Protonix is a proton pump inhibitor (PPI) used to treat ulcers, gastroesophageal reflux (GERD), erosive esophagitis, or Zollinger-Ellison syndrome. Protonix works by blocking acid production in the stomach. It may be used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat certain types of ulcers. It may also be used to treat other conditions as determined by your doctor.

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• tell your doctor and pharmacist if you are allergic to pantoprazole or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: ampicillin (Omnipen, Polycillin, Totacillin); ketoconazole (Nizoral); and vitamins containing iron. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pantoprazole, call your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

What side effects can this medication cause?

Pantoprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache
• stomach pain
• gas or bloating

Pantoprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for Protonix?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking pantoprazole.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

Brand name(s):

Protonix®

Protonix®I.V.




Protonix



Before using
INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking digoxin, iron, itraconazole, ketoconazole, sucralfate, or vitamins with iron. Contact your doctor or pharmacist if you have any questions or concerns about using Protonix.

Directions
Follow the directions for using Protonix provided by your doctor. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. Take Protonix with a little water before or during breakfast. Protonix may be taken with antacids if your doctor has instructed you to take antacids. FOR BEST RESULTS, continue taking Protonix for the full course of treatment even if you feel better in a few days. Do not miss any doses. STORE Protonix at room temperature, away from heat and light. IF YOU MISS A DOSE OF Protonix, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.

Cautions
If your symptoms do not improve or if they become worse, check with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using Protonix. Protonix may affect the results of certain lab tests (e.g., false positive urine screen for THC). Make sure laboratory personnel and your doctors know you use Protonix. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using Protonix during pregnancy. IT IS UNKNOWN IF Protonix IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using Protonix, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects
SIDE EFFECTS, that may go away during treatment, include headache, dizziness, diarrhea, or nausea. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience swelling of hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness; or rash. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions

If you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional information
If you are taking Protonix for gastric ulcers or reflux disease, your symptoms should improve within 4 to 8 weeks. If your symptoms do not improve or if they become worse, contact your doctor. DO NOT SHARE Protonix with others for whom it was not prescribed. DO NOT USE Protonix for other health conditions. KEEP Protonix out of the reach of children and pets. IF USING Protonix FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

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The active ingredient in PROTONIX  (pantoprazole sodium) Delayed- Release Tablets is a substituted benzimidazole, sodium 5-( difluoromethoxy)- 2- [[( 3,4- dimethoxy- 2- pyridinyl) methyl] sulfinyl]- 1 H- benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C₁₆ H₁₄ F₂ N₃ NaO₄ S x 1.5 H₂ O, with a molecular weight of 432.4. The structural formula is:



　

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 5.0 and approximately 220 hours at pH 7.8.