essants
Inform patients and caregivers that potentially fatal additive effects may occur if tramadol hydrochloride and acetaminophen is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see WARNINGS AND PRECAUTIONS (5.6), DRUG INTERACTIONS (7)].
Serotonin Syndrome
Inform patients that tramadol could cause a rare but potentially life-threatening condition, particularly during concomitant use with serotonergic drugs. Warn patients of the symptoms and signs of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare provider if they are taking, or plan to take serotonergic medications [see WARNINGS AND PRECAUTIONS (5.7)].
MAOI Interaction
Inform patients not to take tramadol hydrochloride and acetaminophen while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking tramadol hydrochloride and acetaminophen [see DRUG INTERACTIONS (7)].
Seizures
Inform patients that tramadol hydrochloride and acetaminophen may cause seizures with concomitant use of serotonergic agents (including SSRIs, SNRIs, and triptans) or drugs that significantly reduce the metabolic clearance of tramadol [see WARNINGS AND PRECAUTIONS (5.8)].
Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see WARNINGS AND PRECAUTIONS (5.10)].
Important Administration Instructions
Instruct patients how to properly take tramadol hydrochloride and acetaminophen [see DOSAGE AND ADMINISTRATION (2)].
Do not adjust the dose of tramadol hydrochloride and acetaminophen without consulting with a physician or other healthcare provider.
Do not take more than 4000 milligrams of acetaminophen per day and to call their healthcare provider if they took more than the recommended dose.
Hypotension
Inform patients that tramadol hydrochloride and acetaminophen may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) [see WARNINGS AND PRECAUTIONS (5.12)].
Anaphylaxis
Inform patients that anaphylaxis have been reported with ingredients contained in tramadol hydrochloride and acetaminophen tablets. Advise patients how to recognize such a reaction and when to seek medical attention [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.16), ADVERSE REACTIONS (6)].
Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that tramadol hydrochloride and acetaminophen should not be used for more than 5 days and that prolonged use of opioids such as tramadol hydrochloride and acetaminophen, during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see WARNINGS AND PRECAUTIONS (5.3) and USE IN SPECIFIC POPULATIONS (8.1)].
Embryo-Fetal Toxicity
Inform female patients of rep |
