AcipHex Sprinkle

Name: AcipHex Sprinkle

What Is AcipHex Sprinkle?

Rabeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Rabeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1 year old.

Rabeprazole is used only in adults to treat conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome. Rabeprazole is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Rabeprazole may also be given with an antibiotic to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori).

Rabeprazole is not for immediate relief of heartburn symptoms.

Rabeprazole may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medicine if you are allergic to rabeprazole or to similar medicines such as lansoprazole (Prevacid), esomeprazole (Nexium), omeprazole (Prilosec, Zegerid), or pantoprazole (Protonix).

To make sure rabeprazole is safe for you, tell your doctor if you have:

  • severe liver disease;
  • osteoporosis;
  • low bone mineral density (osteopenia); or
  • low levels of magnesium in your blood.

Taking a proton pump inhibitor such as rabeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medicine long term or at high doses, and in those who are age 50 and older. It is not clear whether rabeprazole is the actual cause of an increased risk of fracture.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether rabeprazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

AcipHex Sprinkle Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • seizure (convulsions);
  • kidney problems--urinating more or less than usual, blood in your urine, swelling, rapid weight gain; or
  • symptoms of low magnesium--dizziness, confusion; fast or uneven heart rate; tremors (shaking) or jerking muscle movements; feeling jittery;muscle cramps, muscle spasms in your hands and feet; cough or choking feeling.

Common side effects may include:

  • headache;
  • pain;
  • sore throat;
  • stomach pain, gas;
  • diarrhea, constipation; or
  • signs of infection (fever, chills, flu symptoms).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

AcipHex Sprinkle Dosage

Rabeprazole is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Rabeprazole is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time.

When treating H. pylori infection, rabeprazole may be needed for only 7 days. Follow your doctor's instructions.

Take this medicine with a full glass of water.

Rabeprazole tablets may be taken with or without food. Rabeprazole delayed-release capsules should be taken 30 minutes before a meal.

Do not crush, break, or chew a rabeprazole tablet. Swallow it whole.

To take delayed-release rabeprazole (AcipHex Sprinkle), open the capsule and sprinkle the medicine into a spoonful of soft food such as applesauce, yogurt, or baby food made from fruit or vegetable. You may also mix the medicine with apple juice, Pedialyte, or infant formula. Swallow right away without chewing. Do not save the mixture for later use; it will go bad after 15 minutes.

Some conditions are treated with a combination of rabeprazole and antibiotics. Use all medications as directed by your doctor. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not change your doses or medication schedule without your doctor's advice.

Take your medicine for the full prescribed length of time. Your symptoms may improve before your condition is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using rabeprazole.

If you use rabeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I discuss with my healthcare provider before taking AcipHex Sprinkle (rabeprazole)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medicine if you are allergic to rabeprazole or:

  • if you also take any medicine that contains rilpivirine, such as Edurant or Complera; or

  • if you also allergic to medicines like rabeprazole, such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), or pantoprazole (Protonix).

To make sure rabeprazole is safe for you, tell your doctor if you have:

  • liver disease;

  • osteoporosis;

  • low bone mineral density (osteopenia); or

  • low levels of magnesium in your blood.

Taking a proton pump inhibitor such as rabeprazole may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medicine long term or at high doses, and in those who are age 50 and older. It is not clear whether rabeprazole is the actual cause of an increased risk of fracture.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether rabeprazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Indications and Usage for Aciphex Sprinkle

Aciphex Sprinkle is indicated for treatment of Gastroesophageal Reflux Disease (GERD) in pediatric patients 1 to 11 years of age for up to 12 weeks.

How Supplied/Storage and Handling

Aciphex Sprinkle delayed-release capsules (5 mg) are supplied as transparent blue and opaque white capsules containing enteric coated granules. Identification and strength (ACX 5mg) are imprinted on the body of the capsule. An arrow (↑) imprint on the capsule cap indicates direction for opening a capsule.

Bottles of 30 (NDC 13551-205-01)

Aciphex Sprinkle delayed-release capsules (10 mg) are supplied as transparent yellow and opaque white capsules containing enteric coated granules. Identification and strength (ACX 10mg) are imprinted on the body of the capsule. An arrow (↑) imprint on the capsule cap indicates direction for opening a capsule.

Bottles of 30 (NDC 13551-210-01)

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Uses of Aciphex Sprinkle

Aciphex Sprinkle is a prescription medicine used for the following conditions:

  • heartburn caused by gastroesophageal reflux disease (GERD)
  • duodenal ulcers
  • acid-related damage to the lining of the esophagus
  • H. pylori infections
  • Zollinger-Ellison syndrome (a condition in which the stomach makes too much acid)

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

Other Requirements

Store Aciphex Sprinkle in a dry place at room temperature, 68°F to 77°F (20°C to 25°C).

Keep Aciphex Sprinkle and all medicines out of the reach of children.

Geriatric

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

For the Consumer

Applies to rabeprazole: oral capsule delayed release, oral tablet enteric coated

Along with its needed effects, rabeprazole (the active ingredient contained in Aciphex Sprinkle) 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 while taking rabeprazole:

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, itching, or skin rash
  • holding false beliefs that cannot be changed by fact
  • increase in the frequency of seizures
  • 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
  • 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
  • skin blisters
  • 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

Some side effects of rabeprazole 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
  • voice changes
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • red, irritated eyes
  • red skin lesions, often with a purple center

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