Therapeutic Index

Each tablet contains:
Piperacillin Sodium / Tazobactam Sodium for Injection

Composition:
Pipranem Inj - 1.125 gm
Each vial contains
Piperacillin sodium equivalent to Piperacillin………….. 1gm
Tazobactam sodium equivalent to Tazobactam………. 125mg

Pipranem Inj  2.25 gm
Each vial contains
Piperacillin sodium equivalent to Piperacillin………….. 2gm
Tazobactam sodium equivalent to Tazobactam………. 250mg

Pipranem Inj  4.5 gm
Each vial contains
Piperacillin sodium equivalent to Piperacillin………….. 4gm
Tazobactam sodium equivalent to Tazobactam………. 500 mg

INDICATIONS
Pipranem Inj  for injection is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam susceptible, beta -lactamase producing strains of the designated microorganisms in the specified conditions listed below:

Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, beta-lactamase producing strains of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus .

Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by piperacillin-resistant, beta-lactamase producing strains of Staphylococcus aureus .

Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, beta-lactamase producing strains of Escherichia coli .

Community-acquired pneumonia (moderate severity only) caused by piperacillin-resistant, beta-lactamase producing strains of Haemophilus influenzae .

Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant, beta-lactamase producing strains of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumannii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa. (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside).

Infections caused by piperacillin-susceptible organisms, for which piperacillin has been shown to be effective, are also amenable to piperacillin/ tazobactam treatment due to its piperacillin content. The tazobactam component of this combination product does not decrease the activity of the piperacillin component against piperacillin-susceptible organisms. Therefore, the treatment of mixed infections caused by piperacillin-susceptible organisms and piperacillin-resistant, beta-lactamase producing organisms susceptible to piperacillin /tazobactam should not require the addition of another antibiotic.

Piperacillin / Tazobactam is useful as presumptive therapy in the indicated conditions prior to the identification of causative organisms because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic organisms.

DOSAGE AND ADMINISTRATION

Pipranem Inj  should be administered by intravenous infusion over 30 minutes.

Adults: The usual total daily dose of Pipranem Inj  is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam).

Initial presumptive treatment of patients with nosocomial pneumonia should start with Pipranem Inj  at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeruginosa is isolated. If Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician.

CONTRAINDICATIONS :

Pipranem Inj  is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.

PACKAGING INFORMATION :

Pipranem Inj   1.125 gm injection is available in vial of 10 mL
Pipranem Inj   2.25 gm injection is available in vial of 20 mL
Pipranem Inj   4.5 gm injection is available in vial of 30 mL


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