he drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
5.15 Risk of Use in Patients with Gastrointestinal Conditions
Tramadol hydrochloride and acetaminophen is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see CONTRAINDICATIONS (4)].
The tramadol in tramadol hydrochloride and acetaminophen tablets may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
5.16 Anaphylaxis and Other Hypersensitivity Reactions
Serious and rarely fatal anaphylactic reactions have been reported in patients receiving therapy with tramadol. When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis, and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive tramadol hydrochloride and acetaminophen. If anaphylaxis or other hypersensitivity occurs, stop administration of tramadol hydrochloride and acetaminophen immediately, discontinue tramadol hydrochloride and acetaminophen permanently, and do not rechallenge with any formulation of tramadol. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction [see CONTRAINDICATIONS (4), INFORMATION FOR PATIENTS (17)].
There have been postmarketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue tramadol hydrochloride and acetaminophen immediately and seek medical care if they experience these symptoms. Do not prescribe tramadol hydrochloride and acetaminophen for patients with acetaminophen allergy.
5.17 Increased Risk of Hepatotoxicity with Concomitant Use of Other Acetaminophen-containing Products
Due to the potential for acetaminophen hepatotoxicity at doses higher than the recommended dose, tramadol hydrochloride and acetaminophen should not be used concomitantly with other acetaminophen containing products.
5.18 Withdrawal
Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including tramadol hydrochloride and acetaminophen. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [see DRUG INTERACTIONS (7)].
When discontinuing tramadol hydrochloride and acetaminophen, in opioid-dependent patients, gradually taper the dosage [see DOSAGE AND ADMINISTRATION (2.4)]. Do not abruptly discontinue tramadol hydrochloride and acetaminophen [see DRUG ABUSE AND DEPENDENCE (9.3)].
5.19 Driving and Operating Machinery
Tramadol hydrochloride and acetaminophen may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or |
