Atarax^® 10mg Film-coated tablets

Hydroxyzine hydrochloride 10mg

10mg film-coated tablets, coloured orange and coded on one side with 'AX'.

Atarax is indicated to assist in the management of anxiety in adults.

Atarax is indicated for the management of pruritus associated with acute and chronic urticaria, including cholinergic and physical types, and atopic and contact dermatitis in adults and children.

Method of administration: oral.

Dosage:

Anxiety

Adults 50-100mg four times daily.

Pruritus

Adults Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily.

Use in the elderly Atarax may be used in elderly patients with no special precautions other than the care always necessary in this age group. The lowest effective maintenance dose and careful observation for side-effects are important.

Use in children From 6 months to 6 years 5-15mg rising to 50mg daily in divided doses and for children over 6 years, 15-25mg rising to 50-100mg daily in divided doses.

As with all medications, the dosage should be adjusted according to the patient's response to therapy.

Renal impairment The total daily dosage should be reduced by half (see 'Special Warnings and Precautions for Use').

Atarax is contra-indicated in patients who have shown previous hypersensitivity to it.

Atarax should be used with caution in patients with impaired renal function (see 'Posology and Method of Administration'). It is uncertain whether the drug may accumulate or have other adverse effects in such patients. Atarax is completely metabolised and one of the metabolites is the active metabolite cetirizine. Cetirizine is renally excreted and clearance is reduced in patients with moderate renal impairment and on dialysis compared to normal volunteers.

Because of its potential anticholinergic effects, Atarax should be used with caution in patients with bladder outflow obstruction.

Patients should be warned that Atarax may enhance their response to alcohol, barbiturates and other CNS depressants.

Atarax is contra-indicated in early pregnancy. Hydroxyzine, when administered to the pregnant mouse, rat and rabbit, induced foetal abnormalities at doses substantially above the human therapeutic range. Clinical data in humans are inadequate to establish safety in early pregnancy. There is inadequate evidence of safety in the later stages of pregnancy. Use in pregnancy only when there is no safe alternative or when the disease itself carries risks for the mother or child.

Use in nursing mothers It is not known whether Atarax is excreted in human milk. Since many drugs are so excreted, Atarax should not be given to nursing mothers.

Patients should be warned that Atarax may impair their ability to perform activities requiring mental alertness or physical co-ordination such as operating machinery or driving a vehicle.

Therapeutic doses of Atarax seldom produce marked impairment of mental alertness. Drowsiness may occur; if so, it is usually transitory and may disappear after a few days of continued therapy or upon reduction of the dose. Dryness of the mouth may be encountered at higher doses. Dizziness, weakness, headache and confusion, and urinary retention have been reported.

Extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered for over four years of uninterrupted therapy. The absence of side-effects has been further demonstrated in experimental studies in which excessively high doses were administered.

Involuntary motor activity, including rare instances of tremor and convulsions, have been reported, usually with doses considerably higher than those recommended. Continuous therapy with over 1g/day has been employed in some patients without these effects having been encountered.

The most common manifestation of Atarax overdosage is hypersedation. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. If vomiting has not occurred spontaneously in conscious patients it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and noradrenaline, or metaraminol. Adrenaline should not be used in this situation as Atarax counteracts its pressor action.

There is no specific antidote. It is doubtful whether haemodialysis has any value in the treatment of overdosage with Atarax. However, if other agents such as barbiturates have been ingested concomitantly, haemodialysis may be indicated.

Atarax is unrelated chemically to phenothiazine, reserpine and meprobamate.

Atarax has been shown clinically to be a rapid-acting anxiolytic with a wide margin of safety. It induces a calming effect in anxious tense adults. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Antihistamine effects have been demonstrated experimentally and confirmed clinically; it is highly effective in alleviating pruritus.

Atarax is rapidly absorbed from the gastro-intestinal tract and effects are usually noted within 15 to 30 minutes after oral administration.

None stated.

Tablet core:

Tablet coating:

Opadry II Orange 85G23730 (10mg only) -contains:

None stated.

24 Months.

Do not store above 25°C.

White opaque 250/51 micron PVC/PCTFE (Aclar) - 20 micron aluminium foil blister strips containing 84 x 10mg tablets, (6 blister strips per carton)

No special requirements.

Alliance Pharmaceuticals Limited

Avonbridge House

Chippenham

Wiltshire

SN15 2BB

United Kingdom

PL 16853/0094

27 April 1987/30 July 1997

April 2010