FDA Label for Omeprazole DR
View Indications, Usage & Precautions
Omeprazole DR Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Pharmacy Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Medication Guide
MEDICATION GUIDE
Omeprazole Delayed-Release Capsules USP
(oh mep' ra zole)
Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about omeprazole delayed-release capsules?
You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed.
Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Omeprazole delayed-release capsules can cause serious side effects, including:
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A type of kidney problem (tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including omeprazole delayed-release capsules, may develop a kidney problem called tubulointerstitial nephritis that can happen at any time during treatment with omeprazole delayed-release capsules. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
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Diarrhea. Omeprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by 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.
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Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take omeprazole delayed-release capsules 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 omeprazole delayed-release capsules.
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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 proton PPI medicines, including omeprazole delayed-release capsules, 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.
Omeprazole delayed-release capsules can have other serious side effects. See “What are the possible side effects of omeprazole delayed-release capsules?”
What are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduce the amount of acid in your stomach.
Omeprazole delayed-release capsules are used in adults:
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for up to 8 weeks for the healing of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
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with certain antibiotics for 10 to 14 days to treat an infection caused by bacteria called H. pylori. If needed, your doctor may decide to prescribe another 14 to 18 days of omeprazole delayed-release capsules by itself after the antibiotics. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back.
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for up to 8 weeks for healing stomach ulcers.
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for up to 4 weeks to treat 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.
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for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). If needed, your doctor may decide to prescribe another 4 weeks of omeprazole delayed-release capsules.
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to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used for longer than 12 months (1 year) for this purpose.
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for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.
For children 2 to 16 years of age, omeprazole delayed-release capsules are used:
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for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
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for up to 8 weeks to treat gastroesophageal reflux disease (GERD) with acid-related damage to the lining of the esophagus [called erosive esophagitis (or EE) due to acid-mediated GERD].
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to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used longer than 12 months (1 year) for this purpose.
Who should not take omeprazole delayed-release capsules?
Do not take omeprazole delayed-release capsules if you:
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are allergic to omeprazole or any of the ingredients in omeprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in omeprazole delayed-release capsules.
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are allergic to any other proton pump inhibitor (PPI) medicine.
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are taking a medicine that contains rilpivirine (EDURANT, COMPLERA) used to treat HIV-1 (Human Immunodeficiency Virus).
What should I tell my doctor before taking omeprazole delayed-release capsules?
Before taking omeprazole delayed-release capsules, tell your doctor about all of your medical conditions, including if you:
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have been told that you have low magnesium levels in your blood
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have liver problems
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have any other medical conditions
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are pregnant or plan to become pregnant. It is not known if omeprazole delayed-release capsules will harm your unborn baby.
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are breastfeeding or plan to breastfeed. Omeprazole passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take omeprazole delayed-release capsules.
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Tell your doctor about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Omeprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how omeprazole delayed-release capsules works. Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin, or if you take clopidogrel (Plavix), methotrexate (Otrxup, Rasuvo, Trexall), St. John’s Wort (Hypericum perforatum), or rifampin (Rimactane, Rifater, Rifamate).
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 omeprazole delayed-release capsules?
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Take omeprazole delayed-release capsules exactly as prescribed by your doctor.
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Do not change your dose or stop omeprazole delayed-release capsules without talking to your doctor.
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Omeprazole delayed-release capsules are usually taken 1 time each day. Your doctor will tell you the time of day to take omeprazole delayed-release capsules, based on your medical condition.
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Take omeprazole delayed-release capsules before a meal.
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Antacids may be taken with omeprazole delayed-release capsules.
Omeprazole Delayed-Release Capsules
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Swallow omeprazole delayed-release capsules whole. Do not chew or crush omeprazole delayed-release capsules.
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If you have trouble swallowing a whole capsule, you can open the capsule and take the contents in applesauce. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take omeprazole delayed-release capsules with applesauce.
If you miss a dose of omeprazole delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.
If you take too much omeprazole delayed-release capsules, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.
What are the possible side effects of omeprazole delayed-release capsules?
Omeprazole delayed-release capsules can cause serious side effects, including:
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See “What is the most important information I should know about omeprazole delayed-release capsules?”
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Vitamin B-12 deficiency. Omeprazole delayed-release capsules 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 omeprazole delayed-release capsules for a long time (more than 3 years).
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Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a PPI 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 develop any of these symptoms:
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seizures
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jitteriness
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spasms of the hands and feet
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dizziness
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jerking movements or shaking (tremors)
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cramps or muscle aches
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abnormal or fast heart beat
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muscle weakness
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spasm of the voice box
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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.
Your doctor may check the level of magnesium in your body before you start taking omeprazole delayed-release capsules or during treatment if you will be taking omeprazole delayed-release capsules for a long period of time.
The most common side effects with omeprazole delayed-release capsules in adults and children include:
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headache
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stomach pain
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nausea
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diarrhea
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vomiting
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gas
In addition to the side effects listed above, the most common side effects in children 2 to 16 years of age include:
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respiratory system events
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fever
Other side effects:
Serious allergic reactions. Tell your doctor if you get any of the following symptoms with omeprazole delayed-release capsules:
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rash
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throat tightness
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face swelling
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difficulty breathing
Your doctor may stop omeprazole delayed-release capsules 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 possible side effects with omeprazole delayed-release capsules. 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 omeprazole delayed-release capsules?
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Store omeprazole delayed-release capsules at room temperature between 20°C to 25°C (68°F to 77°F).
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Keep the container of omeprazole delayed-release capsules closed tightly.
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Keep the container of omeprazole delayed-release capsules dry and away from light.
Keep omeprazole delayed-release capsules and all medicines out of the reach of children.
General information about the safe and effective use of omeprazole delayed-release capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use omeprazole delayed-release capsules for a condition for which it was not prescribed. Do not give omeprazole delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about omeprazole delayed-release capsules. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.
What are the ingredients in omeprazole delayed-release capsules?
Active ingredient in omeprazole delayed-release capsules: omeprazole, USP
Inactive ingredients in omeprazole delayed-release capsules: anhydrous lactose, cetyl alcohol, di-sodium hydrogen phosphate dihydrate, hypromellose, hypromellose phthalate, mannitol, simethicone emulsion 30%, sodium lauryl sulfate and sugar sphere.
The capsule shell for omeprazole delayed-release capsules USP, 10 mg contains D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide.
The capsule shell for omeprazole delayed-release capsules USP, 20 mg contains FD&C Blue No.1, gelatin, sodium lauryl sulfate and titanium dioxide.
The capsule shell for omeprazole delayed-release capsules USP, 40 mg contains D&C Yellow No.10, FD&C Blue No.1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate and titanium dioxide.
The imprinting ink has the following components: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.
Medication Guide available at
WWW.GLENMARKPHARMA-US.COM/MEDGUIDES
Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430
Questions? 1 (888) 721-7115
WWW.GLENMARKPHARMA-US.COM
Product of India
July 2020
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dosage And Administration Section
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Adult Dosage Regimen by Indication
Table 1 shows the recommended dosage of omeprazole in adult patients by indication.
Table 1: Recommended Dosage Regimen of Omeprazole in Adults by Indication
Indication
Dosage of Omeprazole
Treatment Duration
Treatment of Active Duodenal
Ulcer
20 mg once daily
4 weeks1
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy
Omeprazole 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
Take all three drugs twice daily
10 days
In patients with an ulcer present at the time of initiation of therapy, continue omeprazole 20 mg once daily for an additional 18 days for ulcer healing and symptom relief.
Dual Therapy
Omeprazole 40 mg once daily Clarithromycin 500 mg three times daily
14 days
In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.
Active Benign Gastric Ulcer
40 mg once daily
4 to 8 weeks
Treatment of Symptomatic GERD
20 mg once daily
Up to 4 weeks
Treatment of EE due to Acid-Mediated GERD
20 mg once daily
4 to 8 weeks2
Maintenance of Healing of EE due to Acid-Mediated GERD
20 mg once daily3
Controlled studies do not extend beyond 12 months.
Pathological Hypersecretory Conditions
Starting dose is 60 mg once daily;
adjust to patient needs
Daily dosages of greater than 80 mg should be administered in divided doses.
Dosages up to 120 mg three times
daily have been administered.
As long as clinically indicated.
Some patients with Zollinger-Ellison syndrome have been treated continuously for more than 5 years.
1 Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing
2 The efficacy of omeprazole used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole may be considered.
3 Dosage reduction to 10 mg once daily is recommended for patients with hepatic impairment (Child-Pugh Class A, B or C) and Asian patients when used for the maintenance of healing of EE [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3, 12.5)].
2.2 Recommended Pediatric Dosage Regimen by Indication
Table 2 shows the recommended dosage of omeprazole in pediatric patients by indication.
Table 2: Recommended Dosage Regimen of Omeprazole in Pediatric Patients by Indication
Indication
Omeprazole Dosage Regimen and Duration
Patient Age
Weight-Based Dose (mg)
Regimen and Duration
Treatment of Symptomatic GERD
2 to 16 years
10 to less than 20 kg: 10 mg
Once daily for up to 4 weeks
20 kg and greater: 20 mg
Treatment of EE due to Acid- Mediated GERD
2 to 16 years
10 to less than 20 kg: 10 mg
Once daily for 4 to 8 weeks1
20 kg and greater: 20 mg
Maintenance of Healing of EE due to Acid-Mediated GERD
2 to 16 years
10 to less than 20 kg: 10 mg
Once daily. Controlled studies do not extend beyond 12 months
20 kg and greater: 20 mg
1 The efficacy of omeprazole used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole may be considered.
2.3 Administration Instructions
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Take omeprazole delayed-release capsules before meals.
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Antacids may be used concomitantly with omeprazole delayed-release capsules.
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Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
Omeprazole Delayed-Release Capsules
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Swallow omeprazole delayed-release capsules whole; do not chew.
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For patients unable to swallow an intact capsule, omeprazole delayed-release capsules can be opened and administered as follows:
1.
Place one tablespoon of applesauce into a clean container (e.g., empty bowl). The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2.
Open the capsule.
3.
Carefully empty all of the pellets inside the capsule on the applesauce.
4.
Mix the pellets with the applesauce.
5.
Swallow applesauce and pellets immediately with a glass of cool water to ensure complete swallowing of the pellets. Do not chew or crush the pellets. Do not save the applesauce and pellets for future use.
Indications And Usage Section
1 INDICATIONS AND USAGE
1.1 Treatment of Active Duodenal Ulcer
Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
1.2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple Therapy
Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
Dual Therapy
Omeprazole delayed-release capsules in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. 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 [see Clinical Pharmacology (12.4) and the clarithromycin prescribing information, Microbiology section].
1.3 Treatment of Active Benign Gastric Ulcer
Omeprazole delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
1.4 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 2 years of age and older.
1.5 Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
Pediatric Patients 2 Years of Age to Adults
Omeprazole delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD that has been diagnosed by endoscopy in patients 2 years of age and older.
The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.
1.6 Maintenance of Healing of EE Due to Acid-Mediated GERD
Omeprazole delayed-release capsules are indicated for the maintenance healing of EE due to acid-mediated GERD in patients 2 years of age and older.
Controlled studies do not extend beyond 12 months.
1.7 Pathological Hypersecretory Conditions
Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.
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