AcipHex Sprinkle

Name: AcipHex Sprinkle

What happens if I miss a dose?

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 happens if I overdose?

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

Before Using Aciphex Sprinkle

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

Use of rabeprazole for treating gastroesophageal reflux disease (GERD) is not recommended in children younger than 1 year. Appropriate studies have not been performed on the relationship of age to the effects of rabeprazole for treating ulcers associated with infections, duodenal ulcers, or Zollinger-Ellison syndrome 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.

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
  • Bosutinib
  • Cilostazol
  • Clopidogrel
  • Dasatinib
  • Digoxin
  • Erlotinib
  • Eslicarbazepine Acetate
  • Gefitinib
  • Ketoconazole
  • Ledipasvir
  • Methotrexate
  • Mycophenolate Mofetil
  • Nelfinavir
  • Nilotinib
  • Pazopanib
  • Saquinavir
  • Velpatasvir
  • Vismodegib

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.

  • Levothyroxine

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Cranberry

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:

  • Broken bones, history of or
  • Diarrhea, history of or
  • Hypomagnesemia (low magnesium levels), history of or
  • Osteoporosis (weak bones), history of or
  • Systemic lupus erythematosus (SLE) or
  • Vitamin B12 deficiency—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.

Aciphex Sprinkle 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, 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 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

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.

Adverse Reactions

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

  • Acute Interstitial Nephritis [see Warnings and Precautions (5.3)]
  • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.4)]
  • Bone Fracture [see Warnings and Precautions (5.5)]
  • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6)]
  • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.7)]
  • Hypomagnesemia [see Warnings and Precautions (5.8)]

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.

The efficacy of Aciphex Sprinkle was established in a two-part, randomized, multicenter, double-blind, parallel-group study of 127 pediatric patients 1 to 11 years of age with a history of at least one GERD symptom within the 3 months before screening and a positive esophagogastroduodenoscopy (EGD; Hetzel-Dent Endoscopic Classification System, Grade ≥1 and Histological Features of Reflux Esophagitis Scale, Grade >0). The two-part study consisted of a 12-week treatment period in patients with endoscopically-proven GERD followed by a 24-week, double-blinded extension study. Subjects had a mean age of 6 years (range: 1 to 11 years) and 44% (56/127) were female and 56% (71/127) were male. Of the 127 subjects enrolled, 78% (99/127) were white, 10% (13/127) were black, and 2% (3/127) were Asian.

In the study, patients less than 15 kg body weight received either 5 mg or 10 mg Aciphex Sprinkle and patients 15 kg or greater body weight received 10 mg Aciphex Sprinkle. In this study, some patients were treated for 36 weeks. The most common adverse reactions leading to discontinuation were vomiting, abdominal pain, diarrhea, and nausea. The most common adverse reactions from the first 12 weeks of treatment are listed in Table 1.

Table 1: Common Adverse Reactions* in Pediatric Study (Ages 1 To 11 Years First 12 Weeks of Treatment)
Adverse Reaction Patients Less than 15 kg Patients 15 kg or greater
5 mg
(N=21)
%
10 mg
(N=19)
%
10 mg
(N=44)
%
* incidence of adverse reactions ≥9%
Vomiting 10 11 14
Abdominal Pain 0 0 16
Diarrhea 14 21 9
Headache 0 0 9
Nausea 0 0 9

The safety profile was similar for those patients who received treatment for up to 36 weeks.

Adults and Adolescents Experience with Other Rabeprazole Formulations

The data described below reflect exposure to rabeprazole sodium 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 rabeprazole.

An analysis of adverse reactions appearing in ≥2% of rabeprazole-treated patients (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%).

Other adverse reactions seen in controlled clinical trials, which do not meet the above criteria (≥2% of rabeprazole-treated patients 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 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 rabeprazole 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 sodium. 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.

Blood and Lymphatic System Disorders: agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, and thrombocytopenia
Ear and Labyrinth Disorders: vertigo
Eye Disorders: blurred vision
General Disorders and Administration Site Conditions: sudden death
Hepatobiliary Disorders: jaundice
Immune System Disorders: anaphylaxis, angioedema, systemic lupus erythematosus, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)
Infections and Infestations: Clostridium difficile-associated diarrhea
Investigations: Increases in prothrombin time/INR (in patients treated with concomitant warfarin), TSH elevations
Metabolism and Nutrition Disorders: hyperammonemia, hypomagnesemia
Musculoskeletal System Disorders: bone fracture, rhabdomyolysis
Nervous System Disorders: coma
Psychiatric Disorders: delirium, disorientation
Renal and Urinary Disorders: interstitial nephritis
Respiratory, Thoracic and Mediastinal Disorders: interstitial pneumonia
Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions, including bullous and other drug eruptions of the skin; cutaneous lupus erythematosus, erythema multiforme

Drug Interactions

Table 2 includes clinically important drug interactions and interaction with diagnostics when administered concomitantly with Aciphex Sprinkle and instructions for preventing or managing them.

Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 2: Clinically Relevant Interactions Affecting Drugs Co-Administered with Aciphex Sprinkle and Interactions with Diagnostics
Antiretrovirals
Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, nelfinavir) when used concomitantly with rabeprazole may reduce antiviral effect and promote the development of drug resistance
  • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with rabeprazole may increase toxicity.
  • There are other antiretroviral drugs which do not result in clinically relevant interactions with rabeprazole.
Intervention: Rilpivirine-containing products: Concomitant use with Aciphex Sprinkle is contraindicated [see Contraindications (4)]. See prescribing information.
Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with Aciphex Sprinkle. See prescribing information for nelfinavir.
Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities.
Other antiretrovirals: See prescribing information.
Warfarin
Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including rabeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death [see Warnings and Precautions (5.2)].
Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.
Methotrexate
Clinical Impact: Concomitant use of rabeprazole with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of methotrexate with PPIs have been conducted [see Warnings and Precautions (5.9)].
Intervention: A temporary withdrawal of Aciphex Sprinkle may be considered in some patients receiving high-dose methotrexate administration.
Digoxin
Clinical Impact: Potential for increased exposure of digoxin [see Clinical Pharmacology (12.3)].
Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole)
Clinical Impact: Rabeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Intervention: Mycophenolate mofetil (MMF): Co-administration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Aciphex Sprinkle and MMF. Use Aciphex Sprinkle with caution in transplant patients receiving MMF.
See the prescribing information for other drugs dependent on gastric pH for absorption.
Tacrolimus
Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.
Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.
Interactions with Investigations of Neuroendocrine Tumors
Clinical Impact: Serum chromogranin A (CgA) levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.
Intervention: Temporarily stop Aciphex Sprinkle treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
Interaction with Secretin Stimulation Test
Clinical Impact: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.
Intervention: Temporarily stop treatment with ACIPHEX delayed-release tablets at least 14 days before assessing to allow gastrin levels to return to baseline.
False Positive Urine Tests for THC
Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.
Intervention: An alternative confirmatory method should be considered to verify positive results.

Aciphex Sprinkle Overview

Aciphex Sprinkle is a prescription medication used to treat digestive problems such as heartburn and acid reflux.  Aciphex Sprinkle belongs to a group of drugs called proton-pump inhibitors (PPIs). It works by reducing the amount of acid produced in the stomach.

Aciphex Sprinkle also comes in a sprinkle delayed release capsule and is usually taken once a day.

Common side effects of Aciphex Sprinkle include headache, sore throat, and constipation.

Manufacturer

  • Eisai, Inc

Aciphex Sprinkle Drug Class

Aciphex Sprinkle is part of the drug class:

  • Proton pump inhibitors

(web3)