ERACID IV is indicated for short-term treatment of acute acid peptic disorders, including pathological hypersecretory states such as Zollinger-Ellison syndrome for especially allaying associated symptoms.

ERACID IV should be used during pregnancy and lactation only if the potential benefit justifies the probable risks involved. In view of likelihood of pantoprazole to be excreted in human milk, and because of potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or ERACID IV, taking into account the importance of therapy to the mother. Safety and efficacy of ERACID IV ingredients in children have not been established.

Symptomatic response to pantoprazole (ERACID IV) does not preclude the presence of gastric malignancy. Like other proton pump inhibitors, pantoprazole (ERACID IV), has potential to cause gastric carcinoids but the studies have not been conclusive.

Anaphylaxis can occur with ERACID IV injection. Treatment with ERACID IV must be discontinued as soon as it is possible to resume oral pantoprazole therapy. Caution is to be exercised when ethylenediaminetetraacetic acid (EDTA) containing products are coadministered intravenously since ERACID IV incorporates edetate disodium (the salt form of EDTA). Zinc supplementation is to be considered when ERACID IV is advocated in view of edetate disodium's ability to chelate metal ions such as zinc. Parenteral routes other than intravenous are not recommended for ERACID IV.

Pantoprazole intravenous (ERACID IV) can cause abdominal pain, headache, injection site reactions (including thrombophlebitis and abscess), constipation, dyspepsia, nausea, diarrhea, insomnia, dizziness and rhinitis.

ERACID IV may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of ERACID IV for Injection with either 5% Dextrose Injection, 0.9% Sodium Chloride Injection or Lactated Ringer's Injection. When administered through a Y-site, ERACID IV for Injection is compatible with the following solutions: 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer's Injection. Midazolam HCl has been shown to be incompatible with Y-site administration of ERACID IV for Injection. ERACID IV for Injection may not be compatible with products containing zinc. When ERACID IV for Injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.

Fifteen Minute Infusions: ERACID IV for Injection should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection, and further diluted (admixed) with 100 ml of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, 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.

If 80 mg dose is to be administered, the contents of the two ERACID IV vials must be individually reconstituted with 10 ml Sodium Chloride Injection. The contents of the two vials must then be combined and further diluted with 80 ml of 5% Dextrose Injection, 0.9% Sodium Chloride Injection, or Lactated Ringer's Injection, to a total volume of 100 ml with a final concentration of 0.8 mg/ml.

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. ERACID IV for Injection admixtures should be administered intravenously over
a period of approximately 15 minutes at a rate of approximately 7 ml/min.

Two Minute Infusions: ERACID IV for Injection should be reconstituted with 10 ml of 0.9% Sodium Chloride Injection, 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. ERACID IV for Injection should be administered intravenously over a period of at least 2 minutes.

Go Back