Protonix IV (pantoprazole sodium)

Protonix IV may cause serious side effects including:

• unusually fast, slow or irregular heartbeat,
• persistent muscle spasms,
• seizures,
• persistent diarrhea,
• abdominal pain or cramping,
• fever,
• blood or mucus in your stool,
• rash,
• itching,
• swelling of the face, tongue and throat,
• severe dizziness,
• trouble breathing, and
• changes in the amount of urine

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Protonix IV include:

• headache,
• diarrhea,
• redness, pain, or swelling at the injection site,
• nausea,
• abdominal pain,
• vomiting,
• gas,
• dizziness, and
• joint pain

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Protonix IV. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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 Protonix I.V. (pantoprazole sodium) for Injection should be discontinued as soon as the patient is able to receive treatment with Protonix Delayed-Release Tablets or Oral Suspension.

Interference With Antiretroviral Therapy

• Concomitant use of atazanavir or nelfinavir with proton pump inhibitors is not recommended.
• Coadministration of atazanavir or nelfinavir with proton pump inhibitors is expected to substantially decrease atazanavir or nelfinavir plasma concentrations and may result in a loss of therapeutic effect and development of drug resistance.

Coumarin Anticoagulants

• There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including pantoprazole, and warfarin concomitantly.
• Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

Clopidogrel

• Concomitant administration of pantoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition.
• No dose adjustment of clopidogrel is necessary when administered with an approved dose of Protonix.

Drugs For Which Gastric Ph Can Affect Bioavailability

• Pantoprazole causes long-lasting inhibition of gastric acid secretion, therefore pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, and digoxin).

False Positive Urine Tests For THC

• There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving proton pump inhibitors including pantoprazole. An alternative confirmatory method should be considered to verify positive results.

Methotrexate

• Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.

• There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
• Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known.
• Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants.
• Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.