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Zegesic (Acetaminophen / Phenyltoloxamine Citrate) - Warnings and Precautions

 
 



WARNINGS

Do not take this product for pain more than 10 days (adults) or 5 days (children) unless directed by a physician, and do not take for fever for more than 3 days unless directed by a physician. If pain or fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. Caution should be exercised when used in patients with prostatic hypertrophy, urinary retention, bladder neck obstruction, increased ocular pressure, and asthma.

PRECAUTIONS

Information for Patients

Patient consultation should include the following information regarding the proper use of this product:

  • Do not exceed recommended dosage.
  • May be taken with food or milk to lessen gastric irritation.
  • Do not drive or operate heavy machinery if drowsiness or dizziness occurs.
  • Concomitant use of alcohol and other central nervous system depressants (hypnotics, sedatives, tranquilizers and anti-anxiety drugs) while taking this product may have an additive effect on drowsiness.
  • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose. Do not double the dose.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

DRUG & OR LABORATORY TEST INTERACTIONS

Acetaminophen may produce 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, sedatives and tranquilizers.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether phenyltoloxamine citrate or acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy

Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Zgesic Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Acetaminophen is excreted in breast milk in small amounts, but the significance of its effects on nursing infants is not known. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from phenyltoloxamine citrate and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in children under 6 years of age have not been established.

Geriatric Use

Use with caution; antihistamines may cause dizziness, sedation, confusional states and hypotension in the elderly.

Drug Interactions

Monoamine oxidase inhibitors (MAOIs) may prolong and intensify the sedative and

anticholinergic effect of antihistamines; additive CNS effects may occur with concomitant use of alcohol and CNS depressants. Hepatotoxicity has occurred in chronic alcoholics following moderate to excessive doses of acetaminophen.

Page last updated: 2010-07-06

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