Rabeprazole Sodium

Dosage Forms And Strengths

ACIPHEX delayed-release tablets are provided in one strength, 20 mg. The tablets are round, light yellow, enteric coated, biconvex tablets. “ACIPHEX 20” is imprinted in red on one side of the tablet.

Storage And Handling

ACIPHEX 20 mg is supplied as delayed-release light yellow enteric-coated tablets. The name and strength, in mg, (ACIPHEX 20) is imprinted on one side.

Bottles of 30 (NDC 62856-243-30)
Bottles of 90 (NDC 62856-243-90)
Unit Dose Blisters Package of 100 (10 x 10) (NDC 62856-243-41)

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

Distributed by Eisai Inc., Woodcliff Lake, NJ 07677. Revised: Oct 2016

Included as part of the "PRECAUTIONS" Section

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.

ACIPHEX® Sprinkle™
(a-se-feks spr-en-kle)
(rabeprazole sodium) delayed-release capsules

What is the most important information I should know about ACIPHEX Sprinkle?

Your child should take ACIPHEX Sprinkle exactly as prescribed, at the lowest dose possible and for the shortest time needed.

ACIPHEX Sprinkle may help your child’s acid-related symptoms, but your child could still have serious stomach problems. Talk with your child’s doctor.

ACIPHEX Sprinkle can cause serious side effects, including:

• A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including ACIPHEX Sprinkle, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with ACIPHEX Sprinkle. Call your child’s doctor right away if your child has a decrease in the amount that they urinate or if they have blood in their urine.
• Diarrhea caused by an infection (Clostridium difficile) in your child’s intestines. Call your child’s doctor right away if your child has watery stools or stomach pain that does not go away. Your child may or may not have a fever.
• Bone fractures (hip, wrist or spine). Bone fractures in the hip, wrist or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your child’s doctor if your child has a bone fracture, especially in the hip, wrist or spine.
• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including ACIPHEX Sprinkle, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your child’s doctor right away if they have new or worsening joint pain or a rash on their cheeks or arms that gets worse in the sun.

Talk to your child’s doctor about your child’s risk of serious side effects.

ACIPHEX Sprinkle can have other serious side effects. See “What are the possible side effects of ACIPHEX Sprinkle?”

What is ACIPHEX Sprinkle?

ACIPHEX Sprinkle is a prescription medicine called a proton pump inhibitor (PPI). ACIPHEX Sprinkle reduces the amount of acid in the stomach.

ACIPHEX Sprinkle is used in children 1 year to 11 years of age to treat Gastroesophageal Reflux Disease (GERD) for up to 12 weeks.

ACIPHEX Sprinkle is not effective in treating GERD in children under 1 year of age.

ACIPHEX Sprinkle should not be used to treat GERD in babies younger than 1 month of age.

Your child should not take ACIPHEX Sprinkle if they are:

• allergic to rabeprazole, any other PPI medicine, or any of the ingredients in ACIPHEX Sprinkle. See the end of this Medication Guide for a complete list of ingredients.
• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV1 (Human Immunodeficiency Virus).

Before your child takes ACIPHEX Sprinkle, tell your child’s doctor about all of your child’s medical conditions, including if they:

• have low magnesium levels in their blood.
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if ACIPHEX Sprinkle can harm an unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ACIPHEX Sprinkle passes into breast milk. Talk to your child’s doctor about the best way to feed her baby if she takes ACIPHEX Sprinkle.

Tell your child’s doctor about all the medicines your child takes, including prescription and overthe-counter medicines, vitamins, and herbal supplements. Especially tell your child’s doctor if your child takes warfarin (COUMADIN, JANTOVEN) or methotrexate (Otrexup, Rasuvo,Trexall, Xatmep).

How should my child take ACIPHEX Sprinkle?

• Your child should take ACIPHEX Sprinkle exactly as prescribed. Your child’s doctor will prescribe the dose that is right for your child.
• Your child should take ACIPHEX Sprinkle 1 time each day.
• Your child should take ACIPHEX Sprinkle 30 minutes before a meal.
• Your child should not swallow the ACIPHEX Sprinkle capsule whole.
• Prepare and give a dose of ACIPHEX Sprinkle to your child as follows:
  • Open the ACIPHEX Sprinkle capsule in the direction that the arrow (↑) on the capsule is pointing. Sprinkle all of the capsule contents onto a small amount of soft food such as applesauce, fruit or vegetable based baby food, or yogurt. You may also empty all of the capsule contents into a small amount of infant formula, apple juice, or a pediatric electrolyte solution. The food or liquid that you use should be at or below room temperature.
  • Your child should swallow the entire mixture. They should not chew or crush the granules.
  • Your child should take the entire dose within 15 minutes of preparing it. Do not save it for use later.
• If your child misses a dose of ACIPHEX Sprinkle, they should take it as soon as possible. If it is almost time for their next dose, they should not take the missed dose. Your child should take their next dose at their regular time. They should not take 2 doses at the same time.
• If your child takes too much ACIPHEX Sprinkle, call your child’s doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.

What are the possible side effects of ACIPHEX Sprinkle?

ACIPHEX Sprinkle can cause serious side effects, including:

• See “What is the most important information I should know about ACIPHEX Sprinkle?”
• Interaction with warfarin. Taking warfarin with a PPI medicine may lead to an increased risk of bleeding and death. If your child takes warfarin, their doctor may check their blood to see if they have an increased risk of bleeding. If your child takes warfarin during treatment with ACIPHEX Sprinkle, tell their doctor right away if they have any signs or symptoms of bleeding, including:
  • pain, swelling or discomfort
  • menstrual bleeding that is heavier than
  • headaches, dizziness, or weakness normal
  • unusual bruising (bruises that happen without known cause or that grow in o red or black stools size)
  • pink or brown urine
  • coughing up blood
  • nosebleeds
  • vomiting blood or vomit that looks like
  • bleeding gums coffee grounds
  • bleeding from cuts takes a long time to stop
• Low vitamin B-12 levels in the body can happen in people who have taken ACIPHEX Sprinkle for a long time (more than 3 years). Tell your child’s doctor if your child has symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
• Low magnesium levels in the body can happen in people who have taken ACIPHEX Sprinkle for at least 3 months. Tell your child’s doctor if your child has symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

The most common side effects of ACIPHEX Sprinkle include: vomiting, stomach-area (abdomen) pain, diarrhea, headache, and nausea.

These are not all of the possible side effects of ACIPHEX Sprinkle. Call your child’s doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ACIPHEX Sprinkle?

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

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

General Information about the safe and effective use of ACIPHEX Sprinkle.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACIPHEX Sprinkle for a condition for which it was not prescribed. Do not give ACIPHEX Sprinkle to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your child’s doctor or pharmacist for information about ACIPHEX Sprinkle that is written for health professionals.

What are the ingredients in ACIPHEX Sprinkle?

Active ingredient: rabeprazole sodium

Inactive ingredients: colloidal silicon dioxide, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium oxide, magnesium stearate, mannitol, talc, titanium dioxide, carrageenan, potassium chloride, FD&C Blue No. 2 Aluminum Lake (in the 5 mg capsule), FD&C Yellow, No. 6 (in the 10 mg capsule), and gray printing ink.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

This medication can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking rabeprazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS]
• Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
• Bone Fracture [see WARNINGS AND PRECAUTIONS]
• Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
• Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
• Hypomagnesemia [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The data described below reflect exposure to ACIPHEX delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. The studies were primarily placebo-and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers. The population had a mean age of 53 years (range 18-89 years) and had a ratio of approximately 60% male: 40% female. The racial distribution was 86% Caucasian, 8% African American, 2% Asian, and 5% other. Most patients received either 10 mg, 20 mg or 40 mg per day of ACIPHEX delayed-release tablets.

An analysis of adverse reactions appearing in ≥2% of patients treated with ACIPHEX delayed-release tablets (n=1064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs. 1%), pharyngitis (3% vs. 2%), flatulence (3% vs. 1%), infection (2% vs. 1%), and constipation (2% vs. 1%).

Three long-term maintenance studies consisted of a total of 740 adult patients; at least 54% of adult patients were exposed to ACIPHEX delayed-release tablets for 6 months and at least 33% were exposed for 12 months. Of the 740 adult patients, 247 (33%) and 241 (33%) patients received 10 mg and 20 mg of ACIPHEX delayed-release tablets, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole.

The safety profile of rabeprazole in the maintenance studies in adults was consistent with what was observed in the acute studies.

Less common adverse reactions seen in controlled clinical trials (<2% of patients treated with ACIPHEX delayed-release tablets and greater than placebo) and for which there is a possibility of a causal relationship to rabeprazole, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.

In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse reactions unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse reactions for patients who received RAC therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively.

No clinically significant laboratory abnormalities particular to the drug combinations were observed.

For more information on adverse reactions or laboratory changes with amoxicillin or clarithromycin, refer to their respective prescribing information, Adverse Reactions section.

Pediatrics

In a multicenter, open-label study of adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults. The adverse reactions reported without regard to relationship to ACIPHEX delayed-release tablets that occurred in ≥2% of 111 patients were headache (9.9%), diarrhea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%). The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in this study that were not previously observed in adults.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of rabeprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: sudden death; coma; hyperammonemia; jaundice; rhabdomyolysis; disorientation and delirium; anaphylaxis; angioedema; systemic lupus erythematosus, bullous and other drug eruptions of the skin; severe dermatologic reactions, including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme; interstitial pneumonia; interstitial nephritis; TSH elevations; bone fractures; hypomagnesemia and Clostridium difficile-associated diarrhea. In addition, agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, and thrombocytopenia have been reported. Increases in prothrombin time/INR in patients treated with concomitant warfarin have been reported.

Read the entire FDA prescribing information for Aciphex (Rabeprazole Sodium)

Metabolized in the liver, principally by CYP3A and 2C19 isoenzymes.1 7 8 9

Drugs Metabolized by Cytochrome P-450 Enzymes

No clinically important interactions with some drugs that are metabolized by CYP isoenzymes under single dose conditions; effects of rabeprazole have not been studied under steady-state conditions.1

Drugs that Cause Hypomagnesemia

Potential pharmacologic interaction (possible increased risk of hypomagnesemia).327 Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.1 327 (See Hypomagnesemia under Cautions.)

Specific Drugs

• Importance of swallowing tablets whole, without crushing or chewing.1

• Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.305 1

• Risk of hypomagnesemia; importance of immediately reporting and seeking care for any cardiovascular or neurologic manifestations (e.g., palpitations, dizziness, seizures, tetany).1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 23 Antacids may be used concomitantly as needed for pain relief.1 19

• Possible increased risk of Clostridium difficile infection; importance of contacting clinician if persistent watery stools, abdominal pain, and fever occur.335

• Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.