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Rabeprazole (Oral route)

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. It may also be used together with antibiotics 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. 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.

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.

  • Atazanavir
  • Bosutinib
  • Cilostazol
  • Clopidogrel
  • Dasatinib
  • Digoxin
  • Erlotinib
  • Eslicarbazepine Acetate
  • Gefitinib
  • Ketoconazole
  • Ledipasvir
  • Methotrexate
  • Mycophenolate Mofetil
  • Nelfinavir
  • Nilotinib
  • Pazopanib
  • Saquinavir
  • 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 with food, 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 tablets):
    • To treat duodenal ulcers:
      • Adults—20 milligrams (mg) once a day after the morning meal.
      • 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 clarithromycin and amoxicillin.
      • Children—Use and dose must be determined by your doctor.
    • To treat gastroesophageal reflux disease (GERD):
      • Adults—20 milligrams (mg) once a day.
      • Children 12 years of age and older—20 mg once a day.
      • Children younger than 12 years—Use is not recommended.
    • To prevent gastroesophageal reflux disease (GERD):
      • Adults—20 milligrams (mg) once a day.
      • 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.
  • For oral dosage form (delayed-release capsules):
    • To treat gastroesophageal reflux disease (GERD):
      • Children 1 to 11 years and weighing 15 kilograms (kg) or more—10 milligrams (mg) once a day.
      • Children 1 to 11 years and weighing less than 15 kg—5 mg once a day. Your doctor may adjust your dose as needed.
      • Children younger than 1 year—Use is not recommended.

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 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 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®).

Check with your doctor right away if you have a decrease in how much or how often you urinate, bloody or cloudy urine, swelling of the feet or lower legs, rash, or a fever. These may be symptoms of a serious kidney problem.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you take several doses per day or use it for 1 year or more. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.

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 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 or vomiting, trembling, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription 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
cough or hoarseness
dark urine
dry mouth
fever or chills
general tiredness and weakness
light-colored stools
lower back or side pain
nausea and vomiting
painful or difficult urination
rapid weight gain
tingling of the hands or feet
unusual weight gain or loss
yellow eyes and skin
Rare
Bloody urine
continuing ulcers or sores in the mouth
convulsions (seizures)
difficulty with breathing
sore throat
unusual bleeding or bruising
unusual tiredness or weakness
Incidence not known
Back, leg, or stomach pains
bleeding gums
blood in the urine or stools
bloody, black, or tarry stools
change in consciousness
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
general feeling of tiredness or weakness
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 or muscle pain
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
loss of appetite
loss of consciousness
mood or mental changes
muscle cramps
muscle pain or stiffness
muscle spasms (tetany) or twitching
no blood pressure
no breathing
no pulse
nosebleeds
pale skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seeing, hearing, or feeling things that are not there
skin blisters
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
tightness in the chest
trembling
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 intestines
feeling weak
full feeling
heartburn
numbness, tingling, pain, or weakness in the hands or feet
pain
passing gas
runny nose
sleepiness
swollen joints
tender, swollen glands in the neck
voice changes
Incidence not known
Blistering, peeling, or loosening of the skin
red, irritated eyes
red skin lesions, often with a purple center

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.


Last Updated: 7/4/2017
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