Amoxil (amoxicillin capsules, tablets, chewable tablets, and powder for oral suspension) June 2008

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

PRECAUTIONS

• General
  • A high percentage of patients with mononucleosis who receive ampicillin develop an erythematous skin rash. Thus, ampicillin-class antibiotics should not be administered to patients with mononucleosis.
  • Drug Interactions
    • ...reduced efficacy of combined oral estrogen/progesterone contraceptives.

ADVERSE REACTIONS

• Infections and Infestations
  • Mucocutaneous Candidiasis
• Gastrointestinal
  • Black Hairy Tongue
• Hypersensitivity Reactions
  • Anaphylaxis (See WARNINGS)