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Flextra-650 (Acetaminophen / Phenyltoloxamine Citrate) - Drug Interactions, Contraindications, Overdosage, etc


Drug/Laboratory Test Interactions:

Acetaminophen may product false positive test results for urinary 5-hydroxyindoleacetic acid. The sedative effects of Phenyltoloxamine Citrate are additive to the CNS depressant effects of alcohol, hypnotics, sedative and tranquilizers.


Following an acute overdosage, toxicity may result from Phenyltoloxamine Citrate or Acetaminophen.

Acetaminophen: In Acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, daiphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams or fatalities with less than 15 grams.

Treatment: A single or multiple overdose with Phenyltoloxamine Citrate or Acetaminophen is a potentially lethal overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of Ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes).

If the dose of Acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum Acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict Acetaminophen toxicity. Do not await Acetaminophen assay results before initiating treatment. Hepatic eznymes should be obtained initially, and repeated at 24 hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. The toxic dose for adults for Acetaminophen is 10g.


This product should not be administered to patients who have previously exhibited hypersensitivity to Acetaminophen or Phenyltoloxamine Citrate.

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