Sunday, 8 April 2012

AcipHex



Generic Name: Rabeprazole Sodium
Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]-benzimidazole sodium
Molecular Formula: C18H20N3NaO3S
CAS Number: 117976-90-6


Special Alerts:


[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.


BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.


RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .


[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.


The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.


The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .



Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.1 2 3 4 5 6


Uses for AcipHex


Gastroesophageal Reflux (GERD)


Short-term treatment of symptomatic GERD (e.g., heartburn) in patients without erosive esophagitis.1


Short-term treatment of erosive esophagitis in patients with GERD.1 2 3 15 18


Maintain healing and decrease recurrence of erosive esophagitis.1 2 3


Duodenal Ulcer


Short-term treatment of active duodenal ulcer.1 2 3 17


Treatment of Helicobacter pylori infection and duodenal ulcer disease.1 Used in conjunction with amoxicillin and clarithromycin (triple therapy).1


Crohn's Disease-associated Ulcers


Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn's disease†, including esophageal†, gastroduodenal†, and jejunoileal† disease.27 28 29 31 32 33


Pathologic GI Hypersecretory Conditions


Long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome).1 3


AcipHex Dosage and Administration


Administration


Oral Administration


Administer orally; may give without regard to meals, but manufacturer recommends administration after morning meal in patients with duodenal ulcer.1


When used in combination with clarithromycin and amoxicillin for treatment of H. pylori infection and duodenal ulcer disease, take all 3 drugs twice daily with morning and evening meals.1


Swallow tablets intact; do not chew, crush, or split.1


Antacids may be used concomitantly as needed for pain relief.1 19


Dosage


Available as rabeprazole sodium; dosage expressed in terms of the salt.1


Adults


GERD

GERD without Erosive Esophagitis

Oral

20 mg once daily for 4 weeks; may give additional 4 weeks if symptoms are not completely resolved.1


Treatment of Erosive Esophagitis

Oral

20 mg once daily1 2 15 18 for 4–8 weeks.1 15 If not healed after 8 weeks, consider additional 8 weeks of therapy (up to 16 weeks for a single course).1


Maintenance of Healing of Erosive Esophagitis

Oral

20 mg once daily.1 2 15 18 Chronic, lifelong therapy may be appropriate.26


Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

20 mg once daily for up to 4 weeks;1 2 17 18 some patients may require additional therapy.1


Helicobacter pylori Infection and Duodenal Ulcer Disease

Oral

Triple therapy: 20 mg twice daily for 7 days in conjunction with amoxicillin and clarithromycin.1


Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)

Oral

60 mg once daily.1 Dosages up to 100 mg once daily or 60 mg twice daily have been used.1 Divided doses may be required.1 Adjust dosage as needed, continue treatment as long as necessary.1 Has been used continuously for up to 1 year.1


Cautions for AcipHex


Contraindications



  • Known hypersensitivity to rabeprazole, any ingredient in the formulation, or other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, pantoprazole, omeprazole).1



Warnings/Precautions


General Precautions


GI Effects

Response to rabeprazole does not preclude presence of occult gastric neoplasm.1


Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).35 36


Hip Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.39 300 301 302 303 304 305 309 Magnitude of risk is unclear;39 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305


Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.39 301 303 305 307 309


Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients' bone health according to current standards of care.39 303 305 307 309


Specific Populations


Pregnancy

Category B.1


Lactation

Not known whether rabeprazole is distributed into milk; discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy not established in children <18 years of age.1 23


Geriatric Use

No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1


Hepatic Impairment

Use with caution in patients with severe impairment.1 21


Common Adverse Effects


Headache.1


Interactions for AcipHex


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


Specific Drugs










































Drug



Interaction



Comments



Amoxicillin



Increased rabeprazole and 14-hydroxyclarithromycin AUC and plasma concentrations when administered with amoxicillin and clarithromycin1



Not expected to result in toxicity1



Antacids



No clinically important effects on rabeprazole pharmacokinetics1



Atazanavir



Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response40 42



Manufacturer of rabeprazole states that concomitant administration with atazanavir is not recommended40


Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir41 42


For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)41 42


Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended41 42



Clarithromycin



Increased rabeprazole and 14-hydroxyclarithromycin AUC and plasma concentrations when administered with amoxicillin and clarithromycin1



Not expected to result in toxicity1



Clopidogrel



Certain CYP2C19 inhibitors (e.g., omeprazole) can reduce exposure to clopidogrel's active metabolite and decrease platelet inhibitory effect;223 224 225 228 232 233 236 potentially may reduce clopidogrel's clinical efficacy;219 220 221 224 229 230 234 235 236 237 238 240 311


Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown219 220 221 224 232



Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250


American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311



Cyclosporine



Rabeprazole inhibited cyclosporine metabolism in vitro1



Diazepam



No pharmacokinetic interaction observed after single doses1



Gastric pH-dependent drugs (e.g., digoxin, ketoconazole)



Rabeprazole may decrease drug absorption1



Monitor if used concomitantly1



Phenytoin



No pharmacokinetic interaction observed after single doses1



Sucralfate



Possible delayed proton-pump inhibitor absorption and decreased bioavailability 34



Administer proton-pump inhibitor at least 30 minutes before sucralfate34



Theophylline



No pharmacokinetic interaction observed after single doses1



Warfarin



Potential for increased INR and PT1



Monitor PT and INR1


AcipHex Pharmacokinetics


Absorption


Bioavailability


Absolute bioavailability with 20 mg dose is about 52%.1 Repeated dosing does not affect pharmacokinetics.1


Onset


Within 1 hour.1 23 Median inhibition of 24-hour gastric acidity is 88% of maximum after first dose.1


Food


High-fat meal may delay absorption but does not affect extent.1 20 23


Special Populations


AUC increased 50–60% in Japanese males receiving a different rabeprazole formulation.1


AUC doubled in patients with mild to moderate compensated cirrhosis.1 Peak plasma concentrations and AUCs increased 20% in patients with mild to moderate hepatic impairment.1


In geriatric patients, peak plasma concentration increased by 60% and AUCs doubled.1


Distribution


Extent


Not known whether rabeprazole crosses the placenta or is distributed into milk.1


Prolonged binding to gastric parietal proton pump enzyme.1 3


Plasma Protein Binding


Approximately 96%.1


Elimination


Metabolism


Metabolized in the liver, principally by CYP3A and CYP2C19.1 7 8 9 Principal thioether and sulphone metabolites found in plasma are inactive.1


Elimination Route


Excreted as metabolites in urine (90%); remainder in feces.1


Half-life


1–2 hours.1


Special Populations


In patients with mild to moderate compensated cirrhosis, elimination half-life was 2–3 times greater, and clearance decreased to less than one-half.1


In patients with poor CYP2C19 metabolizer phenotype, metabolism is slower than in those with extensive (or rapid) metabolizer phenotype.1


Stability


Storage


Oral


Tablets

25°C (may be exposed to 15–30°C).1


Actions



  • Inhibits basal and stimulated gastric acid secretion.1




  • Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that binds to and inactivates hydrogen-potassium ATPase (proton- or acid-pump), blocking final step in secretion of hydrochloric acid.1 2 3 4 5 6 Sustained inactivation of hydrogen-potassium ATPase results in prolonged duration of action.1 3




  • Suppresses gastric H. pylori in patients with duodenal ulcer and/or reflux esophagitis infected with the organism.2 3 10 11 Combined therapy with rabeprazole and one or more appropriate anti-infectives (e.g., amoxicillin, clarithromycin) can effectively eradicate H. pylori gastric infection.2 3 10 11



Advice to Patients



  • 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.305 309




  • 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




  • 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.)



Preparations


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













Rabeprazole Sodium

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, delayed-release (enteric-coated)



20 mg



AcipHex



Eisai (also promoted by Ortho-McNeil-Janssen)


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Aciphex 20MG Enteric-coated Tablets (EISAI): 30/$233.99 or 90/$660.00



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 24, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



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34. TAP. Prevacid (lansoprazole) delayed-release capsules, for delayed-release oral suspension and delayed-release orally disintegrating tablets prescribing information. Lake Forest, IL; 2003 Aug.



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