Rx Item-Aciphex 20mg Tab 30 By Woodward Pharma

Clinical Information
Gen. Code and Des.
40941 rabeprazole sodium ORAL TABLET DR 20 MG
GCN and Des.
94639 rabeprazole sodium ORAL TABLET DR 20 MG
Strength
20MG DR
Dose Form
TABLET, DELAYED RELEASE (ENTERIC COATED)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
56283600 PROTON-PUMP INHIBITORS
Active Ingredients
7681 rabeprazole sodium 117976906
Inactive Ingredients
2272 mannitol 69658
2537 povidone 9003398



Item info. These highlights do not include all the info. needed to use ACIPHEX DELAYED RELEASE TABLETS safely and effectively. See full prescribing info. for ACIPHEX DELAYED RELEASE TABLETS ACIPHEX (rabeprazole sodium) elayed release tablets for oral use Initial U.S. Approval: 1999 RECENT MAJOR CHANGES Contraindications 04 2016 - -- INDICATIONS AND USAG - - -- -- ACIPHEX delayed release tablet is proton pump inhibitor (PPI) indicated in adults for: Healing of ERosive or Ulcerative Gastroesophageal Reflux Disease (GERD) Maintenance of Healing of ERosive or Ulcerative GERD Treatment of Symptomatic GERD Healing of Duodenal Ulcers (1. ) Helicobacter pylori ERadication to Reduce Risk of Duodenal Ulcer Recurrence (1. ) Treatment of Pathological Hypersecretory Conditions, Including Zollinger Ellison Syndrome (1. ) In adolescent patients 12 years of age and older for: Short term Treatment of Symptomatic GERD (1. ) -- - - DOSAGE AND ADMINISTRATION -- Indication Recommended Dosage Healing of ERosive or Ulcerative Gastroesophageal Reflux Disease (GERD) 20 mg once daily for to weeks Maintenance of Healing of ERosive or Ulcerative GERD *studied for 12 months 20 mg once daily Symptomatic GERD in Adults 20 mg once daily for weeks Healing of Duodenal Ulcers 20 mg once daily after morning meal for up to weeks Helicobacter pylori ERadication to Reduce the Risk of Duodenal Ulcer Recurrence Three Drug Regimen: ACIPHEX 20 mg Amoxicillin 1000 mg Carithromycin 500 mg All three medications should be taken twice daily with morning and evening meals for days Pathological Hypersecretory Conditions, Including Zollinger Ellison Syndrome Starting dose 60 mg once daily then adjust to atient needs Symptomatic GERD in dolescents 12 Years of ge and lder 20 mg once daily for up to weeks Administration Instructions Swallow ACIPHEX elayed r elease ablets whole. Do not chew, crush or split he tablets For the treatment of duodenal ulcers take ACIPHEX delayed release tablets after meal. For Helicobacter pylori radication take ACIPHEX delayed release tablets with food. For all other indications ACIPHEX delayed release tablets can be taken with or wit hout food -- -- DOSAGE FORMS AND STR ENGTHS -- -- - Delayed Release Tablets: 20 mg -- CONTRAINDICATIONS -- - Patients with h istory of hypersensitivity to rabeprazole Patients receiving rilpivirine containing products (4, 7). Refer to the ontraindications section of the prescribing info. for clarithromycin and amoxicillin, when administered in combination with ACIPHEX - - WARNINGS AND PRECAUT ONS - -- -- Gastric Malignancy Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy (5. ) Use with Warfarin M onitor for increases in INR and prothombin time (5. , ) Acute Interstitial Nephritis O bserved in patients taking PPIs Cyanocobalamin (vitamin - 12) Deficiency Daily long term use (e.g., longer than years) may lead to malabsorption or deficiency of cyanocobalamin Clostridium difficile Associated Diarrhea PPI therapy may be associated with increased risk of 5.5 . Bone Fracture Long term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis related fractures of the hip, wrist or spine 5.6 . Hypomagnesemia R eported rarely with prolonged treatment with PPIs 5.7 . Interaction with Methotrexate Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider temporary withdrawal of ACIPHEX delayed release tablets (5.8, 7) -- ADVERSE REACTIONS ost common adverse reactions n adult (>2%) are pain, pharyngitis, flatulence, infection and constipation Most common adverse reactions in adolescents (?2%) are headache, diarrhea, nausea, vomiting and abdominal pain . To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at - 888 274 2378 or FDA at - 800 FDA 1088 or www.fda.gov/medwatch -- -- - -- -- DRUG INTERACTIONS -- - -- See full prescribing info. for list of clinically important drug interactions - USE IN SPECIFIC POPULATIONS Pediatric Use Dosage strength not appropriate for patients less than 12 years 2, 8.4) See 17 for PATIENT COUNSELING info. and Medication Guide Revised 04/16

Rx Item-Aciphex 20mg Tab 30 By Eisai
NDC No.62856-0243-30 UPC/GTIN No.3-62856-24330-8 MPN No. 24330 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

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Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Aciphex 20mg Tab 30 By Eisai
Aciphex 20mg Tab 30 By Eisai

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