Sondox®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SONDOKS® (SONDOX)

Composition:

active substance: 1 tablet contains doxylamine succinate (calculated as anhydrous substance) - 0.015 g;

excipients: magnesium stearate, lactose monohydrate, potato starch, microcrystalline cellulose.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white, round-shaped tablets with bevel and score line.

Pharmacotherapeutic group. Antihistamines for systemic use.

ATC code R06A A09.

Hypnotics and sedatives. ATC code N05C M.

Pharmacological Properties.

Pharmacodynamics.

Doxylamine succinate is an H1-histamine receptor antagonist of the ethanolamine class, exhibiting sedative and atropine-like effects. It has been demonstrated to reduce the time required to fall asleep, as well as improve sleep duration and quality.

Pharmacokinetics.

Maximum plasma concentration (Cmax) is reached on average within 2 hours (Tmax) after administration of doxylamine succinate. The average elimination half-life from plasma (T½) is approximately 0 hours. Doxylamine succinate is partially metabolized in the liver via demethylation and N-acetylation. The elimination half-life may be significantly prolonged in elderly individuals or in patients with renal or hepatic impairment. Various metabolites formed during degradation are not quantitatively significant, as 60% of the administered dose is excreted in urine in the unchanged form of doxylamine.

Clinical characteristics.

Indications.

Periodic and transient insomnia.

Contraindications.

Hypersensitivity to doxylamine succinate or to other antihistamines.

History or family history of closed-angle glaucoma. Urethroprostatic disorders with risk of urinary retention.

Restrictions for use: lung diseases.

Interaction with other medicinal products and other forms of interaction.

When used concomitantly with atropine and atropine-like medicinal products (imipramine antidepressants, anticholinergic antiparkinsonian agents, atropine spasmolytics, disopyramide, phenothiazine neuroleptics), adverse effects such as urinary retention, constipation, and dry mouth may develop.

When used concomitantly with other central nervous system depressants (morphine derivatives: analgesics; antitussives and substitution therapy agents, neuroleptics; barbiturates, benzodiazepines; anxiolytics other than benzodiazepines; sedative antidepressants: amitriptyline, doxepin, mianserin, mirtazapine, trimipramine; sedative H1-antihistamines; centrally acting antihypertensives; others: baclofen, pizotifen, thalidomide), central nervous system depression is enhanced.

Alcohol enhances the sedative effect of doxylamine.

Special precautions for use

Since the drug contains lactose, it is contraindicated in congenital galactosemia, glucose-galactose malabsorption syndrome, and lactase deficiency.

Like all hypnotic or sedative agents, doxylamine succinate may exacerbate nocturnal apnea syndrome (increasing the frequency and duration of apnea episodes). H1-antihistamines should be used with caution in elderly patients due to the risk of dizziness, which may increase the risk of falls (e.g., when getting up at night), with consequences that are often serious in this patient population.

To prevent daytime drowsiness, it is important to ensure that sleep duration after taking the drug is at least 7 hours.

Alcohol consumption should be avoided during treatment.

Impaired alertness or dizziness may occur upon waking up during the night after taking the drug.

Use during pregnancy or breastfeeding

Based on available data, doxylamine may be used during pregnancy after consultation with a physician. If the drug is administered late in pregnancy, the anticholinergic (atropine-like) and sedative properties of this molecule should be taken into account when monitoring newborns.

It is unknown whether doxylamine is excreted into breast milk; therefore, the use of the drug during breastfeeding is not recommended.

Ability to affect reaction speed when driving or operating machinery

The drug affects psychomotor reaction speed; therefore, patients should refrain from driving or operating machinery.

Dosage and Administration.

For oral use. Take 15-30 minutes before bedtime.

The recommended dose is 7.5–15 mg daily (½–1 tablet daily). If necessary, the dose may be increased to 30 mg daily (2 tablets daily).

In elderly patients and patients with renal or hepatic impairment, a lower dose is recommended.

The duration of treatment is 2–5 days. If insomnia persists for longer than 5 days, consult a physician regarding the appropriateness of continued use of the drug.

Children.

For use in children aged 15 years and older.

Overdose.

Possible only when large doses of the drug are administered.

Symptoms. The first signs of acute poisoning include drowsiness; anticholinergic effects such as dry mouth, sinus tachycardia; agitation, hallucinations, ataxia, impaired motor coordination, athetosis, and seizures. Symptoms occur in the order listed, although in some cases tremor and athetosis may be the initial manifestations of acute poisoning. Symptoms of atropinization are frequently observed—mydriasis and accommodation paralysis, facial skin hyperemia, hyperthermia. In the absence of treatment, coma with collapse may develop. Even in the absence of seizures, acute doxylamine poisoning may sometimes cause rhabdomyolysis, which can be complicated by acute kidney injury. This muscle disorder is common and requires systematic screening by measuring creatine phosphokinase activity.

Treatment. Symptomatic. In early stages of poisoning, activated charcoal is recommended (50 g for adults, 1 g/kg for children); artificial ventilation of the lungs, and administration of anticonvulsant agents should be performed.

Side effects.

Anticholinergic effects rarely develop: constipation, dry mouth, urinary retention, accommodation disturbances, tachycardia.

Daytime drowsiness: if this effect occurs, the dose should be reduced.

Allergic reactions are possible, including skin rashes, itching, Quincke's edema, drop in blood pressure.

If any adverse reactions occur, consult a physician.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in a blister pack. 1 or 3 blisters per cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and place of business.

1, Gordiyenkivska Street, Kharkiv, Kharkiv region, 61010, Ukraine.