Diazolin for children

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DIAZOLINE FOR CHILDREN

Composition:

Active substance: mebhydrolin;

1 vial contains mebhydrolin (diazolin) 0.6 g;

5 ml of ready-made suspension contains mebhydrolin (diazolin) 0.03 g (30.0 mg);

Excipients: sugar, glycyrrhizin, povidone, sorbic acid.

Pharmaceutical form. Granules for oral suspension.

Main physico-chemical properties: granules from light cream to cream in color, with a specific odor.

Pharmacotherapeutic group. Antihistamines for systemic use.

ATC code R06AX15.

Pharmacological properties.

Pharmacodynamics. Mebhydrolin belongs to antihistamine agents and is an H1-histamine receptor blocker. Mebhydrolin reduces the spasmogenic effect of histamine on smooth muscles of bronchi and intestines, and also affects vascular permeability. It does not have pronounced sedative or hypnotic effects.

Pharmacokinetics. Rapidly absorbed from the gastrointestinal tract. Bioavailability ranges between 40–60%. Therapeutic effect develops within 15–30 minutes, with maximum effect observed within 1–2 hours. The drug practically does not penetrate the blood-brain barrier, is metabolized in the liver via methylation, induces liver enzymes, and is excreted from the body by the kidneys.

Clinical characteristics.

Indications. Prevention and treatment of seasonal allergic rhinitis, hay fever, urticaria, food and drug allergies, and dermatoses accompanied by skin itching (eczema, neurodermatitis).

Contraindications. Individual hypersensitivity to the drug. Peptic ulcer of the stomach and duodenum, other inflammatory diseases of the gastrointestinal tract, prostatic hyperplasia, closed-angle glaucoma, pylorostenosis, epilepsy, cardiac arrhythmias.

Interaction with other medicinal products and other forms of interaction. The drug potentiates the effect of medicinal products that depress the central nervous system.

Special precautions for use.

When treating young children, it is necessary to strictly adhere to dosage recommendations (psychomotor excitation is possible).

The drug should be used with caution in patients with hepatic or renal insufficiency (dose adjustment and dosing intervals may be required).

The product contains sugar. If the patient has a known intolerance to certain sugars, medical advice should be sought before taking this medicinal product.

Use during pregnancy or breastfeeding. The drug is intended for children aged 2 to 10 years.

Ability to affect reaction rate when driving or operating machinery. The drug is intended for children aged 2 to 10 years.

Method of Administration and Dosage

Before use, add 100 mL of freshly boiled warm water at a temperature between 40 °C and 50 °C to the vial containing granules, and mix for 10 minutes; after that, the suspension is ready for use. Measure the suspension dose using the graduated cup provided in the package.

For children aged 2–3 years, the dose is 2.5 mL; for children aged 4–6 years, 5 mL; for children aged 7–10 years, 7.5 mL, administered 2–3 times daily after meals. The duration of treatment is 5–7 days. The suspension must be shaken well before administration.

Children. The drug is intended for children aged 2 to 10 years.

Overdose. In case of overdose, adverse reactions listed in the relevant section occur more frequently. In such cases, discontinue the drug, administer symptomatic therapy, and, if necessary, carry out general detoxification measures (gastric lavage, forced diuresis).

Side effects.

Gastrointestinal tract: dyspeptic symptoms (heartburn, nausea, epigastric pain).

Central nervous system: dizziness, paresthesia, increased fatigue, drowsiness, blurred vision, tremor, slowed reaction time, anxiety (at night).

Other: dry mouth, urinary disturbances, allergic reactions; granulocytopenia and agranulocytosis may occur very rarely.

Paradoxical reactions such as increased excitability, irritability, tremor, and sleep disturbances may occasionally occur.

Shelf life. 3 years. The shelf life of the suspension is 7 days.

Storage conditions. Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Packaging. 9 g in a bottle with a dosing cup in a carton.

Prescription status. Over-the-counter.

Manufacturer.

Limited Liability Company "Research Plant "GNCLC".

Limited Liability Company "Pharmaceutical Company "Zdorovye".

Manufacturer's address and place of business.

Ukraine, 61057, Kharkiv region, city of Kharkiv, Vorobiova Street, building 8.

(Limited Liability Company "Research Plant "GNCLC")

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.

(Limited Liability Company "Pharmaceutical Company "Zdorovye")