Label Changes for:

Proair HFA (albuterol sulfate) Inhalation Aerosol

September 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 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. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Hypokalemia

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Initial Paragraph
    • Pediatric Patients 4 to 11 Years of Age
  • Postmarketing Experience
    • ...In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as:
      • hypotension, palpitations, nervousness, tremor, hypokalemia, hyperglycemia, and metabolic acidosis (added)

DRUG INTERACTIONS

  • Diuretics
    • ...Consider monitoring potassium levels.
  • Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
    • ...Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

USE IN SPECIFIC POPULATIONS

  • Pediatric Use

NONCLINICAL TOXICOLOGY

  • Carcinogenesis, Mutagenesis, Impairment of Fertility

PATIENT COUNSELING INFORMATION

  • Paradoxical Bronchospasm
  • General Information on Use

CONTRAINDICATIONS

...Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6)].

WARNINGS AND PRECAUTIONS

Hypokalemia

As with other beta-agonists, Proair HFA Inhalation Aerosol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

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