"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Therapeutic: PIPRACIL (piperacillin sodium) is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Intra-Abdominal Infections including hepatobiliary and surgical infections caused by E. coli, Pseudomonas aeruginosa, enterococci, Clostridium spp., anaerobic cocci, or Bacteroides spp., including B. fragilis.
Urinary Tract Infections caused by E. coli, Klebsiella spp., P. aeruginosa, Proteus spp., including P. mirabilis, or enterococci.
Gynecologic Infections including endometritis, pelvic inflammatory disease, pelvic cellulitis caused by Bacteroides spp., including B. fragilis, anaerobic cocci, Neisseria gonorrhoeae, or enterococci (E. faecalis).
Septicemia including bacteremia caused by E. coli, Klebsiella spp., Enterobacter spp., Serratia spp., P. mirabilis, S. pneumoniae, enterococci, P. aeruginosa, Bacteroides spp., or anaerobic cocci.
Lower Respiratory Tract Infections caused by E. coli, Klebsiella spp., Enterobacter spp., P. aeruginosa, Serratia spp., H. influenzae, Bacteroides spp., or anaerobic cocci. Although improvement has been noted in patients with cystic fibrosis, lasting bacterial eradication may not necessarily be achieved.
Skin and Skin Structure Infections caused by E. coli, Klebsiella spp., Serratia spp., Acinetobacter spp., Enterobacter spp., P. aeruginosa, Morganella morganii, Providencia rettgeri, Proteus vulgaris, P. mirabilis, Bacteroides spp., including B. fragilis, anaerobic cocci, or enterococci.
Bone and Joint Infections caused by P. aeruginosa, enterococci, Bacteroides spp., or anaerobic cocci.
Uncomplicated Gonococcal Urethritis caused by N. gonorrhoeae.
PIPRACIL (piperacillin sodium) has also been shown to be clinically effective for the treatment of infections at various sites caused by Streptococcus species including S. pyogenes and S. pneumoniae; however, infections caused by these organisms are ordinarily treated with more narrow spectrum penicillins. Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, PIPRACIL (piperacillin sodium) is particularly useful for the treatment of mixed infections and presumptive therapy prior to the identification of the causative organisms.
Also, PIPRACIL (piperacillin sodium) may be administered as single drug therapy in some situations where normally two antibiotics might be employed.
Piperacillin has been successfully used with aminoglycosides, especially in patients with impaired host defenses. Both drugs should be used in full therapeutic doses.
Appropriate cultures should be made for susceptibility testing before initiating therapy and therapy adjusted, if appropriate, once the results are known.
Prophylaxis: PIPRACIL (piperacillin sodium) is indicated for prophylactic use in surgery including intra-abdominal (gastrointestinal and biliary) procedures, vaginal hysterectomy, abdominal hysterectomy, and cesarean section. Effective prophylactic use depends on the time of administration; PIPRACIL (piperacillin sodium) should be given one-half to one hour before the operation so that effective levels can be achieved in the site prior to the procedure.
The prophylactic use of piperacillin should be stopped within 24 hours, since continuing administration of any antibiotic increases the possibility of adverse reactions, but in the majority of surgical procedures, does not reduce the incidence of subsequent infections. If there are signs of infection, specimens for culture and susceptibility testing should be obtained for identification of the causative microorganism so that appropriate therapy can be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIPRACIL (piperacillin sodium) and other antibacterial drugs, PIPRACIL (piperacillin sodium) should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
PIPRACIL (piperacillin sodium) may be administered by the intramuscular route (see NOTE) or intravenously as a three- to five-minute intravenous injection or as a 20- to 30-minute infusion. The usual dosage of PIPRACIL (piperacillin sodium) for serious infections is 3 to 4 g given every four to six hours as a 20- to 30-minute infusion. For serious infections, the intravenous route should be used.
PIPRACIL (piperacillin sodium) should not be mixed with an aminoglycoside in a syringe or infusion bottle since this can result in inactivation of the aminoglycoside.
The maximum daily dose for adults is usually 24 g/day, although higher doses have been used. Intramuscular injections (see NOTE) should be limited to 2 g per injection site. This route of administration has been used primarily in the treatment of patients with uncomplicated gonorrhea and urinary tract infections.
|Type of Infection||Usual Total Daily Dose|
|Serious infections such as septicemia, nosocomial pneumonia, intra-abdominal infections, aerobic and anaerobic gynecologic infections, and skin and soft tissue infections||12 - 18 g/d I.V. (200 -300 mg/kg/d) in divided doses every 4 to 6 h|
|Complicated urinary tract infections||8 - 16 g/d I.V. (125 -200 mg/kg/d) in divided doses every 6 to 8 h|
|Uncomplicated urinary tract infections and most community-acquired pneumonia||6 - 8 g/d I.M. or I.V. (100 -125 mg/kg/d) in divided doses every 6 to 12 h|
|Uncomplicated gonorrhea infections||2 g I.M.† as a one-time dose|
|† One g of probenecid should be given orally one-half hour prior to injection.|
The average duration of PIPRACIL (piperacillin sodium) treatment is from seven to ten days, except in the treatment of gynecologic infections, which is from three to ten days; the duration should be guided by the patient's clinical and bacteriological progress. For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for S. pyogenes infections should be maintained for at least ten days to reduce the risk of rheumatic fever.
When PIPRACIL (piperacillin sodium) is given concurrently with aminoglycosides, both drugs should be used in full therapeutic doses.
Dosage in Renal Impairment
|> 40||No dosage adjustment necessary|
|20-40||No dosage adjustment necessary||9 g/day
3 g every 8 h
4 g every 8 h
|< 20||6 g/day
3 g every 12 h
3 g every 12 h
4 g every 12 h
For patients on hemodialysis, the maximum daily dose is 6 g/day (2 g every 8 hours). In addition, because hemodialysis removes 30% to 50% of piperacillin in 4 hours, a 1-g additional dose should be administered following each dialysis period.
For patients with renal failure and hepatic insufficiency, measurement of serum levels of piperacillin will provide additional guidance for adjusting dosage.
When possible, PIPRACIL (piperacillin sodium) should be administered as a 20- to 30-minute infusion just prior to anesthesia. Administration while the patient is awake will facilitate identification of possible adverse reactions during drug infusion. (See PRECAUTION: DRUG INTERACTIONS.)
|INDICATION||1st Dose||2nd Dose||3rd Dose|
|Intra-abdominal Surgery||2 g I.V. just prior to surgery||2 g during surgery||2 g every 6 h Post-Op for no more than 24 h|
|Vaginal Hysterectomy||2 g I.V. just prior to surgery||2 g 6 h after 1st dose||2 g 12 h after 1st dose|
|Cesarean Section||2 g I.V. after cord is clamped||2 g 4 h after 1st dose||2 g 8 h after 1st dose|
|Abdominal Hysterectomy||2 g I.V. just prior to surgery||2 g on return to recovery room||2 g after 6 h|
Pediatric patients. Dosages in pediatric patients under 12 years of age have not been studied in adequate and well-controlled clinical trials (See CLINICAL PHARMACOLOGY).
PRODUCT RECONSTITUTION/DOSAGE PREPARATION
|Diluents for Reconstitution|
|Sterile Water for Injection||Sodium Chloride Injection|
|Bacteriostatic¶ Water for Injection||Bacteriostatic¶ Sodium Chloride Injection
Dextrose 5% in Water
Dextrose 5% and 0.9%
Lidocaine#HCl 0.5-1% (without epinephrine)
|¶Either Parabens or Benzyl
#For Intramuscular Use Only. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
|Intravenous Solutions||Intravenous Admixtures|
|Dextrose 5% in Water||Normal Saline [+ KCl 40 mEq]|
|0.9% Sodium Chloride||5% Dextrose in Water [+ KCl 40 mEq]|
|Dextrose 5% and 0.9% Sodium Chloride||5% Dextrose/Normal Saline [+ KCl 40 mEq]|
|Lactated Ringer's Injection† †||Ringer's Injection [+ KCl 40 mEq]|
|Dextran 6% in 0.9% Sodium Chloride||Lactated Ringer's Injection [+ KCl 40 mEq] † †|
|† † When PIPRACIL® is further diluted with Lactated Ringer's Injection, the diluted solution must be administered within 2 hours.|
Reconstitution Directions for Conventional Vials: Reconstitute each gram of PIPRACIL (piperacillin sodium) with at least 5 mL of a suitable diluent (except Lidocaine HCl 0.5%-1% without epinephrine) listed above. Shake well until dissolved. Reconstituted solution may be diluted to the desired volume (eg, 50 or 100 mL) in the above listed intravenous solutions and admixtures.
Directions for Administration
Intermittent IV Infusion
Infuse diluted solution over period of about 30 minutes. During infusion, it is desirable to discontinue the primary intravenous solution.
Intravenous Injection (Bolus)
Reconstituted solution should be injected slowly over a 3-to 5-minute period to help avoid vein irritation.
(Conventional Vials Only)
Reconstitution Directions: Reconstitute each gram of PIPRACIL (piperacillin sodium) with 2 mL of a suitable diluent listed above to achieve a concentration of 1 g per 2.5 mL. Shake well until dissolved.
Directions for Administration
When indicated by clinical and bacteriological findings, intramuscular administration of 6 to 8 g daily of PIPRACIL (piperacillin sodium) , in divided doses, may be utilized for initiation of therapy. In addition, intramuscular administration of the drug may be considered for maintenance therapy after clinical and bacteriologic improvement has been obtained with intravenous piperacillin sodium treatment. Intramuscular administration should not exceed 2 g per injection at any one site.
The preferred site is the upper outer quadrant of the buttock (ie, gluteus maximus).
The deltoid area should be used only if well-developed, and then only with caution to avoid radial nerve injury. Intramuscular injections should not be made into the lower or mid-third of the upper arm.
Stability of PIPRACIL (piperacillin sodium) Following Reconstitution
PIPRACIL (piperacillin sodium) is stable in both glass and plastic containers when reconstituted with recommended diluents and when diluted with the intravenous solutions and intravenous admixtures indicated above.
Pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20° to 25°C [68° to 77°F]), or after 48 hours if stored at refrigerated temperature (2° to 8°C [36° to 46°F]). Vials should not be frozen after reconstitution.
PIPRACIL® (piperacillin for injection) is available in vials containing freeze-dried piperacillin sodium powder equivalent to two, three, and four g of piperacillin. One g of piperacillin (as a monosodium salt) contains 1.85 mEq (42.5 mg) of sodium.
2 gram/Vial-10 per box-NDC 0206-3879-16
3 gram/Vial-10 per box-NDC 0206-3882-55
4 gram/Vial-10 per box-NDC 0206-3880-25
Store at controlled room temperature 20°C-25°C (68°F-77°F).
Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev 03/07. FDA revision date: 04/17/08This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/12/2008
Additional Pipracil Information
- Pipracil Drug Interactions Center: piperacillin inj
- Pipracil Side Effects Center
- Pipracil Overview including Precautions
- Pipracil FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
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