Pantoprazole – Protonix ®

Pantoprazole (Protonix ®)

Usual Diluents

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

[40 mg] [100 ml] [15 minutes]
(Total volume = 100ml)
---------------------------------
[80 mg] [80 ml] [15 minutes]
(Total volume = 100ml)

1. Reconstitute each vial of PROTONIX I.V. with 10 mL of 0.9% Sodium Chloride Injection, USP.

2. Combine the contents of the two vials and further dilute with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL.

3. Inspect the diluted PROTONIX I.V. solution visually for particular matter and discoloration prior to and during administration.

4. Administer intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
----------------------------------
Continuous infusion (8 mg/hr)
[80 mg] [80 ml] [ 10 ml/hr]
(Total volume = 100ml)

----------------------------------

Minimum dilution: Diluted vial (4 mg/ml) can be administered over at least 2 minutes.

Storage
The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

Stability / Miscellaneous

INDICATIONS AND USAGE
-Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis:
PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome: PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions.

Prevention of rebleeding in peptic ulcer bleed (unlabeled use): I.V.: 80 mg, followed by 8 mg/hour infusion for 72 hours. Note: A daily infusion of 40 mg does not raise gastric pH sufficiently to enhance coagulation in active GI bleeds.

DOSAGE AND ADMINISTRATION
PROTONIX I.V. for Injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of PROTONIX I.V. for Injection with either 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP. When administered through a Y-site, PROTONIX I.V. for Injection is compatible with the following solutions: 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP.

Midazolam HCl has been shown to be incompatible with Y-site administration of PROTONIX I.V. for Injection. PROTONIX I.V. for Injection may not be compatible with products containing zinc. When PROTONIX I.V. for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

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

Treatment with PROTONIX I.V. for Injection should be discontinued as soon as the patient is able to be treated with PROTONIX Delayed-Release Tablets. Also, data on the safe and effective dosing for conditions other than those described in INDICATIONS AND USAGE, such as life-threatening upper gastrointestinal bleeds, are not available. PROTONIX I.V. 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

Parenteral routes of administration other than intravenous are not recommended.

No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Doses higher than 40 mg/day have not been studied in hepatically-impaired patients. No dosage adjustment is necessary in patients undergoing hemodialysis.

Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis
The recommended adult dose is 40 mg pantoprazole given once daily by intravenous infusion for 7 to 10 days. Safety and efficacy of PROTONIX I.V. for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated (see INDICATIONS AND USAGE ).

Fifteen Minute Infusion
PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted (admixed) with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

PROTONIX I.V. for Injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

Two Minute Infusion
PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. PROTONIX I.V. for Injection should be administered intravenously over a period of at least 2 minutes.

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome
The dosage of PROTONIX I.V. for Injection in patients with pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions varies with individual patients. The recommended adult dosage is 80 mg q12h. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg q8h is expected to maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or administered for more than 6 days have not been studied. (See package insert Clinical Studies section.) Transition from oral to I.V. and from I.V. to oral formulations of gastric acid inhibitors should be performed in such a manner to ensure continuity of effect of suppression of acid secretion. Patients with Zollinger-Ellison Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.

Fifteen Minute Infusion
Each vial of PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be combined and further diluted (admixed) with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL. The reconstituted solution may be stored for up to 6 hours at room temperature prior to further dilution. The admixed solution may be stored at room temperature and must be used within 24 hours from the time of initial reconstitution. Both the reconstituted solution and the admixed solution do not need to be protected from light.

PROTONIX I.V. for Injection should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.

Two minute Infusion
PROTONIX I.V. for Injection should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL. The reconstituted solution may be stored for up to 24 hours at room temperature prior to intravenous infusion and does not need to be protected from light. The total volume from both vials should be administered intravenously over a period of at least 2 minutes.

HOW SUPPLIED
PROTONIX® I.V. (pantoprazole sodium) for Injection is supplied as a freeze-dried powder containing 40 mg of pantoprazole per vial.

PROTONIX I.V. for Injection is available as follows:
NDC 0008-0923-51 One carton containing 1 vial of PROTONIX I.V. for Injection (each vial containing 40 mg pantoprazole).

Storage
Store PROTONIX I.V. for Injection vials at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.] Protect from light. Caution: the reconstituted product should not be frozen. United States Patent Numbers: 4,758,579; 6,780,881.

Wyeth® Marketed by Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, Germany W10447C017 ET01 Rev 12/07

Source: [package insert]