AcipHex Sprinkle

Name: AcipHex Sprinkle

What is AcipHex Sprinkle (rabeprazole)?

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

Rabeprazole is used short-term 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 in adults to promote healing of duodenal ulcers or erosive esophagitis (damage to your esophagus caused by stomach acid).

Rabeprazole may also be given with an antibiotic to prevent duodenal 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.

How should I take AcipHex Sprinkle (rabeprazole)?

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.

Do not give this medicine to a child without medical advice. Certain forms and strengths of rabeprazole should not be given to a child younger than 12 years old.

AcipHex Sprinkle should not be given to a child younger than 1 year old.

Rabeprazole is for short-term use only, usually 4 to 8 weeks. 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 dosing instructions very carefully.

Take this medicine with a full glass of water.

If you take rabeprazole to treat duodenal ulcers, take the medicine after a meal. If you take rabeprazole to prevent ulcers caused by Helicobacter pylori, take the medicine with food. If you take rabeprazole for any other condition, you may take the medicine with or without food.

The rabeprazole delayed-release capsule (AcipHex Sprinkle) 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.

AcipHex Sprinkle (rabeprazole) 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;

  • symptoms of low magnesium--dizziness, confusion; fast or uneven heart rate; tremors (shaking) or jerking muscle movements; feeling jittery; muscle pain or weakness, muscle spasms in your hands and feet; cough or choking feeling; or

  • signs of bleeding (if you also take warfarin)--headaches, unusual weakness, dizziness; unusual bleeding (nosebleeds, bleeding gums); red or pink urine; abnormal vaginal bleeding or heavy menstrual flow; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or any bleeding that will not stop.

Common side effects may include:

  • headache;

  • sore throat;

  • diarrhea, constipation; or

  • stomach pain, gas, nausea, vomiting.

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.

Dosage Forms and Strengths

Aciphex Sprinkle is provided as:

  • 5 mg: transparent blue and opaque white No. 2 capsule imprinted with "↑" on the capsule cap and "ACX 5mg" on the capsule body.
  • 10 mg: transparent yellow and opaque white No. 2 capsule imprinted with "↑" on the capsule cap and "ACX 10mg" on the capsule body.

Overdosage

Seven reports of accidental overdosage with rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg rabeprazole once daily. No specific antidote for rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable.

In the event of overdosage, treatment should be symptomatic and supportive.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

PRINCIPAL DISPLAY PANEL - 10 mg Alternate Bottle Label

NDC 13551-210-01

Rx only

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

10 mg

30 capsules

FSC Laboratories



ACIPHEX   SPRINKLE
rabeprazole sodium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13551-205
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM (RABEPRAZOLE) RABEPRAZOLE SODIUM 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
DIACETYLATED MONOGLYCERIDES  
ETHYLCELLULOSES  
HYDROXYPROPYL CELLULOSE (TYPE H)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
MAGNESIUM OXIDE  
MAGNESIUM STEARATE  
MANNITOL  
TALC  
TITANIUM DIOXIDE  
CARRAGEENAN  
POTASSIUM CHLORIDE  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
Product Characteristics
Color BLUE (transparent) , WHITE (opaque) Score no score
Shape CAPSULE (Oval) Size 10mm
Flavor Imprint Code ACX;5mg
Contains     
Packaging
# Item Code Package Description
1 NDC:13551-205-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204736 10/01/2014
ACIPHEX   SPRINKLE
rabeprazole sodium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13551-210
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM (RABEPRAZOLE) RABEPRAZOLE SODIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
DIACETYLATED MONOGLYCERIDES  
ETHYLCELLULOSES  
HYDROXYPROPYL CELLULOSE (TYPE H)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
MAGNESIUM OXIDE  
MAGNESIUM STEARATE  
MANNITOL  
TALC  
TITANIUM DIOXIDE  
CARRAGEENAN  
POTASSIUM CHLORIDE  
FD&C YELLOW NO. 6  
Product Characteristics
Color YELLOW (transparent) , WHITE (opaque) Score no score
Shape CAPSULE (Oval) Size 10mm
Flavor Imprint Code ACX;10mg
Contains     
Packaging
# Item Code Package Description
1 NDC:13551-210-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204736 10/01/2014
Labeler - Avadel Pharmaceuticals (USA), Inc. (169886244)
Revised: 08/2017   Avadel Pharmaceuticals (USA), Inc.

Aciphex Sprinkle Interactions

Tell your doctor about all of the medicines you are taking or are planning to take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • atazanavir (Reyataz)
  • cyclosporine (Sandimmune, Neoral)
  • digoxin (Lanoxin)
  • ketoconazole (Nizoral)
  • warfarin (Coumadin)
  • theophylline (THEO-24 Thelair)
  • diazepam (Valium)
  • phenytoin (Dilantin)
  • antibiotics

Aciphex Sprinkle and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Aciphex Sprinkle falls into category B. There are no well-done studies that have been done in humans with Aciphex Sprinkle. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

For Healthcare Professionals

Applies to rabeprazole: oral delayed release capsule, oral delayed release tablet, oral tablet extended release

General

The most commonly reported side effects are headache, diarrhea, and abdominal pain.[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 21%), abdominal pain (up to 16%), vomiting (up to 14%)
Common (1% to 10%): Nausea, constipation, flatulence, benign fundic gland polyps
Uncommon (0.1% to 1%): Dyspepsia, dry mouth, eructation
Rare (0.01% to 0.1%): Gastritis, stomatitis
Postmarketing reports: Clostridium difficile-associated diarrhea[Ref]

Other

Common (1% to 10%): Infection, non-specific pain, influenza-like illness, asthenia
Uncommon (0.1% to 1%): Chills, pyrexia/fever
Postmarketing reports: Sudden death, facial swelling[Ref]

Respiratory

Common (1% to 10%): Cough, pharyngitis, rhinitis
Uncommon (0.1% to 1%): Bronchitis, sinusitis
Postmarketing reports: Dyspnea, interstitial pneumonia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, taste disturbance/perversion
Uncommon (0.1% to 1%): Somnolence, hepatic encephalopathy
Postmarketing reports: Coma, vertigo[Ref]

Hepatic encephalopathy occurred in patients with underlying cirrhosis.[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Leg cramps, arthralgia, fracture of hip/wrist/spine
Postmarketing reports: Rhabdomyolysis, bone fractures[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Erythema
Rare (0.01% to 0.1%): Pruritus, sweating, bullous reactions
Very rare (less than 0.01%): Erythema multiforme, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome
Frequency not reported: Subacute cutaneous lupus erythematosus
Postmarketing reports: Urticarial skin eruptions, other drug eruptions, severe dermatological reactions, systemic lupus erythematosus, fatal TEN[Ref]

Erythema and bullous reactions usually resolved after discontinuation.[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Nervousness
Rare (0.01% to 0.1%): Depression
Frequency not reported: Confusion
Postmarketing reports: Disorientation, delirium[Ref]

Cardiovascular

Common (1% to 10%): Chest pain
Frequency not reported: Peripheral edema
Postmarketing reports: Hypotension[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased hepatic enzymes
Rare (0.01% to 0.1%): Hepatitis, jaundice[Ref]

Increased hepatic enzymes occurred in patients with underlying cirrhosis.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary tract infection[Ref]

Hematologic

Rare (0.01% to 0.1%): Neutropenia, leukopenia, thrombocytopenia, leukocytosis
Postmarketing reports: Pancytopenia, agranulocytosis, bicytopenia, hemolytic anemia, increase in prothrombin time/INR[Ref]

Increased prothrombin time/INR occurred in patients taking warfarin concomitantly.[Ref]

Metabolic

Rare (0.01% to 0.1%): Anorexia, weight gain
Frequency not reported: Hypomagnesemia, hyponatremia
Postmarketing reports: Hyperammonemia[Ref]

Renal

Rare (0.01% to 0.1%): Interstitial nephritis[Ref]

Ocular

Rare (0.01% to 0.1%): Visual disturbance
Postmarketing reports: Blurred vision[Ref]

Endocrine

Frequency not reported: Gynecomastia
Postmarketing reports: TSH elevations[Ref]

Hypersensitivity

Hypersensitivity reactions included facial swelling, hypotension, dyspnea, erythema, and bullous reactions; these reactions typically resolved after discontinuation.[Ref]

Rare (0.01% to 0.1%): Hypersensitivity
Postmarketing reports: Acute systemic allergic reactions, anaphylaxis/anaphylactic reactions, angioedema[Ref]

Some side effects of Aciphex Sprinkle may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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