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U.S. Department of Health and Human Services

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Theophylline in 5% Dextrose injection, USP, Flexible Plastic Container March 2009

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

 

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS

  • When Signs and Symptoms of Theophylline Toxicity are Present

PRECAUTIONS

  • Monitoring Serum Theophylline Concentrations
    • "Saliva concentrations of theophylline cannot be used reliably to adjust dosage without special techniques...
    • Clinical evaluation and periodic laboratory determinations are necessary to monitor changes...
    • ..Do not use plastic container in series connection...
    • ..These solutions are intended for intravenous administration...
    • ..Use only if solution is clear and container and seals are intact.

ADVERSE REACTIONS

  • Hypercalcemia has been reported in a patient with hyperthyroid disease at therapeutic theophylline concentrations.
  • “Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

CONTRAINDICATIONS

  • Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products

WARNINGS

  • When Signs and Symptoms of Theophylline Toxicity are Present
    • “Solutions containing dextrose without electrolytes should not be administered simultaneously with blood through the same infusion set... ...Because dosages of these drugs are titrated to response, no additives should be made to Theophylline in 5% Dextrose Injection USP."