Rabeprazole Sodium (Page 9 of 10)

14.6 Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults

Twelve patients with idiopathic gastric hypersecretion or Zollinger-Ellison syndrome have been treated successfully with Rabeprazole Sodium Delayed-Release Tablets at doses from 20 to 120 mg for up to 12 months. Rabeprazole Sodium Delayed-Release Tablets produced satisfactory inhibition of gastric acid secretion in all patients and complete resolution of signs and symptoms of acid-peptic disease where present. Rabeprazole Sodium Delayed-Release Tablets also prevented recurrence of gastric hypersecretion and manifestations of acid-peptic disease in all patients. The high doses of Rabeprazole Sodium Delayed-Release Tablets used to treat this small cohort of patients with gastric hypersecretion were well tolerated.

14.7 Pediatric GERD

Symptomatic GERD in Adolescents 12 to 16 Years of Age

In a multicenter, randomized, open-label, parallel-group study, 111 adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD were randomized and treated with either Rabeprazole Sodium Delayed-Release Tablets 10 mg or Rabeprazole Sodium Delayed-Release Tablets 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy.

15 REFERENCES

1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically -Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January 2000.

16 HOW SUPPLIED/STORAGE AND HANDLING

Rabeprazole Sodium Delayed-Release Tablets 20 mg is supplied as delayed-release blue enteric-coated round tablets debossed with “KU” on one side and “7″ on the other.

55700-238-30

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).

How to Take Rabeprazole Sodium Delayed-Release Tablets

Patients should be cautioned that Rabeprazole Sodium Delayed-Release Tablets should be swallowed whole. The tablets should not be chewed, crushed, or split. Rabeprazole Sodium Delayed-Release Tablets can be taken with or without food.

Advise patients to immediately report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea [see Warnings and Precautions (5.5) ].

Manufactured by:

Kremers Urban Pharmaceuticals Inc.,

a subsidiary of Lannett Company, Inc.

Seymour, IN 47274

Made in the USA

CIA76374E
Rev. 02/2016

​Medication Guide

MEDICATION GUIDE
Rabeprazole Sodium (ra-BEP-ra-zole SOE-dee-um) Delayed-Release Tablets

CIA76375E
Rev. 02/2016

Read the Medication Guide that comes with Rabeprazole Sodium Delayed-Release Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about Rabeprazole Sodium Delayed-Release Tablets?

Rabeprazole Sodium Delayed-Release Tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Rabeprazole Sodium Delayed-Release Tablets can cause serious side effects, including:

  • Diarrhea. Rabeprazole Sodium Delayed-Release Tablets may increase your risk of getting severe diarrhea. This diarrhea may be caused by in an infection (Clostridium difficile) in your intestines.
    Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
  • Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor (PPI) medicines for a long period of time (1 year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take Rabeprazole Sodium Delayed-Release Tablets exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take Rabeprazole Sodium Delayed-Release Tablets.

Rabeprazole Sodium Delayed-Release Tablets can have other serious side effects. See “What are the possible side effects
of Rabeprazole Sodium Delayed-Release Tablets?

What is Rabeprazole Sodium Delayed-Release Tablets?

Rabeprazole Sodium Delayed-Release Tablet is a prescription medicine called a Proton Pump Inhibitor (PPI). Rabeprazole Sodium Delayed-Release Tablets reduces the amount of acid in your stomach.

Rabeprazole Sodium Delayed-Release Tablets is used in adults:

  • for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE) and to relieve symptoms, such as heartburn pain. If needed, your doctor may decide to prescribe another 8 weeks of Rabeprazole Sodium Delayed-Release Tablets.
  • to maintain the healing of the esophagus and relief of symptoms related to EE. It is not known if Rabeprazole Sodium Delayed-Release Tablets is safe and effective if used longer than 12 months (1 year).
  • for 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD).
    GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.
  • for up to 4 weeks for the healing and relief of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
  • for 7 days with certain antibiotic medicines to treat 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 rare condition called Zollinger-Ellison syndrome.
    Rabeprazole Sodium Delayed-Release Tablets is used in adolescents 12 years of age and older:
  • for up to 8 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD).

Rabeprazole Sodium Delayed-Release Tablets is used in adolescents 12 years of age and older to treat symptoms of Gastroesophageal Reflux Disease (GERD) for up to 8 weeks.

It is not known if Rabeprazole Sodium Delayed-Release Tablets is safe and effective in children under the age of 12.

Who should not take Rabeprazole Sodium Delayed-Release Tablets?

Do not take Rabeprazole Sodium Delayed-Release Tablets if you:

  • are allergic to rabeprazole or any of the other ingredients in Rabeprazole Sodium Delayed-Release Tablets. See the end of this Medication Guide for a complete list of ingredients in Rabeprazole Sodium Delayed-Release Tablets.
  • are allergic to any other Proton Pump Inhibitor (PPI) medicine.

What should I tell my doctor before taking Rabeprazole Sodium Delayed-Release Tablets?

Before you take Rabeprazole Sodium Delayed-Release Tablets tell your doctor if you:

  • have been told that you have low magnesium levels in your blood.
  • have liver problems.
  • have any allergies.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if Rabeprazole Sodium Delayed-Release Tablets can harm your unborn baby.
  • are breastfeeding. It is not known if Rabeprazole Sodium Delayed-Release Tablets passes into your breast milk.Talk to your doctor about the best way to feed your baby if you take Rabeprazole Sodium Delayed-Release Tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Rabeprazole Sodium Delayed-Release Tablets may affect how other medicines work, and other medicines may affect how Rabeprazole Sodium Delayed-Release Tablets works.

Especially tell your doctor if you take:

  • atazanavir (Reyataz)
  • cyclosporine (Sandimmune, Neoral)
  • digoxin (Lanoxin)
  • ketoconazole (Nizoral)
  • warfarin (Coumadin)
  • theophylline (THEO-24 Thelair)
  • diazepam (Valium)
  • phenytoin (Dilantin)
  • an antibiotic that contains amoxicillin or clarithromycin
  • a “water pill” (diuretic)
  • methotrexate
  • mycophenolate mofetil (Cellcept)

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Rabeprazole Sodium Delayed-Release Tablets?

  • Take Rabeprazole Sodium Delayed-Release Tablets 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 Rabeprazole Sodium Delayed-Release Tablets unless you talk to your doctor. Take Rabeprazole Sodium Delayed-Release Tablets for as long as it is prescribed even if you feel better.
  • Rabeprazole Sodium Delayed-Release Tablets is usually taken one time each day. Your doctor will tell you the time of day to take Rabeprazole Sodium Delayed-Release Tablets, based on your medical condition.
  • Rabeprazole Sodium Delayed-Release Tablets can be taken with or without food. Your doctor will tell you whether to take this medicine with or without food based on your medical condition.
  • Swallow each Rabeprazole Sodium Delayed-Release Tablet whole with water. Do not chew, crush, or split Rabeprazole Sodium Delayed-Release Tablets. Tell your doctor if you cannot swallow tablets whole. You may need a different medicine.
  • If you miss a dose of Rabeprazole Sodium Delayed-Release Tablets, 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 Rabeprazole Sodium Delayed-Release Tablets, call your doctor or Poison Control Center right away, or go to the nearest hospital emergency room.
  • Your doctor may prescribe antibiotic medicines with Rabeprazole Sodium Delayed-Release Tablets to help treat a stomach infection and heal stomach (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 possible side effects of Rabeprazole Sodium Delayed-Release Tablets?

Rabeprazole Sodium Delayed-Release Tablets can cause serious side effects including:

  • See “What is the most important information I should know about Rabebprazole Sodium Delayed-Release Tablets?”
  • Vitamin B-12 deficiency. Rabeprazole Sodium Delayed-Release Tablets reduce the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on Rabeprazole Sodium Delayed-Release Tablets for a long time (more than 3 years).
  • Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a Proton Pump Inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.
    Tell your doctor right away if you have any of these symptoms:
    • seizures
    • dizziness
    • abnormal or fast heart beat
    • jitteriness
    • jerking movements or shaking (tremors)
    • muscle weakness
    • spasms of the hands and feet
    • cramps or muscle aches
    • spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking Rabeprazole Sodium Delayed-Release Tablets, during treatment, or if you will be taking Rabeprazole Sodium Delayed-Release Tablets for a long period of time.

The most common side effects with Rabeprazole Sodium Delayed-Release Tablets include:

  • headache
  • pain
  • sore throat
  • gas
  • infection
  • constipation

Other side effects:

  • Serious allergic reactions. Tell your doctor if you have any of the following symptoms with Rabeprazole Sodium Delayed-Release Tablets.
  • rash
  • face swelling
  • throat tightness
  • difficulty breathing

Your doctor may stop Rabeprazole Sodium Delayed-Release Tablets if these symptoms happen.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of Rabeprazole Sodium Delayed-Release Tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Rabeprazole Sodium Delayed-Release Tablets?

  • Store Rabeprazole Sodium Delayed-Release Tablets in a dry place at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Rabeprazole Sodium Delayed-Release Tablets and all medicines out of the reach of children.

General Information about Rabeprazole Sodium Delayed-Release Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Rabeprazole Sodium Delayed-Release Tablets for a condition for which it was not prescribed. Do not give Rabeprazole Sodium Delayed-Release Tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Rabeprazole Sodium Delayed-Release Tablets. If you would like more information, talk to your doctor. You can also ask your doctor or pharmacist for information about Rabeprazole Sodium Delayed-Release Tablets that is written for healthcare professionals. For more information, call 1-844-834-0530.

What are the ingredients in Rabeprazole Sodium Delayed-Release Tablets?

Active Ingredient: rabeprazole sodium

Inactive Ingredients: crospovidone, FD&C Blue #1, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc and triethyl citrate.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Kremers Urban Pharmaceuticals Inc.,

a subsidiary of Lannett Company, Inc.

Seymour, IN 47274

Made in the USA

CIA76375ERev. 02/2016

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