REENOCEF-XP (Ceftriaxone Sodium & Tazobactam Sodium )

Ceftriaxone sodium is a sterile, semisynthetic, broad spectrum cephalosporin antibiotic. Tazobactam sodium is a penicillinic acid sulfone Beta-lactamase inhibitor with a structure similar to that of sulbactam & clavulanic acid. It inactivates susceptible Beta-lactmase by irreversibly binding to the catalytic region of the enzyme. The combination of Tazobactam and ceftriaxone sodium is active against all the organisms resistant to Ceftriaxone.

COMPOSITION

Each vial contains sterile Ceftriaxone Sodium IP equivalent to Ceftriaxone Anhydrous 1000mg tazobactam Sodium equivalent to Tazobactam USP 125mg and 10 ml Water for Injection IP for IV injection.

DOSAGE FORM

Powder for reconstitution (intravenous (I.V)/intramuscular (I.M).

PHARMACOKINECTICS

Ceftriaxone interferes with the biosynthesis of the peptidoglycan component of the bacterial cell way by binding to and inactivating penicllin-binding proteins (PBPs). Tazobactam is a penicillanic acid sulfone derivative with beta-lactamase inhibitory properties. It enhances the activity of beta-lactam antibacterials against beta-lactamase-producing bacteria.

Distribution

Ceftriaxone: 98% bound to plasma proteins; crosses the blood brain barrier. Tazobactam: About 30% bound to plasma proteins; widely distributed to tissues and body fluids.

Excretion

Ceftriaxone: Elimination half-life is about 8.7 hours; 33-67% removed as unchanged drug. Tazobactam: Removed mainly via kidneys with 80% of an administered dose as unchanged drug.

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of REENOCEF-XP Injection, it should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. REENOCEF-XP Injection is mainly indicated in the following conditions: Lower respiratory tract infections and community-acquired pneumonia, Acute bacterial otitis media, Skin and skin structure infections, Urinary tract infections, Uncomplicated gonorrhea, Pelvic inflammatory disease, Bacterial septicemia, Bone and joint infections, Intra-abdominal infections, Bacterial meningitis, Pre-operative prophylaxis of infections associated with surgery

ADVERSE REACTION

Superinfection; anaphylaxis; diarrhoea; local reactions; blood dyscrasias; rash, fever, pruritus; elevated transaminases and alkaline phosphatase. GI effects; pseudomembranous colitis; hematologic effects; hypersensitivity reactions; CNS disturbances; hypertension; chest pain; edema; moniliasis; rhinitis; dyspnea; hypotension; ileus; syncope; local Inj site reactions; rigors.

Potentially Fatal: Pseudomembranous colitis; nephrotoxicity.

PRECAUTIONS

Information Not Available

SPECIAL PRECAUTIONS

History of penicillin allergy; lactation. Consider possibility of pseudomembranous colitis in patients who present with diarrhoea subsequent to the admin of antibacterial agents. Monitor prothrombin time in patients with impaired vitamin K synthesis or low vitamin K stores during treatment. Prolonged treatment may result in overgrowth of non-susceptible organisms. Caution in patients with a history of GI disease, especially colitis. Discontinue treatment in patients who develop signs/symptoms suggestive of gallbladder disease. Not to be used in hyperbilirubinemic neonates, especially premature.

PRECAUTIONS

Probenecid; aminoglycosides; vecuronium, methotrexate; oral anticoagulants; heparin. Potentially Fatal: Disulfiram-like reaction with alcohol. Nephrotoxicity with aminoglycosides and furosemide.

DOSAGE

Adult:

Expressed in terms of ceftriazone/tazobactam: 1000/125 mg once daily or in equally divided doses twice a day. Total daily dose should not exceed 4 g of ceftriaxone. Continue treatment for at least 2 days after the signs and symptoms have resolved. Usual duration: 7-14 days; longer treatment may be needed in more serious infections. For Streptococci pyogenes infections, treatment should continue for at least 10 days.

Child:

Expressed in terms of ceftriaxone: Serious infections: 50-75 mg/kg/day, given in divided doses every 12 hours. Total daily dose should not exceed 2 g of ceftriaxone. Continue treatment for at least 2 days after the signs and symptoms have resolved. Usual duration: 7-14 days; longer treatment may be needed in more serious infections. For Streptococci pyogenes infections, treatment should continue for at least 10 days.

PACKING

REENOCEF-XPis supplied as sterile powder in glass vial. REENOCEF-XPIV Injection: Combipack containing sterile Ceftriaxone Sodium IP equivalent to Ceftriaxone Anhydrous 1000mg tazobactam Sodium equivalent to Tazobactam USP 125mg and 10 ml Water for Injection IP for IV injection.