Label Changes for:

Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) tablets

August 2009

Changes have been made to the WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

WARNINGS

  • a box has been placed around the paragraph regarding Ischemic Heart Disease
Pheochromocytoma
  • If Lopressor is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.
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