Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity reactions (anaphylactic) have occurred in patient receiving beta-lactam antibiotics. Before therapy with TIRONEM is started, careful inquiry should be made concerning a previous history of hypersensitivity reactions to other active substances in this class or to beta-lactam antibiotics. TIRONEM should be used with caution in patients with such a history. If a hypersensitivity reaction to TIRONEM occur, it should be discontinued immediately and appropriate measures taken. Serious acute hypersensitivity (anaphylactic) reactions require immediate emergency treatment.
Seizures: Although infrequently, seizure have been reported during treatment with other Carbapenems.
Pseudomembranous colitis: Just like the use of any antibacterial drugs, Pseudomembranous colitis due to Clostridium difficile has been reported with TIRONEM as with nearly all antibacterial agents and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patient who present with diarrhea during or subsequent to the administration of Doripenem (see Adverse Reactions).
Super-infection: Administration of TIRONEM, like other antibiotics, has been associated with emergence and selection of strains with reduced susceptibility. Patients should be carefully monitored during therapy. If super-infection occurs, appropriate measures should be taken. Prolonged use of TIRONEM should be avoided.
Pneumonitis: Pneumonitis can occur if TIRONEM used via inhalation. Therefore, TIRONEM should not be administered by this route.
Use in Pregnancy: Clinical data of TIRONEM on pregnancy are very limited. Animal studies are insufficient to draw conclusion for pregnancy, embryonal/foetal development, parturition or postnatal development. The potential risk for human is unknown. TIRONEM should not be used during pregnancy unless clearly necessary.
Use in Lactation: It is not known whether TIRONEM is excreted in human breast milk. A study in rats has shown that TIRONEM and its metabolite are transferred to milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with TIRONEM should be made taking into account the benefit of breastfeeding to the child and the benefit of TIRONEM therapy to the woman.
Effects on Ability to Drive and Use Machines: No studies on the effects of TIRONEM on the ability to drive and use machines have been performed. Based on reported adverse drug reaction, it is not anticipated that TIRONEM will affect the ability to drive and use machines.