Rabeprazole

(ra be' pray zole)

Brand Name(s): AcipHex^®

IMPORTANT NOTICE:

[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the ''Drug Facts'' label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.

The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

WHY is this medicine prescribed?

Rabeprazole is used to treat conditions where the stomach produces too much acid, including ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Rabeprazole is used in combination with other medications to eliminate H. pylori, a bacterium that causes ulcers. Rabeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Rabeprazole comes as a delayed-release (long-acting) tablet to take by mouth. It is usually taken once a day for 4 to 8 weeks, but it is sometimes taken for a longer time. When taken for ulcers, rabeprazole should be taken after the morning meal. When taken in combination with other medications to eliminate H. pylori, rabeprazole is taken twice a day, with the morning and evening meals, for 7 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rabeprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

What SPECIAL PRECAUTIONS should I follow?

Before taking rabeprazole,

• tell your doctor and pharmacist if you are allergic to rabeprazole, lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: cyclosporine (Neoral, Sandimmune), clopidogrel (Plavix), digoxin (Lanoxin), and ketoconazole (Nizoral). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rabeprazole, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Rabeprazole may cause side effects. Tell your doctor if these symptoms are severe or do not go away:

• headache
• upset stomach
• diarrhea
• stomach pain
• vomiting
• constipation
• dry mouth
• increased or decreased appetite
• muscle or bone pain
• drowsiness
• dizziness
• difficulty falling asleep or staying asleep

There may be other side effects from rabeprazole. Call your doctor if you have any unusual problems while taking this medication.

What STORAGE CONDITIONS are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.