Alburx

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• Csl Behring Ag
  

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  Alburx | Direct Rx

  

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  2.1 Recommended Dosing Schedule

   Pantoprazole is supplied as delayed-release tablets. The recommended dosages are outlined in Table 1.

   Table 1: Recommended Dosing Schedule for Pantoprazole

  Indication Dose Frequency Short-Term Treatment of Erosive Esophagitis Associated With GERD Adults 40 mg Once daily for up to 8 weeks* Children (5 years and older)
   ≥ 15 kg to < 40 kg
   ≥ 40 kg
  20 mg
  40 mg
  Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis Adults 40 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults 40 mg Twice daily**

   * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole may be considered.

   ** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.

  2.2 Administration Instructions

   Directions for method of administration for pantoprazole sodium delayed-release tablets are presented in Table 2.

  Table 2: Administration Instructions

  Formulation

  Route

  Instructions*

  Delayed-Release Tablets

  Oral

  Swallowed whole, with or without food

   * Patients should be cautioned that Pantoprazole Sodium Delayed-Release Tablets should not be  split, chewed, or crushed.

  Pantoprazole Sodium Delayed-Release Tablets USP

  Pantoprazole sodium delayed-release tablets USP should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed‑release tablets USP.

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• Csl Behring Ag
  

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  Alburx | Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.

  

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  ZOSYN should be administered by intravenous infusion over 30 minutes.

  2.1 Adult Patients

  The usual total daily dose of ZOSYN 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 ZOSYN treatment is from 7 to 10 days.

  ZOSYN should be administered by intravenous infusion over 30 minutes.

  2.2 Nosocomial Pneumonia

  Initial presumptive treatment of patients with nosocomial pneumonia should start with ZOSYN 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 ZOSYN treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.

  2.3 Renal Impairment

  In patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of ZOSYN should be reduced to the degree of actual renal function impairment. The recommended daily doses of ZOSYN for patients with renal impairment are as follows:

  Table 1: Recommended Dosing of ZOSYN in Patients with Normal Renal Function and Renal - Impairment (As total grams piperacillin/tazobactam) Renal Function (creatinine clearance, mL/min) All Indications (except nosocomial pneumonia) Nosocomial Pneumonia * Creatinine clearance for patients not receiving hemodialysis † 0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days >40 mL/min 3.375 q 6 h 4.5 q 6 h 20–40 mL/min* 2.25 q 6 h 3.375 q 6 h <20 mL/min* 2.25 q 8 h 2.25 q 6 h Hemodialysis† 2.25 q 12 h 2.25 q 8 h CAPD 2.25 q 12 h 2.25 q 8 h

  For patients on hemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g ZOSYN (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of ZOSYN is necessary for CAPD patients.

  2.4 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 ZOSYN 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 ZOSYN dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.

  It has not been determined how to adjust ZOSYN dosage in pediatric patients with renal impairment.

  2.5 Reconstitution and Dilution of Powder Formulations

  Pharmacy bulk vials

  Reconstituted stock solution must be transferred and further diluted for intravenous infusion.

  The pharmacy bulk vial is for use in a hospital pharmacy admixture service only under a laminar flow hood. After reconstitution, entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and contents should be dispensed as aliquots into intravenous solution using aseptic technique. Use entire contents of pharmacy bulk vial promptly. Discard unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

  Reconstitute the pharmacy bulk vial with exactly 152 mL of a compatible reconstitution diluent, listed below, to a concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam. Shake well until dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

  Single dose vials

  Reconstitute ZOSYN vials with a compatible reconstitution diluent from the list provided below.

  2.25 g, 3.375 g, and 4.5 g ZOSYN should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.

  Compatible Reconstitution Diluents for Pharmacy and Single Dose Vials

  0.9% sodium chloride for injection
  Sterile water for injection
  Dextrose 5%
  Bacteriostatic saline/parabens
  Bacteriostatic water/parabens
  Bacteriostatic saline/benzyl alcohol
  Bacteriostatic water/benzyl alcohol

  Reconstituted ZOSYN solutions for both bulk and single dose vials should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous solution listed below. Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

  Compatible Intravenous Solutions for Pharmacy and Single Dose Vials

  0.9% sodium chloride for injection
  sterile water for injection1
  Dextran 6% in saline
  Dextrose 5%
  Lactated Ringer's Solution (compatible only with reformulated ZOSYN containing EDTA and is compatible for co-administration via a Y-site)

  ZOSYN should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

  ZOSYN is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

  ZOSYN should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.

  Stability of ZOSYN Powder Formulations Following Reconstitution

  ZOSYN reconstituted from bulk and single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. The pharmacy bulk vial should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

  Single dose or pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]). Vials should not be frozen after reconstitution.

  Stability studies in the I.V. bags have demonstrated chemical stability (potency, pH of reconstituted solution and clarity of solution) for up to 24 hours at room temperature and up to one week at refrigerated temperature. ZOSYN contains no preservatives. Appropriate consideration of aseptic technique should be used.

  ZOSYN reconstituted from bulk and single vials can be used in ambulatory intravenous infusion pumps. Stability of ZOSYN in an ambulatory intravenous infusion pump has been demonstrated for a period of 12 hours at room temperature. Each dose was reconstituted and diluted to a volume of 37.5 mL or 25 mL. One-day supplies of dosing solution were aseptically transferred into the medication reservoir (I.V. bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer's instructions. Stability of ZOSYN is not affected when administered using an ambulatory intravenous infusion pump.

  1 Maximum recommended volume per dose of sterile water for injection is 50 mL. 2.6 Compatibility with Aminoglycosides

  Due to the in vitro inactivation of aminoglycosides by piperacillin, ZOSYN and aminoglycosides are recommended for separate administration. ZOSYN and aminoglycosides should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated [see Drug Interactions (7.1)].

  In circumstances where co-administration via Y-site is necessary, ZOSYN formulations containing EDTA are compatible for simultaneous co-administration via Y-site infusion only with the following aminoglycosides under the following conditions:

  Table 2: Compatibility with Aminoglycosides  
  Aminoglycoside  
  ZOSYN Dose (grams) ZOSYN Diluent Volume * (mL) Aminoglycoside Concentration Range † (mg/mL)  
  Acceptable Diluents * Diluent volumes apply only to single vials and bulk pharmacy containers † The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10–15 mg/kg/day in two daily doses for amikacin and 3–5 mg/kg/day in three daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with ZOSYN containing EDTA has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions. Amikacin 2.25
  3.375
  4.5 50
  100
  150 1.75 – 7.5 0.9% sodium chloride or 5% dextrose Gentamicin 2.25
  3.375
  4.5 50
  100
  150 0.7 – 3.32 0.9% sodium chloride or 5% dextrose

  Only the concentration and diluents for amikacin or gentamicin with the dosages of ZOSYN listed above have been established as compatible for co-administration via Y-site infusion. Simultaneous co-administration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by ZOSYN.

  ZOSYN is not compatible with tobramycin for simultaneous co-administration via Y-site infusion. Compatibility of ZOSYN with other aminoglycosides has not been established.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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