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GENERIC
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37.5 mg tramadol / 325 mg acetaminophen
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INDICATIONS
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acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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MECHANISM OF ACTION
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Opioid agonist, antitussive Analgesic, antipyretic
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MICROBIOLOGY
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Tramadol: opioid agonist and inhibitor of norepinephrine and serotonin re-uptake. Mode of action of tramadol is not completely understood
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Acetaminophen: Nonopioid, nonsalicylate analgesic; may work peripherally to block pain impulse generation; acts on hypothalamus to produce antipyresis
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CONTRAINDICATIONS & WARNINGS
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All children younger than 12 years of age | Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy | Significant respiratory depression | Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment | Known or suspected gastrointestinal obstruction, including paralytic ileus | Previous hypersensitivity to tramadol, acetaminophen, any other component of this product, or opioids | Monoamine oxidase inhibitors (MAOIs)
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PEDIATRIC USE
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Contraindicated in all children younger than 12 years of age. The safety and effectiveness of ULTRACET in pediatric patients have not been established.
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PREGNANCY
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Category C Use during pregnancy may cause neonatal opioid withdrawal syndrome
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NOTE
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Schedule IV indicated for short-term use of five days or less.
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