Zolibac IM/IV Injection

Zolibac is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory Tract Infections, Urinary Tract Infections, Skin and Skin Structure Infections, Biliary Tract Infections, Bone and Joint Infections, Genital Infections, Septicemia, Endocarditis and Perioperative Prophylaxis.

Cefazolin is a 1st generation broad spectrum parenteral Cephalosporin antibiotic.It interferes with the synthesis of bacterial cell wall by inhibiting transpeptidase enzyme. As a result the bacterial cell wall is weakened,the cell swells and then ruptures.

Adult Dose

• Moderate to severe infection: 500 mg to 1 gm for every 6 to 8 hours
• Mild infections caused by susceptible Gram-positive cocci: 250 mg to 500 mg for every 8 hours
• Acute uncomplicated urinary tract infections: 1 gm for every 12 hours
• Pneumococcal pneumonia: 500 mg for every 12 hours
• Severe life-threatening infections (e.g. Endocarditis, Septicemia): 1 gm to 1.5 gm for every 6 hours. In rare instances, doses up to 12 gm per day can be used

Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are:

• 1 gm IM or IV administered half hour to 1 hour prior to the start of surgery.
• For lengthy operative procedures (e.g. 2 hours or more), 500 mg to 1 gm IM or IV during surgery.
• 500 mg to 1 gm IM or IV every 6 to 8 hours for 24 hours postoperatively.

In surgery where the occurrence of infection may be particularly devastating (e.g. open-heart surgery and prosthetic arthroplasty), the prophylactic administration may be continued for 3 to 5 days following the completion of surgery.

Probenecid may decrease renal tubular secretion of Cephalosporins when used concurrently, resulting in increased and more prolonged Cephalosporin blood levels.

Cefazolin is contraindicated in patients with known allergy to the Cephalosporin group of Antibiotics.

Common side effects include:Injection site reactions (pain, swelling, skin rash, or a hard lump), diarrhea, stomach pain, stomach cramps, nausea, vomiting, loss of appetite, skin rash or itching, hives, white patches or sores inside the mouth or on the lips, vaginal itching or discharge,heartburn, gas,rectal itching,confusion, weakness, hypotension, drowsiness, headache and allergic reactions.

Pregnancy Category B. Cefazolin is present in very low concentrations in the milk of nursing mothers.Caution should be exercised when Cefazolin is administered to a nursing woman.

• As with all Cephalosporins, Zolibac should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly Colitis.
• As with other β-lactam antibiotics, seizures may occur if inappropriately high doses are administered to patients with impaired renal function.

Patients with Impaired Renal Function:

• Creatinine clearance 35 to 54 ml/min: 1 unit dose (based on unit doses of 500 mg & 1 gm) Every 8 hours
• Creatinine clearance 11 to 34 ml/min: ½ unit dose (based on unit doses of 500 mg & 1 gm) Every 12 hours
• Creatinine clearance 10 ml/min: ½ unit dose (based on unit doses of 500 mg & 1 gm) Every 18 to 24 hours

Patients with Hepatic Insufficiency: No dosage adjustment is necessary in patients with hepatic insufficiency.

Pediatric Dose: In pediatric patients, a total daily dosage of 25 to 50 mg per kg of body weight, divided into 3 or 4 equal doses, is effective for most mild to moderate infections. Total daily dosage may be increased to 100 mg per kg of body weight for severe infections. Safety for use in premature infants and in neonates has not been established.

First generation Cephalosporins

The content of one vial is to be dissolved in 2 ml (for 500 mg IM/IV Injection) & 2.5 ml (for 1 gm IM/IV Injection) Water for Injection.

After reconstitution, Zolibac is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C). Reconstituted solution may range in color from pale yellow to yellow without a change in potency.