Instruction for use: Atarax

Dosage form: Solution for intravenous injection; Coated tablets; Film-coated tablets

Active substance: Hydroxyzine

Description of the active substance. The above scientific information is generalizing and cannot be used to decide on the feasibility of using a particular medicinal product.

Indications

Symptomatic treatment of anxiety in adults, psychomotor agitation, feelings of internal tension, increased irritability in neurological (generalized anxiety and adaptation disorder) and somatic diseases; Abstinence alcohol syndrome; Premedication and postoperative period (as part of combination therapy); Itching of allergic origin (symptomatic therapy).

Contraindications

Hypersensitivity to hydroxyzine and cetirizine, aminophylline or ethylenediamine; Porphyria; V / a, IV or SC introduction; pregnancy; The period of labor activity; lactation; Age to 1 year (with / m introduction) or 3 years (with oral administration).

Application in pregnancy and breastfeeding

Contraindicated in pregnancy and during childbirth.

For the duration of treatment, breastfeeding should be discontinued (metabolites are excreted into breast milk, see "Pharmacokinetics").

Side effects

Possible side effects are given below for body systems and frequency of occurrence.

Classification of WHO frequency of development of side effects: very often (≥1 / 10); Often (≥1 / 100, <1/10); Infrequently (≥1 / 1000, <1/100); Rarely (≥1 / 10000, <1/1000); Very rarely (<1/10000).

The most frequent adverse reactions were drowsiness, headache, blocking, dry mouth and fatigue.

From the immune system: rarely - hypersensitivity; Very rarely anaphylactic shock.

From the nervous system: very often - drowsiness; Often - headache, fatigue; Infrequently - dizziness, insomnia, tremor; Rarely - cramps, dyskinesia.

From the side of the psyche: infrequently - agitation, confusion; Rarely - hallucinations, disorientation.

From the side of the organ of vision: rarely - violation of accommodation, visual impairment.

From the heart: rarely - tachycardia; Frequency unknown - prolongation of the QT interval on the ECG, ventricular tachycardia of the "pirouette" type.

From the side of the vessels: rarely - a decrease in blood pressure.

From the respiratory system, chest and mediastinum: very rarely - bronchospasm.

From the digestive tract: infrequently - nausea; Rarely vomiting, constipation.

From the liver and biliary tract: rarely - a violation of functional liver tests; Frequency is unknown - hepatitis.

From the side of the kidneys and urinary tract: rarely - delay urination.

From the skin and subcutaneous tissues: rarely - itching, rash (erythematous, maculopapular), hives, dermatitis; Very rarely - angioedema, sweating, acute generalized exanthematous pustular eruption, erythema multiforme, Stevens-Johnson syndrome.

General disorders: rarely - hyperthermia, malaise.

In single cases, prolonged pain in the place of the IM introduction was noted.

The following side effects were observed when taking cetirizine - the main metabolite of hydroxyzine - thrombocytopenia, aggression, depression, tic, dystonia, paresthesia, oculogic crisis, diarrhea, dysuria, enuresis, asthenia, edema, weight gain and can be observed with hydroxyne.

Precautionary measures

While the use of drugs having m-anticholinergic properties and CNS depressants, hydroxyzine dose should be reduced.

Hydroxyzine can lead to a lengthening of the QT interval on the electrocardiogram, so the simultaneous use with other drugs that can disturb the heart's activity, may increase the risk of arrhythmias. It is assumed that the other drugs, which cause changes in the electrocardiogram (atropine, antiparkinsonian agents, lithium carbonate, quinidine, phenothiazines, procainamide, tricyclic antidepressants, thioridazine) can aggravate and amplify changes that may be caused Hydroxyzine, and increase the risk of sudden death. It is necessary to avoid the simultaneous use of two or more drugs prolonging the QT interval, due to the risk of additive effects, which can cause the development of potentially life-threatening severe cardiac arrhythmias.

In renal and / or liver failure, doses should be reduced.

In the elderly, the dosage should be selected individually, starting at half the minimum dose and adjusting in the recommended dosage range.

If it is necessary to set allergological tests or conduct a methacholine test, the use of hydroxyzine should be discontinued 5 days before the study to prevent the generation of distorted data.

During treatment with hydroxyzine, alcohol should be avoided.

Injectable forms of hydroxyzine are for intravenous injection only.

Impact on the ability to manage vehicles and mechanisms. Hydroxysin may impair the ability to concentrate and the speed of psychomotor reactions. The use of other sedative drugs can enhance this effect. Therefore, one should refrain from driving vehicles and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.