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Hydroxyzine HCl

Symptomatic relief of anxiety. Relief of pruritus due to allergic conditions eg, urticaria, contact dermatitis or histamine-mediated pruritus. Sedative when used as premed & following general anesth.

Anti-anxiety Adult FC tab & Syr 25-100 mg qid. Max: 600 mg daily. Oral soln 50-100 mg qid. Childn >6 yr 50-100 mg daily in divided doses, <6 yr 50 mg daily in divided doses. Pruritus due to allergic conditions eg, chronic urticaria, atopic & contact dermatoses & histamine-mediated pruritus Adult 25 mg tid-qid. Childn >6 yr Initially 15-25 mg daily, may be increased to 50-100 mg daily in divided doses, if necessary, 6 mth to 6 yr Initially 5-15 mg daily, may be increased to 50 mg daily in divided doses, if necessary. Sedation (as premed & following general anesth) Adult 50-100 mg/dose. Childn 0.6 mg/kg. Hepatic insufficiency Oral soln Reduce dose to ¹/₃ of total daily dose. Moderate to severe renal impairment Oral soln Reduce dose to ½.

May be taken with or without food.

History of hypersensitivity to hydroxyzine HCl, cetirizine, levocetirizine or any piperazine derivatives. 1st trimester pregnancy & lactation. FC tab & Syr: Premature infants. Oral soln: Patients w/ QT interval prolongation or who have risk factors.

Contraindicated in patients w/ risk factors of cardiac arrhythmias or in combination w/ other drugs increasing risk of abnormal ECG eg, erythromycin. Dry mouth, dysuria, thick mucus, blurred vision, dizziness & confusion. Drowsiness, hallucination, urinary retention, low BP, irritability, insomnia & seizures (paradoxical reaction) in childn & elderly. Narrow-angle glaucoma, prostatic hyperplasia, urinary stricture, asthma or COPD. Patients w/ high BP, CV disease, hyperthyroid, history of asthma or emphysema; risk factors for QT prolongation, congenital & family history of long QT syndrome, other conditions predisposing to QT prolongation & ventricular arrhythmia & recent MI, uncompensated heart failure & bradyarrhythmias; other risk factors for QT prolongation/Torsades de Pointes (eg, preexisting cardiac disease, electrolyte imbalances, concomitant arrhythmogenic use). Not to drink alcohol or anything mixed w/ alcohol. Concomitant use w/ CNS suppressants eg, benzodiazepines, anticholinergics & antidepressants. May affect ability to drive or operate machines. Not to be used in 1st trimester pregnancy & lactation. Not to exceed 100 mg daily in adults, 50 mg daily in elderly or 2 mg/kg daily in childn weighing <40 kg. Not to be used in elderly.

Drowsiness; dry mouth; hypotension. FC tab & Syr: Lassitude, urinary retention. Oral soln: Dizziness, ataxia, weakness, slurred speech, headache, agitation, increased anxiety, tremor, seizure; nausea, bitter taste, increased GI peristalsis; wheezing, chest tightness; flushing, acute generalized exanthematous pustulosis, fixed drug eruption, skin rash; prolonged QT interval, Torsade de Pointes.

Additive or potentiated action of other CNS depressants (eg, opiates or other analgesics, barbiturates or other sedatives, anesth or alcohol). Inhibited & reversed vasopressor effect of epinephrine. Increased blood conc w/ potent inhibitors of alcohol dehydrogenase or CYP3A4/5. Additive effects w/ some CYP2D6 substrates. Concomitant use w/ QT-prolonging drugs &/or induced Torsade de Pointes eg, class III antiarrhythmics (eg, amiodarone, sotalol), some antidepressants (eg, citalopram), antibiotics (eg, sparfloxacin), methadone; MAOIs. Additive anticholinergic effects w/ anticholinergics.

Antihistamines & Antiallergics / Anxiolytics

N05BB01 - hydroxyzine ; Belongs to the class of diphenylmethane derivatives anxiolytics. Used in the management of anxiety, agitation or tension.

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