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ACIPHEX (RABEPRAZOLE SODIUM) by EISAI INC.
ACIPHEX (RABEPRAZOLE SODIUM) EISAI INC.

Swallow whole. Do not chew or crush.

It is very important that you take or use this exactly as directed. Do not skip doses or discontinue unless directed by your doctor.

This medicine may be taken with or without food.


INDICATIONS:
Condition of Increased Mast Cells
Benign Tumors of the Hormone Producing Glands
Zollinger-Ellison Syndrome
Condition in which Stomach Acid is Pushed Into the Esophagus
Medication Treatment for Healing Gastroesophageal Reflux
Bleeding from Stomach, Esophagus or Duodenum
Ulcer of the Duodenum
Ulcer of Duodenum caused by Bacteria Helicobacter Pylori
Stomach Ulcer from Aspirin/Ibuprofen-Like Drugs Prevention
Excessive Production of Stomach Acid

CONTRAINDICATIONS:
RABEPRAZOLE: Disease of Liver
RABEPRAZOLE: Fractures
RABEPRAZOLE: Hypomagnesemia
RABEPRAZOLE: Osteoporosis

MONOGRAPH - PATIENT:
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

RABEPRAZOLE DELAYED-RELEASE - ORAL (ra-BEP-ra-zole)

COMMON BRAND NAME(S): Aciphex

USES: Rabeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Rabeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking rabeprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily with or without food. Dosage and length of treatment are based on your medical condition and response to treatment. Do not crush, chew, or split this medication. Swallow it whole. If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take rabeprazole at least 30 minutes before sucralfate. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Headache may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rabeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, omeprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease. Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss. Proton pump inhibitors (such as rabeprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. The effects on a nursing infant are unknown. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: clopidogrel, nelfinavir. Some products need stomach acid so that the body can absorb them properly. Rabeprazole decreases stomach acid, so it may change how well these products work. Some affected products include amphetamines, ampicillin, atazanavir, digoxin, iron supplements, azole antifungals such as ketoconazole, among others.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. If your doctor instructs you to use this medication regularly for a long time, laboratory and medical tests (such as a magnesium blood test) may be performed periodically to monitor your progress or check for side effects. Keep all regular medical and laboratory appointments.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2011 Copyright(c) 2011 First DataBank, Inc.


MONOGRAPH - FOOD & DRUG:
No significant food-drug interactions found.

RELATED DISEASES:
Acute Gastrointestinal Ulcer with Hemorrhage
Acute Hemorrhage
Acute Peptic Ulcer
Bacterial Infection
Disorder of Immune Function
Disorder of the Digestive System
Duodenal Ulcer
Erosive Gastritis
Esophageal Varices
Esophagitis
Gastric Cancer
Gastric Hypersecretory Conditions
Gastritis
Gastroesophageal Reflux
Gastrointestinal Hemorrhage
Gastrointestinal Ulcer
Hemodynamic Instability
Hemorrhage
Hemorrhage with Cardiovascular Instability
Infection
Neoplasm
Peptic Ulcer
Predisposition to GI Hemorrhage
Reflux Esophagitis
Severe GI Bleeding within Last 10 Days
Significant Bleeding
Upper GI Bleed

RELATED ICD CODES:
Abnormal Secretion of Gastrin [251.5]
Acute Duodenal Ulcer Not Otherwise Specified [532.3]
Acute Duodenal Ulcer Not Otherwise Specified with Obstruction [532.31]
Acute Duodenal Ulcer Not Otherwise Specified Without Obstruction [532.30]
Acute Duodenal Ulcer with Hemorrhage [532.0]
Acute Duodenal Ulcer with Hemorrhage and Perforation [532.2]
Acute Duodenal Ulcer with Hemorrhage and Perforation Without Obstruction [532.20]
Acute Duodenal Ulcer with Hemorrhage with Obstruction [532.01]
Acute Duodenal Ulcer with Hemorrhage Without Obstruction [532.00]
Acute Duodenal Ulcer with Hemorrhage, Perforation and Obstruction [532.21]
Acute Duodenal Ulcer with Perforation [532.1]
Acute Duodenal Ulcer with Perforation with Obstruction [532.11]
Acute Duodenal Ulcer with Perforation Without Obstruction [532.10]
Acute Gastric Ulcer Not Otherwise Specified [531.3]
Acute Gastric Ulcer Not Otherwise Specified with Obstruction [531.31]
Acute Gastric Ulcer Not Otherwise Specified Without Obstruction [531.30]
Acute Gastric Ulcer with Hemorrhage [531.0]
Acute Gastric Ulcer with Hemorrhage and Obstruction [531.01]
Acute Gastric Ulcer with Hemorrhage and Perforation [531.2]
Acute Gastric Ulcer with Hemorrhage and Perforation Without Obstruction [531.20]
Acute Gastric Ulcer with Hemorrhage Without Obstruction [531.00]
Acute Gastric Ulcer with Hemorrhage, Perforation and Obstruction [531.21]
Acute Gastric Ulcer with Perforation [531.1]
Acute Gastric Ulcer with Perforation and Obstruction [531.11]
Acute Gastric Ulcer with Perforation Without Obstruction [531.10]
Acute Gastritis with Hemorrhage [535.01]
Adverse Effects of Unspecified Analgesic and Antipyretic in Therapeutic Use [E935.9]
Alcoholic Gastritis with Hemorrhage [535.31]
Atrophic Gastritis with Hemorrhage [535.11]
Bleeding Esophageal Varices in Other Diseases [456.20]
Chronic Duodenal Ulcer Not Otherwise Specified [532.7]
Chronic Duodenal Ulcer Not Otherwise Specified with Obstruction [532.71]
Chronic Duodenal Ulcer Not Otherwise Specified Without Obstruction [532.70]
Chronic Duodenal Ulcer with Hemorrhage [532.4]
Chronic Duodenal Ulcer with Hemorrhage and Obstruction [532.41]
Chronic Duodenal Ulcer with Hemorrhage and Perforation [532.6]
Chronic Duodenal Ulcer with Hemorrhage and Perforation Without Obstruction [532.60]
Chronic Duodenal Ulcer with Hemorrhage Without Obstruction [532.40]
Chronic Duodenal Ulcer with Hemorrhage, Perforation and Obstruction [532.61]
Chronic Duodenal Ulcer with Perforation [532.5]
Chronic Duodenal Ulcer with Perforation with Obstruction [532.51]
Chronic Duodenal Ulcer with Perforation Without Obstruction [532.50]
Chronic Gastric Ulcer Not Otherwise Specified [531.7]
Chronic Gastric Ulcer Not Otherwise Specified with Obstruction [531.71]
Chronic Gastric Ulcer Not Otherwise Specified Without Obstruction [531.70]
Chronic Gastric Ulcer with Hemorrhage [531.4]
Chronic Gastric Ulcer with Hemorrhage and Obstruction [531.41]
Chronic Gastric Ulcer with Hemorrhage and Perforation [531.6]
Chronic Gastric Ulcer with Hemorrhage and Perforation Without Obstruction [531.60]
Chronic Gastric Ulcer with Hemorrhage Without Obstruction [531.40]
Chronic Gastric Ulcer with Hemorrhage, Perforation and Obstruction [531.61]
Chronic Gastric Ulcer with Perforation [531.5]
Chronic Gastric Ulcer with Perforation and Obstruction [531.51]
Chronic Gastric Ulcer with Perforation Without Obstruction [531.50]
Diseases of Esophagus [530]
Duodenal Ulcer [532]
Duodenal Ulcer Not Otherwise Specified [532.9]
Duodenal Ulcer Not Otherwise Specified with Obstruction [532.91]
Duodenal Ulcer Not Otherwise Specified Without Obstruction [532.90]
Duodenitis with Hemorrhage [535.61]
Dyspepsia and other Specified Disorders of Function of Stomach [536.8]
Esophageal Disorder Not Otherwise Specified [530.9]
Esophageal Disorders Not Elsewhere Classified [530.89]
Esophageal Reflux [530.81]
Esophageal Varices with Bleeding [456.0]
Esophagitis [530.1]
Gastric Ulcer [531]
Gastric Ulcer Not Otherwise Specified [531.9]
Gastric Ulcer Not Otherwise Specified with Obstruction [531.91]
Gastric Ulcer Not Otherwise Specified Without Obstruction [531.90]
Gastritis and Duodenitis Not Otherwise Specified with Hemorrhage [535.51]
Gastritis Not Elsewhere Classified with Hemorrhage [535.41]
Gastrointestinal Hemorrhage [578]
Gastrointestinal Hemorrhage Not Otherwise Specified [578.9]
Gastrojejunal Ulcer [534]
Gastrojejunal Ulcer Not Otherwise Specified [534.9]
Gastrojejunal Ulcer Not Otherwise Specified Without Obstruction [534.90]
Helicobacter Pylori Infection [041.86]
Hemorrhage Not Otherwise Specified [459.0]
Hypertrophic Gastritis with Hemorrhage [535.21]
Long-Term (Current) Use of Non-Steroidal Anti-Inflammatories [V58.64]
Lymphoid & Histiocytic Tissue Malignant Neoplasms of Extranodal & Solid Organ Sites [202.90]
Malignant Mast Cell Tumors [202.6]
Malignant Mast Cell Tumors of Axillary and Upper Limb Lymph Nodes [202.64]
Malignant Mast Cell Tumors of Inguinal and Lower Limb Lymph Nodes [202.65]
Malignant Mast Cell Tumors of Intra-Abdominal Lymph Nodes [202.63]
Malignant Mast Cell Tumors of Intrapelvic Lymph Nodes [202.66]
Malignant Mast Cell Tumors of Intrathoracic Lymph Nodes [202.62]
Malignant Mast Cell Tumors of Lymph Nodes of Head, Face and Neck [202.61]
Malignant Mast Cell Tumors of Lymph Nodes of Multiple Sites [202.68]
Malignant Mast Cell Tumors of Spleen [202.67]
Malignant Mast Cell Tumors of Unspecified Site- Extranodal and Solid Organ Sites [202.60]
Malignant Neoplasms of Lymphoid and Histiocytic Tissue Not Elsewhere Classified [202.9]
Multiple Endocrine Neoplasia [MEN] Type I [258.01]
Multiple Endocrine Neoplasia [MEN] Type IIA [258.02]
Multiple Endocrine Neoplasia [MEN] Type IIB [258.03]
Neoplasm of Uncertain Behavior of Endocrine Glands and Nervous System [237]
Neoplasm of Uncertain Behavior of Other and Unspecified Endocrine Glands [237.4]
Neoplasm of Uncertain Behavior of Other and Unspecified Parts of Nervous System [237.9]
Neoplasms of Unspecified Nature [239]
Neoplasms of Unspecified Nature of Other Specified Sites [239.89]
Other Esophageal Disorders [530.8]
Other Esophagitis [530.19]
Other Neoplasm of Unspecified Nature [239.8]
Other Pancreatic Disorder [251]
Other Specified Bacterial Infections [041.8]
Pancreatic Disorder Not Elsewhere Classified [251.8]
Pancreatic Disorder Not Otherwise Specified [251.9]
Peptic Ulcer Not Otherwise Specified [533.9]
Peptic Ulcer Not Otherwise Specified Without Obstruction [533.90]
Peptic Ulcer, Site Not Otherwise Specified [533]
Polyglandular Activity in Multiple Endocrine Adenomatosis [258.0]
Polyglandular Dysfunction [258]
Polyglandular Dysfunction Not Otherwise Specified [258.9]
Reflux Esophagitis [530.11]
Stomach Function Disorder Not Otherwise Specified [536.9]
Stomach Function Disorders [536]
Unspecified Esophagitis [530.10]

Indication: Benign Tumors of the Hormone Producing Glands:

take 3 tablets (60 mg) by oral route once daily
take 3 tablets (60 mg) by oral route 2 times per day
take 5 tablets (100 mg) by oral route once daily

Indication: Condition in which Stomach Acid is Pushed Into Esophagus:

take 1 tablet (20 mg) by oral route once daily
take 1 tablet (20 mg) by oral route once daily for 4 weeks
take 1 tablet (20 mg) by oral route once daily for 8 weeks

Indication: Condition of Increased Mast Cells:

take 3 tablets (60 mg) by oral route once daily
take 3 tablets (60 mg) by oral route 2 times per day
take 5 tablets (100 mg) by oral route once daily

Indication: Excessive Production of Stomach Acid:

take 3 tablets (60 mg) by oral route once daily
take 3 tablets (60 mg) by oral route 2 times per day
take 5 tablets (100 mg) by oral route once daily

Indication: Medication Treatment for Healing Gastroesophageal Reflux:

take 1 tablet (20 mg) by oral route once daily

Indication: Symptoms Accompanying Esophageal Reflux of Stomach Acid:

take 1 tablet (20 mg) by oral route once daily
take 1 tablet (20 mg) by oral route once daily for 4 weeks

Indication: Ulcer of the Duodenum:

take 1 tablet (20 mg) by oral route once daily after the morning meal
take 1 tablet (20 mg) by oral route once daily for 4 weeks after the m orning meal

Indication: Zollinger-Ellison Syndrome:

take 3 tablets (60 mg) by oral route once daily
take 3 tablets (60 mg) by oral route 2 times per day
take 5 tablets (100 mg) by oral route once daily

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