, film-coated, 15 mg.
    Packaging:30 tablets per polypropylene tube, sealed with a polyethylene lid. 1 tuba together with instructions for use in a cardboard box.
    Storage conditions:At a temperature of 15-25 ° C. Keep out of the reach of children.
    Shelf life:5 years. Do not use the product after the expiry date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:P N008683 / 01
    Date of registration:06.07.2010
    The owner of the registration certificate:Bristol-Myers SquibbBristol-Myers Squibb France
    Manufacturer: & nbsp
    Representation: & nbspBRISTOL-Majers SKVIBB, LLCBRISTOL-Majers SKVIBB, LLCRussia
    Information update date: & nbsp28.09.2015
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