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Cefratam powder for injection

Dexa Medica

Ingredients in every vial

Cefoperazone 1000 mg
Sulbactam 500 mg

Each package contains

1 vial of 1 g

Dosage form

Powder for injection

Dosage formPowder for Injection

Flavour

None

W.H.O. classification

J01D
J01D

A.T.C. Level 1

Anatomical Main group

J - Antiinfectives for systemic use
J01D

A.T.C. Level 2

Therapeutic subgroup

J01 - Antibacterials for Systemic Use
J01D

A.T.C. Level 3

Pharmacological subgroup

J01D - Other Beta-Lactam Antibacterials in ATC

Available in

Indonesia
Cambodia

Warnings

Alcohol

NOT RECOMMENDEDThis item should not be used with alcohol.

Machinery

SAFE IF PRESCRIBEDThis item is safe for use while operating heavy machinery.

Pregnancy

CONSULT YOUR DOCTORSafety of this item for use during pregnancy has not been established. Please consult your doctor.

Lactation

CAUTIONThis item may not be safe for use during lactation. Use with caution and after consultation with your doctor.

Indication

Monotherapy
Cefratam is indicated for the treatment of the following infections when caused by susceptible organisms:
– Upper and lower respiratory tract infections
– Upper and lower urinary tract infections
– Peritonitis, cholecystitis, cholangitis, and others intra-abdominal infections
– Skin and soft tissue infections
Combination therapy
Because of the broad spectrum of activity of Cefratam, most infections can be treated adequately with this antibiotic alone. However, Cefratam may be used concomitantly with other antibiotics if such combinations are indicated. If an aminoglycoside is used (see section Incompatibilities aminoglycoside), renal function should be monitored during the course of therapy (see section dosage and administration in renal dysfunction).

Dosage

1 MONTH TO 18 YEARS OLD
Daily dosage recommendations for CEFRATAM in children are 40-80 mg/kg/day. Doses should be administered every 6 to 12 hours in equally divided doses.

In serious or refractory infections, these dosages may be increased up to 160 mg/kg/day of the 1:1 ratio. Doses should be administered in two to four equally divided doses.

18 YEARS OLD AND ABOVE
Daily dosage recommendations for CEFRATAM in adults are 2-4 g.
Doses should be administered every 12 hours in equally divided doses.

In severe or refractory infections, the daily dosage of CEFRATAM may be increased up to 8 g with the ratio 1:1 (i.e., 4 g cefoperazone activity). Patients who receive the 1:1 ratio may require additional cefoperazone administered separately. Doses should be administered every 12 hours in equally divided doses.

The recommended maximum daily dosage of sulbactam is 4 g.

UP TO 1 MONTH
For neonates in the first week of life, CEFRATAM should be given every 12 hours. The maximum daily dosage of sulbactam in pediatrics should not exceed 80 mg/kg/day. For doses of CEFRATAM requiring more than 80 mg/kg/day cefoperazone activity, additional cefoperazone should be administered separately.

METHOD OF ADMINISTRATION
CEFRATAM administered by intravenous injection or infusion or intramuscular route.

PATIENTS WITH IMPAIRED HEPATIC FUNCTION
Dose modification may be necessary in cases of severe biliary obstruction, severe hepatic disease or in cases of renal dysfunction coexistent 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 2 g/day of cefoperazone.

PATIENTS WITH IMPAIRED RENAL FUNCTION
Dosage regimens of CEFRATAM should be adjusted in patients with marked decrease in renal function (creatinine clearance of less than 30 ml/min) to compensate for the reduced clearance of sulbactam. Dosage adjusment for CEFRATAM as follows:
– Patients with creatinine clearances less than 15 ml/minute should receive a maximum of 500 mg of sulbactam every 12 hours (maximum daily dosage of 1 g sulbactam)
– Patients with creatinine clearances between 15 and 30 ml/minute should receive a maximum of 1 g of sulbactam administered every 12 hours (maximum daily dosage of 2 g sulbactam)

In severe infections, it may be necessary to administer additional cefoperazone. The pharmacokinetic profile of sulbactam is significantly altered by hemodialysis. The serum half-life of cefoperazone is reduced slightly during hemodialysis. Thus, dosing should be scheduled to follow a dialysis period.