Indications of Brodactam (4 gm+0.5 gm)/vial
Piperacillin and tazobactam is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the ... Read morePiperacillin and tazobactam is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.Intra-abdominal Infections: Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus.Skin and Skin Structure Infections: Uncomplicated and complicated skin and skin structure infections, including Cellulites, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus.Female Pelvic Infections: Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli.Community-acquired pneumonia: Community-acquired pneumonia (moderate severity only) caused by β lactamase producing isolates of Haemophilus influenzae.Nosocomial pneumonia: Nosocomial pneumonia (moderate to severe) caused by β-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumanii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside).
Broad spectrum penicillins, Other beta-lactam Antibiotics
Piperacillin, a broad spectrum, semi-synthetic 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 is a penicillanic acid sulfone derivative with β-lactamase inhibitory properties. In combination, tazobactam enhances the activity of piperacillin against β-lactamase-producing bacteria. Piperacillin and tazobactam has a wide range of activity and is active against gm+ve and gm-ve aerobic and anaerobic bacteria.
Dosage & Administration of Brodactam (4 gm+0.5 gm)/vial
Adults and children over 12 years: Piperacillin & Tazobactam may be given by slow intravenous infusion (over 20-30 minutes). The usual dosage for adults and children over 12 years is Piperacillin 4 gm and Tazobactam 0.5 gm IV infusion given every eight hours. The total daily dose of Piperacillin & Tazobactam depends on the severity and localization of the infection and can vary from 2.25 gm to 4.50 gm administered every six or eight hours. In neutropenia the recommended dose is Piperacillin 4 gm and Tazobactam 0.5 gm given every six hours in combination with an aminoglycoside.For children weighing less than 40 kg: The dose should be adjusted to 90 mg/kg administered every six hours, in combination with an aminoglycoside, not exceeding 4.5 gm every six hours. Children under 2 years: Piperacillin & Tazobactam is not recommended for use in children below 2 years old due to insufficient data on safety.
Dosage of Brodactam (4 gm+0.5 gm)/vial
Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam 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). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.
Interaction of Brodactam (4 gm+0.5 gm)/vial
Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary. Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.
Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.
Side Effects of Brodactam (4 gm+0.5 gm)/vial
Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).
Pregnancy & Lactation
Pregnancy Category B. Piperacillin and tazobactam cross the placenta in humans. Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied. Caution should be exercised when piperacillin and tazobactam for IV infusion is administered to a nursing woman
Precautions & Warnings
Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.
Overdose Effects of Brodactam (4 gm+0.5 gm)/vial
There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Use In Special Populations
Pediatric Use: Use of piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. Safety and efficacy in pediatric patients less than 2 months of age have not been established. There are no dosage recommendations for piperacillin and tazobactam in pediatric patients with impaired renal function.Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal insufficiency.
Reconstitute initially (2.25 g in 10 mL, 4.5 g in 20 mL) with water for inj, glucose 5% or NaCl 0.9%, then further dilute to 50-150 mL with compatible infusion soln.
Broad spectrum penicillins, Other beta-lactam Antibiotics
Mode Of Action
Piperacillin, a broad spectrum, semi-synthetic 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 is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.
Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.
Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients