PRILOSEC Omeprazole magnesium

Get an overview of PRILOSEC (omeprazole magnesium granule, delayed release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in PRILOSEC can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as PRILOSEC.

Drug Basics

Brand Name: PRILOSEC

Generic Name: OMEPRAZOLE MAGNESIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: GRANULE, DELAYED RELEASE

Data Current As Of: 2018-10-05

indications & usage

treatment of active duodenal ulcer

PRILOSEC is 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.

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

PRILOSEC 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

PRILOSEC in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.

Among patients who fail therapy, PRILOSEC 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].

treatment of active benign gastric ulcer

PRILOSEC is indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.

treatment of symptomatic gastroesophageal reflux disease (gerd)

PRILOSEC is indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 1 year of age and older.

treatment of erosive esophagitis (ee) due to acid-mediated gerd

Pediatric Patients 1 Year of Age to Adults

PRILOSEC is 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 1 year of age and older.

The efficacy of PRILOSEC 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 PRILOSEC may be considered.

Pediatric Patients 1 Month to Less than 1 Year of Age

PRILOSEC is indicated for the short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.

maintenance of healing of ee due to acid-mediated gerd

PRILOSEC is indicated for the maintenance healing of EE due to acid-mediated GERD in patients 1 year of age and older.

Controlled studies do not extend beyond 12 months.

pathological hypersecretory conditions

PRILOSEC is indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Adverse Reactions

Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

Drug Interactions

Advise patients to report to their healthcare provider if they start treatment with clopidogrel, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Warnings and Precautions (5.6, 5.9, 5.11)].

Administration

  •  
    • Take PRILOSEC before meals.
    • Antacids may be used concomitantly with PRILOSEC.
    • 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.

PRILOSEC Delayed-Release Capsules

  •  
    • Swallow PRILOSEC delayed-release capsules whole; do not chew.
    • For patients unable to swallow an intact capsule, PRILOSEC delayed-release capsules can be opened and administered in applesauce, as described in the Medication Guide.

PRILOSEC For Delayed-Release Oral Suspension

  •  
    • PRILOSEC for delayed-release oral suspension is intended to be prepared in water and administered orally or via a nasogastric (NG) or gastric tube, as described in the Medication Guide.

PRILOSEC is a trademark of the AstraZeneca group of companies.

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

©AstraZeneca 2016

medication guide

PRILOSEC® (pry-lo-sec)

(omeprazole)

delayed-release capsules

PRILOSEC® (pry-lo-sec)

(omeprazole magnesium)

for delayed-release oral suspension

Read this Medication Guide before you start taking PRILOSEC 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 PRILOSEC?

PRILOSEC may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

PRILOSEC can cause serious side effects, including:

  • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PRILOSEC, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PRILOSEC. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • Diarrhea. PRILOSEC 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.
  • 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 PRILOSEC 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 PRILOSEC.
  • 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 PRILOSEC, 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.

PRILOSEC can have other serious side effects. See “What are the possible side effects of PRILOSEC?”

What is PRILOSEC?

PRILOSEC is a prescription medicine called a proton pump inhibitor (PPI). PRILOSEC reduces the amount of acid in your stomach.

PRILOSEC is used in adults:

  • 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.
  • 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 PRILOSEC 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.
  • for up to 8 weeks for healing stomach ulcers.
  • 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.
  • 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 PRILOSEC.
  • to maintain healing of the esophagus. It is not known if PRILOSEC is safe and effective when used for longer than 12 months (1 year) for this purpose.
  • 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 1 to 16 years of age, PRILOSEC is used:

  • for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
  • 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].
  • to maintain healing of the esophagus. It is not known if PRILOSEC is safe and effective when used longer than 12 months (1 year) for this purpose.

For children 1 month to less than 12 months (1 year) of age, PRILOSEC is used:

  • for up to 6 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]. It is not known if PRILOSEC is safe and effective for other uses in children 1 month to less than 12 months (1 year) of age, or in children less than 1 month of age.

Who should not take PRILOSEC?

Do not take PRILOSEC if you:

  • are allergic to omeprazole or any of the ingredients in PRILOSEC. See the end of this Medication Guide for a complete list of ingredients in PRILOSEC.
  • are allergic to any other proton pump inhibitor (PPI) medicine.
  • 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 PRILOSEC?

Before taking PRILOSEC, tell your doctor about all of your medical conditions, including if you:

  • have been told that you have low magnesium levels in your blood
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if PRILOSEC will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. PRILOSEC passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take PRILOSEC.
  • Tell your doctor about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. PRILOSEC may affect how other medicines work, and other medicines may affect how PRILOSEC 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 PRILOSEC?

  • Take PRILOSEC exactly as prescribed by your doctor.
  • Do not change your dose or stop PRILOSEC without talking to your doctor.
  • PRILOSEC is usually taken 1 time each day. Your doctor will tell you the time of day to take PRILOSEC, based on your medical condition.
  • Take PRILOSEC before a meal.
  • Antacids may be taken with PRILOSEC.

PRILOSEC Delayed-Release Capsules

  • Swallow PRILOSEC Capsules whole. Do not chew or crush PRILOSEC Capsules.
  • 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 PRILOSEC Capsules with applesauce.

PRILOSEC For Delayed-Release Oral Suspension

  • PRILOSEC Suspension is mixed with water and can be taken by mouth, or given through a nasogastric tube (NG tube) or gastric tube.
  • See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take PRILOSEC Suspension, and how to mix and give PRILOSEC Suspension through a nasogastric tube or gastric tube.

If you miss a dose of PRILOSEC, 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 PRILOSEC, 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 PRILOSEC?

PRILOSEC can cause serious side effects, including:

  • See “What is the most important information I should know about PRILOSEC?”
  • Vitamin B-12 deficiency. PRILOSEC reduces 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 PRILOSEC 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 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:

  • jitteriness
  • jerking movements or shaking (tremors)
  • abnormal or fast heart beat
  • spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking PRILOSEC or during treatment if you will be taking PRILOSEC for a long period of time.

The most common side effects with PRILOSEC in adults and children include:

  • stomach pain
  • diarrhea
  • gas

In addition to the side effects listed above, the most common side effects in children 1 to 16 years of age include:

  • respiratory system events
  • fever

Other side effects:

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with PRILOSEC:

  • rash
  • throat tightness
  • difficulty breathing

Your doctor may stop PRILOSEC 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 PRILOSEC. 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 PRILOSEC?

  • Store PRILOSEC Delayed-Release Capsules at room temperature between 59°F to 86°F (15°C to 30°C).
  • Store PRILOSEC For Delayed-Release Oral Suspension at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep the container of PRILOSEC Delayed-Release Capsules closed tightly.
  • Keep the container of PRILOSEC Delayed-Release Capsules dry and away from light.

Keep PRILOSEC and all medicines out of the reach of children.

General information about the safe and effective use of PRILOSEC.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PRILOSEC for a condition for which it was not prescribed. Do not give PRILOSEC 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 PRILOSEC. 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 PRILOSEC?

Active ingredient in PRILOSEC Delayed-Release Capsules: omeprazole

Inactive ingredients in PRILOSEC Delayed-Release Capsules: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose, lactose, mannitol, sodium lauryl sulfate. Capsule shells: gelatin-NF, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD&C Blue #2, D&C Red #7 Calcium Lake, and, in addition, the 10 mg and 40 mg capsule shells also contain D&C Yellow #10.

Active ingredient in PRILOSEC For Delayed-Release Oral Suspension: omeprazole magnesium

Inactive ingredients in PRILOSEC For Delayed-Release Oral Suspension: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer C, polysorbate, sugar spheres, talc, and triethyl citrate.

Inactive granules in PRILOSEC For Delayed-Release Oral Suspension: citric acid, crospovidone, dextrose, hydroxypropyl cellulose, iron oxide and xanthan gum.

Manufactured by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

PRILOSEC is a trademark of the AstraZeneca group of companies. ©2016 AstraZeneca Pharmaceuticals LP. All rights reserved.

For more information, go to www.astrazeneca-us.com or call 1-800-236-9933.

  •  This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: DATE 10/2016

INSTRUCTIONS FOR USE

PRILOSEC ® (pry-lo-sec)

(omeprazole)

delayed-release capsules

PRILOSEC ® (pry-lo-sec)

(omeprazole magnesium)

for delayed-release oral suspension

PRILOSEC delayed-release capsules (PRILOSEC Capsules)

Taking PRILOSEC Capsules with applesauce:

  • 1.Place 1 tablespoon of applesauce into a clean container.
  • 2.Carefully open the capsule and sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce.
  • 3.Swallow the applesauce and pellet mixture right away. Do not chew or crush the pellets. Do not store the applesauce and pellet mixture for later use.

PRILOSEC for delayed-release suspension (PRILOSEC Suspension)

Taking PRILOSEC Suspension:

  • 1.PRILOSEC Suspension comes in packets containing 2.5 mg and 10 mg of PRILOSEC.
  • 2.Use an oral syringe to draw up the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe.
  • 3.If your dose of PRILOSEC is 2.5 mg, add 5 mL of water to a clean container. Empty the contents of the 2.5 mg packet into the container of water.
  • 4.If your dose of PRILOSEC is 10 mg, add 15 mL of water to a clean container. Empty the contents of the 10 mg packet into the container of water.
  • 5.If you or your child are instructed to use more than 1 packet for your dose of PRILOSEC, follow the mixing instructions provided by your pharmacist or doctor.
  • 6.Stir.
  • 7.Leave it for 2 to 3 minutes to thicken.
  • 8.Stir and drink within 30 minutes. If not used within 30 minutes, throw away this dose and mix a new dose.
  • 9.If any medicine remains after drinking, add more water, stir, and drink right away.

Giving PRILOSEC Suspension with water through a nasogastric tube (NG tube) or gastric tube:

For people who have an NG tube or gastric tube that is size 6 or larger, PRILOSEC may be given as follows:

  • 1.PRILOSEC Suspension comes in packets containing 2.5 mg and 10 mg of PRILOSEC.
  • 2.Use only a catheter tipped syringe to give PRILOSEC through a NG tube or gastric tube that is size 6 or larger.
  • 3.If your dose of PRILOSEC is 2.5 mg, add 5 mL of water to a catheter tipped syringe. Add the contents of the 2.5 mg packet to the syringe.
  • 4.If your dose of PRILOSEC is 10 mg, add 15 mL of water to a catheter tipped syringe. Add the contents of the 10 mg packet to the syringe.
  • 5.Shake the syringe right away and then leave it for 2 to 3 minutes to thicken.
  • 6.Shake the syringe and inject through the NG tube or gastric tube into the stomach within 30 minutes.
  • 7.Refill the syringe with the same amount of water you used to prepare your dose of PRILOSEC (5 mL or 15 mL of water depending on your dose).
  • 8.Shake the syringe and flush any remaining medicine from the NG tube or gastric tube into the stomach.

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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