Name:
Donormil tablets p / o 15 mg in tubes No. 30 in pack No. 1
Description:
Tablets, film-coated, white, rectangular, with a score line on both sides. The main active ingredient Doxylamine succinate Form of release Film-coated tablets Dosage 30 pcs The drug has a sedative effect, suppresses cognitive abilities and slows down psychomotor reactions. The first generation of histamine H1 receptor blockers can have m-anticholinergic, ?-adrenergic blocking and antiserotonin effects, which can cause dry mouth, constipation, urinary retention, disturbances 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 attacks. One tablet of the drug contains 100 mg of lactose monohydrate, which should be taken into account in patients with rare congenital galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. Influence on the ability to drive vehicles and mechanisms In connection with possible drowsiness during the daytime, you should avoid driving vehicles, working with mechanisms and other activities that require quick mental and motor reactions. Pharmacological action Blocker of histamine H1 receptors from the group of ethanolamines. The drug has a hypnotic, sedative and m-anticholinergic effect. Reduces the time to fall asleep, increases the duration and quality of sleep, while not changing the phase of sleep. Duration of action – 6-8 hours. Pharmacokinetics Absorption and distribution of Cmax on average is achieved 2 hours after ingestion. Absorption is high. Metabolism and excretion It penetrates well through histohematic barriers (including the BBB). Metabolized in the liver. T1 / 2 – about 10 hours. Excreted by 60% by the kidneys unchanged, partially through the gastrointestinal tract. Pharmacokinetics in special clinical situations In patients over 65 years of age, as well as with hepatic and renal insufficiency, T1 / 2 may be prolonged. When repeating 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 for use – transient sleep disorders. Dosage and administration Inside. 1/2-1 tab./day with a small amount of liquid, 15-30 minutes before bedtime. If treatment is ineffective, on the recommendation of a doctor, the dose may be increased to 2 tablets. The duration of treatment is from 2 to 5 days; if insomnia persists, a doctor should be consulted. Patients with renal and hepatic insufficiency: in connection with data on an increase in plasma concentration and a decrease in plasma clearance of doxylamine, a dose adjustment is recommended towards a decrease. Elderly patients over 65 years of age: Histamine H1 receptor blockers should be used with caution in this group of patients due to possible dizziness and delayed reactions with the danger of falling (for example, during night awakenings after taking sleeping pills). In view of the data on an increase in plasma concentration, a decrease in plasma clearance and an increase in T1 / 2, a downward dose adjustment is recommended. 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. If this drug is prescribed 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. Due to the possibility of developing a sedative or stimulating effect in a child, breastfeeding while using the drug should not be. Precautions for patients with a history of sleep apnea – due to the fact that doxylamine succinate may aggravate sleep apnea syndrome (sudden cessation of breathing during sleep); patients over 65 years of age – due to possible dizziness and delayed reactions with the danger of falls (for example, during night awakenings after taking sleeping pills), as well as due to a possible increase in T1 / 2; patients with renal and hepatic insufficiency (T1 / 2 may increase). Interaction with other drugs While taking the drug Donormil® with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, antitussive drugs), neuroleptics, anxiolytics, blockers of histamine H1 receptors with sedative action, central antihypertensive drugs, thalidomide, baclofen, pizotifen, the inhibitory effect on the central nervous system is enhanced. When taken simultaneously with m-anticholinergics (atropine, imipramine antidepressants, antiparkinsonian drugs, atropine antispasmodics, disopyramide, phenothiazine antipsychotics), the risk of side effects such as urinary retention, constipation, dry mouth increases. Because ethanol enhances the sedative effect of most histamine H1 receptor blockers, incl. and the drug Donormil®, it is necessary to avoid its simultaneous use with alcoholic beverages and drugs containing ethanol. 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, accompanied by a violation of the outflow of urine; – congenital galactosemia, glucose-galactose malabsorption, lactase deficiency; – children and adolescents up to 15 years of age. Composition of doxylamine succinate 15 mg Excipients: lactose monohydrate – 100 mg, croscarmellose sodium – 9 mg, microcrystalline cellulose – 15 mg, magnesium stearate – 2 mg. The composition of the film shell: macrogol 6000 – 1 mg, hypromellose – 2.3 mg, Sepispers AR 7001 (hypromellose – 2-4%, titanium dioxide CI 77891 – 25-31%, propylene glycol – 30-40%, water – up to 100%) – 0.7 mg. OverdoseSymptoms: daytime sleepiness, agitation, dilated pupil (mydriasis), disturbances of accommodation, dry mouth, redness of the skin of the face and neck (hyperemia), fever (hyperthermia), sinus tachycardia, confusion, hallucinations, decreased mood, anxiety, impaired coordination of movements, trembling (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 doxylamine poisoning can cause rhabdomyolysis, which is often accompanied by acute renal failure. In such cases, standard therapy with constant monitoring of CPK levels is indicated. If symptoms of poisoning appear, you should immediately consult a doctor. Treatment: symptomatic (m-cholinomimetics, etc.), as a means of first aid, activated charcoal is indicated (in the amount of 50 g for adults and 1 g / kg of body weight for children). Side effect On the part of the digestive system: constipation, dry mouth. From the side of the cardiovascular system: palpitations. On the part of the organ of vision: visual impairment and accommodation, blurred vision. From the urinary system: urinary retention. From the side of the nervous system: daytime drowsiness (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 CPK. From the musculoskeletal system: rhabdomyolysis. If any of the above side effects worsen or other side effects appear, the patient should inform the doctor. Storage conditions The drug should be stored out of the reach of children at a temperature of 15-25°C. Buy Donormil tablets p/o 15mg №30 №1 Price for Donormil tablets p/o 15mg №30 №1
INN | DOXYLAMINE |
---|---|
The code | 15 742 |
Barcode | 3 585 553 245 834 |
Dosage | 15mg |
Active substance | doxylamine |
Manufacturer | UPSA SAS, France |
Importer | "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; ALC "Dominantafarm", Minsk, 220140 Minsk, Dombrovskaya st., 15, room 10a, room 10a-41; Closed joint-stock company "Unipharm", 223060, Minsk region, Novodvorsky s / council, 40-1, room. 36, area of the village of Bolshoye Stiklevo; Foreign unitary trade and manufacturing enterprise "Belinvestfarma", Minsk, Leshchinskogo st., 8/4-2; ODO "TISHAS", Minsk, 220028 Belarus, Minsk, Mayakovsky st., 144, room 7; LLC "LIGMATON", Republic of Belarus, Minsk region, Minsk district, Senitsky s / s, 68/3-3, Senitsa district., 223056; SOOO "Brititrade", 223021, Minsk district, Shchomyslitsky s / s, 18 |
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