rabeprazole (Oral route)

ra-BEP-ra-zole

Commonly used brand name(s):

In the U.S.

• Aciphex

Available Dosage Forms:

• Tablet, Enteric Coated

Therapeutic Class: Antiulcer

Pharmacologic Class: Proton Pump Inhibitor

Uses For rabeprazole

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.

rabeprazole is available only with your doctor's prescription.

Before Using rabeprazole

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 rabeprazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rabeprazole 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.

Pediatric

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 .

Geriatric

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

Pregnancy

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.

Interactions with Medicines

Using rabeprazole 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
• Clopidogrel
• Dasatinib
• Erlotinib
• Mycophenolate Mofetil
• Nelfinavir

Using rabeprazole 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.

• Cranberry
• Digoxin
• Itraconazole
• Ketoconazole

Interactions with Food/Tobacco/Alcohol

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 rabeprazole. 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 rabeprazole

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

Take rabeprazole 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 rabeprazole.

rabeprazole 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 .

rabeprazole 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 rabeprazole 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 rabeprazole. 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 rabeprazole, 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 rabeprazole

It is very important that your doctor check your progress at regular visits to make sure that rabeprazole 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 .

rabeprazole 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 rabeprazole .

Serious stomach conditions may occur while taking rabeprazole with antibiotics. Stop using rabeprazole 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 .

rabeprazole Side Effects

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:

• 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

• Breathing interruptions
• bloody urine
• continuing ulcers or sores in mouth
• convulsions (seizures)
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

• 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:

• Change in taste bad unusual or unpleasant (after)taste

• 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

• 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.

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

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