Properties
What is it?
International Nonproprietary Name DIMETINDENE Active Substance DIMETHINDENE Clinical-Pharmacological Group Antihistamine, anti-allergy and anti-itch agent Composition and Dosage Form Oral drops: In a 20 ml bottle 1 ml (20 drops) – Dimetindene maleate 1 mg Excipients: Methylparahydroxybenzoate (preservative E218), ethanol, dehydro-hydrogen phosphate, sodium dihydrate, sorbitol, purified water Gel for external use: In a 30 g tube 1 g – Dimetindene maleate 1 mg Excipients: Benzalkonium chloride, sodium edetate, carbopol 974 P (carbomer 934P), propylene glycol, sodium hydroxide, purified water Indications Symptomatic treatment of allergic diseases: Urticaria Seasonal allergic rhinitis Drug and food allergies Pruritus associated with cholestasis and other skin pruritus, including in diseases accompanied by rash Insect bites The gel is used for solar erythema and superficial burns Dosage and Administration Adults and children over 12 years of age: Total daily dose: 3–6 mg (60–120 drops), divided into three doses 20–40 drops 3 times a day For patients prone to drowsiness: 40 drops before bedtime (during dinner), 20 drops in the morning Children 1–12 years of age: Doses are determined by age; frequency of administration – 3 times a day Gel: On the affected skin area 2–4 times a day Note: Drops should not be stored at high temperatures Added to infant food immediately before feeding, or can be taken diluted with a teaspoon of tea Side Effects Drops: Drowsiness (frequent, especially at the beginning of treatment) Rarely: gastrointestinal disorders, dry mouth, dizziness, headache, peripheral edema, skin rash, muscle spasms, respiratory disorders Gel: Temporary skin dryness or burning sensation Rarely: skin rash, itching In case of any unusual reaction, consult a doctor Contraindications Hypersensitivity to dimetindene and components Angle-closure glaucoma Urinary outflow disorders (e.g., prostate hypertrophy) Drops are not prescribed for infants under 1 month of age, especially premature babies First trimester of pregnancy