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PROTONIX
(pro-TAH-nix) (pantoprazole sodium)

For Delayed-Release Oral Suspension and Delayed-Release Tablets

Read the Patient Information that comes with PROTONIX before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is PROTONIX?

PROTONIX is a prescription medicine called a proton pump inhibitor (PPI).

PROTONIX is used in adults for:

• Up to 8 weeks for short-term treatment of acid-related damage to the lining of the esophagus (erosive esophagitis) caused by gastroesophageal reflux disease (GERD). If needed, your doctor may prescribe an additional 8 weeks of PROTONIX
• Maintain healing of acid-related damage to the lining of the esophagus and helps prevent return of heartburn symptoms caused by GERD. PROTONIX has not been studied for treatment lasting longer than 1 year
• Treating a rare condition called Zollinger-Ellison Syndrome, where the stomach makes more than the normal amount of acid

PROTONIX is used in children ages 5 years to 16 years old for short-term treatment (for up to 8 weeks) of acid-related damage to the lining of the esophagus (erosive esophagitis) caused by GERD. PROTONIX is not for children under 5 years old.

Who should not take PROTONIX?

Do not take PROTONIX if you are:

• allergic to any of the ingredients in PROTONIX. See the end of this leaflet for a complete list of ingredients in PROTONIX.
• allergic to any proton pump inhibitor (PPI). If you do not know if your medicines are PPIs, please ask your doctor.

What should I tell my doctor before taking PROTONIX?

Before taking PROTONIX, tell your doctor if you:

• have been told that you have low magnesium levels in your blood
• are pregnant, think you may be pregnant, or are planning to become pregnant. It is not known if PROTONIX will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breastfeeding or planning to breastfeed. PROTONIX may pass into your milk. Talk with your doctor about the best way to feed your baby if you take PROTONIX.

Tell your doctor about all of the medicines you take, including prescription and nonprescription drugs, vitamins and herbal supplements. PROTONIX may affect how other medicines work, and other medicines may affect how PROTONIX works. Especially tell your doctor if you take:

• Warfarin (Coumadin, Athrombin-K, Jantoven, Panwarfin)
• Ketoconazole (Nizoral)
• Atazanavir (Reyataz), Nelfinavir (Viracept)
• Iron supplements
• Ampicillin antibiotics
• Methotrexate

Ask your doctor if you are not sure if any of your medicines are the kind listed above.

How should I take PROTONIX?

• Take PROTONIX exactly as prescribed by your doctor.
• Do not change your dose or stop PROTONIX without talking to your doctor.
• If you forget to take a dose of PROTONIX, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to try to make up for a missed dose.
• If you take too much PROTONIX, call your doctor right away.
• See the Patient Instructions for Use at the end of this leaflet for detailed instructions about:
  • how to take PROTONIX tablets
  • how to take PROTONIX For Delayed-Release Oral Suspension
  • how to mix and give PROTONIX For Delayed-Release Oral Suspension through a nasogastric tube or gastric tube.

What are the possible side effects of PROTONIX?

• Serious allergic reactions. Tell your doctor if you get any of the following symptoms with PROTONIX
• rash
• face swelling
• throat tightness
• difficult breathing
• Stomach lining weakening with long-term use
• Vitamin B-12 deficiency

Your doctor may stop PROTONIX if these symptoms happen.

• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms:

• seizures
• dizziness
• abnormal or fast heartbeat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking PROTONIX or during treatment; if you will be taking PROTONIX for a long period of time.

The most common side effects with PROTONIX in adults include:

The most common side effects with PROTONIX in children include:

People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine.

Tell your doctor about any side effects that bother you or that do not go away.

These are not all the possible side effects with PROTONIX. Talk with your doctor or pharmacist if you have any questions about side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store PROTONIX?

• Store PROTONIX at room temperature between 59° to 86°F (15° to 30°C).
• Keep PROTONIX and all medicines out of the reach of children.

General Information

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use PROTONIX for a condition for which it was not prescribed. Do not give PROTONIX to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet provides a summary of the most important information about PROTONIX. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

For more information, go to www.wyeth.com or call toll-free 1-800-934-5556.

What are the ingredients in PROTONIX?

Active ingredient: pantoprazole sodium sesquihydrate

Inactive ingredients in PROTONIX Delayed-Release Tablets: 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.

Inactive ingredients in PROTONIX For Delayed-Release Oral Suspension, 40 mg: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.

Patient Instructions for Use

PROTONIX Tablets

• You can take PROTONIX tablets with food or on an empty stomach.
• Swallow PROTONIX tablets whole.
• If you have trouble swallowing a PROTONIX 40 mg tablet, you can take two 20 mg tablets instead.
• Do not split, chew, or crush PROTONIX tablets.

PROTONIX Oral Suspension

• PROTONIX oral suspension should be taken 30 minutes before a meal
• PROTONIX oral suspension should only be taken with applesauce or apple juice 30 minutes before a meal.
• PROTONIX should not be taken in or with water or other liquids, or with other foods. See “Directions for use” below.
• PROTONIX oral suspension should not be chewed or crushed.
• PROTONIX oral suspension packet should not be divided to make a smaller dose.

Directions for use with applesauce:

• Open packet.
• Sprinkle granules on one teaspoonful of applesauce. Do not use any other foods. Do not crush or chew the granules.
• Take within 10 minutes of putting the granules into the teaspoon of applesauce.
• Take sips of water to make sure the granules are washed down into the stomach. Repeat water sips as necessary.

Directions for use with apple juice:

• Open packet.
• Empty granules into a small cup or teaspoon with one teaspoonful of apple juice.
• Stir the mix for 5 seconds (granules will not break up) and swallow it right away.
• To make sure that the entire dose is taken, rinse the container once or twice with apple juice to get out any leftover granules. Swallow the apple juice right away.

Nasogastric Tube or Gastrostomy Tube Administration

For people who have a nasogastric (NG) tube or gastrostomy tube in place, PROTONIX oral suspension can be given as follows:

• Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Throw away the plunger.
• Connect the catheter tip of the syringe to a 16 French (or larger) tube.
• Hold the syringe attached to the tubing as high as possible while giving PROTONIX oral suspension to prevent any bending of the tubing.
• Empty the contents of the packet into the barrel of the syringe.
• Add 10 mL (2 teaspoonfuls) of apple juice and gently tap or shake the barrel of the syringe to help empty the syringe.
• Do this again at least two more times using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should be left in the syringe.

Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.