What is ATARAX 25MG Film-coated tablet used for?

Atarax is indicated for: symptomatic treatment of anxiety in adults aged 18 years and over; symptomatic treatment of pruritus in adults, adolescents, and children aged 6 years and over.

What pharmaceutical form is ATARAX 25MG Film-coated tablet available in?

ATARAX 25MG Film-coated tablet: Tabletki powlekane 25 mg

What are the side effects of ATARAX 25MG Film-coated tablet?

Clinical trials Overview Adverse reactions are primarily associated with CNS depressant effects or paradoxical CNS stimulation, anticholinergic effects, or hypersensitivity reactions. List of adverse reactions Oral administration of hydroxyzine: The table below lists adverse reactions reported in placebo-controlled clinical trials with an incidence of at least 1% following hydroxyzine administration. The trials included 735 subjects treated with hydroxyzine at doses up to 50 mg

Who should NOT take ATARAX 25MG Film-coated tablet?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, to cetirizine, other piperazine derivatives, aminophylline, or ethylenediamine Porphyria Patients with known acquired or congenital QT prolongation Patients with known risk factors for QT prolongation, including known cardiovascular disease, significant electrolyte imbalance (hypokalaemia, hypomagnesaemia), family history of sudden cardiac death, significant bradycardia, and concomitant

Does ATARAX 25MG Film-coated tablet interact with other medications?

Potentiation of the effects of hydroxyzine should be considered when the medicinal product is used concomitantly with CNS depressants and substances with anticholinergic properties. In such cases, individual dose adjustment is required. Alcohol also potentiates the effects of hydroxyzine. Hydroxyzine antagonises the effects of betahistine and cholinesterase inhibitors. Treatment should be discontinued at least 5 days before allergy testing or a methacholine bronchial provocatio

Can ATARAX 25MG Film-coated tablet be used during pregnancy?

Fertility No relevant clinical data are available on the effect of hydroxyzine on human fertility. Women of childbearing potential should use effective contraception during treatment with hydroxyzine. Pregnancy Animal studies have shown reproductive toxicity. Hydroxyzine crosses the placental barrier, and fetal concentrations are higher than maternal concentrations. Currently, no relevant epidemiological data are available regarding the use of hydroxyzine during pregnancy. Hydr

What ATC class does ATARAX 25MG Film-coated tablet belong to?

ATARAX 25MG Film-coated tablet: ATC N05BB01. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

ATARAX 25MG Film-coated tablet

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: anxiolytics, diphenylmethane derivatives ATC code: N05BB01 The active substance hydroxyzine dihydrochloride is a diphenylmethane derivative that is chemically distinct from phenothiazines, reserpine, meprobamate, or benzodiazepines. Mechanism of action Hydroxyzine dihydrochloride does not depress cortical activity; rather, its effect is due to suppression of activity in certain key areas of the subcortical region of the central nervous system. Pharmacodynamic effects Antihistaminic and bronchodilatory effects have been demonstrated experimentally and confirmed clinically.‍‍‍‍‍‍‍ The antiemetic effect has been confirmed by the apomorphine and veriloid tests. Pharmacological and clinical studies indicate that hydroxyzine at therapeutic doses does not increase gastric secretion or acidity, and in most cases has a mild antisecretory effect. Following intradermal administration of histamine or antigens, a reduction in wheal and flare response has been demonstrated in healthy adult volunteers and in children. Hydroxyzine also effectively relieves pruritus in various forms of urticaria, eczema, and dermatitis. In cases of hepatic impairment, the antihistaminic effect of a single dose may persist for up to 96 hours after administration. EEG recordings in healthy volunteers demonstrate anxiolytic and sedative effects. The anxiolytic effect has been confirmed using various standardised psychometric tests. Polysomnographic recordings in patients with anxiety and insomnia showed an increase in total sleep time, a decrease in total nocturnal wakefulness, and a reduction in sleep onset latency either after a single dose or after repeated daily doses of 50 mg. In anxious patients, a dose of 50 mg three times daily resulted in decreased muscle tension. No memory impairment was observed. After completion of a 4-week course of treatment in patients with anxiety, no withdrawal symptoms were reported. Onset of action The antihistaminic effect begins approximately 1 hour after oral administration. Sedative effects appear 30–45 minutes after administration of the tablets. Hydroxyzine also has spasmolytic and sympatholytic effects. It has a weak affinity for muscarinic receptors. Hydroxyzine also exhibits mild analgesic activity.

⚠️ Warnings

Hydroxyzine should be used with caution in patients with an increased risk of convulsions. Young children are more susceptible to developing adverse effects on the central nervous system (see section 4.8).‍‍‍‍‍‍‍ Convulsions are also reported more frequently in children than in adults. Hydroxyzine has anticholinergic effects. Therefore, caution is required when administering it to patients with glaucoma, urinary tract obstruction, decreased gastrointestinal motility, myasthenia gravis, or dementia. When hydroxyzine is administered concomitantly with other CNS depressants or medicinal products with anticholinergic properties, dosage adjustment is required (see section 4.5). Alcohol should not be consumed during treatment with hydroxyzine (see section 4.5). QT prolongation Hydroxyzine has been associated with QT prolongation on the ECG. Cases of QT prolongation and torsade de pointes have been reported during post-marketing surveillance in patients taking hydroxyzine. Most of these patients had other risk factors, electrolyte abnormalities, and concomitant medications that may have contributed (see section 4.8). Hydroxyzine should be used at the lowest effective dose for the shortest possible duration. Treatment with hydroxyzine must be discontinued if signs and symptoms that may be associated with cardiac arrhythmia occur, and the patient must seek immediate medical attention. Patients must be advised to report any cardiac symptoms immediately. Elderly patients The use of hydroxyzine in elderly patients is not recommended due to reduced elimination of hydroxyzine in this population compared with adult patients and the increased risk of adverse effects (e.g. anticholinergic effects) (see sections 4.2 and 4.8). In elderly patients, it is recommended to start treatment at half the recommended dose due to the prolonged duration of action (see section 4.2). Hepatic and renal impairment In patients with hepatic impairment or moderate to severe renal impairment, the usual daily dose should be reduced (see section 4.2). The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

ATARAX 25MG Film-coated tablet

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