What is the most important information I should know about PROTONIX?
In children 5 years of age and older, PROTONIX is used for:
PROTONIX is not for use in children under 5 years of age.
Do not take PROTONIX if you are:
Before taking PROTONIX, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).
Stop taking PROTONIX and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.
General information about the safe and effective use of PROTONIX.
What are the ingredients in PROTONIX?
This Medication Guide has been approved by the U.S. Food and Drug Administration.
This product's label may have been updated. For the most recent prescribing information, please go to www.pfizer.com.
under license from
D78467 Konstanz, Germany
Revised: March 2022
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)].
Severe Cutaneous Adverse Reactions
Advise patients to discontinue PROTONIX and immediately call their healthcare provider for further evaluation [see Warnings and Precautions (5.5)].
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 (5.6)].
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 (5.7)].
Hypomagnesemia and Mineral Metabolism
Advise patients to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia, to their healthcare provider, if they have been receiving PROTONIX for at least 3 months [see Warnings and Precautions (5.8)].
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 (5.8)] and high dose methotrexate [see Warnings and Precautions (5.13)].
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.