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International Nonproprietary Name - Hydroxyzine HCL Clinical-Pharmacological Group: Allergology → Histamine H1 Receptor Blockers → Systemic Medications → First-generation drugs Central Nervous System → Anxiolytics and Hypnotics Composition Active Substance: Hydroxyzine Hydrochloride 25mg. Excipients: Lactose Monohydrate 54.80mg, Microcrystalline Cellulose 28.00mg, Magnesium Stearate 1.50mg, Silicon Dioxide (Anhydrous) 0.70mg. Coating: Opadry® Y-1-7000 3.30mg (Titanium Dioxide 0.21mg, Hypromellose 2.06mg, Macrogol 400 1.03mg). Description White, elongated, film-coated tablets with a transverse score on both sides. Pharmacotherapeutic Group: Anxiolytic (Tranquilizer). Indications • Symptomatic treatment of anxiety in adults • As a sedative in premedication • Symptomatic treatment of pruritus of allergic origin Contraindications • Hypersensitivity to any component of the preparation, cetirizine and other piperazine derivatives, aminophylline or ethylenediamine • Porphyria • Children under 3 years of age • Pregnancy, childbirth or lactation period • Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (as the tablets contain lactose). • History of QT interval prolongation. Precautions In myasthenia gravis, prostatic hyperplasia with difficulty in urination, constipation, glaucoma, dementia, predisposition to seizures, predisposition to arrhythmias, including electrolyte imbalance (hypokalemia, hypomagnesemia) in patients with a history of heart disease or when using drugs that can cause arrhythmias. Method of Administration and Dosage Oral Children For symptomatic treatment of pruritus of allergic origin Aged 3 to 6 years: 1mg/kg per day - 2.5mg/kg/day in divided doses. Aged 6 years and older: 1mg/kg/day - 2.0mg/kg/day in divided doses. For premedication - 1mg/kg at night before anesthesia. The number of tablets is determined by the doctor based on the child's weight, according to the recommended doses. Adults For symptomatic treatment of anxiety: Standard dose 50mg per day, divided into 3 doses (½ tablet (12.5mg) in the morning, ½ tablet (12.5mg) during the day, and 1 tablet (25mg) at night). In severe cases, the dose can be increased up to 12 tablets (300mg) per day. For symptomatic treatment of pruritus of allergic origin: Initial dose 1 tablet (25mg) before bedtime, if necessary, the dose can be increased to 1 tablet (25mg) 3-4 times a day. For premedication in surgical practice: 2-8 tablets (50-200mg) at night before anesthesia. The maximum single dose for an adult should not exceed 8 tablets (200mg), the maximum daily dose should not exceed 12 tablets (300mg). Use in Special Patient Groups The dose is selected individually, depending on the patient's response to treatment, within the recommended dosage range. Use in the Elderly In elderly patients, treatment is initiated with half the dose. For symptomatic treatment of anxiety: ½ tablet (12.5mg) in the morning and ½ tablet (12.5mg) in the evening. For symptomatic treatment of pruritus of allergic origin: Initial dose ½ tablet (12.5mg) before bedtime, if necessary, the dose can be increased to ½ tablet (12.5mg) 3-4 times a day. For premedication in surgical practice: 1-4 tablets (25-100mg) at night before anesthesia. Use in Patients with Renal Impairment and Liver Dysfunction In patients with moderate to severe renal impairment, as well as liver failure, dose reduction is necessary. In patients with liver failure, a 33% reduction in the daily dose is recommended.