RABEPRAZOLE (Systemic)?

Some commonly used brand names are:

In the U.S.?

• AcipHex

? Not commercially available in Canada.

Category

• Gastric acid pump inhibitor
• Antiulcer agent

Description

Rabeprazole (ra-BE-pray-zole) is usedto 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 inwhich the stomach produces too much acid. Sometimes rabeprazole is used alongwith 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

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For rabeprazole, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual or allergicreaction to rabeprazole. Also tell your health care professional if you areallergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy?Studies have not been done in humans. However, studies in animalshave not been shown that rabeprazole causes harm to the fetus.

Breast-feeding?Rabeprazole may pass into the breast milk. Since this medicinehas 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-feedingduring treatment. Be sure you discussed the risks and benefits of the medicinewith your doctor.

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

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingrabeprazole, it is especially important that your health care professionalknow if you are taking any of the following:

• Cyclosporine (e.g., Neoral)?Rabeprazole may increase the amountof cyclosporine in the blood.

• Digoxin (e.g., Lanoxin)?Rabeprazole may increase the amountof digoxin in the blood.

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

• Warfarin (e.g., Coumadin)?May cause serious unwanted effectsincluding 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 splitthe tablet. Take this medicine for the full timeof treatment, even if you begin to feel better. Also, keep your appointmentswith your doctor for check-ups so that your doctor will be better able totell you when to stop taking this medicine.

Dosing?The dose of rabeprazole will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of rabeprazole. If your dose is different,do not change it unless your doctor tells you to do so.

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

• For oral dosage form (delayed-releasetablet):
  • 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 determinedby 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 determinedby your doctor
  • To treat duodenal ulcers:
    • Adults?20 mg once a day after the morning meal for up to 4weeks.
    • Children up to 18 years of age?Use and dose must be determinedby 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 beforethe morning and evening meals for seven days.
    • Children up to 18 years of age?Use and dose must be determinedby your doctor.
  • To treat conditions in which the stomach produces too much acid:
    • Adults?At first, 60 mg once a day. Your doctor may increaseyour dose if needed.
    • Children up to 18 years of age?Use and dose must be determinedby your doctor.

Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.

Storage?To store this medicine:

• 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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. 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 atregular visits to make sure that this medicine is working properlyand to check for unwanted effects. If your condition does not improve, orit becomes worse, discuss this with your doctor.

Side Effects of This Medicine

Alongwith its needed effects, a medicine may cause some unwanted effects. Althoughnot all of these side effects may occur, if they do occur they may need medicalattention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Rare

Breathing interruptions; bloody urine; convulsions (seizures); chills, fever, or sore throat; continuing ulcersor sores in mouth; unusual bleeding or bruising; unusual tiredness or weakness; yelloweyes or skin

Incidence not known

Blistering, peeling, loosening of skin; change in consciousness; clay-colored stools; cloudy urine; confusion about identity,place, person, and time; continuing nausea or vomiting; cough; dark urine; difficult breathing; difficulty swallowing; fast heartbeat; greatlydecreased frequency of urination or amount of urine; hallucinations; hives, itching, puffiness or swellingof the eyelids or around the eyes, face, lips or tongue; holding false beliefs that cannot be changed by fact; increase in frequency of seizures; itching; joint or muscle pain; large, hive-likeswelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; loss of appetite; lossof consciousness; muscle cramps or spasms; muscle pain or stiffness; no blood pressure; no breathing; no pulse; red, irritated eyes; red skin lesions, often with a purple center; shortnessof breath; skin blisters; skin rash; sores, ulcers, or white spots in mouthor on lips; swelling of face; swelling of feet or lower legs; tightness in chest; tiredness and weakness; unusual excitement, nervousness or restlessness; wheezing

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects continue or are bothersome:

More common

Headache

Less common or rare

Constipation; diarrhea ; dizziness; feeling weak; gas; heartburn; itchy skin; nausea and vomiting; numbness, tingling, pain, or weakness in hands or feet; sleepiness; stomach pain

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.