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U.S. Department of Health and Human Services

Safety

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Lopressor HCT (metoprolol tartrate USP and hydrochlorothiazide USP) Tablets July 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Lopressor
    • Bronchospastic Diseases
    • Major Surgery
    • Diabetes and Hypoglycemia

ADVERSE REACTIONS

  • Postmarketing Experience (section added)

WARNINGS: Lopressor

Bronchospastic Diseases

PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS, including Lopressor HCT...

Major Surgery

The necessity or desirability of withdrawing beta-blocking therapy, including Lopressor HCT, prior to major surgery is controversial; the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures...

Diabetes and Hypoglycemia

...Beta blockers, including Lopressor HCT, may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected...