Tazocin 4.5 g Powder Injection for Intravenous Use

Approved Indication/s for Use:

• For the treatment of patients with moderate to severe infections caused by piperacillin resistant, piperacillin/tazobactam susceptible, β-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, β-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, β-lactamase producing strains of Staphylococcus aureus.
• Postpartum endometritis or pelvic inflammatory disease caused by piperacillin resistant, β- lactamase producing strains producing strains of Escherichia coli.
• Community-acquired pneumonia (moderate severity only) caused by piperacillin resistant, β-lactamase producing strains of Haemophilus influenzae.

• As a combination product :

o        Infections caused by piperacillin susceptible organisms, for which piperacillin  has been shown to be effective are also amenable to TAZOCIN treatment due to its piperacillin content. 

o        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.

Contraindications:

·         Hypersensitivity to any of the beta-lactams (including penicillins and cephalosporins) or to betalactamase inhibitors.

Special Warnings:   (see product insert for full prescribing information)

• Before initiating therapy with piperacillin/tazobactam, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid [including shock]) reactions have been reported in patients receiving therapy with penicillins including piperacillin/tazobactam.

• These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. Serious hypersensitivity reactions require the discontinuation of the antibiotic, and may require administration of epinephrine and other emergency measures.

• Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.

Precautions:  (see product insert for full prescribing information)

• Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. 

·         May increase a patient’s overall sodium intake. Hypokalemia may occur in patients with low potassium reserves or who are receiving concomitant medications that may lower potassium levels.

·         Leukopenia and neutropenia may occur, especially during prolonged therapy.

Use in Patients with Renal Impairment :  The intravenous dose should be adjusted to the degree of renal function impairment.

Pregnancy:  Pregnant women should be treated only if the expected benefit outweighs the possible risks to the pregnant woman and fetus.

Lactation:  Women who are breast-feeding should be treated only if the expected benefit outweighs the possible risks to the woman and child.

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Geriatric use : Dosage should be adjusted in the presence of renal insufficiency

Interactions:

• Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium.

·         During simultaneous administration of heparin, oral anticoagulants and other drugs that may affect the blood coagulation system including thrombocyte function, appropriate coagulation tests should be performed more frequently and monitored regularly.

• Piperacillin may reduce the excretion of methotrexate; therefore, serum levels of methotrexate should be monitored in patients to avoid drug toxicity.

·         Concurrent administration of probenecid and piperacillin/tazobactam produces a longer half-life and lower renal clearance for both piperacillin and tazobactam.

 
Adverse Reactions:   (see product insert for full prescribing information)

• Common (³ 1%) adverse reactions include diarrhea, nausea, vomiting, rash

·         See product insert for the uncommon, rare and very rare adverse reactions.

·         Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the

            presence of renal failure).                                                           

Dosage and Administration:  (see product insert for full prescribing information)

• Piperacillin/tazobactam must be given by slow intravenous infusion (e.g., over 20-30 minutes) or slow intravenous injection (over at least 3-5 minutes).

• Duration of Therapy : The duration of therapy should be guided by the severity of the infection and the patient’s clinical and bacteriological progress.
• Adults and Children 12 Years and Older : In general, recommended total daily dosage is 12 g piperacillin /1.5 g tazobactam given in divided doses every 6 or 8 hours. Doses as high as 18g piperacillin /2.25 g tazobactam per day in divided doses can be used in severe infections.

Availability :    Box of 10 vials (1 vial @ 4.5 g)