Medicinal Products

ATARAX 100 mg / 2 mL Solution for injection (SC, IM, IV) Box of 100 ampoules of 2 ml

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Hydroxyzine
laboratory: Ucb Pharma SA

Injection solution (SC, IM, IV)
All forms

Indication

- Minor manifestations of anxiety.
- Premedication to general anesthesia.

Dosage ATARAX 100 mg / 2 mL Solution for injection (SC, IM, IV) Box of 100 ampoules of 2 ml

RESERVED FOR THE ADULT.
- Adult: 1 to 3 ampoules a day.
- Elderly, severe hepatic or renal insufficiency: it is recommended to reduce the dosage by half.
- IM channel preferably.
- Strict IV following dilution in at least 10 ml of saline: it is recommended to inject the product very slowly. The product can be administered as an infusion after dilution in a 100 ml vial (see section on warnings and precautions for use).
- The treatment will be short-lived.

Against indications

CONTRAINDICATED:
- Known hypersensitivity to one of the constituents of the drug, to one of its metabolites, to another derivative of piperazine, to aminophylline, or to ethylene diamine.
- Intra-arterial administration (risk of thrombophlebitis or tissue necrosis).
- Related to the anticholinergic effect :
. risk of glaucoma by closing the angle,
. risk of urinary retention related to a urethroprostatic disorder.
NOT RECOMMENDED :
- The use of ATARAX subcutaneously is not recommended. It should only be used in exceptional circumstances where the oral routes, IM and IV are unusable.
- The administration of ATARAX is not recommended for patients with cognitive or confounding disorders because of the risk of aggravation due to the pharmacodynamic properties of the product.
- Breast-feeding: In the absence of data on the passage of hydroxyzine in breast milk, and given the sedative and atropine properties of this substance, breastfeeding is not recommended during treatment with hydroxyzine.
- Patients should be advised against the absorption of alcoholic beverages during treatment.

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, statistically more frequent adverse events with intramuscular hydroxyzine were as follows:
IM Hydroxyzine (N = 367) / Placebo (N = 306) .
. Injection site pain: 22.1% / 8.2%.
. Oral dryness: 10.9% / 2.6%.
. Drowsiness: 9.3% / 2.9%.
Adverse effects reported since marketing are:
- Skin reactions:
erythema, pruritus, eczema; very rarely fixed pigmented erythema.
- Allergic manifestations:
urticaria; more rarely bronchospasm, angioedema, anaphylactoid reaction.
- Psychiatric effects:
confusion, more rarely excitation, hallucinations, disorientation, insomnia.
- Neurological effects:
drowsiness, more rarely convulsions, dyskinesias, tremor, vertigo.
- Ophthalmological effects:
disturbances of accommodation.
- Cardiovascular effects:
tachycardia, hypotension.
- Gastrointestinal effects:
dry mouth, constipation.
- Urological effects:
urinary retention.
- Other:
Thrombophlebitis and tissue necrosis (see section on warnings and precautions for use).

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