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rabeprazole sod dr 20 mg tab generic aciphex

Out of Stock Manufacturer KREMERS/LANNETT 62175030246
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Uses

Gastroesophageal Reflux

Rabeprazole is used for the short-term (4-8 weeks) treatment of erosive or ulcerative esophagitis in patients with gastroesophageal reflux disease (GERD). The drug also is used as maintenance therapy following healing of erosive or ulcerative esophagitis to reduce recurrence of the disease. In addition, rabeprazole is used for the treatment of symptoms (e.g., heartburn) of GERD in patients without erosive or ulcerative esophagitis. Potential benefits in gastroesophageal reflux and esophagitis are thought to result principally from reduced acidity of gastric contents induced by the drug and resultant reduced irritation of esophageal mucosa; the drug can effectively relieve symptoms of esophagitis (e.g., heartburn) and promote healing of ulcerative and erosive lesions.

Suppression of gastric acid secretion is considered by the American College of Gastroenterology (ACG) to be the mainstay of treatment for GERD, and a proton-pump inhibitor or histamine H2-receptor antagonist is used to achieve acid suppression, control symptoms, and prevent complications of the disease. Because GERD is considered to be a chronic disease, the ACG states that many patients with GERD require long-term, even lifelong, treatment. The ACG states that proton-pump inhibitors are more effective (i.e., provide more frequent and more rapid symptomatic relief and healing of esophagitis) than histamine H2-receptor antagonists in the treatment of GERD, and are effective and appropriate as maintenance therapy in many patients with the disease. Proton-pump inhibitors also provide greater control of acid reflux than do prokinetic agents (e.g., cisapride [no longer commercially available in the US], metoclopramide) without the risk of severe adverse effects associated with these agents.

Efficacy of rabeprazole for treating acute GERD was established in 2 short-term (up to 8 weeks) controlled studies in adults; rabeprazole was more effective than placebo or ranitidine and at least as effective as omeprazole in healing lesions and providing symptomatic relief. Efficacy as maintenance therapy following healing of erosive or ulcerative esophagitis was established in two 52-week controlled studies in adults; maintenance of lesion healing and symptomatic relief were superior with rabeprazole versus placebo. Efficacy in patients with symptomatic GERD without erosive or ulcerative esophagitis was established in 2 short-term (4 weeks) controlled studies in patients with daytime and nocturnal heartburn, no endoscopic evidence of esophageal erosion, and 5 or more episodes of heartburn during the 7 days immediately prior to randomization. The percentage of daytime or nocturnal periods free of heartburn symptoms was greater, daily antacid consumption was substantially decreased, and other GERD-associated symptoms (regurgitation, belching, early satiety) were improved in patients receiving rabeprazole sodium 20 mg daily compared with those receiving placebo.

Antacids may be used concomitantly as needed for pain relief.

For further information on the treatment of GERD,

Duodenal Ulcer

Rabeprazole is used for the short-term (up to 4 weeks) treatment of active duodenal ulcers. Efficacy for treating acute duodenal ulcers was established in two 4-week studies; rabeprazole was more effective than placebo and at least as effective as omeprazole in healing ulcers and providing symptomatic relief. Antacids may be used concomitantly as needed for pain relief.

Rabeprazole is used in combination with amoxicillin and clarithromycin (triple therapy) for the treatment of Helicobacter pylori infection and duodenal ulcer disease in individuals with active duodenal ulcer or a history of duodenal ulcer within the preceding 5 years. Efficacy of rabeprazole-based triple therapy for H. pylori eradication was established in a double-blind, parallel-group comparison study in patients with H. pylori infection; patients were stratified in a 1:1 ratio between those with peptic ulcer disease (active ulcer or a history of ulcer in the past 5 years) and symptomatic patients with no endoscopic evidence of peptic ulcer disease. Patients received 3, 7, or 10 days of therapy with rabeprazole (20 mg twice daily), amoxicillin (1 g twice daily), and clarithromycin (500 mg twice daily) or 10 days of therapy with omeprazole (20 mg twice daily), amoxicillin (1 g twice daily), and clarithromycin (500 mg twice daily).H. pylori eradication was defined as a negative C urea breath test 6 weeks or more after completion of the assigned regimen.H. pylori eradication rates achieved with the 7- and 10-day rabeprazole regimens (77.3 and 78.1%, respectively, by intent-to-treat analysis) were similar to those achieved with the 10-day omeprazole regimen (73.3%); eradication rates achieved with the 3-day rabeprazole regimen (27.3%) were inferior to those achieved with the other regimens. For a more complete discussion of H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection,

Pathologic GI Hypersecretory Conditions

Rabeprazole is used in the long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome). Experience in the treatment of these conditions is limited, but rabeprazole has been used effectively for up to 12 months; the optimum duration of treatment has not been clearly established.

Crohn's Disease-associated Ulcers

Although evidence currently is limited, proton-pump inhibitors have been used for gastric acid-suppressive therapy as an adjunct in the symptomatic treatment of upper GI Crohn's disease, including esophageal, gastroduodenal, and jejunoileal disease. Most evidence of efficacy to date has been from case studies in patients with Crohn's-associated peptic ulcer disease unresponsive to other therapies (e.g., H2-receptor antagonists, cytoprotective agents, antacids, and/or sucralfate).

For further information on the management of Crohn's Disease,

Dosage and Administration

Administration

Rabeprazole sodium is administered orally, generally once daily. Rabeprazole sodium tablets should not be chewed, crushed, or split. Food may delay the rate but does not affect the extent of GI absorption of the drug; therefore, rabeprazole generally may be given without regard to meals.

Although the manufacturer currently recommends dosing rabeprazole after the morning meal for duodenal ulcers because clinical studies establishing efficacy for this use employed such dosing, other evidence indicates that the drug may be given without regard to meals in the morning or at bedtime. The possibility that time of administration could facilitate treatment compliance should be considered.

When rabeprazole is used in combination with clarithromycin and amoxicillin (triple therapy) for the treatment of H. pylori infection, all 3 drugs should be taken twice daily with the morning and evening meals. Although concomitant administration of rabeprazole with clarithromycin and amoxicillin may result in increased peak plasma concentrations and areas under the plasma concentration-time curves (AUCs) of rabeprazole and 14-hydroxyclarithromycin (the active metabolite of clarithromycin), the increased exposure to these drugs is not expected to be clinically important.

Dosage

Gastroesophageal Reflux

The recommended adult dosage of rabeprazole sodium for the short-term treatment of erosive or ulcerative esophagitis in patients with gastroesophageal reflux disease (GERD), maintenance therapy following healing of erosive or ulcerative esophagitis, and short-term treatment of symptomatic GERD in patients without erosive or ulcerative esophagitis is 20 mg once daily. The duration of therapy for acute treatment of erosive or ulcerative esophagitis in patients with GERD is 4-8 weeks; an additional 8-week course of therapy may be considered in patients if esophageal healing is incomplete after the first course of treatment. Controlled studies for maintenance therapy following healing of erosive or ulcerative esophagitis did not extend beyond 12 months. The manufacturer states that the duration of therapy for symptomatic GERD in patients without erosive or ulcerative esophagitis is 4 weeks; an additional 4-week course of therapy may be considered in patients whose symptoms have not completely resolved after the first course of treatment. However, the American College of Gastroenterology (ACG) states that chronic, even lifelong, therapy with a proton-pump inhibitor is appropriate in many patients with GERD.

The recommended dosage of rabeprazole sodium for the short-term treatment of symptomatic GERD in adolescents 12 years of age and older is 20 mg once daily for up to 8 weeks.

Duodenal Ulcer Disease

The recommended adult dosage of rabeprazole sodium for short-term treatment of duodenal ulcers is 20 mg daily, and the usual duration of therapy is 4 weeks; most patients heal within 4 weeks, but some may require additional therapy to achieve healing.

When rabeprazole sodium is used in combination with clarithromycin and amoxicillin (triple therapy) for the treatment of H. pylori infection in patients with active duodenal ulcer or a history of duodenal ulcer in the preceding 5 years, the usual adult dosage of rabeprazole sodium is 20 mg twice daily for 7 days.

Pathologic GI Hypersecretory Conditions

The recommended initial adult dosage of rabeprazole sodium for the treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome) is 60 mg once daily. Dosages up to 100 mg once daily or 60 mg twice daily have been used. Some patients may require divided doses. Dosage should be adjusted as necessary and continued for as long as clinically indicated. Some patients have been treated continuously with the drug for up to 1 year.

Special Populations

Caution should be exercised in dosing patients with severe hepatic impairment, particularly because of the lack of clinical data in this patient population. However, accumulation of rabeprazole at the usual dosage of 20 mg daily is unlikely, and dosage adjustment is not necessary in those with mild to moderate hepatic impairment.

Dosage adjustment also is not necessary in geriatric patients nor in patients with renal impairment.

Cautions

Contraindications

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

Warnings/Precautions

Gastric Malignancy

Symptomatic response to therapy with rabeprazole does not preclude the occult presence of gastric neoplasm. Approximately 4% of patients had intestinal metaplasia during follow-up (up to 40 months), with no consistent changes noted.

Clostridium difficile Infection

Available data suggest a possible association between use of proton-pump inhibitors and risk of Clostridium difficile infection, including C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis). In most observational studies to date, the risk of C. difficile infection in patients exposed to proton-pump inhibitors has ranged from 1.4-2.75 times that in patients not exposed to proton-pump inhibitors; however, some observational studies have found no increase in risk. Although many of the cases occurred in patients who had other risk factors for CDAD, including advanced age, comorbid conditions, and/or use of broad-spectrum anti-infectives, the US Food and Drug Administration (FDA) concluded that a contributory role for proton-pump inhibitors could not be definitively ruled out. The mechanism by which proton-pump inhibitors might increase the risk of CDAD has not been elucidated. Although it has been suggested that reduction of gastric acidity by gastric antisecretory agents might facilitate colonization with C. difficile, some studies have raised questions about this proposed mechanism or have suggested that the observed association is the result of confounding with other risk factors for CDAD. FDA also is reviewing the risk of CDAD in patients exposed to histamine H2-receptor antagonists.

CDAD can be serious in patients who have one or more risk factors for C. difficile infection and are receiving concomitant therapy with a proton-pump inhibitor; colectomy and, rarely, death have been reported. FDA recommends that patients receive proton-pump inhibitors at the lowest effective dosage and for the shortest possible time appropriate for their clinical condition. Patients experiencing persistent diarrhea should be evaluated for CDAD and should be managed with appropriate supportive therapy (e.g., fluid and electrolyte management), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia). (For further precautionary information about this adverse effect, .)

Musculoskeletal Effects

Findings from several observational studies suggest that therapy with proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., one year or longer), may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The magnitude of risk is unclear; causality has not been established. FDA is continuing to evaluate this safety concern. Although controlled studies are required to confirm these findings, patients should receive proton-pump inhibitors at the lowest effective dosage and for the shortest possible time appropriate for their clinical condition. Individuals who are at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D and should have their bone health assessed and managed according to current standards of care.

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients receiving long-term therapy (for at least 3 months or, in most cases, for longer than one year) with proton-pump inhibitors, including rabeprazole. Clinically serious adverse effects associated with hypomagnesemia, which are similar to manifestations of hypocalcemia, include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval. Other reported adverse effects include paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuance of the proton-pump inhibitor. Following discontinuance of the proton-pump inhibitor, hypomagnesemia resolved within a median of one week; upon rechallenge, hypomagnesemia recurred within a median of 2 weeks.

In patients expected to receive long-term therapy with a proton-pump inhibitor or in those receiving a proton-pump inhibitor concomitantly with digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), clinicians should consider measurement of serum magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter. ( and also .)

Specific Populations

Pregnancy

Category B.

Lactation

It is unknown whether rabeprazole is distributed into milk; discontinue nursing or drug because of potential risk in nursing infants.

Pediatric Use

Efficacy and safety of rabeprazole for short-term treatment of symptomatic GERD in adolescents 12-16 years of age are supported by controlled clinical trials in adults and additional safety and pharmacokinetic studies in adolescents. The pharmacokinetic and adverse effect profiles of rabeprazole in adolescents with symptomatic or endoscopically diagnosed GERD were similar to those in adults. Safety and efficacy of rabeprazole for uses other than short-term treatment of symptomatic GERD have not been established in pediatric patients.

Safety and efficacy of the drug in children younger than 12 years of age have not been established.

Geriatric Use

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

Severe Hepatic Impairment

Use with caution.(See Dosage and Administration: Special Populations.)

Common Adverse Effects

Adverse effects occurring in 2% or more of patients receiving rabeprazole in controlled clinical trials and reported more frequently with rabeprazole than with placebo include pain, pharyngitis, flatulence, infection, and constipation.

Drug Interactions

Rabeprazole is extensively metabolized, mainly via hepatic cytochrome P-450 (CYP) 3A and 2C19 isoenzymes.

Drugs that Cause Hypomagnesemia

Potential pharmacologic interaction (possible increased risk of hypomagnesemia). In patients receiving diuretics (i.e., loop or thiazide diuretics) or other drugs that may cause hypomagnesemia, monitoring of magnesium concentrations should be considered prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.(See Hypomagnesemia under Cautions: Warnings/Precautions.)

Gastric pH-Dependent Drugs

Potential pharmacokinetic interaction; increased or decreased drug absorption at increased gastric pH values (e.g., digoxin, ketoconazole). Increased monitoring during concomitant use with rabeprazole.

Antiretroviral Agents

Atazanavir

Potential pharmacokinetic interaction (possible altered oral absorption of atazanavir at increased gastric pH, resulting in decreased plasma atazanavir concentrations). Concomitant use of omeprazole 40 mg once daily and atazanavir (with or without low-dose ritonavir) results in a substantial decrease in plasma concentrations of atazanavir and possible loss of the therapeutic effect of the antiretroviral agent. The manufacturer of rabeprazole states that concomitant administration with atazanavir is not recommended. If atazanavir is administered in an antiretroviral treatment-naive patient receiving a proton-pump inhibitor, a ritonavir-boosted regimen of 300 mg of atazanavir once daily with ritonavir 100 mg once daily with food is recommended. The dose of the proton-pump inhibitor should be administered approximately 12 hours before ritonavir-boosted atazanavir; the dose of the proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent). Concomitant use of proton-pump inhibitors with atazanavir is not recommended in antiretroviral treatment-experienced patients.

Fosamprenavir

Concomitant use of esomeprazole with fosamprenavir (with or without ritonavir) did not substantially affect concentrations of amprenavir (active metabolite of fosamprenavir). No dosage adjustment is required when proton-pump inhibitors are used concomitantly with fosamprenavir (with or without ritonavir).

Lopinavir

Concomitant use of omeprazole with the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir) did not have a clinically important effect on plasma concentrations or area under the concentration-time curve (AUC) of lopinavir. No dosage adjustment is required when proton-pump inhibitors are used concomitantly with lopinavir/ritonavir.

Raltegravir

Pharmacokinetic interaction with omeprazole (substantially increased peak plasma concentration and AUC of raltegravir); however, no dosage adjustment is recommended when proton-pump inhibitors are used concomitantly with raltegravir.

Rilpivirine

Pharmacokinetic interaction with omeprazole (decreased plasma concentrations and AUC of rilpivirine). Concomitant use of other proton-pump inhibitors also may result in decreased plasma concentrations of rilpivirine. Concomitant use of rilpivirine and proton-pump inhibitors is contraindicated.

Saquinavir

Potential pharmacokinetic interaction (increased peak plasma concentration and AUC of saquinavir). Concomitant use of omeprazole 40 mg once daily and ritonavir-boosted saquinavir (saquinavir 1 g twice daily and ritonavir 100 mg twice daily) increased the peak plasma concentration and AUC of saquinavir by 75 and 82%, respectively. Caution is advised if proton-pump inhibitors are used concomitantly with ritonavir-boosted saquinavir, and patients should be monitored for saquinavir toxicity.

Clopidogrel

Potential pharmacokinetic interaction (decreased plasma concentration of the active metabolite of clopidogrel) and pharmacodynamic interaction (reduced antiplatelet effects) between proton-pump inhibitors and clopidogrel. Clopidogrel is metabolized to its active metabolite by cytochrome P-450 (CYP) isoenzyme 2C19 (CYP2C19). Concurrent use of omeprazole or esomeprazole, which inhibit CYP2C19, with clopidogrel reduces exposure to the active metabolite of clopidogrel and decreases platelet inhibitory effects. Although the clinical importance has not been fully elucidated, a reduction in the effectiveness of clopidogrel in preventing cardiovascular events is possible. Proton-pump inhibitors vary in their potency for inhibiting CYP2C19. The change in inhibition of adenosine diphosphate (ADP)-induced platelet aggregation associated with concomitant use of proton-pump inhibitors is related to the change in exposure to the active metabolite of clopidogrel. In pharmacokinetic and pharmacodynamic studies in healthy individuals, dexlansoprazole, lansoprazole, and pantoprazole had less effect on the antiplatelet activity of clopidogrel than did omeprazole or esomeprazole.

The decision to use a proton-pump inhibitor concomitantly with clopidogrel should be based on the assessed risks and benefits in individual patients. The American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that the reduction in GI bleeding risk with proton-pump inhibitors is substantial in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or nonsteroidal anti-inflammatory agents [NSAIAs]; H. pylori infection) and may outweigh any potential reduction in the cardiovascular efficacy of antiplatelet treatment associated with a drug-drug interaction. In contrast, ACCF/ACG/AHA states that patients without such risk factors receive little if any absolute risk reduction from proton-pump inhibitor therapy, and the risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor in these patients.

If concomitant therapy with a proton-pump inhibitor and clopidogrel is considered necessary, use of an agent with little or no CYP2C19-inhibitory activity should be considered. Alternatively, treatment with a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine) may be considered, although such agents may not be as effective as a proton-pump inhibitor in providing gastric protection; cimetidine should not be used since it also is a potent CYP2C19 inhibitor. There currently is no evidence that histamine H2-receptor antagonists (other than cimetidine) or other drugs that reduce gastric acid (e.g., antacids) interfere with the antiplatelet effects of clopidogrel. For further information on interactions between proton-pump inhibitors and clopidogrel,

Cyclosporine

Potential pharmacokinetic interaction (inhibition of cyclosporine metabolism).

Digoxin

Hypomagnesemia (e.g., resulting from long-term use of proton-pump inhibitors) sensitizes the myocardium to digoxin and, thus, may increase the risk of digoxin-induced cardiotoxic effects. In patients receiving digoxin, monitoring of magnesium concentrations should be considered prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.

Methotrexate

Potential pharmacokinetic interaction (increased serum methotrexate concentrations, possibly resulting in toxicity) when proton-pump inhibitors, including rabeprazole, are used concomitantly with methotrexate. Increased serum concentrations and delayed clearance of methotrexate and/or its metabolite hydroxymethotrexate, with or without symptoms of methotrexate toxicity, have been reported in patients receiving methotrexate (usually at doses of 300 mg/m to 12 g/m) concomitantly with a proton-pump inhibitor. Although most of the reported cases occurred in patients receiving high doses of methotrexate, toxicity also has been reported in patients receiving low dosages of methotrexate (e.g., 15 mg per week) concomitantly with a proton-pump inhibitor. No formal studies of interactions between high-dose methotrexate and proton-pump inhibitors have been conducted to date.

The manufacturer of rabeprazole states that temporary discontinuance of proton-pump inhibitor therapy may be considered in some patients receiving high-dose methotrexate therapy. Some clinicians recommend either withholding proton-pump inhibitor therapy for several days before and after methotrexate administration or substituting a histamine H2-receptor antagonist for the proton-pump inhibitor when acid suppressive therapy is indicated during methotrexate therapy. Pending further evaluation, some clinicians state that these recommendations should extend to patients receiving low-dose methotrexate.

Sucralfate

Potential pharmacokinetic interaction. Concomitant administration of lansoprazole or omeprazole with sucralfate resulted in delayed absorption and decreased bioavailability of these proton-pump inhibitors. Administer proton-pump inhibitors at least 30 minutes before sucralfate.

Warfarin

Increases in the international normalized ratio (INR) and prothrombin time have been reported in patients receiving warfarin concomitantly with a proton-pump inhibitor, including rabeprazole. Because such increases may lead to abnormal bleeding and death, monitoring of INR and prothrombin time may be necessary during concomitant use with rabeprazole.

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