History of hypersensitivity to carbapenem, penicillin or cephem antibiotics. Personal or familial predisposition to allergic reactions eg, bronchial asthma, rash or urticaria. Severe renal disorder. (See Pharmacokinetics under Actions.) Poor oral food intake or who are receiving parenteral alimentation and patients in poor general health. Patients should be observed carefully because vitamin K deficiency symptoms may develop. History of epilepsy or patients with central nervous system disorder. Central nervous system disorder eg, convulsion or disturbed consciousness is likely to occur.
Important Precautions: Since no methods are available to reliably predict the potential occurrence of shock or anaphylactoid reaction due to Omegacin, the following measures should be taken: Patients should be carefully interviewed in advance to obtain any past history of such reactions to drugs. Any history of allergy to antibiotics or other agents must be ascertained.
Emergency measures must be readily available for the treatment of shock, when Omegacin is used.
Patients should be resting and kept under careful observation from the beginning until after the end of administration of Omegacin. Patients should be observed especially carefully immediately after the beginning of administration.
Effects on Laboratory Tests: Caution is required in the following: False-positive results may occur in urine glucose tests with Benedict's solution, Fehling's solution and Clinitest, but not with Tes-Tape. Positive results may occur in the direct Coombs' test.
Use in Pregnancy & Lactation: Omegacin should be used in pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. The safety of Omegacin in pregnant women has not been established.
It is advisable to avoid using Omegacin in lactating mothers. If use of Omegacin is judged to be essential, breastfeeding must be discontinued during treatment. It has been reported that Omegacin is excreted in breast milk in animal studies (rats).
Use in Children: The safety of Omegacin in low birth weight infants, newborns, suckling infants, infants and children has not been established.
Use in the Elderly: Special attention should be paid to the following points when Omegacin is used in elderly patients. Omegacin should be used with care and the dose and dosing interval must be adjusted based on careful clinical observation of the patient's condition. (See Pharmacokinetics under Actions.) Adverse reactions are likely to occur in elderly patients since they often have reduced physiological function. In elderly patients, use of Omegacin may be associated with the development of a bleeding tendency due to vitamin K deficiency.