AcipHex Sprinkle

Name: AcipHex Sprinkle

AcipHex Sprinkle Interactions

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

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with rabeprazole, especially:

  • amoxicillin;
  • atazanavir;
  • clarithromycin;
  • cyclosporine;
  • diazepam (Valium);
  • digoxin, digitalis;
  • a diuretic (water pill);
  • ketoconazole;
  • methotrexate;
  • mycophenolate mofetil;
  • phenytoin;
  • theophylline; or
  • warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may interact with rabeprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Uses For Aciphex Sprinkle

Rabeprazole is used to treat duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. It may also be used together with antibiotics to treat ulcers associated with infections caused by the H. pylori bacteria. Rabeprazole is a proton pump inhibitor (PPI) that decreases the amount of acid produced by the stomach.

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

Precautions While Using Aciphex Sprinkle

It is very important that your doctor check your progress 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 and other laboratory tests may be needed to check for unwanted effects.

Do not use rabeprazole together with medicines containing rilpivirine (eg, Complera®, Edurant®, Odefsey®).

Check with your doctor right away if you have a decrease in how much or how often you urinate, bloody or cloudy urine, swelling of the feet or lower legs, rash, or a fever. These may be symptoms of a serious kidney problem.

This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you take several doses per day or use it for 1 year or more. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.

Cutaneous or systemic lupus erythematosus may occur or gets worse in lupus patients and are taking PPI. Call your doctor right away if you have a joint pain or skin rash on your cheeks or arms that gets worse when exposed in the sun.

This medicine may cause hypomagnesemia (low magnesium in the blood). Your doctor may check your blood levels if you are taking this medicine for more than 1 year or if you are taking certain medicines together with rabeprazole. Check with your doctor right away if you have drowsiness, a loss of appetite, mood or mental changes, muscle spasms or twitching, seizures, nausea or vomiting, trembling, or unusual tiredness or weakness.

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 Sprinkle Dosage and Administration

Dosage Regimen

Aciphex Sprinkle is recommended for up to 12 weeks in pediatric patients 1 to 11 years of age and is dosed by body weight:

  • Less than 15 kg: 5 mg once daily with the option to increase to 10 mg once daily, if inadequate response.
  • 15 kg or more: 10 mg once daily.

Administration Recommendations

  • Take the dose 30 minutes before a meal.
  • Do not swallow the capsule whole.
  • Open a capsule and sprinkle entire contents on a small amount of soft food (e.g., applesauce, fruit or vegetable based baby food, or yogurt) or empty contents into a small amount of liquid (e.g., infant formula, apple juice, or pediatric electrolyte solution). Food or liquid should be at or below room temperature.
  • Do not chew or crush the granules.
  • Take the entire dose within 15 minutes of preparation.
  • Do not store mixture for future use.
  • Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take 2 doses at the same time.

Warnings and Precautions

Presence of Gastric Malignancy

In adults, symptomatic response to therapy with ACIPHEX does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

Interaction with Warfarin

Steady state interactions of rabeprazole and warfarin have not been adequately evaluated in patients. There have been reports of increased INR and prothrombin time in patients receiving a proton pump inhibitor and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with Aciphex Sprinkle and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [see Drug Interactions (7)].

Acute Interstitial Nephritis

Acute interstitial nephritis has been observed in patients taking PPIs including rabeprazole sodium. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue Aciphex Sprinkle if acute interstitial nephritis develops [see Contraindications (4)].

Clostridium difficile-Associated Diarrhea

Published observational studies suggest that PPI therapy like Aciphex Sprinkle may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)].

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents.

Bone Fracture

Several published observational studies in adults suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2), Adverse Reactions (6.2)].

Aciphex Sprinkle is indicated for short-term treatment up to 12 weeks. Treatment for longer than 12 weeks is not recommended.

Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including rabeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Aciphex Sprinkle, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. Serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

Cyanocobalamin (Vitamin B-12) Deficiency

Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with Aciphex Sprinkle.

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in adult patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [see Adverse Reactions (6.2)].

Aciphex Sprinkle is indicated for short-term treatment of up to 12 weeks. Treatment for longer than 12 weeks is not recommended.

Interaction with Methotrexate

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7)].

Patient Counseling Information

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide).

Acute Interstitial Nephritis

Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with acute interstitial nephritis [see Warnings and Precautions (5.3)].

Clostridium difficile-Associated Diarrhea

Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.4)].

Bone Fracture

Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions (5.5)].

Cutaneous and Systemic Lupus Erythematosus

Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.6)].

Cyanocobalamin (Vitamin B-12) Deficiency

Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving Aciphex Sprinkle for longer than 3 years [see Warnings and Precautions (5.7)]

Hypomagnesemia

Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia to the patient’s healthcare provider, if they have been receiving Aciphex Sprinkle for at least 3 months [see Warnings and Precautions (5.8)]

Drug Interactions

Advise the patient or caregiver to report to the patient’s healthcare provider if they are taking rilpilvirine-containing products [see Contraindications (4)], warfarin or high-dose methotrexate [see Warnings and Precautions (5.2, 5.9)].

Administration

  • Take the dose 30 minutes before a meal.
  • Do not swallow the capsule whole.
  • Open the Aciphex Sprinkle capsule and sprinkle the granule contents on a small amount of soft food (e.g., applesauce, fruit or vegetable based baby food, or yogurt) or empty contents into a small amount of liquid (e.g., infant formula, apple juice, or pediatric electrolyte solution). Food or liquid should be at or below room temperature.
  • Do not chew or crush the granules.
  • Take the entire dose within 15 minutes of preparation.
  • Do not store mixture for future use.
  • Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take 2 doses at the same time.

Avadel

Distributed and Marketed by Avadel Pharmaceuticals (USA), Inc. Chesterfield, MO 63005
ACIPHEX® is a registered trademark of Eisai R&D Management Co., Ltd;
ACIPHEX® Sprinkle™ is a trademark of Eisai R&D Management Co., Ltd, each of which is licensed to Avadel Pharmaceuticals (USA), Inc.



MEDICATION GUIDE
ACIPHEX® Sprinkle™ (a-se-feks spr-en-kle)
(rabeprazole sodium delayed-release capsules)
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: July 2017
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 HIV-1 (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 over-the-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
    • headaches, dizziness, or weakness
    • unusual bruising (bruises that happen without known cause or that grow in size)
    • nosebleeds
    • bleeding gums
    • bleeding from cuts takes a long time to stop
    • menstrual bleeding that is heavier than normal
    • pink or brown urine
    • red or black stools
    • coughing up blood
    • vomiting blood or vomit that looks like coffee grounds
  • 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.

Distributed and Marketed by Avadel Pharmaceuticals (USA), Inc. Chesterfield, MO 63005
ACIPHEX® is a registered trademark of Eisai R&D Management Co., Ltd;
ACIPHEX® Sprinkle™ is a trademark of Eisai R&D Management Co., Ltd, each of which is licensed to Avadel Pharmaceuticals (USA), Inc.
For more information, go to www.aciphexsprinkle.com or call 1-877-622-2320.


PRINCIPAL DISPLAY PANEL - 5 mg Bottle Label

NDC 13551-205-01

Rx only

AcipHex® Sprinkle™
(rabeprazole sodium)
Delayed-Release Capsules

5 mg

30 capsules

Avadel



Aciphex Sprinkle Precautions

Serious side effects have been reported with Aciphex Sprinkle including the following:

  • serious allergic reactions. Tell your doctor if you have any of the following symptoms:
  • rash
  • face swelling
  • throat tightness
  • difficulty breathing
  • low blood magnesium. Tell your doctor right away if you have any of these symptoms:
    • seizures
    • dizziness
    • abnormal or fast heart beat
    • jitteriness
    • jerking movements or shaking (tremors)
    • muscle weakness
    • spasms of the hands and feet
    • cramps or muscle aches
    • spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking Aciphex Sprinkle, during treatment, or if you will be taking Aciphex Sprinkle for a long period of time.

  • Clostridium difficile (C. difficile) associated diarrhea. Tell your healthcare provider if you experience any or all of the following symptoms:
  • watery diarrhea (at least three bowel movements per day for two or more days)
  • loss of appetite
  • abdominal pain or tenderness
  • nausea
  • fever

Do not take Aciphex Sprinkle if you are:

  • allergic to any of the ingredients in Aciphex Sprinkle
  • allergic to other proton pump inhibitors
  • less than 12 years of age

Aciphex Sprinkle Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Aciphex Sprinkle there are no specific foods that you must exclude from your diet when receiving this medication.

Aciphex Sprinkle Overdose

If you take too much Aciphex Sprinkle, call your doctor or local Poison Control Center right away, or seek emergency medical attention right away.

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