Contraindications
Tapentadol may increase the risk of seizures, and should be administered with care to epileptic patients and patients who are taking other drugs which lower the seizure threshold.
Since tapentadol may increase intracranial pressure by depressing respiration and increasing CO2 retention, it should not be administered to patients suffering from head injuries, brain tumors, or other conditions which increase intracranial pressure.
Taptentadol is contraindicated in patients with severe bronchial asthma, hypercapnia, and patients who have or are suspected to have paralytic ileus, due to the increased risk of respiratory depression.
Due to reduced clearance, tapentadol should be administered with caution to patients with moderate hepatic impairment (with reduced dosage), and not at all in patients with severe hepatic impairment.
As with other mu-opioid agonists, tapentadol may cause spasms of the Sphincter of Oddi, and is therefore discouraged for use in patients with biliary tract disease such as acute pancreatitis.
No human control studies have been conducted regarding the safety of tapentadol during pregnancy, although animal studies have suggested that it poses a risk of emryofetal toxicity. As such, the FDA has placed it into pregnancy category C. Women should avoid taking tapentadol during pregnancy unless the benefit outweighs the risk to the fetus.
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