Pantoprazole Sodium (Page 8 of 8)
14.2 Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome
Two studies measured the pharmacodynamic effects of 6 day treatment with pantoprazole sodium for injection in patients with ZE Syndrome (with and without multiple endocrine neoplasia type I). In one of these studies, an initial treatment with pantoprazole sodium for injection in 21 patients (29 to 75 years; 8 female; 4 Black, 1 Hispanic, 16 White) reduced acid output to the target level (10 mEq/h or less) and significantly reduced H+ concentration and the volume of gastric secretions; target levels were achieved within 45 minutes of drug administration.
In the other study of 14 patients (38 to 67 years; 5 female; 2 Black, 12 White) with ZE Syndrome, treatment was switched from an oral PPI to pantoprazole sodium for injection. Pantoprazole sodium for injection maintained or improved control of gastric acid secretion.
In both studies, total doses of 160 or 240 mg per day of pantoprazole sodium for injection, administered in divided doses, maintained basal acid secretion below target levels in all patients. Target levels were 10 mEq/h in patients without prior gastric surgery, and 5 mEq/h in all patients with prior gastric acid-reducing surgery. Once gastric acid secretion was controlled, there was no evidence of tolerance during this 7 day study. Basal acid secretion was maintained below target levels for at least 24 hours in all patients and through the end of treatment in these studies (3 to 7 days) in all but 1 patient who required a dose adjustment guided by acid output measurements until acid control was achieved. In both studies, doses were adjusted to the individual patient need, but gastric acid secretion was controlled in greater than 80% of patients by a starting regimen of 80 mg every 12 hours.
16 HOW SUPPLIED/STORAGE AND HANDLING
Pantoprazole sodium for injection is supplied as a freeze-dried powder containing 40 mg of pantoprazole per vial.
Pantoprazole sodium for injection is available as follows:
NDC 72572-550-01 – Package of 1 vial. The vial contains pantoprazole sodium for injection equivalent to 40 mg pantoprazole.
NDC 72572-550-10 – Package of 10 vials. Each vial contains pantoprazole sodium for injection equivalent to 40 mg pantoprazole.
Storage and Handling
Store pantoprazole sodium for injection vials at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from light.
17 PATIENT COUNSELING INFORMATION
Adverse Reactions
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
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- Hypersensitivity and Severe Skin Reactions [see Warnings and Precautions (5.2)]
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- Injection Site Reactions [see Warnings and Precautions (5.3)]
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- Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.4)]
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- Acute Tubulointerstitial Nephritis [see Contraindications (4), Warnings and Precautions (5.5)]
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- Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.6)]
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- Bone Fracture [see Warnings and Precautions (5.7)]
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- Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8)]
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- Hepatic Effects [see Warnings and Precautions (5.9)]
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- Hypomagnesemia [see Warnings and Precautions (5.10)]
Drug Interactions
Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [Contraindications (4)] and high dose methotrexate [Warnings and Precautions (5.14)].
Pregnancy
Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Dist by: Civica, Inc., Lehi, Utah 84043
Mfd by: Lek Pharmaceuticals d.d.
SI-1526 Ljubljana, Slovenia
Principal Display Panel
NDC 72572-550 -01
Pantoprazole Sodium for Injection
40 mg*/vial
*Equivalent to 40 mg pantoprazole per vial.
For intravenous infusion only.
1 Single-Dose Vial
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| Labeler — Civica, Inc. (081373942) |
Revised: 12/2020 Civica, Inc.
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