Drug Interactions between ibrutinib and Soma Compound with Codeine

GENERALLY AVOID: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants (e.g., nonbenzodiazepine sedatives/hypnotics, anxiolytics, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol) may result in profound sedation, respiratory depression, coma, and death. The risk of hypotension may also be increased with some CNS depressants (e.g., alcohol, benzodiazepines, phenothiazines).

MANAGEMENT: The use of opioids in conjunction with benzodiazepines or other CNS depressants should generally be avoided unless alternative treatment options are inadequate. If coadministration is necessary, the dosage and duration of each drug should be limited to the minimum required to achieve desired clinical effect, with cautious titration and dosage adjustments when needed. Patients should be monitored closely for signs and symptoms of respiratory depression and sedation, and advised to avoid driving or operating hazardous machinery until they know how these medications affect them. Cough medications containing opioids (e.g., codeine, hydrocodone) should not be prescribed to patients using benzodiazepines or other CNS depressants including alcohol. For patients who have been receiving extended therapy with both an opioid and a benzodiazepine and require discontinuation of either medication, a gradual tapering of dose is advised, since abrupt withdrawal may lead to withdrawal symptoms. Severe cases of benzodiazepine withdrawal, primarily in patients who have received excessive doses over a prolonged period, may result in numbness and tingling of extremities, hypersensitivity to light and noise, hallucinations, and epileptic seizures.

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MONITOR CLOSELY: Coadministration of ibrutinib and drugs that interfere with platelet function or coagulation may potentiate the risk of bleeding complications. In clinical trials, 5% of patients with mantle cell lymphoma had Grade 3 or higher bleeding events such as subdural hematoma, gastrointestinal bleeding, and hematuria. Overall, bleeding events including bruising of any grade occurred in 48% of patients treated with ibrutinib 560 mg daily. The mechanism for the bleeding events is not well understood, although treatment with ibrutinib is associated with a high frequency of thrombocytopenia. Treatment-emergent grade 3 or 4 thrombocytopenia was reported in 17% of patients during clinical trials, while thrombocytopenia of all grades was reported in 57%. Fatal bleeding events have been reported during postmarketing use.

MANAGEMENT: Concomitant use of other medications that interfere with platelet function or coagulation should be considered cautiously in patients treated with ibrutinib. Close clinical and laboratory observation for bleeding complications is recommended during therapy. The INR should be monitored more frequently during coadministration of warfarin. In addition, some authorities recommend avoiding the use of supplements that have an inhibitory effect on platelet function such as fish oil (omega-3 polyunsaturated fatty acids), flaxseed, and vitamin E preparations (AU, CA, UK) because of an increased risk of bleeding. Patients should be advised to promptly report any signs of bleeding to their physician, including pain, swelling, headache, dizziness, weakness, prolonged bleeding from cuts, increased menstrual flow, vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or brown urine, or red or black stools.

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