(pantoprazole sodium)

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Instructions for Use PROTONIX (pro-TAH-nix) (pantoprazole sodium) for delayed-release oral suspension

Instructions for Use PROTONIX (pro-TAH-nix) (pantoprazole sodium) for delayed-release oral suspension

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Gastric Malignancy

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)].

Bone Fracture

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)].

Drug Interactions

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)].

Pregnancy

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)].

Administration

•
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.

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:

•
A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PROTONIX. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
•
Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
•
Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
•
Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body). Some people who take PPI medicines, including PROTONIX, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
•
Low magnesium and other mineral levels in your body can happen in people who have taken PROTONIX for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

Talk to your doctor about your risk of these serious side effects.
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:

•
up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 weeks of PROTONIX in patients whose EE does not heal.
•
maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD. It is not known if PROTONIX is safe and effective when used for longer than 12 months for this purpose.
•
the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.

In children 5 years of age and older, PROTONIX is used for:

•
up to 8 weeks for the healing and symptom relief of EE.
It is not known if PROTONIX is safe if used longer than 8 weeks in children.

PROTONIX is not for use in children under 5 years of age.
It is not known if PROTONIX is safe and effective in children for treatment other than EE.

Do not take PROTONIX if you are:

•
allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in PROTONIX. See the end of this Medication Guide for a complete list of ingredients.
•
taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking PROTONIX, tell your doctor about all of your medical conditions, including if you:

•
have low magnesium levels, low calcium levels and low potassium levels in your blood.
•
are pregnant or plan to become pregnant. PROTONIX may harm your unborn baby. Tell your doctor if you become pregnant or think you may be pregnant during treatment with PROTONIX.
•
are breastfeeding or plan to breastfeed. PROTONIX can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take PROTONIX.

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).

How should I take PROTONIX?

•
Take PROTONIX exactly as prescribed by your doctor.
PROTONIX delayed-release tablets (PROTONIX tablets):
o
Do not split, chew, or crush PROTONIX tablets.
o
Swallow PROTONIX tablets whole, with or without food.
o
Tell your doctor if you are not able to swallow your PROTONIX tablet.
 
PROTONIX for delayed-release oral suspension (PROTONIX for oral suspension):
o
You may use antacids while taking PROTONIX tablets.
o
Do not split, chew, or crush PROTONIX for oral suspension.
o
Take PROTONIX for oral suspension about 30 minutes before a meal.
o
PROTONIX for oral suspension should only be given by mouth mixed in apple juice or applesauce or through a nasogastric (NG) tube or gastrostomy tube mixed in apple juice. Do not mix PROTONIX for oral suspension in liquids other than apple juice or foods other than applesauce.
o
Do not divide a packet of PROTONIX for oral suspension to make a smaller dose.
o
See the "Instructions for Use" at the end of this Medication Guide for instructions on how to mix and take PROTONIX for oral suspension by mouth in applesauce or apple juice or how to mix and give the suspension through an NG tube or gastrostomy tube mixed in apple juice.
•
If you miss a dose of PROTONIX, take it as soon as possible. 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 2 doses at the same time.
•
If you take too much PROTONIX, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.

What are the possible side effects of PROTONIX?
PROTONIX can cause serious side effects, including:

•
See "What is the most important information I should know about PROTONIX?"
•
Low vitamin B-12 levels in your body can happen in people who have taken PROTONIX for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
•
Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
•
Severe skin reactions. PROTONIX can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
o
Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
o
You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.

Stop taking PROTONIX and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.
The most common side effects of PROTONIX in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.
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.

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.

Logo

under license from
Takeda GmbH
D78467 Konstanz, Germany

LAB-0574-16.0

Revised: March 2022

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.
•
PROTONIX for oral suspension:
o
should only be taken with applesauce or apple juice.
o
should not be mixed in water or other liquids, or other foods.
o
packet should not be divided to make a smaller dose.
•
Taking PROTONIX for oral suspension with applesauce:
1.
Open the packet of PROTONIX for oral suspension.
2.
Sprinkle all of the granules in the packet on 1 teaspoon of applesauce.
3.
Swallow the granules and applesauce within 10 minutes of putting the granules on the teaspoon of applesauce.
4.
Take sips of water to make sure the granules are washed down into the stomach. Take more sips of water as needed.
•
Taking PROTONIX for oral suspension with apple juice:
1.
Open the packet of PROTONIX for oral suspension.
2.
Empty all of the granules in the packet into a small cup that contains 1 teaspoon of apple juice.
3.
Stir the granules-apple juice mixture for 5 seconds. The granules will not break up.
4.
Swallow the mixture right away.
5.
To make sure that the entire dose is taken, add more apple juice to the cup, stir and swallow the apple juice right away.
6.
Repeat step 5 if there are granules left in the cup.
•
Giving PROTONIX for oral suspension through a nasogastric (NG) tube or gastrostomy tube:
•
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.
1.
Remove the plunger from a 60 mL (2 ounce) catheter-tip syringe. Throw away the plunger.
2.
Connect the tip of the catheter-tip syringe to the NG tube or gastrostomy tube.
3.
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.
4.
Open the packet of PROTONIX for oral suspension.
5.
Empty all the granules in the packet into the catheter-tip syringe.
6.
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.
7.
Repeat step 6 at least 2 more times until there are no granules left in the catheter-tip syringe.

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.

This Instructions for Use 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.

Logo

under license from
Takeda GmbH
D78467 Konstanz, Germany

LAB-1511-1.0

Revised: March 2022

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