Properties
What is it?
Trade Name Galazolini® 0.05% Galazolini® 0.1% International Nonproprietary Name Xylometazoline hydrochloride Dosage Form - Nasal drops, solution, 0.05% - Nasal drops, solution, 0.1% Composition of 1 ml: Active substance: Xylometazoline hydrochloride 0.5 mg and 1.0 mg; Excipients: Sodium phosphate x 12 H2O, Sodium dihydrogen phosphate x H2O, Sodium chloride, Sorbitol, Disodium ethylenediaminetetraacetate, Benzalkonium chloride 50%, Distilled water. Description Colorless or almost colorless, transparent liquid. Pharmacological Properties Pharmacotherapeutic group: Preparations for the treatment of nasal diseases. Sympathomimetic ATC code: R01AA07. The medicinal product contains xylometazoline hydrochloride. When applied to the nasal mucosa, it causes vasoconstriction, relieves swelling, suppresses hyperemia of the mucous membranes of the nasopharyngeal cavity, and also reduces the amount of secretion. Indications for Use The medicinal product is used for the symptomatic treatment of the following conditions: - Acute rhinitis of viral or bacterial origin; - Acute or chronic, recurrent inflammation of the nasal passages; - Allergic rhinitis; - Acute inflammation of the middle ear – to restore Eustachian tube patency. Method of Administration and Dosage Nasal drops 0.05% 1 drop contains 0.025 mg of xylometazoline hydrochloride. - Children from 4 months to 2 years: 1 drop of solution in each nostril every 8-12 hours. - Children from 2 to 12 years: Usually 2-3 drops of solution in each nostril every 8-10 hours. Nasal drops 0.1% 1 drop contains 0.05 mg of xylometazoline hydrochloride. - Children over 12 years of age and adults: Usually 2-3 drops in each nostril every 8-10 hours. The duration of treatment should not exceed 7 days, and continuation of treatment for more than 2 weeks is strictly contraindicated. Side Effects Local: - Burning sensation - Unpleasant sensation of dryness of the nasal mucosa - Sneezing - Reactive hyperemia. Other: - Tachycardia - Increased blood pressure Very rarely: - Restlessness, insomnia, fatigue, headache, nausea. Contraindications - Hypersensitivity to the components of the preparation - Glaucoma with narrow-angle of the anterior chamber of the eye - Increased intraocular pressure - Atrophic rhinitis - Arterial hypertension - Severe atherosclerosis - Tachycardia - Hyperthyroidism - Conditions after surgical operations involving opening of the dura mater - Children under 4 months of age