Release date- 29072019 - KENILWORTH - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending ZERBAXA 3g dose (ceftolozane and tazobactam
) for an additional indication for the treatment of hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), in adults.
Piperacillin, given in combination with efficiency-booster tazobactam
, is a broad-spectrum antibiotic used to combat serious infections such as sepsis or pn eumonia.
The United States Food and Drug Administration (FDA) has approved a new indication for the earlier approved Zerbaxa (ceftolozane and tazobactam
) intended for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older, it was reported yesterday.
Biopharmaceutical company Merck (NYSE:MRK) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for the use of ZERBAXA (ceftolozane and tazobactam
) for the treatment of patients 18 years and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) that are proven or strongly suspected to be caused by susceptible bacteria.
Piperacillin-tazobactam (PTZ) is a combination of piperacillin and the blactamase inhibitor tazobactam
. Piperacillin-tazobactam has a broad-spectrum antibacterial activity that covers aerobic gram-positive, gram-negative, and anaerobic bacteria but does not cover MRSA [2, 3].
In a pilot study, piperacillin (87 mg/kg) in combination with tazobactam
(11 mg/kg) was administered intramuscularly (IM) to 2 birds, and blood samples were obtained at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours after administration.
Escherichia coli ATCC 25922,Pseudomonas aeruginosa ATCC 27853 and Staphylococcus aureus ATCC 25923 were used as quality control strains.Antimicrobial discs used for sensitivity testing by disc diffusion method were Imepenem 10mcg, piperacillin/ tazobactam
100/10 mcg, Ceftazidime 30mcg Cefotaxime 30mcg, Amikacin 30mcg, Gentamicin 10mcg, Levofloxacin 5mcg, Ceftroaxone 30 mcg, Cefoxitin 30mcg, Amoxycillin/ Clavulanic acid 20/10mcg.
cefixime, ceftazidime, co-trimoxazole, ciprofloxacin, gentamicin, amikacin, cefoperazone + sulbactam, piperacillin + tazobactam
, meropenem, polymyxin - B, and aztreonam were used.
coli susceptibility rate by year in community isolates 2011 2012 2013 2014 n = 123 n = 119 11 = 110 11 = 139 Ampicillin -- -- -- -- Amoxicillin- clavulanic 79% 72% 75% 77% acid Piperacillin- 93% 96% 94% 96% tazobactam
Cefuroxime 95% 95% 96% 98% Cefotaxime 98% 99% 100% 99% Ceftazidime 100% 99% 100% 99% Imipenem 98% 100% 99% 100% Gentamicin 92% 94% 91% 96% Cotrimoxazole 73% 74% 81% 75% Nitrofurantoin 98% 100% 98% 100% Fosfomycin 99% 100% 99% 100% E.
They tested 12 of the most common types of antibiotics, finding that two combinations in particular - piperacillin and tazobactam
, and imipenem and cilastatin - led to a higher risk of a life-threatening inflammatory condition called graft-versus-host disease (GVHD).
Although bone marrow suppression with leucopenia is mentioned as an important side effect of piperacillin/ tazobactam
, isolated thrombocytopenia without affection of red cells and leucocytosis has been reported only in few cases.