Instructions for Donormyl (Doxylamine) pills
English product name
Donormyl
Release form:
Coated tablets
Description:
The tablets, covered with a film shell of white color, are rectangular, with a risk on both sides.
1 tab.
doxylamine succinate 15 mg
Auxiliary substances: lactose monohydrate - 100 mg, sodium croscarmellose - 9 mg, cellulose microcrystalline - 15 mg, magnesium stearate - 2 mg.
Film sheath composition: 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.
10 pcs - polypropylene tubes (1) - cardboard packs.
30 pcs - polypropylene tubes (1) - cardboard packs.
ATC codes
R06AA09 Doxylamine
Clinical-pharmacological groups / Group affiliation
Sleeping drug Donormyl
Active substance:
doxylamine succinate
Pharmacotherapy group
Histamine H1 receptor antagonist
Storage Conditions:
The drug Donormyl should be stored in a place inaccessible to children at a temperature of 15 to 25 ° C.
Best before date
Shelf life is 3 years. Do not apply after expiry date.
Pharmacological effect:
Histamine H1 receptor blocker from the ethanol group. The drug Donormyl has a sleeping, sedative and m-cholinocentative effect. It reduces falling asleep time, improves sleep duration and quality without changing sleep phases. Duration of action - 6-8 hours.
Testimony:
transient sleep disturbances.
Method of use, course and dosage:
Inside. 1/2-1 tabb./day, flush with a small amount of liquid, 15-30 minutes before sleep. If the treatment is ineffective, the dose may be increased to 2 tabs on the doctor's recommendation.
Duration of treatment from 2 to 5 days; if insomnia persists, you should see a doctor.
Kidney and liver failure patients: Due to evidence of increased plasma concentration and decreased plasma clearance of doxylamine, a downward dose correction is recommended.
Elderly patients over 65: histamine H1 receptor blockers should be carefully prescribed to this group of patients due to possible dizziness and delayed reactions with a risk of falling (for example, during night waking after taking sleeping pills). In view of evidence of increased plasma concentration, decreased plasma clearance and increased T1/2, a downward dose correction is recommended.
Overdose:
Symptoms: daytime drowsiness, arousal, pupil dilation (midriasis), accommodation disorders, dry mouth, redness of the face and neck skin (hyperemia), fever (hyperthermia), sinus tachycardia, disorder of consciousness, hallucinations, decreased mood, anxiety, violation of coordination of movements, tremors (tremors), involuntary movements (atetosis), convulsions (epileptic syndrome), coma. Involuntary movements are sometimes a harbinger of seizures, which can indicate a severe poisoning. Even in the absence of cramps, severe doxylamine poisoning can cause the development of rhabdomyolysis, which is often accompanied by acute renal failure. In such cases, standard therapy with constant control of CFC level is shown.
If you have symptoms of poisoning, you should immediately consult a doctor.
Treatment: symptomatic (m-cholinometics, etc.), the first aid is indicated by activated carbon (50 g for adults and 1 g/kg for children).
Drug interaction Donormyl:
Simultaneously taking the drug Donormyl with sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), barbiturates, benzodiazepines, clonidine, morphine derivatives (analgesics, anti-cough preparations), neuroleptics, anxiolytics, sedative histamine H1 receptor blockers, central antihypertensive preparations, thalidomide, baclofen, pizotifen intensifies the oppressive action on the CNS.
When taken simultaneously with m-choline-blocking agents (atropine, imipramine antidepressants, antiparkinsonian drugs Donormyl, atropine spasmolytics, disopiramide, phenothiazine neuroleptics), the risk of side effects such as delayed urine, constipation, dry mouth increases.
Since alcohol increases the sedative effect of most histamine H1 receptor blockers, including Donormyl, it is necessary to avoid it at the same time
It is not known whether doxylamine penetrates breast milk. Due to the possibility of developing sedative or stimulating effects in the child should not be breastfed when using the drug Doxylamine.
Side Effect:
On the digestive side: constipation, dry mouth.
On the cardiovascular side: the feeling of a heartbeat.
From the viewpoint of: visual impairments and accommodation, blurred vision.
From the urinary system: urine delay.
From the nervous system: daytime sleepiness (in which case the dose of the drug Doxylamine should be reduced); confusion, hallucinations.
From the side of the musculoskeletal system: rabdomyolysis.
On the laboratory side: increase in CFC level.
If any of the above side effects become worse or other side effects not mentioned in the instructions appear, the patient should inform the doctor.
Contraindications for use Doxylamine:
increased sensitivity to doxylamine and other components doxylamine. Or other antihistamines;
closed-angle glaucoma of >span class="systran_space" lang="en"> eye or >span class="systran_space" lang="en"> family history of closed-angle glaucoma;
Urethra and prostate diseases, accompanied by urine disorders;
congenital galactosemia, glucose-galactic malabsorption, lactase deficiency;
Children and adolescents under >span class="systran_space" lang="en"> age of fifteen.
Use with caution: patients with anamnesis of apnea cases - because doxylamine succinate can exacerbate night apnea syndrome (sudden sleep of respiratory arrest);
patients over sixty-five years old due to possible dizziness and >span class="systran_space" lang="en"> reactions with a risk of falling (for example, during >span class="systran_space" lang="en"> night-time wakefulness after taking sleeping pills), as well as possible T1/2 increases;
Patients with kidney and liver failure T1/2 can increase
Special Instructions:
It should be taken into account that insomnia can be caused by a number of reasons, when it is not necessary to prescribe this drug Doxylamine.
The drug Doxylamine has sedative effects, suppresses cognitive abilities and slows psychomotor reactions. The first generation of histamine H1 receptor blockers may have m-cholinoblocking, α-adrenaline blocking and anti-serotonin effects, which can cause dry mouth, constipation, urine retention, accommodation and vision impairment.
Like all sleeping pills or sedatives, doxylamine succinate can exacerbate night apnea syndrome (sudden sleep respiratory arrest) - increasing the number and duration of apnea attacks.
The possible abuse of first-generation histamine H1 receptor blockers, including doxylamine, may lead to physical and psychological dependence, reported against the backdrop of deliberate use of higher doses than recommended.
One tablet contains 100 mg of monohydrate lactose, which should be taken into account in patients with rare congenital galactosis intolerance, lactase deficiency lapp or glucose-galactosis malabsorption.
Influence on the ability to control vehicles and machinery
Due to possible sleepiness during the daytime, you should avoid driving, working with mechanisms and other activities that require rapid mental and motor responses.
Application for kidney disorders
Use with caution in patients with kidney failure (T1/2 may increase).
Use in liver disorders
Use with caution in patients with liver failure (T1/2 may increase).
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 waking after taking sleeping pills).
Use in children
It is contraindicated in children and adolescents under 15 years of age.
Nosology (ICD codes)
F51.2
Sleep and wake disorders of inorganic etiology
