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Doribax (Doripenem) Powder for solution 500 mg 10 bottle

Doribax (Doripenem) Powder for solution 500 mg 10 bottle

Brand: Janssen
Product Code: 169
Availability: In Stock
Price: $450.00
Qty:     - OR -  

Doribax - antibacterial drug, carbapenemase a synthetic broad-spectrum antibiotic.

Indications and dosage: Doribax is indicated for the treatment of infections caused by strains of bacteria sensitive to doripenem: nosocomial pneumonia, including pneumonia associated with mechanical ventilation; complicated intra-abdominal infections; complicated urinary tract infections, including complicated and uncomplicated pyelonephritis with/without concomitant bacteremia.Before application of the drug Doribax should do a skin test for tolerability. Doribax to use 500 mg every 8 hours as an infusion over 1-4 hours. Course — 5-14 days.

Overdose:In phase 1 studies in healthy volunteers, who received 2 g doripenem by1-hour infusion every 8 hours 10 to 14 days, there was a high frequency of rash (5 of 8 patients). The rash disappeared within 10 days after the application doripenem.In case of overdose, discontinue the introduction of Doribax i implement support measures to its elimination by the kidneys. Doribax is removed from the body by hemodialysis, but not documented a single case of the use of hemodialysis in overdose.

Contraindications:Doribax is contraindicated in patients with known hypersensitivity to doripenem or other carbapenems, as well as patients who have had was anaphylactic reactions to beta-lactam antibiotics.

Composition and properties:1 vial contains doripenem monohydrate 500 mg (anhydrous substance).

Form release: Powder for preparation of solution for infusion 500 mg vial, № 1, № 10

Pharmacological action: Doribax has strong in vitro activity against aerobic and anaerobic gram-positive and gram-negative bacteria. Compared to imipenem and Meropenem it 2 - 4 times more active on P. aeruginosa.Doribax has a bactericidal effect by inhibiting biosynthesis of the bacterial cell wall. Doribax penitsillinazoy inactivate many important proteins (PRP), which leads to inhibition of cell wall synthesis and subsequent cell death. Most affinity regarding PSB S. aureus 1, 2 and 4. In E. coli cells and P. Doribax aeruginosa binds strongly with PSB 2, which is involved in maintaining the bacterial shape of the cells, as well as with PSB 3 and 4.In vitro studies showed that Doribax weakly inhibits the action of other antibiotics, and is not suppressed by antibiotics. Described additive activity or weak synergy with amikacin and levofloxacin regarding P. aeruginosa and against gram-positive bacteria with daptomycin, levofloxacin and vancomycin.Preclinical studies of the correlation of pharmacokinetics / pharmacodynamics (PK / PD) showed that like other beta-lactam antibiotics, the time during which the concentration of Doribax in plasma exceeds that of the IPC (% T> MEC) against the infecting pathogen, is best correlated with its efficiency. The value of the ratio FC / FD is not significantly dependent on genera and species of bacteria or bacterial resistance to antibiotics of other classes. In the model neutropenia in mice% T> IPC Doribax ranged from 12% to 29% relative to the bacteriostatic effect; from 21% to 36% to reduce the number of bacteria 1 log10 on and from 27% to 43% to reduce the number of bacteria 2 log10. The time during which the concentration exceeded Doribax MICK needed to identify its bacteriostatic effect on P. aeruginosa and to reduce the number of bacteria 1 log10 was 23 and 28%, respectively.A conservative estimate of the% T> IPC is equal to 35-40% was used in the studies phase 3 to select doses for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. Modeling Monte Carlo simulation using data on the sensitivity of microorganisms obtained in the completed phase 3 studies and data on population pharmacokinetics showed that the target of 35% T> MICK was achieved in more than 90% of patients with nosocomial pneumonia, complicated infections of the urinary tract and complicated intra-abdominal infections, regardless of kidney function.The increase in time infusion Doribax to 4 hours ensures maximum% T> MIK for a specific dose and is the basis for the guidelines for 4-hour infusions in patients with nosocomial pneumonia, including pneumonia associated with mechanical ventilation if there is risk that the infection caused by less sensitive pathogens. The simulation results Monte Carlo simulation confirmed the feasibility of 500 mg 4-hour infusion every 8 ??h in patients with normal renal function for infections caused by pathogens for which the MIC is Doribax? 4 mg / l. Similarly,% T> IPC increases with increasing dose. Modeling Monte Carlo simulation showed that the 1-hour and 4-hour infusion of 1 g every 8 ??h provide a 99% probability of target T> 35% for MICK? 4 mg / l? 8 mg / l, respectively.Mechanisms of resistance of bacteria to it doripenem include inactivation of enzymes hydrolyze carbapenems, mutant or acquired PSB, reducing the permeability of the outer membrane and active outflow of Doribax from the cell. Doribax stable to hydrolysis by most beta-lactamases, including penicillinase and cephalosporinase produced by gram-positive and gram-negative bacteria, except for relatively rare carbapenemase beta-lactamase. Selection in vitro of resistant strains of P. aeruginosa at a concentration 4 times higher than the MIC (IPC), occurred with a frequency of <2x10-9 for seven of the eight strains exposed to Doribax, which was lower than the frequency of selection for ertapenem, imipenem , Meropenem, carbenicillin, ceftazidime, ciprofloxacin and tobramycin. Despite the probability of the existence of cross-resistance, some strains resistant to other carbapenems sensitive doripenem.Storage conditions: Store Doribax out of reach of children. In the original packaging at a temperature not exceeding 30 ° C.

Storage of the prepared solution. After dissolution in sterile water for injection or 0.9% sodium chloride solution (saline), a suspension of Doribax can be stored in the vial for 1 hour prior to its dilution in infusion solution.

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