SulPron™

Composition

Each vial contains sulbactam sodium/cefoperazone sodium combination in a 1:1 ratio in terms of free sulbactam/cefoperazone equivalent to sulbactam 500 mg and cefoperazone 500 mg in 1gm strength and equivalent to sulbactam 1000 mg and cefoperazone 1000 mg in 2g injection. It does not contain any excipients.
 

Indications

Monotherapy: 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. Combination Therapy: Because of the broad spectrum of activity of sulbactam/cefoperazone, most infections can be treated adequately with this antibiotic alone. However, SULPRON may be used concomitantly with other antibiotics if such combinations are indicated. If an aminoglycoside is used, renal function should be monitored during the course of therapy.
 

Contraindications

Patients with known allergy to penicillins, sulbactam, cefoperazone or any of the cephalosporins.
Use in pregnancy: Should be used during pregnancy only if clearly needed.
Use in lactation: Only small quantities of sulbactam and cefoperazone are excreted in human milk. Although both drugs pass poorly into breast milk of nursing mothers, caution should be exercised when sulbactam/cefoperazone is administered to a nursing mother.
Use in children: Sulbactam/cefoperazone has been effectively used in infants. It has not been extensively studied in premature infants or neonates. Therefore, in treating premature infants and neonates, potential benefits and possible risks involved should be considered before instituting therapy.
 

Adverse Drug Reactions

Diarrhea/loose stools (3.9%), nausea and vomiting (0.6%), hypersensitivity manifested by maculopapular rash (0.6%) and urticaria (0.08%). Slight decreases in neutrophils (0.4%), neutropenia (0.5%), Decreased hemoglobin (0.9%) or hematocrit (0.9%). Transient eosinophilia (3.5%) and thrombocytopenia (0.8%), Headache (0.04%), fever (0.5%), injection pain (0.08%) and chills (0.04%).
 

Storage

As reconstituted solution in vial, SULPRON remains stable for 24 hrs when stored at or below room temperature.
 

Dosage

Adults: 2-4g daily, Doses should be administered every 12 hrs in equally divided doses. In severe or refractory infections, the daily dosage of sulbactam/cefoperazone may be increased up to 8 g. Children: 40-80mg/kg/day. Doses should be administered every 6-12 hrs 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. Neonates: For neonates in the 1st week of life, SULPRON should be given every 12 hrs. The maximum daily dosage of sulbactam in pediatrics should not exceed 80 mg/kg/day.
Patients with Renal Dysfunction: Dosage regimens of sulbactam/cefoperazone should be adjusted in patients with marked decrease in renal function. 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.

Intravenous Injections

For intermittent infusion, each vial of sulbactam/cefoperazone should be reconstituted with the appropriate amount of 5% Dextrose in Water, 0.9% Sodium Chloride Injection or Sterile Water for Injection and then diluted to 20 mL with the same solution followed by administration over 15-60 min. For IV injection, each vial should be reconstituted as mentioned previously and administered over a minimum of 3 min.

Intramascular

5% Dextrose in Water, 0.9% Sodium Chloride Injection or Sterile Water for Injection should be used for reconstitution. Lidocaine HCl 2% is a suitable vehicle for IM administration, however, not for initial reconstitution (see Incompatibilities under Interactions).

Presentations Available

SULPRON 1g: Pack of 1g vial + 5ml sterile water for injection; SULPRON 2g: pack of 2g vial 10 ml sterile water for injection


MORE PRODUCTS >