Aciphex

Generic Name: 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: Gastric Acid Secretion Inhibitor

Pharmacologic Class: Proton Pump Inhibitor

Uses For Aciphex

Rabeprazole is used to treat certain conditions where there is too much acid in the stomach. It is used to treat duodenal ulcers and gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus. Sometimes rabeprazole is used along with antibiotics (e.g., amoxicillin, clarithromycin) to treat ulcers associated with infections caused by the H. pylori bacteria.

Rabeprazole is also used to treat Zollinger-Ellison syndrome, a condition in which the stomach produces too much acid.

Rabeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

Before Using Aciphex

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rabeprazole to treat GERD in children younger than 12 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of rabeprazole to treat other approved indications in the pediatric population. 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

	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.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rilpivirine

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


• Citalopram


• Clopidogrel


• Dasatinib


• Erlotinib


• Methotrexate


• Mycophenolate Mofetil


• Nelfinavir


• Nilotinib

Using this medicine 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hypomagnesemia (low magnesium in the blood), history of or


• Osteoporosis (bone problem) or


• Stomach infection (e.g., pseudomembranous colitis)—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Aciphex

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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.

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.

If you are taking this medicine to treat an ulcer that is associated with an H. pylori infection, take it together with the antibiotics (e.g., amoxicillin, clarithromycin) at the same time of day.

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 tablets):
  
  • To treat duodenal ulcers:
    
    • Adults—20 milligrams (mg) once a day after the morning meal. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat duodenal ulcers with H. pylori infection:
    
    • Adults—20 milligrams (mg) taken with a meal two times a day. The dose is usually taken together with clarithromycin plus amoxicillin. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat gastroesophageal reflux disease (GERD):
    
    • Adults—20 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    
    
    • Teenagers and children 12 years of age—20 mg once a day. Your doctor may adjust your dose if needed.
    
    
    • Children younger than 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. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • To treat 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 Aciphex

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, discuss this with your doctor.

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. If you or your child are using this medicine with clarithromycin, do not use it with cisapride (Propulsid®) or pimozide (Orap®).

This medicine may cause a serious type of allergic reaction when used in patients treated with antibiotics (e.g., amoxicillin). Call your doctor right away if you or your child have trouble breathing or swallowing; or any swelling of your hands, face, or mouth while you or your child 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 or your child 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.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine or use it for one year or more.

This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may want to check your blood levels if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Stop using this medicine and check with your doctor right away if you have convulsions (seizures); fast, racing, or uneven heartbeat; muscle spasms (tetany); tremors; or unusual tiredness or weakness.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Aciphex 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:

Less common

• Bloating or swelling of the 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 the hands or feet


• unusual weight gain or loss


• yellow eyes and skin

Rare

• Bloody urine


• continuing ulcers or sores in the mouth


• convulsions (seizures)


• difficulty with breathing


• sore throat


• unusual bleeding or bruising


• unusual tiredness or weakness

Incidence not known

• Back, leg, or stomach pains


• bleeding gums


• blood in the 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


• difficulty with swallowing


• dizziness


• drowsiness


• 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 the frequency of seizures


• itching


• joint or muscle pain


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


• loss of appetite


• loss of consciousness


• mood or mental changes


• muscle cramps


• muscle pain or stiffness


• muscle spasms [tetany] or twitching seizures


• no blood pressure


• no breathing


• no pulse


• nosebleeds


• pale skin


• pinpoint red spots on the 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 the lips or in the mouth


• swollen glands


• tightness in the chest


• trembling


• 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

• Bad, unusual, or unpleasant (after) taste


• change in taste

Less common

• Body aches or pain


• congestion


• constipation


• diarrhea


• excess air or gas in the stomach or intestines


• feeling weak


• full feeling


• heartburn


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


• pain


• passing gas


• runny nose


• sleepiness


• swollen joints


• tender, swollen glands in the neck


• trouble with swallowing


• voice changes

Incidence not known

• Blistering, peeling, or loosening of the 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.

See also: Aciphex side effects (in more detail)

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More Aciphex resources

• Aciphex Side Effects (in more detail)
• Aciphex Use in Pregnancy & Breastfeeding
• Drug Images
• Aciphex Drug Interactions
• Aciphex Support Group
• 29 Reviews for Aciphex - Add your own review/rating

• Aciphex Prescribing Information (FDA)


• Aciphex MedFacts Consumer Leaflet (Wolters Kluwer)


• Aciphex Consumer Overview


• AcipHex Monograph (AHFS DI)

Compare Aciphex with other medications

• Barrett's Esophagus
• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• GERD
• Helicobacter Pylori Infection
• Stomach Ulcer
• Zollinger-Ellison Syndrome