Zolibac Injection 1 gm/5 ml

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Indications

Cefazolin 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.

Therapeutic Class

First generation Cephalosporins

Pharmacology

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.

Dosage & Administration

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.

Interaction

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.

Contraindications

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

Side Effects

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 & Lactation

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.

Precautions & Warnings

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.

Use in Special Populations

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.

Reconstitution

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.

Storage Conditions

After reconstitution, Cefazolin is stable for 24 hours at room temperature or for 10 days if stored under refrigeration (5°C or 41°F). Reconstituted solution may range in color from pale yellow to yellow without a change in potency.

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