CEFOPERAZONE - INJECTION 1 gm

Cefoperazone for Injection U.S.P.

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Composition

Each vial contains:
Sterile Cefoperazone SodiumUSP
Equivalent to Cefoperazone 1000 mg

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Indications

• Respiratory tract infections • Peritonitis and other intra-abdominal infections • Bacterial septicemia • Infections of the skin and skin structures • Pelvic inflammatory disease, endometritis, and other infections of the female genital tract • Urinary tract infections • Enterococcal infections

Dosage and Administration

Sterile Cefoperazone sodium can be administered by IM or IV injection (following dilution). The usual adult daily dose is 2 to 4 grams per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6–12 grams divided into 2, 3, or 4 administrations ranging from 1.5 to 4 grams per dose. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

CONTRAINDICATIONS:

It is contraindicated in patients with known hypersensitivity to cephalosporin –class of antibiotics.

WARNINGS & PRECAUTIONS:

WARNINGS

Before therapy with Cefoperazone is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs. This product should be given cautiously to penicillin sensitive patients. Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures. Pseudomembranous colitis has been reported with the use of Cephalosporins (and other broad-spectrum antibiotics); therefore, it Is important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use.

PRECAUTIONS

Although transient elevations of the BUN and serum creatinine have been observed, cefoperazone alone does not appear to cause significant nephrotoxicity. However, concomitant administration of aminoglycosides and other cephalosporins has caused nephrotoxicity because renal excretion is not the main route of excretion of cefoperazone, patients with renal failure require no adjustment in the dosage when usual doses are administered. As with other antibiotics, vitamin deficiency has occurred rarely in patients treated with cefoperazone. Patient should be cautioned about ingestion of alcoholic beverages following the administration of cefoperazone.

DRUG-INTERACTIONS:

A false-positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solution.

PREGNANCY AND LACTATION:

Cefoperazone should not be used in pregnant women unless the benefit outweighs the risk. Cefoperazone is excreted in human breast milk in very low concentrations.Caution should be exercised when Cefoperazone is administered to a nursing woman.

UNDESIRABLE EFFECTS:

Hypersensitivity – Skin reactions, drug fever, or a Coombs’ test may likely occur in patients with a history of allergies, particularly to penicillins. Hematology – Reversible neutropenia may occur with prolonged administration. Slight decrease in neutrophil count , hemoglobins or hematocrit have been reported. Hepatic – Patient with a history of liver disease may develop significantly elevated liver function enzymes during cefoperazone therapy. After cefoperazone therapy was discontinued, the patient’s hepatic enzyme returned to pre – treatment level. Gastrointestinal – Diarrhoea or loose motion has been reported in some patients. These symptoms responded to symptomatic therapy and ceased when cefoperazone therapy was stopped. Local Reactions: It is well tolerated following intramuscular administration. Occasionally, transient pain (1 in 140) may follow administration by this route. When CEFOPERAZONE is administered by intravenous infusion some patients may develop phlebitis (1 in 120) at the infusion site because cefoperazone has no activity against this organism.

PHARMACOLOGICAL ACTION:

Cefoperazone is active in vitro against a wide range of aerobic and anaerobic, gram-positive and gram-negative pathogens. The bactericidal action of Cefoperazone results from the inhibition of bacterial cell wall synthesis. Cefoperazone has a high degree of stability in the presence of beta-lactamases produced by most gram-negative pathogens. Cefoperazone is usually active against organisms which are resistant to other beta-lactam antibiotics because of beta-lactamase production.

STORAGE INSTRUCTIONS:

Store below 25°C , in a dry place. Protect from light.

NATURE AND CONTENTS OF CONTAINER:

A vial of 1000 mg is packed in a printed Primary Carton along with the Pack Insert.

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