Medicinal Products

ATARAX 10 mg / 5 mL

Generic drug of the therapeutic class: Allergology
active ingredients: Hydroxyzine
laboratory: Ucb Pharma SA

Syrup
Bottle (+ syringe for oral administration) of 200 ml
All forms

Indication

- Minor manifestations of anxiety.
- Premedication to general anesthesia.
- Symptomatic treatment of urticaria. - In children over 3 years of age, second-line treatment of sleep insomnia related to a state of hyper-arousal (increased vigilance related to anxiety at bedtime), after failure of behavioral measures alone.

Dosage ATARAX 10 mg / 5 mL Syrup Bottle (+ syringe for oral administration) of 200 ml

Oral way.
1 ml of syrup corresponds to 2 mg of hydroxyzine dihydrochloride.
The amount of syrup will be measured using the 0, 25 ml 0.25 ml graduated oral syringe.
Dosage:
- Adult :
The average dose is 30 to 120 mg / day, ie 15 to 60 ml of syrup / day.
- Child:. In sleep insomnia in children older than 3 years, the suggested dosage is 1 mg / kg / day, and treatment will be short-term (up to 2 weeks). . In other indications in children from 30 months to 15 years :
The maximum dose is 1 mg / kg / day, depending on age and weight:
from 30 months to 6 years (10 to 20 kg) : 5 to 10 ml of syrup a day.
from 6 to 10 years (20 to 30 kg) : 10 to 15 ml of syrup a day.
from 10 to 15 years (30 to 40 kg) : 15 to 20 ml of syrup.
- These doses can be reduced by half when only a momentary effect is desired.
- Elderly, severe hepatic or renal insufficiency: it is recommended to reduce the dosage by half.
- The treatment will be short-lived.

Against indications

· Known hypersensitivity to any of the components of the drug, to any of its metabolites, to another piperazine derivative, to aminophylline, or to ethylene diamine.

· Related to the anticholinergic effect:

o risk of glaucoma by closing the angle,

o risk of urinary retention related to a urethro-prostatic disorder.

· Patients with porphyria

· Patients with acquired or congenital QT interval prolongation

Atarax side effects

The adverse effects of ATARAX are mainly related to its action on the central nervous system, its anticholinergic effects and the hypersensitivity reactions it can cause.

In placebo-controlled studies, the adverse events, regardless of their attributions, which were ≥ 1% during oral treatment with hydroxyzine were as follows:

Unwanted events

% of patients

Hydroxyzine (N = 735)

Placebo (N = 630)

Drowsiness

13.7

2.7

headaches

1.6

1.9

Tired

1, 364

0.63

Oral dryness

1.22

0.63

Adverse effects reported since marketing are:

Skin reactions

· Erythema, pruritus, eczema; very rarely: fixed pigmented erythema, generalized acute exanthematous pustulosis, erythema multiforme, bullous toxidermias including Stevens Johnson syndromes and / or Lyell syndromes.

Allergic manifestations

· Urticaria; more rarely bronchospasm, angioedema, anaphylactoid reaction.

Psychiatric effects

· Confusion, more rarely excitation, hallucinations, disorientation.

Neurological effects

· Rarely convulsions, dyskinesias, tremors, vertigo, insomnia.

Ophthalmological effects

· Accommodation disorders.

Cardiovascular effects

· Tachycardia, hypotension, prolonged QT interval on the electrocardiogram, torsade de pointe.

Hepatobiliary disorders

Not known: hepatitis, increased liver enzymes: transaminases, alkaline phosphatase, gamma-GT and bilirubin.

Gastrointestinal effects

· Constipation.

Urological effects

· urinary retention.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. www.ansm.sante.fr.

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