Pronunciation:

ra-BE-pray-zole

Brand Names:

• Aciphex

Dosage Forms:

• Tablet, Enteric Coated

Classifications:

Therapeutic—

Antiulcer

Pharmacologic—

Proton Pump Inhibitor

Uses of This Medicine:

Rabeprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat duodenal ulcers and gastroesophageal reflux disease (GERD), a condition in which the acid in the stomach washes back up into the esophagus. Rabeprazole is also used to treat Zollinger-Ellison syndrome, a condition in which the stomach produces too much acid. Sometimes rabeprazole is used along with antibiotics to treat ulcers associated with infections caused by the H. pylori bacteria (germ) .

Rabeprazole 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 rabeprazole in children below 12 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 rabeprazole in the elderly .

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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—

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
• Dasatinib

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Liver disease—Use with caution. May increase chance of side effects.

• Stomach infection—Use with caution. May make the condition worse.

Proper Use of This Medicine:

Swallow the delayed-release tablet whole. Do not crush, chew, or split the tablet. You may take this medicine with or without food, based on your medical condition .

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

This medicine is sometimes given together with other medicines to treat ulcers. Be sure you understand about the risks and proper use of any other medicine your doctor gives you together with rabeprazole .

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions .

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 tablet):
  • To treat gastroesophageal reflux disease (GERD):
    • Adults—20 milligrams (mg) once a day for 4 to 8 weeks.
    • Children and teenagers 12 to 18 years of age—20 milligrams (mg) once a day for up to 8 weeks.
    • Children below 12 years of age—Use and dose must be determined by your doctor .
  • 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 duodenal ulcers:
    • Adults—20 milligrams (mg) once a day after the morning meal for up to 4 weeks.
    • Children—Use and dose must be determined by your doctor.
  • To treat duodenal ulcers related to infection with H. pylori:
    • Adults—20 milligrams (mg) twice a day, plus amoxicillin 1000 mg (1 gram) twice a day plus clarithromycin 500 mg twice a day, all taken together before the morning and evening meals for seven days.
    • Children—Use and dose must be determined by your doctor.
  • To treat conditions in which the stomach produces too much acid (e.g., 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 progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. If your condition does not improve, or if it becomes worse, discuss this with your doctor .

This medicine may cause a serious type of allergic reaction called anaphylaxis, especially when used in patients treated with antibiotics (e.g., amoxicillin). Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine .

Serious stomach conditions may occur while taking this medicine with antibiotics. Stop using this medicine and check with your doctor immediately if you are having more than one of these symptoms: abdominal or stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, unusual tiredness or weakness .

Do not take other medicines unless they have been discussed with your doctor. Your doctor may adjust the doses of your medications or monitor you carefully for side effects .

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 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 hands or feet

unusual weight gain or loss

yellow eyes and skin

Rare

Breathing interruptions

bloody urine

continuing ulcers or sores in mouth

convulsions (seizures)

sore throat

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Back, leg, or stomach pains

bleeding gums

blood in 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

difficult breathing

difficulty swallowing

dizziness

fast heartbeat

general body swelling

general feeling of tiredness or weakness

greatly decreased frequency of urination or amount of urine

headache

high fever

hives

holding false beliefs that cannot be changed by fact

increase in frequency of seizures

itching

joint or muscle pain

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

loss of appetite

loss of consciousness

muscle cramps or spasms

muscle pain or stiffness

no blood pressure

no breathing

no pulse

nosebleeds

pale skin

pinpoint red spots on skin

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

seeing, hearing, or feeling things that are not there

shortness of breath

skin blisters

skin rash

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

swollen glands

tightness in chest

unpleasant breath odor

unusual excitement, nervousness, or restlessness

vomiting of blood

wheezing

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

Change in taste bad unusual or unpleasant (after)taste

Less common

Body aches or pain

congestion

constipation

diarrhea

excess air or gas in stomach or intestines

feeling weak

full feeling

heartburn

muscle pains or stiffness

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

pain

passing gas

runny nose

sleepiness

swollen joints

tender, swollen glands in neck

trouble in swallowing

voice changes

Incidence not known

Blistering, peeling, or loosening of 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.