SULPERAZON 1G IMIV

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CEFOPERAZONE SODIUM; SULBACTAM SODIUM

Available from:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

CEFOPERAZONE SODIUM; SULBACTAM SODIUM

Units in package:

1gm mcg/mL; 1 gm mcg/mL

Manufactured by:

Haupt Pharma Latina S.r.l.

Summary of Product characteristics

Pfizer Confidential
1. NAME OF THE MEDICINAL PRODUCT
SULPERAZON
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulbactam sodium/cefoperazone sodium combination is available as a dry powder for reconstitution
in a 1:1 ratio in terms of free SBT/CPZ.
Sulbactam sodium is a derivative of the basic penicillin nucleus. It is an irreversible beta -lactamase
inhibitor for parenteral use only. Chemically it is sodium penicillinate sulfone. It contains 92 mg
sodium (4 mEq) per gram. Sulbactam is an off -white crystalline powder which is highly soluble in
water. The molecular weight is 255.22.
Cefoperazone sodium is a semisynthetic broad -spectrum cephalosporin antibiotic for parenteral
use only. It contains 34 mg sodium (1.5 mEq) per gram. Cefoperazone is a white crystalline
powder which is freely soluble in water. The molecular weight is 667.65.
3. PHARMACEUTICAL FORM
Vials of the 1:1 product contain the equivalent of 500 mg + 500 mg and 1000 mg + 1000 mg of
sulbactam and cefoperazone, respectively.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Monotherapy
Sulbactam/cefoperazone is indicated for the treatment of the following infections when caused by
susceptible organisms:
Respiratory Tract Infections (Upper and Lower)
Urinary Tract Infections (Upper and Lower)
Peritonitis, Cholecystitis, Cholangitis, and Other Intra -abdominal infections
Septicemia
Meningitis
Skin and Soft Tissue Infections
Bone and Joint Infections
Pelvic Inflammatory Disease, Endometritis, Gonorrhea, and Other Infections of the Genital Tract