Rabeprazole

What it is used for

Rabeprazole sodium delayed-release tablets is a 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. Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence.

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome. In adolescent patients 12 years of age and older for: Short-term Treatment of Symptomatic GERD. 1.1 Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD).

For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of rabeprazole sodium delayed-release tablets may be considered. 1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance).

Controlled studies do not extend beyond 12 months. 1.3 Treatment of Symptomatic GERD in Adults Rabeprazole sodium delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks. 1.4 Healing of Duodenal Ulcers in Adults Rabeprazole sodium delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers.

Most patients heal within four weeks. 1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults Rabeprazole sodium delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. 1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults Rabeprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older Rabeprazole sodium delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

The most important thing to know

You should take rabeprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. 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: A type of kidney problem (acute tubulointerstitial nephritis).

Some people who take proton pump inhibitor (PPI) medicines, including rabeprazole sodium delayed-release tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with rabeprazole sodium delayed-release tablets. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

Diarrhea caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer).

Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including rabeprazole sodium delayed-release tablets, may develop certain types of lupus erythematosus or have worsening of the lupus they already have.

Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects. Rabeprazole sodium delayed-release tablets can have other serious side effects. See “

How to take it

Take rabeprazole sodium delayed-release tablets exactly as prescribed. Rabeprazole sodium delayed-release tablets are usually taken 1 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. Do not chew, crush, or split rabeprazole sodium delayed-release tablets. Tell your doctor if you cannot swallow tablets whole. 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, you should not take the missed dose. You should take your next dose at your regular time. Do not take 2 doses at the same time. If you take too much rabeprazole sodium delayed-release tablets, call your doctor or your poison control center at 1-800-222-1222 right away, or go to the nearest emergency room.

If your doctor prescribes antibiotic medicines with rabeprazole sodium delayed-release tablets, read the patient information that comes with the antibiotic medicines before you take them. What are the possible side effects of rabeprazole sodium delayed-release tablets? Rabeprazole sodium delayed-release tablets can cause serious side effects, including: Interaction with warfarin.

Taking warfarin with a PPI medicine may lead to an increased risk of bleeding and death. If you take warfarin, your doctor may check your blood to see if you have an increased risk of bleeding. If you take warfarin during treatment with rabeprazole sodium delayed-release tablets, tell your doctor right away if you have any signs or symptoms of bleeding, including: pain, swelling or discomfort headaches, dizziness, or weakness unusual bruising (bruises that happen without known cause or that grow in size) nosebleeds bleeding gums bleeding from cuts take a long time to stop menstrual bleeding that is heavier than normal pink or brown urine red or black stools coughing up blood vomiting blood or vomit that looks like coffee grounds Low vitamin B-12 levels in the body can happen in people who have taken rabeprazole sodium delayed-release tablets for a long time (more than 3 years).

Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs. Low magnesium levels in the body can happen in people who have taken rabeprazole sodium delayed-release tablets for at least 3 months.

Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice. Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.

Severe skin reactions. Rabeprazole sodium delayed-release tablets can cause rare but serious skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening: Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).

You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. Stop taking rabeprazole sodium delayed-release tablets and call your doctor right away. These symptoms may be the first sign of a severe skin reaction. The most common side effects of rabeprazole sodium delayed-release tablets in a

Side effects, and when to stop

” What are rabeprazole sodium delayed-release tablets? Rabeprazole sodium delayed-release tablets are a prescription medicine called a proton pump inhibitor (PPI). Rabeprazole sodium delayed-release tablets reduce the amount of acid in your stomach. In adults, rabeprazole sodium delayed-release tablets are used for: 8 weeks up to 16 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.

maintaining healing of the esophagus and relief of symptoms related to EE. It is not known if rabeprazole sodium delayed-release tablets are safe and effective if used longer than 12 months (1 year). up to 4 weeks to treat daytime and nighttime heartburn and other symptoms that happen with Gastroesophageal Reflux Disease (GERD).

up to 4 weeks for the healing and relief of symptoms of duodenal ulcers. 7 days with certain antibiotic medicines to treat an infection and stomach (duodenal) ulcers caused by bacteria called H. pylori. the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

In adolescents 12 years of age and older, rabeprazole sodium delayed-release tablets are used for up to 8 weeks to treat symptoms of GERD. It is not known if rabeprazole sodium delayed-release tablets are safe and effective in children less than 12 years of age for other uses. Rabeprazole sodium delayed-release tablets should not be used in children under 12 years of age.

Who should not take it

Do not take rabeprazole sodium delayed-release tablets if you are: allergic to rabeprazole, any other PPI medicine, or any of the ingredients in rabeprazole sodium delayed-release tablets. See the end of this Medication Guide for a complete list of ingredients. taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

Before you take rabeprazole sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you: have low magnesium levels, low calcium levels and low potassium levels in your blood. have liver problems. are pregnant or plan to become pregnant. It is not known if rabeprazole sodium delayed-release tablets can harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if rabeprazole sodium 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 over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin or if you take warfarin (COUMADIN, JANTOVEN), methotrexate (OTREXUP, RASUVO, TREXALL, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).

Storing it

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.