iency.
5.11 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
The use of tramadol hydrochloride and acetaminophen in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [see CONTRAINDICATIONS (4)].
Patients with Chronic Pulmonary Disease: Tramadol hydrochloride and acetaminophen-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of tramadol hydrochloride and acetaminophen [see WARNINGS AND PRECAUTIONS (5.2)].
Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics, or altered clearance, compared to younger, healthier patients [see WARNINGS AND PRECAUTIONS (5.2)].
Monitor such patients closely, particularly when initiating and titrating tramadol hydrochloride and acetaminophen and when tramadol hydrochloride and acetaminophen is given concomitantly with other drugs that depress respiration [see WARNINGS AND PRECAUTIONS (5.6), DRUG INTERACTIONS (7)]. Alternatively, consider the use of non-opioid analgesics in these patients.
5.12 Severe Hypotension
Tramadol hydrochloride and acetaminophen may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see DRUG INTERACTIONS (7)]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of tramadol hydrochloride and acetaminophen. In patients with circulatory shock, tramadol hydrochloride and acetaminophen may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of tramadol hydrochloride and acetaminophen in patients with circulatory shock.
5.13 Risk of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), tramadol hydrochloride and acetaminophen may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with tramadol hydrochloride and acetaminophen.
Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of tramadol hydrochloride and acetaminophen in patients with impaired consciousness or coma.
5.14 Serious Skin Reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of t |
