ATARAX Film-coated tablet Ref.[7284] Active ingredients: Hydroxyzine

When prescribing the syrup, the dose should be expressed in volume (ml) rather than weight (mg). The quantity of oral solution should be measured with an oral syringe with a scale which indicates 0.25 ml.

Posology

Atarax should be used at the lowest effective dose and for the shortest possible duration.

Adults

For symptomatic treatment of anxiety in adults from 18 years of age:

50 mg/day in 3 separate administrations of 12.5 mg, 12.5 mg, 25 mg. It is at the discretion of the prescriber whether a larger dose should be taken in the evening. In more severe cases doses of up to 100 mg/day can be used. The maximum daily dose is 100 mg per day.

For symptomatic treatment of pruritus in adults, 18 years of age:

Starting dose of 25 mg up to 1 hour before going to bed, to be followed if necessary with doses up to 25 mg 3 to 4 times daily.

In adults, the maximum daily dose is 100 mg per day.

Special population

The dosage should be adapted within the recommended dose range, according to patient's response to treatment.

Elderly

It is recommended to initiate treatment with half the recommended dose due to prolonged effect. The lowest possible dose should be chosen when treating the elderly. The maximum daily dose for the elderly is 50 mg/day (see section 4.4).

Patients with hepatic impairment

In patients with hepatic dysfunction, it is recommended to reduce the daily dose by 33%.

Patients with renal impairment

Dosage should be reduced in patients with moderate or severe renal function impairment due to decreased excretion of its metabolite cetirizine.

Refer to the following table and adjust the dose as indicated.

Dosing Adjustments for Adult Patients with Impaired Renal Function:

Paediatric population (Children from 12 months)

Atarax film-coated tablets are not recommended in children under 6 years as they may not be able to swallow tablets.

Other pharmaceutical forms such as Atarax oral solution may be more appropriate for administration to children from 12 months of age or patients that cannot swallow tablets.

The safety and efficacy of Atarax in children aged below 12 months has not been established. No data is available.

For symptomatic treatment of pruritus:

In children from 12 months: 1 mg/kg/day up to 2 mg/kg/day in divided doses.

In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day. In children over 40 kg in weight, the maximum daily dose is 100 mg/day.

Method of administration

Oral use.

The quantity of syrup will be measured with a syringe graduated in 0.25 ml for oral administration.

Symptoms observed after an important overdose are mainly associated with excessive anticholinergic load, CNS depression or CNS paradoxical stimulation. They include, nausea, vomiting, tachycardia, pyrexia, somnolence, impaired papillary reflex, tremor, confusion, or hallucination. This may be followed by depressed level of consciousness, respiratory depression, convulsions, hypotension, or cardiac arrythmia including bradycardia. Deepening coma and cardiorespiratory collapse may ensue.

Airway, breathing and circulatory status must be closely monitored with continuous ECG recording and an adequate oxygen supply should be available. Cardiac and blood pressure monitoring should be maintained until the patient is free of symptoms for 24 hours. Patients with altered mental status should be checked for simultaneous intake of other drugs or alcohol and should be given oxygen, naloxone, glucose, and thiamine if deemed necessary.

Norepinephrine or metaraminol should be used if vasopressor is needed. Epinephrine should not be used.

Syrup of ipecac should not be administered in symptomatic patients or those who could rapidly become obtunded, comatose or convulsing, as this could lead to aspiration pneumonitis. Gastric lavage with prior endotracheal intubation may be performed if a clinically significant ingestion has occurred. Activated charcoal may be left in the stomach but there are scant data to support its efficacy. It is doubtful that hemodialysis or hemoperfusion would be of any value. There is no specific antidote. Literature data indicate that, in the presence of severe, life-threatening, intractable anticholinergic effects unresponsive to other agents, a therapeutic trial dose of physostigmine may be useful. Physostigmine should not be used just to keep the patient awake. If cyclic antidepressants have been coingested, use of physostigmine may precipitate seizures and intractable cardiac arrest. Also avoid physostigmine in patients with cardiac conduction defects.

The medicinal product as packaged for sale:

25 mg film-coated tablet: 5 years.

Syrup: 2 years.

The medicinal product as packaged for sale:

25 mg film-coated tablet: Do not store above 25ºC and keep blister in the outer carton.

Syrup: Do not store above 25ºC and keep container in the outer carton.

The medicinal product must be kept inside the outer carton because of the sensitivity to light of hydroxyzine dihydrochloride.

Atarax 25 mg Film-coated tablets: The film-coated tablets are packed in thermoformed PVC/aluminium "blister" strips. Pack size of 25 tabs.

Atarax 2 mg/ml syrup: The syrup is filled in an amber glass bottle (type III – Ph. Eur.) closed by a polypropylene child-proof screw cap equipped with a polyethylene inner joint. A syringe is included for oral administration (Polyethylene/Polystyrene). Pack size of 200 mL.

Not all pack sizes may be marketed.

No special requirements.