Ultracet Drug Interactions

Overview: Based on its pharmacodynamic and pharmacokinetic properties, tramadol and paracetamol exhibits a potential for pharmacodynamic and pharmacokinetic interactions. The various types of interactions, associated general recommendations and lists of examples are described in Tables 3a and 3b as follows. These lists of examples are not comprehensive and therefore it is recommended that the label of each drug that is co-administered with tramadol and paracetamol be consulted for information related to interaction pathways, potential risks, and specific actions to be taken with regards to co-administration (see Pharmacology: Pharmacokinetics: Metabolism under Actions). (See Tables 3a and 3b.)

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QTc Interval-Prolonging Drugs: The concomitant use of ULTRACET with QTc interval-prolonging drugs should be avoided. Drugs that have been associated with QTc interval prolongation and/or torsade de pointes include, but are not limited to, the examples in the following list. Chemical/pharmacological classes are listed if some, although not necessarily all, class members have been implicated in QTc interval prolongation and/or torsade de pointes: Class IA antiarrhythmics (e.g., quinidine, procainamide, disopyramide); Class III antiarrhythmics (e.g., amiodarone, sotalol, ibutilide, dronedarone); Class 1C antiarrhythmics (e.g., flecainide, propafenone); antipsychotics (e.g., chlorpromazine, pimozide, haloperidol, droperidol, ziprasidone, risperidone); antidepressants (e.g., fluoxetine, citalopram, venlafaxine, tricyclic/tetracyclic antidepressants [e.g., amitriptyline, imipramine, maprotiline]); opioids (e.g., methadone); macrolide antibiotics and analogues (e.g., erythromycin, clarithromycin, azithromycin, tacrolimus); quinolone antibiotics (e.g., moxifloxacin, levofloxacin, ciprofloxacin); pentamidine; antimalarials (e.g., quinine, chloroquine); azole antifungals (e.g., ketoconazole, fluconazole, voriconazole); domperidone; 5-hydroxytryptamine (5-HT)3 receptor antagonists (e.g., ondansetron); tyrosine kinase inhibitors (e.g., sunitinib, nilotinib, ceritinib, vandetanib); arsenic trioxide; histone deacetylase inhibitors (e.g., vorinostat); beta-2 adrenoceptor agonists (e.g., salmeterol, formoterol).
Drugs that Affect Electrolytes: The use of ULTRACET with drugs that can decrease electrolyte levels should be avoided to the extent possible. Drugs that can decrease electrolyte levels include, but are not limited to, the following: loop, thiazide, and related diuretics; laxatives and enemas; amphotericin B; high-dose corticosteroids; proton pump inhibitors.
The previous list of potentially interacting drugs is not comprehensive. Current information sources should be consulted for newly approved drugs that prolong the QTc interval or decrease electrolytes, as well as for older drugs for which these effects have recently been established. (See Cardiovascular under Precautions; Other Clinically Significant Adverse Experiences Previously Reported in Clinical Trials or Post-marketing Reports with Tramadol under Adverse Reactions; Pharmacology: Pharmacodynamics: Cardiac Electrophysiology under Actions.)
Drug-Food Interactions: When ULTRACET was administered with food, the time to peak plasma concentration was delayed for approximately 35 minutes for tramadol and almost one hour for paracetamol. However, peak plasma concentration and the extent of absorption of either tramadol or paracetamol were not affected. The clinical significance of this difference is unknown.
Drug-Lifestyle Interactions: The concomitant use of alcohol should be avoided (see Warnings).