Children younger than 12 years of age.
Postoperative 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.
Hypersensitivity to tramadol, any other component of this product or opioids.
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days.
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.
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.
Risk of Suicide: Do not prescribe for suicidal or addiction-prone patients.
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of QDOLO in patients with circulatory shock.
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 QDOLO in patients with impaired consciousness or coma.
The most common incidence of treatment-emergent adverse events (≥15.0%) in patients from clinical trials were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.
Table 1: Cumulative Incidence of Adverse Reactions for Tramadol HCl Tablets in Chronic Trials of Nonmalignant Pain (N=427)
|Up to 7 Days||Up to 30 Days||Up to 90 Days|
* CNS Stimulation is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations.
To report SUSPECTED ADVERSE REACTIONS, contact Athena Bioscience, LLC. at 1-833-874-2664 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with QDOLO because they may reduce analgesic effect of QDOLO or precipitate withdrawal symptoms.
May cause fetal harm.
Breastfeeding not recommended.