Donormyl coated pills 15mg N30
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Active ingredients
Doxylamine
Release form
Pills
Composition
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 AP 7001 (hypromellose - 2-4%, titanium dioxide CI 77891 - 25-31%, propylene glycol - 30-40%, water - up to 100%) - 0.7 mg.
Pharmacological effect
Histamine H1 receptor blocker 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
The absorption and distribution of Cmax is achieved on average 2 hours after ingestion. Absorption is high. Metabolism and excretion Well penetrates histohematogenous barriers (including BBB). Metabolized in the liver. T1 / 2 - about 10 hours. Produced at 60% by the kidneys unchanged, in part through the gastrointestinal tract. Pharmacokinetics in special clinical situations In patients over 65 years of age, as well as in hepatic and renal failure, T1 / 2 may be extended. By repeating the treatment courses, 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.
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 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 depression 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), 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.
Dosage and administration
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 insufficiency: In connection with the data on the increase in plasma concentration and a decrease in the plasma clearance of doxylamine, dose adjustment in the direction of reduction is recommended. Elderly patients over 65: histamine H1 receptor blockers should be used with caution in this group of patients due to possible dizziness and delayed reactions with danger of falling (for example, during night awakenings after taking sleeping pills). Due to the increase in plasma concentration, a decrease in plasma clearance and an increase in T1 / 2, a downward dose adjustment is recommended.
Side effects
On the part of the digestive system: constipation, dry mouth. Since the cardiovascular system: palpitations. On the part of the organ of vision: visual impairment and accommodation, blurred vision. On the part of the urinary system: urinary retention. On the part of the nervous system: daytime sleepiness (in this case, the dose of the drug should be reduced); confusion, hallucinations. From the laboratory indicators: an increase in the level of CPK. On the part of the musculoskeletal system: rhabdomyolysis. If any of the above side effects are exacerbated or other side effects appear, the patient should inform the doctor.
Overdose
Symptoms: daytime sleepiness, agitation, pupil dilation (mydriasis), accommodation disturbances, dry mouth, reddening of the skin of the face and neck (hyperemia), increased body temperature (hyperthermia), sinus tachycardia, disorder of consciousness, hallucinations, decreased mood, anxiety, disturbance 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 administration of activated carbon is shown (in the amount of 50 g for adults and 1 g / kg of body weight for children).
Interaction with other drugs
While taking the drug Donormyl with sedatives drugs, thalidomide, baclofen, pizotifenom increases 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 H1 receptor blockers, including and the drug Donormyl, it is necessary to avoid its simultaneous use with alcoholic beverages and drugs containing ethanol.
special instructions
It should be taken into account 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 H1 receptor blockers can have m-anticholinergic, α-adreno-blocking and anti-serotonin effects, which can cause dry mouth, constipation, urinary retention, accommodation and vision problems. 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 tablet 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. Impact on the ability to drive vehicles and mechanisms In connection with the possible drowsiness in the daytime, it is necessary to avoid driving vehicles, working with mechanisms and other activities that require quick mental and motor responses.