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 products used for colds, coughs.

Active ingredient

Composition

1 tablet contains:

the active ingredient: doxylamine succinate 15 mg;

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

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

How to take, the dosage

It is taken orally. Adults with insomnia, sleep disorders – 15-25 mg 15-30 minutes before sleep.

In allergic reactions – in doses up to 25 mg every 4-6 hours.

In children aged 6-12 years, 6.25-12.5 mg every 4-6 hours if necessary.

The maximum daily dose for adults is 150 mg.

Interaction

In concomitant use with antidepressants, barbiturates, benzodiazepines, clonidine, opioid analgesics, neuroleptics, tranquilizers the CNS inhibitory effect of doxylamine is increased.

Concomitant use with atropine and atropine-like agents, imipramine, antiparkinsonian agents with anticholinergic action, disopyramide, phenothiazine derivatives increases the risk of anticholinergic side effects (dry mouth, constipation, urinary retention).

Concomitant use with ethanol increases the sedative effect of doxylamine.

Special Instructions

It should be taken into account that insomnia may be caused by a number of reasons for which this medication is not necessary.

Reslip® has a sedative effect, suppresses cognitive abilities, and slows psychomotor reactions. First generation H1-antihistamine drugs may have m-cholin-blocking, anti-alpha-adrenergic, and antiserotonin effects, which may cause dry mouth, constipation, urinary retention, accommodation, and visual disturbances.

Like all sleeping pills or sedatives, doxylamine can aggravate nocturnal apnea syndrome (sudden respiratory arrest in sleep) by increasing the number and duration of apnea attacks.

The drug contains 50 mg of lactose monohydrate per tablet, which should be considered in patients with rare congenital galactose intolerance Lapp lactase deficiency or glucose-galactose malabsorption.

Influence on driving and operating ability

With regard to possible drowsiness during daytime, driving, operating machinery and other activities requiring increased concentration and rapid psychomotor reactions should be avoided.

Contraindications

Hypersensitivity to doxylamine and other components of the drug, or to other antihistamines; closed angle glaucoma or family history of closed angle glaucoma; urethral and prostate diseases accompanied by impaired urine flow; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; childhood and adolescence

Side effects

Gastrointestinal tract: constipation, dry mouth.

Cardiovascular system disorders: palpitations.

Visual system disorders: visual and accommodation disorders, blurred vision.

Nervous system disorders: daytime sleepiness (in this case the drug dose should be reduced), confusion, hallucinations.

Renal and urinary tract disorders: urinary retention.

Laboratory findings: increased levels of creatine phosphokinase.

Musculoskeletal disorders: rhabdomyolysis.

If any of the adverse reactions listed in the instructions worsen, or if you notice any other adverse events not listed in the instructions, tell your doctor.

Overdose

Symptoms: Daytime drowsiness, agitation, dilated pupils (mydriasis), accommodation disorders, dry mouth, redness of the face and neck skin (hyperemia), increased body temperature (hyperthermia), sinus tachycardia, impaired consciousness, hallucinations, reduced mood, anxiety, movement coordination disorders, tremors (tremor), involuntary movements (athetosis), convulsions (epileptic syndrome), coma.

The involuntary movements are sometimes precursors to seizures, which may indicate a severe degree of poisoning. Even in the absence of seizures severe doxylamine poisoning may cause development of rhabdomyolysis, which is often accompanied by acute renal failure. In such cases, standard therapy with continuous monitoring of creatine phosphokinase level is indicated.

In case of symptoms of poisoning, seek medical attention immediately.

The treatment: symptomatic (m-cholinomimetics, etc.), as a first aid measure activated charcoal is indicated (50 g – for adults and 1 g/kg body weight for children).

Pregnancy use

On the basis of adequate and well-controlled studies, docosilamine can be used in pregnant women throughout pregnancy.

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

Similarities