Protonix (pantoprazole sodium) for GERD: Side Effects, Dosage

Generic drug: pantoprazole sodium

Brand name: Protonix IV

What is Protonix IV (pantoprazole sodium), and how does it work?

Protonix IV (pantoprazole sodium) is a prescription medicine used to treat the symptoms of Erosive Esophagitis associated with GERD, short-term treatment of GERD, and Zollinger-Ellison Syndrome. Protonix IV may be used alone or with other medications.

Protonix IV belongs to a class of drugs called Proton Pump Inhibitors.

It is not known if Protonix IV is safe and effective in children younger than 5 years of age.

What are the side effects of Protonix IV?

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.

What is the dosage for Protonix IV?

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.

QUESTION

GERD is the back up of stomach acid into the esophagus.
See Answer

What drugs interact with Protonix IV?

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.

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Is Protonix IV safe to use while pregnant or breastfeeding?

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.