PANTIN Gastro-resistant tablet Ref.[116007] Active ingredients: Pantoprazole

Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

The recommended adult dosage of Pantoprazole sodium is 40 mg given once daily by intravenous infusion for 7 to 10 days.

Discontinue treatment with PROTONIX I.V. as soon as the patient is able to receive treatment with PROTONIX Delayed-Release Tablets or Oral Suspension.

Data on the safe and effective dosing for conditions other than those described such as lifethreatening upper gastrointestinal bleeds, are not available. Pantoprazole sodiumonce daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.

Preparation and Administration Instructions for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis

Only for intravenous infusion; other parenteral routes of administration are not recommended.

Fifteen Minute Infusion

1. Reconstitute Pantoprazole sodium with 10 mL of 0.9% Sodium Chloride Injection, USP.
2. Further dilute 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.
3. Inspect the diluted Pantoprazole sodium 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.

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.

Do not freeze the reconstituted solution.

Two Minute Infusion

1. Reconstitute Pantoprazole sodium with 10 mL of 0.9% Sodium Chloride Injection, USP, to a final concentration of approximately 4 mg/mL.
2. Inspect the diluted Pantoprazole sodium solution visually for particular matter and discoloration prior to and during administration.
3. Administer intravenously over a period of at least 2 minutes.

Storage

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.

Do not freeze the reconstituted solution.

Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

The recommended adult dosage of Pantoprazole sodium 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. 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 ZE Syndrome may be vulnerable to serious clinical complications of increased acid production even after a short period of loss of effective inhibition.

Preparation and Administration Instructions for Pathological Hypersecretion Including Zollinger-Ellison Syndrome

Only for intravenous infusion; other parenteral routes of administration are not recommended.

Fifteen Minute Infusion

1. Reconstitute each vial of Pantoprazole Sodium 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 Pantoprazole sodium 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.

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.

Do not freeze the reconstituted solution.

Two Minute Infusion

1. Reconstitute Pantoprazole Sodium with 10 mL of 0.9% Sodium Chloride Injection, USP, per vial to a final concentration of approximately 4 mg/mL.
2. Inspect the diluted Pantoprazole Sodium solution visually for particular matter and discoloration prior to and during administration.
3. Administer the total volume from both vials intravenously over a period of at least 2 minutes.

Storage

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.

Do not freeze the reconstituted solution.

Compatibility Information

• Administer Pantoprazole Sodium intravenously through a dedicated line or through a Ysite.
• Flush the intravenous line before and after administration of Pantoprazole Sodium 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 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.
• Pantoprazole Sodium may not be compatible with products containing zinc.
• When Pantoprazole Sodium is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

Experience in patients taking very high doses of pantoprazole (greater than 240 mg) is limited. Adverse reactions seen in spontaneous reports of overdose generally reflect the known safety profile of pantoprazole.

Pantoprazole is not removed by hemodialysis. In case of overdose, treatment should be symptomatic and supportive.

Single intravenous doses of pantoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) were lethal to mice, rats and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limbsplay, lateral position, segregation, absence of ear reflex, and tremor.

24 Months.

Store below 30°C, Protect from light.

1×1's Pack: 10 mL Clear Tubular Glass Vial.

Not Applicable.