Prilosec

DRUG DESCRIPTION

The active ingredient in PRILOSEC (omeprazole) Delayed-Release Capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is:

Omeprazole Structural Formula Illustration

Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.

The active ingredient in PRILOSEC (omeprazole magnesium) for Delayed Release Oral Suspension, is 5-Methoxy-2-[[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, magnesium salt (2:1)

Omeprazole magnesium is a white to off white powder with a melting point with degradation at 200C. The salt is slightly soluble (0.25 mg/mL) in water at 25C, and it is soluble in methanol. The half-life is highly pH dependent.

The empirical formula for omeprazole magnesium is (C17H18N3O3S)2 Mg, the molecular weight is 713.12 and the structural formula is:

PRILOSEC (omeprazole) is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose, lactose, mannitol, sodium lauryl sulfate and other ingredients. The capsule shells have the following inactive ingredients: 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.

Each packet of PRILOSEC (omeprazole) For Delayed-Release Oral Suspension contains either 2.8 mg or 11.2 mg of omeprazole magnesium (equivalent to 2.5 mg or 10 mg of omeprazole), in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer C, polysorbate, sugar spheres, talc, and triethyl citrate, and also inactive granules. The inactive granules are composed of the following ingredients: citric acid, crospovidone, dextrose, hydroxypropyl cellulose, iron oxide and xantham gum. The omeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric or direct gastric administration.

What are the possible side effects of omeprazole (Prilosec, Prilosec OTC)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

  • stomach pain, gas;
  • nausea, vomiting, diarrhea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088....

Read All Potential Side Effects and See Pictures of Prilosec

What are the precautions when taking omeprazole (Prilosec)?

Before taking omeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, pantoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss.

In addition, before you...

Read All Potential Precautions of Prilosec


Prilosec Consumer (continued)

SIDE EFFECTS: Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this product, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking omeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, pantoprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn with lightheadedness/sweating/dizziness, chest pain or shoulder pain (especially with trouble breathing, sweating, lightheadedness, pain spreading to arms/jaw/neck/shoulders), unexplained weight loss.

In addition, before you self-treat with this medication, tell your doctor if you have any of these signs of a serious condition: trouble/pain swallowing food, bloody vomit, vomit that looks like coffee grounds, bloody/black stools, heartburn for over 3 months, frequent chest pain, frequent wheezing (especially with heartburn), nausea/vomiting, stomach pain.

Proton pump inhibitors (such as omeprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. The effects on a nursing infant are unknown. Consult your doctor before breast-feeding.


Prilosec Patient Information Including Side Effects

Brand Names: Prilosec, Prilosec OTC

Generic Name: omeprazole (Pronunciation: oh MEP ra zol)

  • What is omeprazole (Prilosec)?
  • What are the possible side effects of omeprazole (Prilosec)?
  • What is the most important information I should know about omeprazole (Prilosec)?
  • What should I discuss with my healthcare provider before taking omeprazole (Prilosec)?
  • How should I take omeprazole (Prilosec)?
  • What happens if I miss a dose (Prilosec)?
  • What happens if I overdose (Prilosec)?
  • What should I avoid while taking omeprazole (Prilosec)?
  • What other drugs will affect omeprazole (Prilosec)?
  • Where can I get more information?

What is omeprazole (Prilosec)?

Omeprazole decreases the amount of acid produced in the stomach.

Omeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions caused by excess stomach acid. Omeprazole is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).

Omeprazole may also be given together with antibiotics to treat gastric ulcer caused by infection with helicobacter pylori (H. pylori).

Omeprazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of omeprazole (Prilosec)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

  • stomach pain, gas;
  • nausea, vomiting, diarrhea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about omeprazole (Prilosec)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, dizziness, pain spreading to the arm or shoulder, sweating, nausea or vomiting, and a general ill feeling.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have heart disease or liver disease. You may need a dose adjustment or special tests to safely take this medication.

Omeprazole is not for immediate relief of heartburn symptoms.

Some conditions are treated with a combination of omeprazole and antibiotics. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the condition is completely treated.

Prilosec OTC (over-the-counter) should be taken only once every 24 hours for 14 days. It may take up to 4 days for full effect. Do not take more than one tablet every 24 hours.

Allow at least 4 months to pass before you start another 14-day treatment with Prilosec OTC. Call your doctor if you have additional symptoms and need treatment before the 4 months has passed.

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