Rabeprazole sodium

What is Rabeprazole sodium?

• Rabeprazole sodium (Aciphex) is a proton-pump inhibitor used to reduces the amount of acid that is made by your stomach.

What are the uses of this medicine?

This medicine is used in adults:

• for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) Gastroesophageal Reflux Disease (GERD).
• to maintain healing of damage (erosions) and relief of heartburn symptoms with GERD. Aciphex has not been studied for treatment lasting longer than 12 months (1 year).
• for the treatment of daytime and nighttime heartburn and other symptoms that happen with GERD.
• for short-term treatment (up to 4 weeks) in the healing and relief of stomach-area (duodenal) ulcers. The duodenal area is the area where food passes when it leaves the stomach. The main symptom of a duodenal ulcer is a steady pain in the stomach area.
• with certain antibiotic medicines for the treatment of an infection caused by bacteria called H. pylori. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back.
• for the long-term treatment of conditions where your stomach makes too much acid. This includes a condition called Zollinger-Ellison syndrome.

Aciphex is used in adolescents 12 years of age and above:

• For the short-term (up to 8 weeks) treatment of GERD.
• The safety and effectiveness of Aciphex has not been established for children under the age of 12.

How does this medicine work?

• The sodium salt of the prodrug rabeprazole, a substituted benzimidazole proton pump inhibitor, with potential anti-ulcer activity.
• After protonation, accumulation, and transformation to the active sulfenamide within the acidic environment of gastric parietal cells, rabeprazole selectively and irreversibly binds to and inhibits the H+, K+ATPase (hydrogen-potassium adenosine triphosphatase) enzyme system located on the parietal cell secretory surface, inhibiting gastric acid secretion.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to any of the ingredients in Aciphex.
• are allergic to any other Proton Pump Inhibitor (PPI) medicine.

What drug interactions can this medicine cause?

• Increase INR and prothrombin times have been reported with concomitant use with warfarin. Patients need to be monitored.
• Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro.
• Aciphex inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).
• Aciphex may reduce the plasma levels of atazanavir.

Is this medicine FDA approved?

• Initial U.S. Approval: 1999

How should this medicine be used?

Recommended Dosage: Healing of Erosive or Ulcerative GERD

• The recommended adult oral dose is one Aciphex 20 mg delayed-release tablet to be taken once daily for four to eight weeks.

Maintenance of Healing of Erosive or Ulcerative GERD

• The recommended adult oral dose is one Aciphex 20 mg delayed-release tablet to be taken once daily.

Treatment of Symptomatic GERD

• The recommended adult oral dose is one Aciphex 20 mg delayed-release tablet to be taken once daily for 4 weeks.

Healing of Duodenal Ulcers

• The recommended adult oral dose is one Aciphex 20 mg delayed-release tablet to be taken once daily after the morning meal for a period up to four weeks.

• Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Three Drug Regimen All three medications should be taken twice daily with morning and evening meals for 7 days:

• Aciphex 20 mg
• Amoxicillin 1000 mg
• Clarithromycin 500 mg

Treatment of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

• The dosage of Aciphex in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day.

Short-term Treatment of GERD in Adolescent Patients 12 Years of Age and Above

• The recommended oral dose for adolescents 12 years of age and above is 20 mg once daily for up to 8 weeks.

Administration

• Take Aciphex exactly as prescribed. Your doctor will prescribe the dose that is right for you and your medical condition. Do not change your dose or stop taking Aciphex unless you talk to your doctor. Take Aciphex for as long as it is prescribed even if you feel better.
• Aciphex is usually taken once a day. Your doctor will tell you the time of day to take Aciphex, based on your medical condition.
• Aciphex can be taken with or without food. Your healthcare provider will tell you whether to take this medicine with or without food based on your medical condition.
• Swallow each Aciphex tablet whole with water. Do not chew, crush, or split Aciphex tablets because this will damage the tablet and the medicine will not work. Tell your doctor if you cannot swallow tablets whole. You may need a different medicine.
• If you miss a dose of Aciphex, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.
• If you take too much Aciphex, call your doctor or Poison Control Center right away, or go to the emergency room.
• Your doctor may prescribe antibiotic medicines with Aciphex to help treat a stomach infection and heal stomach-area (duodenal) ulcers that are caused by bacteria called H. pylori. Make sure you read the patient information that comes with an antibiotic before you start taking it.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 20 mg

This medicine is available in fallowing brand namesː

• Aciphex

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• pain
• pharyngitis
• flatulence
• infection
• constipation

What special precautions should I follow?

• Patients should be cautioned that Aciphex delayed-release tablets should be swallowed whole. The tablets should not be chewed, crushed, or split. Aciphex can be taken with or without food.
• Patients treated with a proton pump inhibitor and warfarin may need to be monitored for increases in INR and prothrombin time due to risk of abnormal bleeding.
• Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy.

What to do in case of emergency/overdose?

• There has been no experience with large overdoses with rabeprazole.

Management of overdosage:

• No specific antidote for rabeprazole is known.
• Rabeprazole is extensively protein bound and is not readily dialyzable.
• In the event of overdosage, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• There are, however, no adequate and well-controlled studies in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Aciphex for the treatment of GERD patients <12 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: rabeprazole sodium
• Inactive ingredients of the 20 mg tablet are carnauba wax, crospovidone, diacetylated monoglycerides, ethylcellulose, hydroxypropyl cellulose, hypromellose phthalate, magnesium stearate, mannitol, propylene glycol, sodium hydroxide, sodium stearyl fumarate, talc, and titanium dioxide. Iron oxide yellow is the coloring agent for the tablet coating. Iron oxide red is the ink pigment.

Who manufactures and distributes this medicine?

• Manufactured and Marketed by Eisai Inc., Woodcliff Lake, NJ
• Marketed by PRICARA, Unit of Ortho-McNeil-Janssen Pharmaceuticals, Inc., Raritan, NJ

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
• Protect from moisture.

The antiulcer agents in clinical use

Proton Pump Inhibitors

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Selective Histamine Type 2 Receptor Antagonists or H2 Blockers

• Cimetidine
• Famotidine
• Nizatidine
• Ranitidine

• Dailymed label info on Rabeprazole sodium
• FDA Rabeprazole sodium

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