HYDROXYZINE HYDROCHLORIDE

Posology Hydroxyzine Tablets should be used at the lowest effective dose and for the shortest possible duration. In adults and children over 40 kg in weight, the maximum daily dose is 100mg per day. Anxiety Adults 50-100mg daily in divided doses Pruritis Adults Starting dose of 25mg at night increasing as necessary to 25mg three or four times daily.

4). A reduced dose is advised. 2 ‘Pharmacokinetic properties’) Paediatric Population In children up to 40 kg in weight, the maximum daily dose is 2 mg/kg/day. From 6 months to 6 years, 5-15mg daily in divided doses adjusted depending on the child’s weight.

In children and adolescents over 40kg in weight, the maximum daily dose is 100mg per day. For children over 6 years, starting at 15-25mg and increasing to 50-100mg daily in divided doses adjusted according to the child’s weight. As with all medications, the dosage should be adjusted according to the patient's response to therapy.

Hepatic impairment The total daily dose should be reduced by 33%. 4 ‘Special Warnings and Precautions for Use’). 4 'Special Warnings and Precautions for Use').

Method of administration:

Oral

The most common adverse effect of the sedating antihistamines is CNS depression. Effects vary from slight drowsiness to deep sleep, and include lassitude, dizziness, and incoordination. Paradoxical stimulation may occasionally occur, especially at high doses and in children and the elderly.

If sedative effects occur, they may diminish after a few days of treatment. Other common adverse effects include headache, psychomotor impairment and antimuscarinic effects. Adverse events are listed below by system Organ Class and frequency.

g. 4), tachycardia, palpitation Not known Vascular disorders hypotension, flushing Not known Respiratory, thoracic and mediastinal disorders bronchospasm, thickened respiratory tract secretions, wheezing, nasal stuffiness, dryness of throat Not known Gastrointestinal disorders constipation, dryness of the mouth, nausea, vomiting, increased gastric reflux, diarrhoea, epigastric pain, increased GI peristalsis Not known Hepatobiliary disorders liver dysfunction Not known Skin and subcutaneous tissue disorders dermatitis, fixed drug eruption, pruritis, erythema, papular rash, sweating increased, urticaria, hair loss, eczema, acute generalised exanthematous pustulosis (AGEP), toxic epidermal necrolysis Stevens- Johnson syndrome, erythema multiforme Very rare Muscoskeletal and connective tissue disorders myalgia Not known Renal and urinary disorders urinary retention, dysuria Not known Reproductive system and breast disorders priapism, impotence, early menses Not known General disorders and administration site conditions fatigue, malaise, lassitude, pyrexia, dryness of respiratory mucosae, asthenia, tightness of chest, irritability, chills Not known Investigations liver function tests abnormal, weight increased Not known Footnotes 1,2, 3 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. 4 dyskinesia may follow termination of prolonged antihistamine therapy. Children and the elderly are more susceptible to side-effects.

Cardiovascular effects Hydroxyzine has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been cases of QT interval prolongation and torsade de pointes in patients taking hydroxyzine.

8). Hydroxyzine should be used at the lowest effective dose and for the shortest possible duration. Treatment with hydroxyzine should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should seek immediate medical attention.

Patients should be advised to promptly report any cardiac symptoms. Patients with hepatic impairment Due to its sedative properties, use of hydroxyzine should be avoided in severe liver disease due to an increased risk of coma, and in patients with hepatic failure due to possibility of hepatic encephalopathy.

Hydroxyzine elimination is impaired in patients with hepatic dysfunction secondary to primary biliary cirrhosis. 2 'Posology and Method of Administration'). It is uncertain whether the drug may accumulate or have other adverse effects in such patients.

Hydroxyzine Tablets are 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.

g. 8). 2 ‘Pharmacokinetic properties’) Because of its potential antimuscarinic actions, Hydroxyzine Tablets should be used with caution in patients suffering from angle-closure glaucoma, urinary retention, prostatic hyperplasia, or pyroduodenal obstruction.

g. 5 ‘Interaction with other medicinal products and other forms of interaction’). 5 ‘Interaction with other medicinal products and other forms of interaction’). Treatment should be stopped for one week before skin testing for allergy is undertaken, and for 96 hours prior to a methocholine test.

1 ‘List of excipients’) • Patients with a known acquired or congenital QT interval prolongation. 5). 1). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.