FDA expands hypertension drug Benicar use for pediatric patients

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The FDA has approved the hypertension treatment Benicar (olmesartan medoxomil, Daiichi Sankyo) for use in children and adolescents six to 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults.

Benicar is an angiotensin II receptor blocker (ARB), which blocks the action of angiotensin II that increases blood pressure, according to the Parsippany, N.J.-based company. The approval of this expanded indication was based on a phase III study examining the antihypertensive effects of Benicar in pediatric patients, Daiichi reported.

The dosage and administration considerations are as follows:

  • No initial dosage adjustments are recommended with Benicar in elderly or in moderate to marked renal impairment (creatinine clearance <40 mL/min) or hepatic dysfunction.
  • In patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly with impaired renal function), initiate Benicar under close medical supervision and give consideration to use of a lower starting dose.