Hydroxyzine: Important Eight Recommendations by European Medicines Agency

Hydroxyzine: Important Eight Recommendations by

European Medicines Agency

 

(1) Hydroxyzine has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT interval prolongation and cardiac arrhythmia events (confirmed by clinical and post-marketing data)

(2) The potential risk of QT interval prolongation and torsades de pointes can therefore be adequately minimised through measures targeting the identified risk factors and restricting the use of hydroxyzine to the lowest effective dose for the shortest possible duration.

(3) The maximum dose in adults should be a total of 100 mg daily; in the elderly, if use cannot be avoided the maximum daily dose should be 50 mg.

(4) The maximum daily dose in children up to 40 kg in weight should be 2 mg/kg/day;
children over 40 kg should be given the adult dose.

(5) Use of hydroxyzine is contraindicated in patients with:

  • known acquired or congenital QT interval prolongation, or with a known risk factor for QT interval prolongation such as cardiovascular disease
  • Significant electrolyte imbalance (hypokalaemia, hypomagnesaemia)
  • Family history of sudden cardiac death
  • Significant bradycardia, or 
  • Concomitant use of drugs known to prolong the QT interval and/or induce torsades de pointes.

 

(6) Use is not recommended in elderly patients, due to reduced elimination of hydroxyzine in these patients and greater vulnerability to anticholinergic effects and other adverse reactions.

(7) The medicine should be used with caution in:

  • Patients with bradycardia
  • Patients taking hypokalaemia-inducing medicines.

 

(8) Care is also required when hydroxyzine is co-administered with drugs known to be potent inhibitors of alcohol dehydrogenase or CYP3A4/5.

SourceEuropean Medicines Agency, 2015.

 

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Dr. Harvinder Singh, M.D. (Admin)


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