Aciphex Drug Information

RABEPRAZOLE (Systemic)†

Some frequently used brand names are:

In the U.S.—

• AcipHex

† Not tradable in Canada.

Category

• Gastric acid pump inhibitor
• Antiulcer agent

Description

Rabeprazole (ra-BE-pray-zole) 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 disease, a condition in which the stomach produces too much acid. Sometimes rabeprazole is used along with antibiotics to treat ulcers associated with infection 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.

• Oral
• Delayed-release tablet (U.S.)

Before Using This Medicine

When deciding if it's worth using a medicine, the risk of taking it must be carefully weighed against the benifit it can do. This is the decision you and your doctor are to make together. Concerning rabeprazole, the following aspects should be taken into account:

Allergies—Inform your doctor if you have ever experienced any unusual or allergic reaction to rabeprazole. Also tell your doctor if you are allergic to any other substances, like foods, preservatives, dyes.

Pregnancy—No studies have been conducted in humans. However, studies in animals have not been shown that rabeprazole causes harm to the fetus.

Breast-feeding—Rabeprazole may pass into the breast milk. Since this medicine has been shown to cause a decrease in body weight gain in animal studies, it may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you discussed the risks and benefits of the medicine with your doctor.

Children—There is no specific information comparing the use of rabeprazole in children with use in other age groups.

Older adults—In studies done to date that have included older adults, rabeprazole did not cause different side effects or problems than it did in younger adults.

Other medicines—Although some medicines should not be used together at all, there are cases when 2 different medicines maybe used together even if an interaction might occur. In such cases, your doctor may advise you to change the dose, or other precautions may be required. When you are taking rabeprazole, it is essential to tell your health care professional if you are taking any of the following:

• Cyclosporine (e.g., Neoral)—Rabeprazole may increase the amount of cyclosporine in the blood.

• Digoxin (e.g., Lanoxin)—Rabeprazole may increase the amount of digoxin in the blood.

• Ketoconazole (e.g., Nizoral tablets)—Rabeprazole may decrease the amount of ketoconazole absorbed into the body.

• Warfarin (e.g., Coumadin)—May cause serious unwanted effects including abnormal bleeding

Other medical problems—

• Liver disease—May increase chance of side effects
• Stomach infection—May make the condition worse

Proper Use of This Medicine

Swallow the tablet whole. Do not crush, chew, or split the tablet . You should take this medicine for the full time of treatment, even if you start feeling 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.

Dosing—The dose of rabeprazole will vary for different patients. Adhere to the orders of your doctor or the instructions on the label . The information below includes only the average doses of rabeprazole. If your dose differs, you should not change it unless your doctor tells you to do so.

The number of doses you take each day and the length of time you take the medicine depend on the medical problem for which you are taking rabeprazole

• For oral dosage form (delayed-release tablet):
  • To treat gastroesophageal reflux disease (GERD):
    • Adults—20 mg once a day for 4 to 8 weeks.
    • Children up to 18 years of age—Use and dose must be determined by your doctor
  • To prevent gastroesophageal reflux disease (GERD):
    • Adults—20 mg once a day.
    • Children up to 18 years of age—Use and dose must be determined by your doctor
  • To treat duodenal ulcers:
    • Adults—20 mg once a day after the morning meal for up to 4 weeks.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.
  • To treat duodenal ulcers related to infection with H. pylori
    • Adults—20 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 up to 18 years of age—Use and dose must be determined by your doctor.
  • To treat conditions in which the stomach produces too much acid:
    • Adults—At first, 60 mg once a day. Your doctor may increase your dose if needed.
    • Children up to 18 years of age—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. You should not double doses.

Storage—To store this medicine properly, follow the instructions below:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

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 it becomes worse, discuss this with your doctor.

Side Effects of This Medicine

Alongside with its expected effects, any medicine may be the cause of some unwanted effects. Although not all of these side effects may happen, if they do happen they may require medical attention.

Consult your doctor immediately if any of the side effects from the list below occur:

Other side effects that may occur generally do not require any medical attention. These side effects may disappear in the course of treatment as your body gets used to the medicine. Nevertheless, inform your doctor if any of the side effects below persist or became annoying:

Other side effects not mentioned above may also happen in some patients. If you notice any other effects, tell your doctor about it.