Protonix (pantoprazole sodium) is a prescription medication used to treat and manage certain stomach and esophagus problems. Protonix belongs to the medication class of proton pump inhibitors (PPI) and is most commonly prescribed for erosive esophagitis (esophagus inflammation) related to gastroesophageal reflux disease (GERD). It can also be used for hypersecretory conditions including Zollinger-Ellison Syndrome, a rare digestive disorder that results in too much stomach acid. This medication is sometimes prescribed off-label for Barrett esophagus, Helicobacter pylori infections, and ulcers. Protonix is typically taken as a 40 mg delayed-release tablet by mouth once daily.
Tablet delayed-release: 20 mg, 40 mg
Oral granules delayed-release: 40 mg
Intravenous: 40 mg
Protonix is a brand-name medication that works by lowering the amount of acid in the stomach and is FDA approved to treat erosive esophagitis associated with GERD and Zollinger-Ellison Syndrome. Erosive esophagitis occurs as a severe form of GERD in which the lining of the esophagus is damaged by the backup of stomach acid. Additionally, Protonix can be used off-label for other conditions that cause the stomach to produce too much acid.
The most common side effects of Protonix include headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and joint pain. Other PPIs include Prilosec (omeprazole), Nexium (esomeprazole), Prevacid (lansoprazole), Dexilant (dexlansoprazole), and Aciphex (rabeprazole). While some are prescription drugs only, Prilosec, Nexium, and Prevacid all have formulations available for purchase over-the-counter.
RELATED: Protonix vs. Nexium: Differences, similarities, and which is better for you
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Protonix dosage chart |
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|---|---|---|---|
| Indication | Starting dosage | Standard dosage | Maximum dosage |
| Erosive esophagitis from GERD | 40 mg tablet by mouth once daily | 40 mg tablet by mouth once daily for up to 8 weeks | 80 mg/day |
| Maintenance of healing of erosive esophagitis | 40 mg tablet by mouth once daily | 40 mg tablet by mouth once daily | 80 mg/day |
| Zollinger-Ellison syndrome | 40 mg tablet by mouth twice daily | 40 mg tablet by mouth twice daily | 240 mg/day |
| H. pylori infection (off-label) | 40 mg tablet by mouth twice daily | 40 mg tablet by mouth twice daily for 10-14 days | 160 mg/day |
| Duodenal ulcer (off-label) | 40 mg tablet by mouth once daily | 40 mg tablet by mouth once daily for 2 weeks | Not specified |
| Gastric ulcer (off-label) | 40 mg tablet by mouth once daily | 40 mg tablet by mouth once daily for 4 weeks | Not specified |
Protonix can be used for the short-term treatment and maintenance of healing of erosive esophagitis associated with GERD. Patients experiencing this condition have stomach acid that backs up into the esophagus causing inflammation, irritation, and damage to the throat lining. Symptoms include painful and difficulty swallowing as well as chest pain with eating. Protonix works to decrease the amount of stomach acid so that the esophagus can heal. Typically, adults will be instructed to take one Protonix 40 mg delayed-release tablet by mouth once daily for up to eight weeks. Those who have not healed after eight weeks of Protonix treatment may be able to take an additional eight-week course.
It’s important for healthcare professionals to prescribe the lowest dose for the shortest duration of therapy. This recommendation is due to increased risks that are associated with long-term Protonix usage. These risks include vitamin B-12 deficiency, bone fractures, fundic gland polyps, and low magnesium levels (hypomagnesemia). It is important for patients taking Protonix long-term to ensure adequate vitamin D and calcium supplementation for bone health.
Protonix can be used for the long-term treatment of pathological hypersecretory conditions including Zollinger-Ellison Syndrome, a rare disorder that develops when one or more tumors form in the pancreas and duodenum (first part of the small intestine). These tumors are called gastrinomas and cause the stomach to make large amounts of acid. Too much acid can lead to peptic ulcers forming in the duodenum and elsewhere in the upper intestine.
PPIs, like Protonix, can be prescribed long-term to help manage Zollinger-Ellison Syndrome. Protonix works to reduce the acid in the stomach that helps to relieve peptic ulcer pain and allow for healing. Typically, the dose is higher than most PPI treatments. Adults can be prescribed one Protonix 40 mg delayed-release tablet by mouth twice daily. These patients are at a higher risk of developing the serious side effects associated with long-term Protonix use, so it is important for patients to discuss the risks versus benefits with their healthcare provider.
Protonix is approved for pediatric use in children 5 years and older for the treatment of erosive esophagitis associated with GERD. Similar to the adult dosing for GERD, Protonix should be used short-term in children for up to eight weeks. The Protonix dosing is based on the child’s weight.
Protonix dosage by weight |
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|---|---|---|---|
| Age | Weight | Recommended dosage (tablet) | Maximum dosage |
| 5 years and older | 15-40 kg (about 33-89 lbs) | 20 mg tablet by mouth once daily for up to 8 weeks | 20 mg/day |
| >40 kg (about >89 lb) | 40 mg tablet by mouth once daily for up to 8 weeks | 40 mg/day |
Protonix does not have any dosage restrictions for older patients, people with kidney impairment, or people with liver impairment. However, the manufacturer reports that doses higher than 40 mg per day have not been studied in patients with liver impairment. People with liver impairment should thoroughly discuss their medical history with their healthcare provider before starting Protonix treatment.
Protonix does not have official FDA approval for use in animals, however, it can be prescribed off-label by veterinarians. Some veterinarians use Protonix in dogs and cats for stomach ulcer prevention and treatment, and to treat Helicobacter pylori infections.
Protonix can be given by mouth or by IV to animals. The standard dosage for dogs is 0.3 to 0.45 mg per pound by mouth once daily.
Protonix is available as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. These unique formulations make the administration of Protonix important to know and follow.
Swallow the tablets whole with food or on an empty stomach.
Do not crush, break, or chew it
If there is difficulty swallowing a 40 mg tablet, two 20 mg tablets can be taken instead
Take the medicine mixed in apple juice or applesauce at least 30 minutes before a meal.
To prepare with applesauce: Mix the packet contents with 1 teaspoon of applesauce. Do not mix with water or other liquids or food. Do not divide the packet contents to make smaller doses. Swallow the mixture within 10 minutes after mixing it. Do not chew or crush the granules. Sip some water after taking the mixture to make sure all medication is washed down.
To prepare with apple juice: Mix the packet contents with 1 teaspoon of apple juice in a small cup. Do not divide the packet contents to make smaller doses. Stir for five seconds (the granules will not dissolve) and drink the mixture immediately. Do not chew or crush the granules. To make sure all of the medicine is taken, add more apple juice to the cup, swish around, and drink it immediately.
Must be mixed in apple juice only.
To prepare for a feeding tube: Connect a 2-ounce (60 milliliters [mL]) catheter-tip syringe to a 16 French or larger tube. Pour the packet contents in the catheter-tip syringe. Add 10 mL of apple juice to the syringe. Gently tap or shake the barrel of the syringe to help empty it. Repeat with 10 mL of apple juice each time at least 2 times. There should be no granules left in the syringe.
Healthcare professionals will instruct patients how much medicine to use so do not take more than directed
This medicine should come with a Medication Guide that a pharmacist can provide if needed along with additional medical advice
If there is a missed dose, take the dose as soon as possible. If it is almost time for the next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light
Protonix comes as either delayed-release tablets or granules. They are designed so that their absorption begins only after the tablet leaves the stomach. As stated by the United States Pharmacopeia (USP), delayed-release tablets help to prevent the medication from being destroyed or inactivated by gastric juices or where it may irritate the gastric mucosa.
With Protonix’s unique formulation, it is important to follow administration guidelines to prevent damage to the delayed-release design. It is important for patients to not split, crush, or chew the Protonix tablets.
Protonix works to decrease the amount of stomach acid and can achieve this after just one dose. The manufacturer states that following the first dose of 40 mg pantoprazole by mouth, a 51% mean inhibition in stomach acid was achieved by 2.5 hours. Additionally, with once-a-day dosing for seven days, the mean inhibition was increased to 85%.
Protonix displayed quick symptom relief in a randomized placebo-controlled clinical trial with regard to oral pantoprazole for erosive esophagitis. The trial concluded that a significantly greater number of patients taking Protonix 40 mg experienced complete relief of daytime and nighttime heartburn and the absence of regurgitation, starting from the first day of treatment, compared with placebo. Additionally, people taking Protonix took significantly fewer antacid tablets per day for gastrointestinal symptom relief including stomach pain and acid reflux than those taking placebo.
Protonix has a half-life of one hour in the body. This means that after one hour of taking Protonix by mouth or IV, about 50% of the medication will be remaining in the body. Half-life can vary between people because it can be affected by several factors including age, kidney function, liver function, and gender.
Protonix is typically taken once daily, but some people may forget to take their dose. If a dose is missed, take the medicine as soon as remembered unless it’s almost time for the next dose. Two doses should not be taken at the same time to make up for a missed dose.
Just like other medications in the PPI class, people should use the lowest dose and shortest duration of Protonix appropriate to the condition being treated. The manufacturer states that published observational studies suggest that PPI therapy may be linked with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.
For short-term treatment of erosive esophagitis associated with GERD, typically treatment is given for up to eight weeks. Adult patients who have not healed after eight weeks of Protonix treatment may be able to take an additional eight-week course. However, for hypersecretory conditions such as Zollinger-Ellison Syndrome, long-term use may be appropriate.
Once therapy is no longer needed, Protonix can be safely discontinued. Acid secretion typically returns to normal within a week after the last dose of Protonix and there was no evidence of rebound excessive stomach acid secretion.
For treatment of erosive esophagitis, doses up to 120 mg per day have been safely given in published clinical trials. For long-term treatment with Protonix in pathological hypersecretory conditions, doses up to 240 mg per day have been used.
The manufacturer states that there is limited data in patients taking very high doses (more than 240 mg) of Protonix. Post-marketing reports of Protonix overdose are generally within the known safety profile. In case of overdosage, treatment should be symptomatic and supportive.
Protonix has a few important drug interactions that healthcare professionals should check before starting treatment. Protonix has a contraindication with the HIV medications nelfinavir and rilpivirine because Protonix may lower the amounts of these medications in the body making them less effective.
The manufacturer suggests caution when using Protonix and other PPIs with methotrexate—a chemotherapy and immunosuppressive medication. They state the concomitant use of PPIs with methotrexate, primarily at high doses, may increase and prolong serum levels of methotrexate. This interaction could lead to methotrexate toxicity and adverse reactions.
Along with other PPIs, Protonix may interact with patients also taking warfarin, a blood thinner. This interaction may lead to abnormal bleeding time so these patients should have their INR and prothrombin time closely monitored.
Some people who have symptoms of GERD may take antacids for quick symptom relief. Fortunately, Protonix can be safely taken at the same time as over-the-counter antacids such as Alka-Seltzer, Maalox, and Tums.
Protonix does not have any interactions with alcohol. However, consuming alcohol can trigger heartburn symptoms that many people with GERD experience. Additionally, alcohol consumption can cause damage to the throat leading to erosive esophagitis. Patients with stomach and esophagus problems should ask their healthcare providers about alcohol use.
Protonix can be used during pregnancy when necessary for treatment. Just like with non-pregnant patients, lifestyle modifications followed by other medications are the initial treatments for GERD before initiating Protonix.
Protonix is present in breastmilk so it is important for nursing mothers to discuss using this medication with their doctors. Protonix can be used with caution in breastfeeding mothers. The decision should be made with regard to the infant’s risk, the benefits of breastfeeding to the infant, and the benefits of Protonix treatment to the mother.
Pantoprazole drug summary, Prescriber’s Digital Reference
Adult dosing, Epocrates
Pediatric dosing, Epocrates
Zollinger-Ellison syndrome, National Institute of Diabetes and Digestive and Kidney Diseases
Oral pantoprazole for erosive esophagitis: a placebo-controlled, randomized clinical trial. Pantoprazole US GERD Study Group, National Library of Medicine
Pantoprazole medication guide, Plumb’s Veterinary
Stephanie Melby, B.S., Pharm.D., received a bachelor of science in nutrition from the University of Minnesota and a doctorate of pharmacy from the University of New England. She has seven years of experience in retail pharmacy and is certified in Medication Therapy Management (MTM). Dr. Melby resides in Minneapolis, Minnesota.
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