Reslip, 15 mg 30 pcs.

Pharmacotherapeutic group: H1-histamine receptor antagonist.

TAC code: R06AA09.

Pharmacological properties

Pharmacodynamics:

A H1-histamine receptor blocker from ethanolamine group. It has hypnotic, antihistaminic, sedative and m-cholinoblocking effects. It shortens time of falling asleep, increases duration and quality of sleep, does not change the phase of sleep. Duration of action – 6-8 hours.

Pharmacokinetics:

After oral administration doxylamine is quickly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentration is determined on average 2 h after oral administration. It is metabolized in the liver. It penetrates well through histohematic barriers, including the blood-brain barrier. Excreted 60% by the kidneys unchanged, partially – through the gastrointestinal tract. The half-life of doxylamine is about 10 hours.

The pharmacokinetics of the drug in special groups of patients:

In patients over 65 years of age and in hepatic and renal insufficiency, the half-life may be prolonged. With repeated courses of treatment, stable plasma concentrations of the drug and its metabolites are reached later and at higher levels.

Indications

Sleep disorders, insomnia.

Allergic reactions, skin itching.

As a component of combination drugs used for colds and coughs.

Pharmacological effect

Pharmacotherapeutic group: H1-histamine receptor antagonist.

ATX code: R06AA09.

Pharmacological properties

Pharmacodynamics:

H1-histamine receptor blocker from the ethanolamine group. It has a hypnotic, antihistamine, sedative and m-anticholinergic effect. Reduces the time to fall asleep, increases the duration and quality of sleep, does not change sleep phases. Duration of action – 6-8 hours.

Pharmacokinetics:

After oral administration, doxylamine is quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is determined on average 2 hours after oral administration. Metabolized in the liver. Penetrates well through histohematic barriers, including the blood-brain barrier. 60% is excreted unchanged by the kidneys, partially through the gastrointestinal tract. The half-life of doxylamine is approximately 10 hours.

Pharmacokinetics of the drug in special groups of patients:

In patients over 65 years of age, as well as with hepatic and renal insufficiency, the half-life may be prolonged. When repeated courses of treatment, a stable concentration of the drug and its metabolites in the blood plasma is achieved later and at a higher level.

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 Reslip® has a sedative effect, suppresses cognitive abilities and slows down psychomotor reactions. The first generation of H1-antihistamines can have m-anticholinergic, anti-alpha-adrenergic and antiserotonin effects, which can cause dry mouth, constipation, urinary retention, disturbances of accommodation and vision.

Like all sleeping pills or sedatives, doxylamine may worsen sleep apnea (sudden stoppage of breathing during sleep), increasing the number and duration of apnea attacks.

One tablet of the drug contains 50 mg of lactose monohydrate, which should be taken into account in patients with rare congenital galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Impact on the ability to drive vehicles and machinery

Due to possible drowsiness during the daytime, you should avoid driving vehicles, operating machinery and other activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Doxylamine

Composition

1 tablet contains:

active ingredient: doxylamine succinate 15 mg;

excipients: lactose monohydrate 50.0 mg, colloidal silicon dioxide (Aerosil) 0.5 mg, microcrystalline cellulose 27.7 mg, croscarcellose sodium 5.0 mg, povidone 0.8 mg, magnesium stearate 1.0 mg.

excipients for the shell: hypromellose (hydroxypropyl methylcellulose) 1.8 mg, macrogol 6000 (polyethylene glycol 6000) 0.6 mg, titanium dioxide 0.6 mg.

Pregnancy

Based on adequate and well-controlled studies, doxylamine can be used in pregnant women throughout pregnancy.

The use of Reslip® during breastfeeding is contraindicated. If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Contraindications

Hypersensitivity to doxylamine and other components of the drug, or to other antihistamines; angle-closure glaucoma or family history of angle-closure glaucoma; diseases of the urethra and prostate gland, accompanied by impaired urine outflow; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; children and adolescents up to 15 years of age.

With caution

Patients with a history of apnea – due to the fact that doxylamine can aggravate sleep apnea syndrome (sudden cessation of breathing during sleep).

Patients over 65 years of age – due to possible dizziness and delayed reactions and the risk of falls (for example, when waking up at night after taking sleeping pills), as well as due to a possible increase in the half-life.

Patients with renal and hepatic insufficiency (half-life may increase).

Side Effects

From the gastrointestinal tract: constipation, dry mouth.

From the cardiovascular system: palpitations.

From the organ of vision: visual impairment and accommodation, blurred vision.

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

From the kidneys and urinary tract: urinary retention.

From laboratory parameters: an increase in the level of creatine phosphokinase.

From the musculoskeletal system: rhabdomyolysis.

If any of the adverse reactions indicated in the instructions worsen or you notice any other adverse effects not listed in the instructions, notify your doctor.

Interaction

When used simultaneously with antidepressants, barbiturates, benzodiazepines, clonidine, opioid analgesics, neuroleptics, and tranquilizers, the inhibitory effect of doxylamine on the central nervous system is enhanced.

When used simultaneously with atropine and atropine-like drugs, imipramine, antiparkinsonian drugs with anticholinergic effects, disopyramide, phenothiazine derivatives, the risk of developing anticholinergic side effects (dry mouth, constipation, urinary retention) increases.

When used simultaneously with ethanol, the sedative effect of doxylamine increases.

Overdose

Symptoms: daytime drowsiness, agitation, dilated pupils (mydriasis), accommodation disturbances, dry mouth, redness of the skin of the face and neck (hyperemia), increased body temperature (hyperthermia), sinus tachycardia, disorder of consciousness, 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 creatine phosphokinase levels is indicated.

If symptoms of poisoning appear, consult a doctor immediately.

Treatment: symptomatic (m-cholinomimetics, etc.), activated carbon is indicated as a first aid remedy (50 g for adults and 1 g/kg body weight for children).

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiration date stated on the package.

Manufacturer

Alium JSC, Russia