Omegacin

Omegacin Adverse Reactions

Manufacturer:

Meiji

Distributor:

DKSH
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Adverse Reactions
Adverse reactions were observed in 64 (2.7%) of 2348 cases evaluated in the clinical study. The main adverse reactions were rash (1%) and diarrhea (including loose stool) (0.7%). In a total of 2287 cases, 522 events of abnormal changes in laboratory test values were observed in 304 cases (13.3%), including increased ALT (GPT) in 144 cases, increased AST (GOT) in 93 cases and eosinophilia in 77 cases (based on the number of patients summed up at the time of the latest approval of indications).
Clinically Significant Adverse Reactions: Shock (<1%) or anaphylactoid reactions (incidence unknown) may occur. Patients should be carefully monitored and if any abnormalities eg, feeling unwell, oral cavity discomfort, stridor, vertigo, defecation desire, tinnitus or diaphoresis are observed, administration should be discontinued and appropriate measures should be taken.
Interstitial pneumonia (0.1 to <5%) may occur. Patients should be carefully monitored and if any abnormalities eg, fever, cough, exertional breathlessness and dyspnea are observed, a chest X-ray should be obtained immediately. When interstitial pneumonia is suspected, administration should be discontinued and appropriate measures eg, administration of adrenocortical hormones should be taken.
Serious colitis with diarrhea or bloody stool eg, pseudomembranous colitis (incidence unknown) may occur. Patients should be carefully monitored and if any abnormality is observed, administration should be discontinued immediately and appropriate measures should be taken.
Central nervous system disorder eg, convulsion or disturbed consciousness (incidence unknown) may occur. Patients should be carefully monitored and if such symptoms occur, administration should be discontinued immediately and appropriate measures should be taken. Since convulsion or disturbed consciousness is more likely to occur in patients with renal disorder or central nervous system disorder, special attention should be given when Omegacin is administered to such patients.
Hepatic function disorder with markedly increased AST (GOT), ALT (GPT), γ-GTP or AL-P or jaundice (incidence unknown) may occur. Patients should be carefully monitored, and periodic laboratory tests should be performed. If any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Serious renal disorder eg, acute renal failure (incidence unknown) may occur. Patients should be carefully monitored, and periodic laboratory tests should be performed. If any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Agranulocytosis, pancytopenia, leucopenia or thrombocytopenia (incidence unknown) may occur. Patients should be carefully monitored, and periodic blood tests should be performed. If any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Clinically Significant Adverse Reactions (Similar Drugs): Muco-cutaneo-ocular syndrome (Stevens-Johnson syndrome) or toxic epidermal necrolysis (Lyell syndrome) may occur when other carbapenem antibiotics are used. Patients should be carefully monitored, and if any abnormalities eg, fever, erythema, itching, ocular hyperemia or stomatitis are observed, administration should be discontinued and appropriate measures should be taken.
Hemolytic anemia may occur when other carbapenem antibiotics are used. Patients should be carefully monitored, and periodic blood tests should be performed. If any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Thrombophlebitis may occur when other carbapenem antibiotics are used. Patients should be carefully monitored, and if any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Pulmonary infiltrates with eosinophilia (PIE) syndrome may occur when other carbapenem antibiotics are used. Patients should be carefully monitored, and if any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Fulminant hepatitis may occur when other carbapenem antibiotics are used. Patients should be carefully monitored, and if any abnormality is observed, administration should be discontinued and appropriate measures should be taken.
Other Adverse Reactions: When the following adverse reactions occur, appropriate measures should be taken to treat the symptoms. (See Table 4).

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