Pantoprazole Sodium (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Pantoprazole sodium for injection is supplied in a single-dose vial as a sterile, freeze-dried, white to off-white, porous cake or powder for reconstitution containing 40 mg of pantoprazole.
Pantoprazole sodium for injection is available as follows:

40 mg per vial:
Single-dose Vials in a carton of 10 NDC 55150-202-10
Single-dose Vials in a carton of 25 NDC 55150-202-25
Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light.
The vial stopper is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Adverse Reactions
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

• Injection Site Reactions [see Warnings and Precautions (5.2)]
• Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3)]
• Acute Tubulointerstitial Nephritis [see Contraindications (4), Warnings and Precautions (5.4)]
• Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.5)]
• Bone Fracture [see Warnings and Precautions (5.6)]
• Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.7)]
• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8)]
• Hepatic Effects [see Warnings and Precautions (5.9)]
• Hypomagnesemia and Mineral Metabolism [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)].
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.auromedics.com or call 1-866-850-2876.
Distributed by:
AuroMedics Pharma LLC
279 Princeton-Hightstown Rd.
E. Windsor, NJ 08520
Manufactured by:
Eugia Pharma Specialities Limited
Hyderabad — 500032
India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg per vial — Container Label

Rx only NDC 55150-202-00
Pantoprazole
Sodium for Injection
40 mg per vial*
For Intravenous Infusion Only.
Sterile Single-dose Vial

(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg per vial — Container-Carton (10 Vials)

Rx only NDC 55150-202-10
Pantoprazole
Sodium for Injection
40 mg per vial*
For Intravenous Infusion Only.
No filter required
Sterile 10 Single-dose Vials
AUROMEDICS

(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg per vial — Container-Carton (25 Vials)

Rx only NDC 55150-202-25
Pantoprazole
Sodium for Injection
40 mg per vial*
For Intravenous Infusion Only.
No filter required
Sterile 25 Single-dose Vials
AUROMEDICS

(click image for full-size original)

Revised: 05/2022 AuroMedics Pharma LLC