Actavis Piperacillin/Tazobactam

Company: Actavis Ireland Ltd.
Legal category: Prescription. Hospital. Sport permitted.
Active ingredients: Piperacillin Na⁺/tazobactam Na⁺ 2.25g (2g/0.25g), 4.5g (4g/0.5g).
Description: Powder for solution for injection or infusion.
Presentation: Prices on request.
Indications: Treatment of moderate to severe systemic and/or local bacterial infections in which β-lactamase producing bacteria are suspected or have been detected. Adults/adolescents/elderly: Nosocomial pneumonia, complicated UTIs (including pyelonephritis), intra-abdominal infections, skin and soft tissue infections, bacterial infections in neutropenic patients. Children (2-12 years): Bacterial infections in neutropenic children.

Pharmacology: Piperacillin, a broad spectrum, semisynthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam, a triazolylmethyl penicillanic acid sulphone, is a potent inhibitor of many β-lactamases, in particular the plasmid-mediated enzymes which commonly cause resistance to penicillins and cephalosporins including third-generation cephalosporins.
Dosage: Slow intravenous injection (over at least 3-5 minutes) or slow intravenous infusion (over 20-30 minutes). Adult: Usual dose is 4.5g every 8 hours; total daily dose range is 2.25g to 4.5g every 6-8 hours depending on severity and localisation of infection. Neutropenia: Recommended dose is 4.5g every 6 hours with an aminoglycoside. Renal impairment: See SPC. Elderly: As per adults. Children: Under 2 years, not recommended. Neutropenia in 2-12 years: < 40 kg, adjust dose to 90mg per kg every 6 hours with an aminoglycoside; maximum dose 4.5g every 6 hours. Renal impairment: See SPC. Over 12 years, as per adults.
Contraindications: Hypersensitivity to the active substances, to other β-lactams (e.g. penicillins, cephalosporins) or to any other β-lactamase inhibitor.
Special precautions: Hypersensitivity to penicillins, cephalosporins and other allergens (discontinue if occurs). May occur: Pseudomembranous colitis (discontinue); leukopenia and neutropenia (periodically assess full blood counts); bleeding manifestations (discontinue); emergence of resistant organisms; neuromuscular excitability or convulsions (at IV doses higher than recommended); hypokalaemia (patients with low K⁺ reserves; perform periodic electrolyte determinations); modest elevations of liver function indices; fever and rash (cystic fibrosis patients). Periodically assess organ system functions, including renal and hepatic (during prolonged therapy). Pregnancy, lactation (only if clearly indicated). Contains Na⁺.
Drug interactions: Caution: Probenecid, tobramycin and gentamicin (severe renal dysfunction), heparin, oral anticoagulants and other drugs affecting coagulation including thrombocyte function, vecuronium or non depolarising muscle relaxants (peri-operative), methotrexate. May give false-positives for glucose in urine using copper-reduction method, and for Aspergillus using Bio-Rad Labs Platelia Aspergillus EIA test.
Adverse drug reactions: GI disorders, rash (including maculopapular rash).
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: 1890 333231. Fax: (021) 4619049. E-mail: contact@actavis.ie