Tablet: Temgesic Sublingual Tablets should not be taken together with alcoholic drinks or medications containing alcohol. Alcohol increases the sedative effect of buprenorphine, which can make driving vehicles and operating machinery hazardous. Temgesic Sublingual Tablets should be used cautiously together with:
Benzodiazepines: This combination may potentiate respiratory depression of central origin, with risk of death; therefore, dosages must be limited. The risk of drug abuse should also be considered. (See Precautions.)
Other central nervous system depressants; other opioid derivatives (analgesics and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances. This combination increases central nervous system depression and can make driving vehicles and operating machinery hazardous.
Monoamine oxidase inhibitors (MAOI): Possible exaggeration of the effects of opioids, based on experience with morphine.
Respiratory and cardiovascular collapses have been reported in patients receiving therapeutic doses of diazepam and Temgesic concomitantly.
To date, no notable interaction has been observed with cocaine.
A suspected interaction between Temgesic Sublingual Tablets and phenoprocoumon resulting in purpura has been reported.
An interaction study of buprenorphine with ketoconazole resulted in increases in buprenorphine and norbuprenorphine concentrations. Subjects receiving Temgesic should be closely monitored, and may require dose-reduction if inhibitors of CYP3A4 (e.g. ketoconazole, gestodene, TAO, the HIV protease inhibitors ritonavir, indinavir and saquinavir) are co-administered. The interaction of buprenorphine with CYP3A4 inducers has not been investigated, therefore it is recommended that patients receiving Temgesic should be closely monitored if enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered.
Ampoule: There is no evidence to indicate that therapeutic doses of buprenorphine do not reduce the analgesic efficacy or standard doses of an opioid and that when buprenorphine is employed within the normal therapeutic range, standard doses of opioid agonist may be administered before the effects of the former have ended without compromising analgesia. However, in individuals on high doses of opioids buprenorphine may precipitate abstinence effects due to its properties as a partial agonist.
Temgesic may cause some drowsiness which may be potentiated by other centrally acting agents, including alcohol, tranquilisers, sedatives and hypnotics. Temgesic should be used with caution in patients receiving monoamine oxidase inhibitors, although animal studies have given no evidence of interactions.
Although interaction studies have not yet been performed, since the drug is metabolised by CYP3A4 (see Pharmacology: Pharmacokinetics under Actions), it is expected that gestodene, troleandomycin, ketoconazole, norfluoxetine, ritonavir, indinavir and saquinavir inhibit its metabolism. Alternatively, inducers of this enzyme such as phenobarbital, carbamazepine, phenytoin, rifampicin may reduce the levels of the drug. Since the magnitude of an inducing or inhibitory effect is unknown, such drug combinations should be avoided.
Temgesic has no known effects on diagnostic laboratory tests.