MEDICATION GUIDE PROTONIX (pro-TAH-nix) (pantoprazole sodium) delayed-release tablets and PROTONIX (pro-TAH-nix) (pantoprazole sodium) for delayed-release oral suspension |
What is the most important information I should know about PROTONIX? You should take PROTONIX exactly as prescribed, at the lowest dose possible and for the shortest time needed. PROTONIX may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. PROTONIX can cause serious side effects, including:
PROTONIX can have other serious side effects. See "What are the possible side effects of PROTONIX?" |
What is PROTONIX? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. In adults, PROTONIX is used for:
It is not known if PROTONIX is safe and effective in children for treatment other than EE. |
Do not take PROTONIX if you are:
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Before taking PROTONIX, tell your doctor about all of your medical conditions, including if you:
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How should I take PROTONIX?
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What are the possible side effects of PROTONIX? PROTONIX can cause serious side effects, including:
The most common side effects of PROTONIX in children include: upper respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain. These are not all the possible side effects of PROTONIX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store PROTONIX? Store PROTONIX at room temperature between 68°F to 77°F (20°C to 25°C). Keep PROTONIX and all medicines out of the reach of children. |
General information about the safe and effective use of PROTONIX. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. 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 that you have. It may harm them. You can ask your doctor or pharmacist for information about PROTONIX that is written for health professionals. |
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: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide. For more information go to www.pfizer.com or call 1-800-438-1985. |
Instructions for Use
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
for delayed-release oral suspension
PROTONIX for delayed-release oral suspension (PROTONIX for oral suspension):
Important information:
- Do not split, chew, or crush PROTONIX for oral suspension.
- Take PROTONIX for oral suspension about 30 minutes before a meal.
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PROTONIX for oral suspension:
- should only be taken with applesauce or apple juice.
- should not be mixed in water or other liquids, or other foods.
- packet should not be divided to make a smaller dose.
- Open the packet of PROTONIX for oral suspension.
- Sprinkle all of the granules in the packet on 1 teaspoon of applesauce.
- Swallow the granules and applesauce within 10 minutes of putting the granules on the teaspoon of applesauce.
- Take sips of water to make sure the granules are washed down into the stomach. Take more sips of water as needed.
- Open the packet of PROTONIX for oral suspension.
- Empty all of the granules in the packet into a small cup that contains 1 teaspoon of apple juice.
- Stir the granules-apple juice mixture for 5 seconds. The granules will not break up.
- Swallow the mixture right away.
- To make sure that the entire dose is taken, add more apple juice to the cup, stir and swallow the apple juice right away.
- Repeat step 5 if there are granules left in the cup.
- PROTONIX for oral suspension may be given through an NG tube or gastrostomy tube that is size 16 French or larger. Do not give PROTONIX for oral suspension through an NG tube or gastrostomy tube smaller than size 16 French.
- Mix PROTONIX for oral suspension only in apple juice when giving through an NG tube or gastrostomy tube.
- Remove the plunger from a 60 mL (2 ounce) catheter-tip syringe. Throw away the plunger.
- Connect the tip of the catheter-tip syringe to the NG tube or gastrostomy tube.
- Hold the syringe attached to the NG tube or gastrostomy tube as high as possible while giving PROTONIX for oral suspension to prevent the tubing from bending.
- Open the packet of PROTONIX for oral suspension.
- Empty all the granules in the packet into the catheter-tip syringe.
- Add 10 mL (2 teaspoons) of apple juice into the catheter-tip syringe and gently tap or shake the syringe to help empty the syringe.
- Repeat step 6 at least 2 more times until there are no granules left in the catheter-tip syringe.
Store PROTONIX at room temperature between 68°F to 77°F (20°C to 25°C).
Keep PROTONIX and all medicines out of the reach of children.
This Medication Guide and Instructions for Use has been approved by the U.S. Food and Drug Administration.
This product's label may have been updated. For current full prescribing information, please go to www.pfizer.com.
under license from
Takeda GmbH
D78467 Konstanz, Germany
LAB-0574-13.0
Revised: June 2018