PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM- pantoprazole sodium injection, powder, for solution
Akorn, Inc.

1 INDICATIONS AND USAGE

1.1 Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

Pantoprazole Sodium 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 Pantoprazole Sodium for Injection as a treatment of patients with GERD and a history of erosive esophagitis for more than 10 days have not been demonstrated.

1.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome

Pantoprazole Sodium for Injection is indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults.

2 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.

Pantoprazole Sodium 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 Pantoprazole Sodium 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, Pantoprazole Sodium 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 Pantoprazole Sodium for Injection. Pantoprazole Sodium for Injection may not be compatible with products containing zinc. When Pantoprazole Sodium for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

2.1 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 Pantoprazole Sodium for Injection should be discontinued as soon as the patient is able to receive treatment with Pantoprazole Sodium 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 (1)] such as life-threatening upper gastrointestinal bleeds, are not available.

Pantoprazole Sodium for Injection 40 mg once daily dose not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

Fifteen Minute Infusion

Pantoprazole Sodium 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.

Pantoprazole Sodium 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

Pantoprazole Sodium 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. Pantoprazole Sodium for Injection should be administered intravenously over a period of at least 2 minutes.

2.2 Pathological Hypersecretion Including Zollinger-Ellison Syndrome

Recommended Dosage

The dosage of Pantoprazole Sodium 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 dosing 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 not been studied [see Clinical Studies (14)]. 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 even after a short period of loss of effective inhibition.

Administration and Preparation Instructions

Fifteen Minute Infusion

Each vial of Pantoprazole Sodium 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.

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

Two minute Infusion

Pantoprazole Sodium 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.

3 DOSAGE FORMS AND STRENGTHS

Pantoprazole Sodium for Injection is supplied as a freeze-dried powder containing 40 mg of pantoprazole per vial.

4 CONTRAINDICATIONS

Pantoprazole Sodium for Injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation [see Warnings and Precautions (5.2)] or any substituted benzimidazole.

5 WARNINGS AND PRECAUTIONS

5.1 Implications of Symptomatic Response

Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy.

5.2 Hypersensitivity and Severe Skin Reactions

Anaphylaxis and other serious reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN) has been reported with use of intravenous pantoprazole. These may require emergency medical treatment [see Adverse Reactions (6.2)].

5.3 Injection Site Reactions

Thrombophlebitis was associated with the administration of intravenous pantoprazole.

5.4 Potential for Exacerbation of Zinc Deficiency

Pantoprazole Sodium for Injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients treated with Pantoprazole Sodium for Injection who are prone to zinc deficiency. Caution should be used when other EDTA containing products are also co-administered intravenously.

5.5 Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines. (See Dosage and Administration and Adverse Reactions sections).

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