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:|
|Before taking PROTONIX, tell your doctor about all of your medical conditions, including if you:|
|How should I take PROTONIX?|
|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.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Advise patients to return to their healthcare provider if they have a suboptimal response or an early symptomatic relapse [see Warnings and Precautions (5.1)].
Acute Tubulointerstitial Nephritis
Advise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Contraindications (4), Warnings and Precautions (5.2)].
Clostridium difficile-Associated Diarrhea
Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3)].
Advise patients to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions (5.4)].
Cutaneous and Systemic Lupus Erythematosus
Advise patients to immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.5)].
Cyanocobalamin (Vitamin B-12) Deficiency
Advise patients to report any clinical symptoms that may be associated with cyancobalamin deficiency to their healthcare provider if they have been receiving PROTONIX for longer than 3 years [see Warnings and Precautions (5.6)].
Advise patients to report any clinical symptoms that may be associated with hypomagnesemia to their healthcare provider, if they have been receiving PROTONIX for at least 3 months [see Warnings and Precautions (5.7)].
Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [see Contraindications (4)] digoxin [see Warnings and Precautions (5.7)] and high dose methotrexate [see Warnings and Precautions (5.12)].
Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
- Do not split, crush, or chew PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets.
- PROTONIX oral suspension packet is a fixed dose and cannot be divided to make a smaller dose.
- Swallow PROTONIX Delayed-Release Tablets whole, with or without food in the stomach.
- Concomitant administration of antacids does not affect the absorption of PROTONIX Delayed-Release Tablets.
- Take PROTONIX For Delayed-Release Oral Suspension approximately 30 minutes before a meal.
- Administer PROTONIX For Delayed-Release Oral Suspension in apple juice or applesauce, as described in the Instructions for Use. Do not administer in water, other liquids, or foods.
- For patients with a nasogastric (NG) or gastrostomy tube, PROTONIX For Delayed-Release Oral Suspension can be administered with apple juice, as described in the Instructions for Use.
- Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.