Classes
DEA Class; Rx
Common Brand Names; Ultracet
- Analgesics, Opioid Combos
Description
Oral combination of an opioid analgesic and a non-opioid, non-salicylate analgesic
Used for the treatment of acute pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate
Tramadol is associated with risk for seizures and suicidal tendency; acetaminophen doses above the maximum recommended are associated with hepatotoxicity
Indications
Contraindications
Hypersensitivity
Children <12 years
Postoperative management in children <18 years following tonsillectomy and/or adenoidectomy
Significant respiratory depression
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
Known or suspected gastrointestinal obstruction, including paralytic ileus
Previous hypersensitivity to tramadol hydrochloride, acetaminophen, any other component of this product, or opioids
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days
Adverse Effects
Abdominal pain
Anxiety
Anorexia
Asthenia
Confusion
Constipation
Diarrhea
Dizziness
Dry mouth
Dyspepsia
Euphoria
Fatigue
Flatulence
Headache
Hot flushes
Insomnia
Nausea
Nervousness
Pruritus
Rash
Somnolence
Sweating
Tremor
Vomiting
Warnings
Use with caution in hepatitis, liver failure, myocardial ischemia, pulmonary edema, vasodilation
As an opioid, the drug exposes users to risks of addiction, abuse, and misuse; assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing the drug, and monitor all patients for development of addiction behaviors and conditions; reduce risks by prescribing drug in smallest appropriate quantity and advising patient on proper disposal of unused drug risk is greatest during initiation of therapy or following a dosage increase; monitor patients closely for respiratory depression, especially within first 24-72 hours of initiating therapy and following dosage increases; to reduce risk, proper dosing and titration are essential; overestimating; dosage when converting patients from another opioid product can result in fatal overdose with first dose
Monitor for sedation and respiratory depression in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness;. avoid use in patients with impaired consciousness or coma
Pregnancy and Lactation
Pregnancy
Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome; available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage
Lactation
Tramadol and its active metabolite, O-desmethyltramadol (M1), are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to M1 via breast milk; women who are ultra-rapid metabolizers of tramadol achieve higher than expected serum levels of opioids, potentially leading to higher levels of M1 in breast milk that can be dangerous in their breastfed infants; in women with normal tramadol metabolism (normal CYP2D6 activity), the amount of tramadol secreted into human milk is low and dose-dependent
Maximum Dosage
300 mg/day PO tramadol and 2,600 mg/day PO acetaminophen.
300 mg/day PO tramadol and 2,600 mg/day PO acetaminophen.
Safety and efficacy have not been established.
12 years: Safety and efficacy have not been established.
1 to 11 years: Use is contraindicated.
Use is contraindicated.