Protonix (Pantoprazole) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 21, 2012

Protonix

Peptic Ulcer »

Peptic ulcer facts

Peptic ulcers are sores in the lining of the stomach or duodenum.
Peptic ulcer formation is related to H. pylori bacteria in the stomach and nonsteroidal anti-inflammatory medications (NSAIDs) in 50% of patients. For the remaining 50% there are miscellaneous or unknown causes.
Ulcer pain may not correlate with the presence or severity of ulceration.
The main symptom of peptic ulcer is upper abdominal pain which can be dull, sharp, or burning. (Bloating and burping are not symptoms of peptic ulcer, and vomiting, poor appetite, and nausea are uncommon symptoms of peptic ulcer.)
Diagnosis of ulcer is made with upper GI series or endoscopy.
Treatment of ulcers involves antibiotic combinations along with stomach acid suppression to eradicate H. pylori, eliminating precipitating factors such as NSAIDs and stomach acid suppression...

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Protonix

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PROTONIX
(pantoprazole sodium) Delayed-Release Tablets

PROTONIX
(pantoprazole sodium) for Delayed-Release Oral Suspension

DRUG DESCRIPTION

The active ingredient in PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension and PROTONIX (pantoprazole sodium) Delayed-Release Tablets is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C₁₆H₁₄F₂N₃NaO₄S x 1.5 H₂O, with a molecular weight of 432.4. The structural formula is:

PROTONIX
(pantoprazole sodium) Structural Formula Illustration

Pantoprazole sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.

The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.

PROTONIX (pantoprazole sodium) is supplied as a for delayed-release oral suspension, available in one strength (40 mg), and as a delayed-release tablet, available in two strengths (20 mg and 40 mg).

Each PROTONIX (pantoprazole sodium) Delayed-Release Tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.

PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension, 40 mg, contains the active ingredient pantoprazole sodium sesquihydrate in the form of enteric-coated granules in unit dose packets. Each unit dose packet contains enteric-coated granules containing 45.1 mg pantoprazole sodium sesquihydrate (equivalent to 40 mg of pantoprazole) with the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.

What are the possible side effects of pantoprazole (Protonix)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely to occur, such as:

nausea, vomiting;
gas, stomach pain;
diarrhea; or
headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088....

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What are the precautions when taking pantoprazole (Protonix)?

Before taking pantoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, omeprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss.

Proton pump inhibitors...

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Last reviewed on RxList: 11/14/2011
This monograph has been modified to include the generic and brand name in many instances.