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Protonix IV

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Protonix I.V.

INDICATIONS

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 adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.

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.

Pathological Hypersecretion Including Zollinger-Ellison Syndrome

PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults.

DOSAGE AND ADMINISTRATION

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

Parenteral routes of administration other than intravenous are not recommended.

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.

Gastroesophageal Reflux Disease Associated With A History Of Erosive Esophagitis

Recommended Dosage

The recommended adult dose is 40 mg pantoprazole given once daily by intravenous infusion for 7 to 10 days.

Treatment with PROTONIX® I.V. (pantoprazole sodium) for Injection should be discontinued as soon as the patient is able to receive treatment with PROTONIX Delayed-Release Tablets or Oral Suspension.

Administration and Preparation Instructions

Data on the safe and effective dosing for conditions other than those described [see 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.

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 Including Zollinger-Ellison Syndrome

Recommended Dosage

The dosage of PROTONIX I.V. for Injection in patients with pathological hypersecretory conditions including Zollinger-Ellison Syndrome varies with individual patients. The recommended adult dosage is 80 mg intravenously every 12 hours. The frequency of d osing can be adjusted to individual patient needs based on acid output measurements. In those patients who need a higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid output below 10 mEq/h. Daily doses higher than 240 mg or administered for more than 6 days have n ot been studied [see Clinical Studies]. Transition from oral to intravenous and from intravenous 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 ev en after a short period of loss of effective inhibition.

Administration and Preparation Instructions

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, o r 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

Dosage Forms And Strengths

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

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 – Single vial containing PROTONIX I.V. for Injection (contains 40 mg pantoprazole),
NDC
0008-0923-55 – Package of 10. Each vial contains PROTONIX I.V. for Injection (each vial containing 40 mg pantoprazole).
NDC 0008-0923-60 – Package of 25. Each vial contains PROTONIX I.V. for Injection (each vial containing 40 mg pantoprazole).

Storage And Handling

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. The reconstituted product should not be frozen.

Distributed by: Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101. under license from Nycomed GmbH D78467 Konstanz, Germany. Revised: Dec 2013

Last reviewed on RxList: 3/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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