Composition, form of production and packaging
The tablets, covered with a film shell of white color, are rectangular, with a risk on both sides.
doxylamine succinate 15 mg
Excipients: lactose monohydrate - 100 mg, croscarmellose sodium - 9 mg, microcrystalline cellulose - 15 mg, magnesium stearate - 2 mg.
Composition of the film coat: macrogol 6000 - 1 mg, hypromellose 2.3 mg, Sepipers AP 7001 (hypromellose - 2-4%, titanium dioxide CI 77891 - 25-31%, propylene glycol 30-40%, water up to 100%) - 0.7 mg.
30 pcs. - polypropylene tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
The blocker of histamine H 1 -receptors from the group of ethanolamines. The drug has a hypnotic, sedative and m-cholinoblocking action. Reduces the time of falling asleep, increases the duration and quality of sleep, while not changing the phase of sleep. The duration of action is 6-8 hours.
Suction and distribution
C max is achieved on average within 2 hours after ingestion. Absorption is high.
Metabolism and excretion
Well penetrates through the histohematological barriers (including GEB). Metabolised in the liver. T 1/2 - about 10 hours. It is excreted by 60% kidneys in an unchanged form, partially through the digestive tract.
Pharmacokinetics in special clinical cases
In patients older than 65 years, as well as with liver and kidney failure, T 1/2 may lengthen.
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.
- transient sleep disturbances.
Inside. 1 / 2-1 tablets / 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 tab.
Duration of treatment from 2 to 5 days; If insomnia persists, you need to see a doctor.
Patients with renal and hepatic insufficiency: in connection with the data on the increase in plasma concentration and the decrease in plasma clearance of doxylamine, a dose correction is recommended in the direction of decreasing.
Patients older than 65 years: blockers of histamine H 1 -receptors should be cautiously assigned to this group of patients due to possible dizziness and delayed reactions with a risk of falling (for example, during night awakenings after taking sleeping pills). In view of the data on the increase in plasma concentration, the decrease in plasma clearance and the increase in T 1/2 , dose correction is recommended in the direction of decrease.
From the digestive system: constipation, dry mouth.
From the cardiovascular system: a feeling of heartbeat.
From the side of the organ of vision: visual impairment and accommodation, unclear vision.
From the urinary system: urinary retention.
From the side of the nervous system: drowsiness during the day (in this case the dose of the drug should be reduced); confusion, hallucinations.
On the part of laboratory indicators: an increase in the level of CK.
From the musculoskeletal system: rhabdomyolysis.
If any of the above side effects are aggravated or other side effects occur, the patient should inform the doctor.
- hypersensitivity to doxylamine and other components of the drug, or to other antihistamines;
- an 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, deficiency of lactase;
- Children and adolescence up to 15 years.
With caution: 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 the risk of falls (for example, during night awakenings after taking sleeping pills), and also in connection with a possible increase in T 1/2 ; patients with renal and hepatic insufficiency (T 1/2 may increase).
PREGNANCY AND LACTATION
Based on adequate and well-controlled studies, doxylamine can be used in pregnant women throughout 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 doxylamine penetrates into breast milk. In connection with the possibility of developing a sedative or stimulating effect in a child, breast-feeding with the drug should not be.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in patients with renal insufficiency (T 1/2 may increase).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution patients with hepatic insufficiency (T 1/2 may increase).
APPLICATION FOR CHILDREN
Contraindicated in children and adolescents under 15 years.
APPLICATION IN ELDERLY PATIENTS
With caution: patients over 65 years of age - due to possible dizziness and delayed reactions with a risk of falling (for example, during night awakenings after taking sleeping pills).
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.
The drug has a sedative effect, suppresses cognitive abilities and slows down the psychomotor reactions. The first generation of histamine H 1 -receptor blockers can cause m-cholinoblocking,? -adrenoblocking and antiserotonin effects, which can cause dry mouth, constipation, urinary retention, accommodation and vision disorders.
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, lactase deficiency lapp or glucose-galactose malabsorption.
Impact on the ability to drive vehicles and mechanisms
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.
Symptoms: daytime sleepiness, excitement, dilated pupil (mydriasis), accommodation disorders, dry mouth, redness of the face and neck skin (hyperemia), fever (hyperthermia), sinus tachycardia, frustration, hallucinations, mood reduction, anxiety, impairment coordination of movements, trembling (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 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 constant control of the level of CK is shown.
When symptoms of poisoning appear, you should immediately consult a doctor.
Treatment: symptomatic (m-holinomimetiki, etc.), as a first aid is shown the reception of activated charcoal (in the amount of 50 g for adults and 1 g / kg of body weight for children).
With the simultaneous administration of Donomil В® with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussive drugs), neuroleptics, anxiolytics, histamine H 1 receptor blockers with sedative action, central antihypertensive drugs, thalidomide, baclofen, pisotifenum, the inhibitory effect on the central nervous system increases.
With simultaneous administration with m-holinoblokiruyuschimi means (atropine, imipramine antidepressants, antiparkinsonics, atropine antispasmodics, disopyramide, phenothiazine antipsychotics), the risk of such side effects as urinary retention, constipation, and dry mouth increases.
Because Ethanol enhances the sedative effect of most blockers of histamine H 1 -receptors, including. and drug Donormil В® , it is necessary to avoid its simultaneous use with alcoholic beverages and medicines containing ethanol.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of 15-25 В° C. Shelf life - 3 years.