Elixime Special Precautions

Tab: Gastrointestinal disturbances including diarrhea, nausea and vomiting, have occurred in some patients receiving Cefuroxime Axetil. There have been rare reports of erythema multiforme, Steven-Johnson syndrome, and toxic epidermal necrolysis. Cefuroxime is considered to be unsafe in patients with porphyria although there is conflicting experimental evidence of porphyrinogenecity.
Powd for inj: Should be given cautiously in the following patients: In principle this drug should not be administered to patients with history of hypersensitivity to this drug or cephem antibiotics, but if inevitable, cautious administration is required.
Patients with history of hypersensitivity to penicillins.
Patients oneself or whose parents, sisters, or brothers are prone to suffer from allergic symptoms such as bronchial asthma, exanthema, urticaria, etc.
Patients with severe renal disorder.
Patients with poor oral ingestion or parenteral nutrition patients, elderly patients, patients with poor general conditions (cautions monitoring is required since vitamin K deficiency may occur).
General Precautions: In order to prevent appearance of the resistant microorganisms susceptibility should be determined and treatment should be continued only for the minimum period of time required.
In order to predict adverse events such as shock, etc. patient history should be taken in detail and skin reaction test should be performed.
Emergency measures have to be available in preparation for occurrence of shock, and even after measures taken the patient should be observed cautiously in stable condition.
It is desirable to perform laboratory test (hepatic function, renal function, blood, etc.) at regular intervals during treatment.
This drug can be administered with combination of aminoglycosides antibiotics or metronidazole. However, these drugs must not be mixed in a syringe.
Interference in Laboratory Test: Caution should be taken as urine-glucose test using Benedict's-reagent, Fehling's reagent, Clinitest, except for Testape reaction, may give false positive results.
Caution should be taken as direct Coomb's test may give false positive results.
Precautions on Application: As vascular pain or venous thrombosis may rarely occur by large intravenous dose, caution should be taken on preparation of injectable solution, site of injection, method of administration, etc. and injection should be given as slowly as possible.
This drug should be used immediately after reconstitution. If the reservation of injectable solution is needed, the intravenous injectable solution should be used within 5 hours at room temperature or 48 hours at 4°C and the solution on intravenously drip infusion should be used within 12 hours at room temperature or 72 hours at 4°C.
Others: It has been reported that minor children have slight or severe auditory dysfunction with treatment of meningitis. After 18-36 hours with administration. Influenza positive strains may express in cultures of cerebral spinal fluid, but it is not known that clinical effects are associated with anything.
Use in Pregnancy: As safety in human pregnancy has not been established, this drug should not be administered to pregnant women or child bearing potential unless therapeutic benefit is considered to exceed the possible risk.
Use in Lactation: Since this drug is excreted in the breast-milk, caution is advised in nursing mothers.