S
Significant respiratory depression. (4)
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
Previous hypersensitivity to tramadol hydrochloride, acetaminophen, any other component of this product, or opioids. (4)
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days (4)
WARNINGS AND PRECAUTIONS
Serotonin Syndrome: May be life-threatening. Can occur with use of tramadol alone, with concomitant use of serotonergic drugs, with drugs that impair metabolism of serotonin or tramadol. (5.7)
Risk of Seizure: Can occur at the recommended dose of tramadol. Concomitant use with other drugs may increase seizure risk. Risk may increase in patients with epilepsy, a history of seizures, and in patients with a recognized risk for seizures. (5.8)
Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients. (5.9)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.10)
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.11)
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of tramadol hydrochloride and acetaminophen in patients with circulatory shock. (5.12)
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of tramadol hydrochloride and acetaminophen in patients with impaired consciousness or coma. (5.13)
ADVERSE REACTIONS
The most common incidence of treatment-emergent adverse events (≥3.0%) in patients from clinical trials were constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with tramadol hydrochloride and acetaminophen because they may reduce analgesic effect of tramadol hydrochloride and acetaminophen or precipitate withdrawal symptoms. (7)
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause fetal harm. (8.1)
Lactation: Not recommended. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 1/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
2.2 Initial Dosage
2.3 Dosage Modification in Patients with Renal Impairment
2.4 Discontinuation of Tramadol Hydrochloride and Acetaminophen Tablets
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Addiction, Abuse and Misuse
5.2 Life-Threatening Respiratory Depression
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