Diazolin 50 mg

Instructions for use of Diazolin 50 mg

Proprietary name of the drug: Diazolin

International nonproprietary name: mebhydrolin

Chemical name: 2,3,4,5-tetrahydro-2-methyl-5-(phenylmethyl)-1H-pyrido[4,3-b]indole.

Dosage form: dragee

Composition per one dragee:

Description:

Dragees are white or white with a yellowish tint, spherical in shape. In cross-section, the dragee is white or white with a slightly brownish or slightly greenish tint. The surface of the dragee should be even, smooth, and uniform in color.

Pharmacotherapeutic group:

Antiallergic agent – H1-histamine receptor blocker.

ATC code: [R06AX15] 

Pharmacological properties

Pharmacological action:

H1-histamine receptor blocker. It has an anti-allergic effect and reduces swelling of the mucous membranes. It weakens the effect of histamine on the smooth muscles of the bronchi, uterus, and intestines, and reduces the severity of blood pressure decrease and increased vascular permeability. Penetrating the CNS insignificantly, unlike first-generation antihistamines, it does not have a pronounced sedative or hypnotic effect. It has weakly expressed M-cholinolytic and anesthetic properties. The therapeutic effect develops 15-30 minutes after administration, with the maximum effect observed after 1-2 hours. The duration of the effect can reach 2 days.

Pharmacokinetics:

Rapidly absorbed from the gastrointestinal tract, may cause irritation of the gastric mucosa, penetrates into all body tissues. Bioavailability ranges from 40-60%. The plasma half-life is about 4 hours. The drug practically does not cross the blood-brain barrier. It is metabolized in the liver by methylation, induces hepatic microsomal enzymes, and is excreted by the kidneys.

Indications for use:

Prevention and treatment of seasonal and allergic rhinitis, hay fever, urticaria, angioedema, allergic dermatoses accompanied by skin itching (eczema, neurodermatitis, etc.), allergic conjunctivitis, skin reaction after an insect bite.

Contraindications for use:

Hypersensitivity to the drug components, prostatic hyperplasia, closed-angle glaucoma, gastric and duodenal ulcers, other inflammatory diseases of the gastrointestinal tract, pyloric stenosis, epilepsy, cardiac arrhythmias (having a vagolytic action, it may improve atrioventricular conduction and contribute to the development of supraventricular arrhythmias), children under 3 years of age, sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Precautions for use:

Use with caution in patients with hepatic and renal insufficiency (dose adjustment and adjustment of dosing intervals may be required).

Use during pregnancy and breastfeeding:

The use of the drug during pregnancy is not recommended. Breastfeeding should be discontinued during drug administration.

Dosage and administration:

The dragees should be taken orally, without chewing, during or immediately after a meal. Adults and children from 12 years old are prescribed 100 mg 1-3 times a day. Maximum doses for adults: single – 300 mg, daily – 600 mg. Children from 3 to 5 years – 50 mg 1-2 times a day, from 5 to 10 years – 50 mg 2-3 times a day, from 10 to 12 years – 50 mg 2-4 times a day. The duration of the treatment course is determined by the nature of the disease and the therapeutic effect achieved.

Side effects:

Gastrointestinal tract: has an irritating effect on the GI mucosa, manifested by dyspeptic symptoms (heartburn, nausea, epigastric pain, etc.).

Nervous system: dizziness, paresthesia, tremor, increased fatigue, drowsiness, anxiety (at night), slowed reaction time.

Other: dry mouth, urinary retention, allergic reactions, very rarely - granulocytopenia and agranulocytosis.

In children – paradoxical reactions: increased excitability, irritability, tremor, sleep disturbance.

Overdose:

Symptoms: confusion, drowsiness, impaired coordination, depression of the central nervous system (up to coma) or stimulant effect on the central nervous system (more common in children); manifestation of anticholinergic action: dry mouth, dilated pupils, flushing of the upper body, nausea, vomiting, epigastric pain.

Treatment: drug withdrawal, gastric lavage, administration of activated charcoal, symptomatic therapy.

Interaction with other medicinal products:

Potentiates the effect of ethanol and sedatives.

Effect on ability to drive vehicles and operate machinery:

During treatment, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Pharmaceutical form

Dragees 50 mg and 100 mg

10 dragees in a contour blister pack made of polyvinyl chloride film and printed lacquered aluminum foil.

1, 2, 3, 4, 5 or 10 contour blister packs together with the instructions for use are placed in a cardboard carton.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf life

3 years 6 months. Do not use after the expiration date printed on the packaging. 

Prescription status

Over-the-counter 

Name and address of the legal entity in whose name the registration certificate is issued / organization accepting claims:

JSC "AVVA RUS", Russia, 121614,

 Moscow, Krylatskie Kholmy st., 30, building 9.

Tel/Fax: +7(495) 956-75-54.

avva.com.ru

Address of the production site:

JSC "AVVA RUS",  Russia, 610044, Kirov region, Kirov, Luganskaya st., 53a.

Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.