Pronunciation:

pan-TOE-pra-zole

Brand Names:

• Protonix

Dosage Forms:

• Packet
• Tablet, Enteric Coated
• Tablet, Delayed Release
• Powder for Suspension

Classifications:

Therapeutic—

Gastric Acid Secretion Inhibitor

Pharmacologic—

Proton Pump Inhibitor

Uses of This Medicine:

Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus. This medicine may also be used to treat Zollinger-Ellison syndrome, a condition where the stomach produces too much acid.

Pantoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of pantoprazole to treat erosive esophagitis in children younger than 5 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pantoprazole in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Amphetamine
• Atazanavir
• Atezolizumab
• Belumosudil
• Benzphetamine
• Bosutinib
• Capecitabine
• Cefuroxime Axetil
• Cilostazol
• Citalopram
• Dabrafenib
• Dacomitinib
• Dasatinib
• Dextroamphetamine
• Erlotinib
• Eslicarbazepine Acetate
• Fedratinib
• Fluconazole
• Gefitinib
• Infigratinib
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Mavacamten
• Methamphetamine
• Methotrexate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Nilotinib
• Octreotide
• Palbociclib
• Pazopanib
• Pexidartinib
• Phenobarbital
• Primidone
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• Sunitinib
• Tocilizumab
• Velpatasvir
• Vismodegib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levothyroxine
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Hypomagnesemia (low magnesium in the blood), history of or
• Osteoporosis (bone problem) or
• Seizures, history of or
• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the delayed-release tablet whole. Do not split, crush, or chew it. You may take the tablet with or without food.

For delayed-release oral suspension granules:

• Applesauce method:
  • 1. Open packet.
  • 2. Mix the packet contents with 1 teaspoonful of applesauce. Do not mix with water, other liquids, or food.
  • 3. Swallow the mixture at least 30 minutes before a meal. Take it within 10 minutes after you mix it.
  • 4. Sip some water after you swallow the mixture. This will make sure all of the granules get all the way to your stomach.
  • 5. Do not chew or crush the granules. Do not divide the packet contents to make smaller doses.
• Apple juice method:
  • 1. Open packet.
  • 2. Mix the packet contents with 1 teaspoon of apple juice in a small cup or container.
  • 3. Stir for 5 seconds (granules will not dissolve) and swallow it immediately or take it at least 30 minutes before a meal.
  • 4. Rinse the container with apple juice to make sure you get all of the medicine. Swallow it immediately.
  • 5. Do not chew or crush the granules. Do not divide the packet contents to make smaller doses.
• Feeding tube:
  • 1. Pour the packet contents in a 2-ounce (60 mL) catheter-tip syringe.
  • 2. Clear any clogs from the feeding tube before you put this medicine mixture into the tube.
  • 3. Add 10 mL of apple juice into the syringe. Gently tap or shake the barrel of the syringe to help rinse the syringe and tube.
  • 4. Repeat with an additional 10 mL of apple juice. No granules should remain in the syringe.
  • 5. Take this medicine at least 30 minutes before a meal.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (delayed-release tablets or suspension):
  • For erosive esophagitis:
    • Adults—40 milligrams (mg) once a day for up to 8 weeks. Your doctor may want you to take pantoprazole for more than 8 weeks for certain conditions.
    • Children 5 years of age and older weighing 40 kilograms (kg) or more—40 mg once a day for up to 8 weeks.
    • Children 5 years of age and older weighing 15 to 39 kg—20 mg once a day for up to 8 weeks.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For Zollinger-Ellison syndrome:
    • Adults—At first, 40 milligrams (mg) 2 times a day. Your doctor may increase your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your and your child's progress at regular visits to make sure this medicine is working properly. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

Do not use pantoprazole together with medicines containing rilpivirine (eg, Complera®, Edurant®, Odefsey®). Using these medicines together may cause unwanted side effects.

Check with your doctor right away if you have a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, nausea, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

Taking this medicine for a long time may make it harder for your and your child's body to absorb vitamin B12. Tell your doctor if you have concerns about this.

Serious stomach conditions may occur while taking this medicine. Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.

Pantoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk ti your doctor if you have concerns.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, nelfinavir, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blurred vision

dry mouth

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

nausea

stomach pain

sweating

trouble breathing

unexplained weight loss

vomiting

Incidence not known

Absence of or decrease in body movements

black, tarry stools

blindness

blistering, peeling, or loosening of the skin

bloating

bloody or cloudy urine

bloody, black, or tarry stools

blurred vision

chest pain or tightness

chills

clay-colored stools

confusion

constipation

continuous ringing or buzzing or other unexplained noise in the ears

cough

dark urine

decreased vision

diarrhea

difficulty with speaking

difficulty with swallowing

dizziness or lightheadedness

drowsiness

fast heartbeat

feeling of constant movement of self or surroundings

fever

greatly decreased frequency of urination or amount of urine

headache

hearing loss

high fever

hives, itching, or skin rash

indigestion

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

loss of appetite

mood or mental changes

muscle cramp, pain, stiffness, spasms, or twitching

muscle cramps in the hands, arms, feet, legs, or face

numbness and tingling around the mouth, fingertips, or feet

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

seizures

sensation of spinning

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain, continuing

swelling of the feet or lower legs

swollen glands

trembling

unexplained bleeding or bruising

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Belching

bloated or full feeling

excess air or gas in the stomach or bowels

passing gas

trouble sleeping

Incidence not known

Decreased interest in sexual intercourse

inability to have or keep an erection

increased watering of the mouth

loss in sexual ability, desire, drive, or performance

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.