Salbec

Salbec Special Precautions

cefoperazone + sulbactam

Manufacturer:

Medochemie

Distributor:

KTZ

Marketer:

Aung Paing Tun
Full Prescribing Info
Special Precautions
Hypersensitivity: Serious, rarely fatal hypersensitivity (anaphylactic) reactions are seen in patients which were administered therapies with beta-lactams or cephalosporins. Such reactions are most likely to appear in patients with history for hypersensitivity to great number of allergens. If hypersensitivity reaction occurs, the medicinal product should be stopped and appropriate treatment should be commenced.
Severe anaphylactic reactions require immediately adrenaline administration. If needed oxygen, corticoids intravenously should be administered and an adequate airway, including intubations should be assured.
Administration in hepatic impairment: Cefoperazone is extensively excreted in bile. The serum half-life of active substance is usually prolonged in patients with hepatic disease and/or biliary obstruction and its urine excretion is increased. Even in severe hepatic impairment, cefoperazone reaches therapeutic bile concentrations, and only 2-4 fold half life prolongations is seen.
Doses modification is required only in cases of severe biliary obstruction, severe hepatic disease or in cases of concomitant renal impairment and some of the previously mentioned conditions.
In patients with hepatic insufficiency and concomitant renal impairment, cefoperazone serum concentrations should be monitored and, if need, doses should be adapted, accordingly. In case careful serum concentrations monitoring is not carried out, cefoperazone dose should not be higher than 2 g.
General principles: As with other antibiotics, vitamin K deficiency had occurred in small number of patients treated with cefoperazone. The mechanism is most probably related to the suppression of gut flora which normally synthesize this vitamin. Those at higher risk include patients with a poor nutritional status, malabsorption states (e.g., cystic fibrosis), and patients on prolonged intravenously nutrition. Prothrombin time should be monitored in these patients and in patient on anticoagulant treatment and exogenous vitamin K should be administered, as indicated.
As with other antibiotics, prolonged use of sulbactam / cefoperazone may result in the overgrowth of nonsusceptible organisms. Careful observation of the patients during treatment is essential. As with all potent, systemic antibiotics, it is recommended during prolonged treatment patients to be monitored for organ and systemic disorders, these include renal, hepatic and haemopoetic systems. It is especially important in new-borns, particularly pre-term, and for breast-fed children.
Effects on Ability to Drive and Use Machines: Cefoperazone is not known to affect the ability to drive or operate machinery. No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: Administration in breast-fed children: Sulbactam/cefoperazone was successfully administered in breast-fed children. Administration in pre-terms and newborns was not studied in detail. Though, before prescribing therapy to pre-terms and newborns, the ratio benefits / risks should be assessed (see Pharmacology: Pharmacokinetics: Administration in children and Toxicology: Preclinical Safety Data under Actions). Cefoperazone does not displace bilirubin from its sites for plasma proteins binding.
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