Sign Out
In principle, Pacferatam is not used in patients with a history of hypersensitivity to cephem class. However, if inevitable, careful administration is required.
Patients with a history of hypersensitivity to penicillins; familial aggregation of allergic reaction including bronchial asthma, rash, urticaria; severe hepatic and renal failure [since serum half-life (t½) of Pacferatam might be prolonged, caution is required in dose determination and dose interval]; patients who have problem of oral administration; patients with parenteral care, the old; patients who are in generally poor condition. (It is required to observe patients because of vitamin K deficiency.)
In order to prevent occurrence of the resistant microorganisms, susceptibility should be determined and treatment should be continued only for the minimum period of time required.
Sufficient injury and previous skin test are recommended to predict reaction eg, shock. Emergency first aid for shock should be made. After administration, patients are maintained in resting states and carefully observed.
Cefoperazone is extensively excreted in bile. The serum t½ of cefoperazone is usually prolonged and urinary excretion of Pacferatam increased in patients with hepatic diseases and/or biliary obstruction. Even with severe hepatic dysfunction, therapeutic concentrations of cefoperazone are obtained in bile and only 2- to 4-fold increase in t½ is seen. Dose modification may be necessary in cases of severe biliary obstruction, hepatic disease or in cases of renal dysfunction co-existent with either of those conditions. In patients with hepatic dysfunction and concomitant renal impairment, cefoperazone serum concentrations should be monitored and dosage adjusted as necessary. In these cases, dosage should not exceed cefoperazone 2 g/day without close monitoring of serum concentrations.
As with other antibiotics, vitamin K deficiency has occurred in a few patients treated with cefoperazone. The mechanism is most probably related to the suppression of gut flora which normally synthesize this vitamin. Those at risk include patients with poor diet, malabsorption states (eg, cystic fibrosis) and patients on prolonged IV alimentation regimens. Prothrombin time should be monitored in these patients.
Use in pregnancy: Since the safety for pregnant women has not been established, Pacferatam is used in women who are pregnant or considering pregnancy only if the therapeutic benefits justify the potential risks.
Use in lactation: Since Pacferatam is excreted in human milk, caution should be exercised when sulbactam/cefoperazone is administered to a nursing mother.
Use in children: The safety has not been established in newborn and premature infants.
Use in elderly: Because elderly patients have decreased biological function, adverse reaction is more likely to occur. Urticaria, stomatitis, leukocytopenia, thrombocytosis, oligochromemia, hepatic dysfunction [elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT)], proteinuria, increased serum creatinine value and increase of serum sodium have been reported.
Bleeding tendency due to vitamin K deficiency might occur.
