Protonix

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....

Read All Potential Side Effects and See Pictures of Protonix

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...

Read All Potential Precautions of Protonix


Protonix Consumer (continued)

SIDE EFFECTS: Headache or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 (such as pantoprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Protonix Patient Information Including Side Effects

Brand Names: Protonix

Generic Name: pantoprazole (Pronunciation: pan TOE pra zole)

  • What is pantoprazole (Protonix)?
  • What are the possible side effects of pantoprazole (Protonix)?
  • What is the most important information I should know about pantoprazole (Protonix)?
  • What should I discuss with my healthcare provider before taking pantoprazole (Protonix)?
  • How should I take pantoprazole (Protonix)?
  • What happens if I miss a dose (Protonix)?
  • What happens if I overdose (Protonix)?
  • What should I avoid while taking pantoprazole (Protonix)?
  • What other drugs will affect pantoprazole (Protonix)?
  • Where can I get more information?

What is pantoprazole (Protonix)?

Pantoprazole is in a group of drugs called proton pump inhibitors. It decreases the amount of acid produced in the stomach.

Pantoprazole is used to treat erosive esophagitis (damage to the esophagus from stomach acid), and other conditions involving excess stomach acid such as Zollinger-Ellison syndrome.

Pantoprazole may also be used for purposes other than those listed in this medication guide.

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.

What is the most important information I should know about pantoprazole (Protonix)?

Do not stop taking pantoprazole even if you begin to feel better. Your symptoms may improve before the condition is fully treated.

Do not crush, chew, or break a delayed-release (enteric-coated) tablet. It is specially made to release the medicine slowly into your body.

The oral granules should be mixed only with applesauce or apple juice to make swallowing easy. Do not use any other type of liquid or soft food. Pantoprazole granules may also be given with apple juice through a nasogastric (NG ) tube.

Some conditions must be treated long-term with pantoprazole. The chronic use of pantoprazole has caused stomach cancer in animal studies, but it is not known if this medication would have the same effects in humans. Talk with your doctor about your specific risk of developing stomach cancer.

Long-term treatment with pantoprazole may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Talk with your doctor if you need long-term pantoprazole treatment and you have concerns about vitamin B-12 deficiency.

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