Pronunciation:

ra-BEP-ra-zole

Brand Names:

• Aciphex
• Aciphex Sprinkle

Dosage Forms:

• Capsule, Delayed Release
• Tablet, Enteric Coated

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Proton Pump Inhibitor

Uses of This Medicine:

Rabeprazole is used to treat duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition where the stomach produces too much acid. It may also be used together with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers associated with infections caused by the H. pylori bacteria. Rabeprazole is a proton pump inhibitor (PPI) that decreases 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—

Use of rabeprazole for treating gastroesophageal reflux disease (GERD) is not recommended in children younger than 1 year of age for Aciphex® Sprinkle™ capsule or in children younger than 12 years of age for Aciphex® delayed-release tablets. Appropriate studies have not been performed on the relationship of age to the effects of rabeprazole for treating ulcers associated with infections, duodenal ulcers, or Zollinger-Ellison syndrome in the pediatric population. 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 rabeprazole in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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
• Carbamazepine
• Cefuroxime Axetil
• Cilostazol
• Clopidogrel
• Dabrafenib
• Dacomitinib
• Dasatinib
• Dextroamphetamine
• Digoxin
• Erlotinib
• Eslicarbazepine Acetate
• Fedratinib
• Fluconazole
• Gefitinib
• Infigratinib
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Mavacamten
• Methamphetamine
• Methotrexate
• Methylphenidate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Nilotinib
• Nirogacestat
• Nivolumab
• Octreotide
• Palbociclib
• Pazopanib
• Pexidartinib
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• Sunitinib
• 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

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:

• Broken bones, history of or
• Diarrhea, history of or
• Hypomagnesemia (low magnesium levels), history of or
• Osteoporosis (weak bones), history of or
• Systemic lupus erythematosus (SLE) or
• Vitamin B12 deficiency—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 the instructions carefully. Ask your doctor or pharmacist if you have any questions.

Swallow the delayed-release tablet whole. Do not crush, chew, or split the tablet. You may take this medicine with or without food. If your doctor tells you to take the medicine in a certain way, follow those instructions.

For children using the delayed-release capsules:

• Do not swallow the capsule whole.
• Take the capsule 30 minutes before a meal.
• Open the capsule and pour the contents on a small amount of soft food (eg, applesauce, fruit or vegetable baby food, yogurt) or in a small amount of liquid (eg, infant formula, apple juice, or pediatric electrolyte solution (Pedialyte®).
• Take the mixture within 15 minutes. Swallow the mixture without chewing. Do not save it for later use.

If you are taking this medicine to treat an ulcer associated with an infection, take it together with the antibiotics (eg, amoxicillin, clarithromycin) at the same time of day.

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 form (delayed-release capsules):
  • To treat gastroesophageal reflux disease (GERD):
    • Children 1 to 11 years of age and weighing 15 kilograms (kg) or more—10 milligrams (mg) once a day.
    • Children 1 to 11 years of age and weighing less than 15 kg—5 mg once a day. Your doctor may adjust your dose as needed.
    • Children younger than 1 year of age—Use is not recommended.
• For oral dosage form (delayed-release tablets):
  • To treat duodenal ulcers:
    • Adults—20 milligrams (mg) once a day after the morning meal for up to 4 weeks. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • To treat duodenal ulcers with H. pylori infection:
    • Adults—20 milligrams (mg) taken with a meal 2 times a day for 7 days. The dose is usually taken together with amoxicillin and clarithromycin.
    • Children—Use and dose must be determined by your doctor.
  • To treat gastroesophageal reflux disease (GERD):
    • Adults—20 milligrams (mg) once a day for up to 4 weeks. Your doctor may adjust your dose as needed.
    • Children 12 years of age and older—20 mg once a day for up to 8 weeks. Your child's doctor may adjust the dose as needed.
    • Children younger than 12 years of age—Use is not recommended.
  • To prevent gastroesophageal reflux disease (GERD):
    • Adults—20 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • To treat Zollinger-Ellison syndrome:
    • Adults—At first, 60 milligrams (mg) once a day. Your doctor may adjust your dose if 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 or your child's progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.

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

Rabeprazole may cause a serious type of allergic reaction when used in patients with conditions treated with antibiotics. Call your doctor right away if you or your child has itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth.

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, skin rash, swelling of the body or feet and ankles, unusual tiredness or weakness, or unusual weight gain. These may be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.

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

Serious stomach conditions may occur while taking this medicine alone or together with antibiotics. 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.

This medicine 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.

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

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 cause hypomagnesemia (low magnesium in the blood). Your doctor may check your blood levels if you are taking this medicine for more than 1 year or if you are taking certain medicines together with rabeprazole. Check with your doctor right away if you have drowsiness, a loss of appetite, mood or mental changes, muscle spasms or twitching, seizures, nausea, vomiting, trembling, 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 to 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

Bloating or swelling of the face, arms, hands, lower legs, or feet

chills

cough

dark urine

dry mouth

fever

general feeling of tiredness and weakness

hoarseness

light-colored stools

lower back or side pain

nausea

painful or difficult urination

rapid weight gain

tingling of the hands or feet

unusual weight gain or loss

vomiting

yellow eyes and skin

Rare

Bloody urine

continuing ulcers or sores in the mouth

difficulty with breathing

seizures

sore throat

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

bloody, black, or tarry stools

change in consciousness

chest tightness

clay-colored stools

cloudy urine

confusion about identity, place, person, and time

continuing nausea or vomiting

difficulty with swallowing

dizziness

drowsiness

fast heartbeat

general body swelling

greatly decreased frequency of urination or amount of urine

headache

high fever

hives, itching, or skin rash

holding false beliefs that cannot be changed by fact

increase in the frequency of seizures

joint pain

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

loss of appetite

loss of consciousness

mood or mental changes

muscle cramps, pain, spasms, stiffness, or twitching

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

no blood pressure

no breathing

no pulse

nosebleeds

numbness and tingling around the mouth, fingertips, or feet

pale skin

pinpoint red spots on the 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

seeing, hearing, or feeling things that are not there

seizures

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

stomach cramps

swollen glands

trembling

trouble breathing

unpleasant breath odor

unusual excitement, nervousness, or restlessness

vomiting of blood

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:

More common

Bad, unusual, or unpleasant (after) taste

change in taste

Less common

Body aches or pain

congestion

constipation

diarrhea

excess air or gas in the stomach or bowels

full feeling

heartburn

numbness, tingling, pain, or weakness in the hands or feet

passing gas

runny nose

sleepiness

swollen joints

tender, swollen glands in the neck

voice changes

Incidence not known

Decreased interest in sexual intercourse

inability to have or keep an erection

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.