Esomeprazole

Esomeprazole is used to treat

• gastroesophageal reflux disease (GERD; a condition where stomach acid flows back into the esophagus (tube between the stomach and throat))
• reduce the chance of ulcers (sores in the lining of the stomach or intestine) in people taking nonsteroidal anti-inflammatory drugs (NSAIDs)
• treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori) in adults.
• conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome
• heartburn

Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Esomeprazole comes as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) capsule and as packets of delayed-release granules for suspension (to be mixed with water) to take by mouth or give through a feeding tube. It is taken once or twice a day. Take esomeprazole at around the same time(s) every day.

Take esomperazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them. If you cannot swallow the capsule, put 1 tablespoon of cool, soft applesauce in an empty bowl. Open one esomeprazole capsule and carefully sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the entire tablespoonful of the applesauce and pellet mixture immediately. Do not crush or chew the pellets in the applesauce. Do not save the pellets and applesauce for later use.

If you are taking the granules for oral suspension, you will need to mix it with water before use. If you are using the 2.5- or 5-mg packet, place 1 teaspoonful (5 mL) of water in a container. If you are using the 10-, 20-, or 40-mg packet, place 1 tablespoonful (15 mL) of water in a container. Add the contents of the powder packet and stir. Wait 2 to 3 minutes to allow the mixture to thicken, and stir the mixture again. Drink the entire mixture within 30 minutes. If any of the mixture is stuck to the container, pour more water into the container, stir and drink all the mixture immediately.

The granules and the contents of the prescription delayed-release capsules can both be given through a feeding tube. If you have a feeding tube, ask your doctor or pharmacist how you should take the medication. Follow those directions carefully.

Do not take nonprescription esomeprazole for immediate relief of heartburn symptoms. It may take 1 to 4 days for you to feel the full benefit of the medication. Call your doctor if your symptoms get worse or do not improve after 14 days or if your symptoms return sooner than 4 months after you finish your treatment. Do not take nonprescription esomeprazole for longer than 14 days or treat yourself with esomeprazole more often than once every 4 months without talking to your doctor.

Continue to take prescription esomeprazole, even if you feel well. Call your doctor if your symptoms worsen or do not improve during this time. Do not stop taking esomeprazole without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking esomeprazole,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with esomeprazole. Other medications may cause dosing changes or extra monitoring when taken with esomeprazole. Make sure you have discussed any medications you are currently taking or plan to take before starting esomeprazole with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking esomeprazole, please get the advice of your doctor or pharmacist.
• you should know that the following nonprescription or herbal products may interact with esomeprazole: iron supplements, St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking esomeprazole. Do not start any of these medications while taking esomeprazole without discussing with your healthcare provider.
• if you plan to take nonprescription esomeprazole, tell your doctor if your heartburn has lasted 3 months or longer, if you have taken it longer than the package says, or if you have experienced any of the following symptoms: lightheadedness, sweating, or dizziness along with your heartburn; chest pain or shoulder pain; shortness of breath or wheezing; pain that spreads to your arms, neck, or shoulders; unexplained weight loss; nausea; vomiting, especially if the vomit is bloody; stomach pain; difficulty swallowing food or pain when you swallow food; or black or bloody stools. You may have a more serious condition that cannot be treated with nonprescription medication.
• tell your doctor if you have or have ever had a low level of magnesium, calcium, or potassium in your blood; hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood]); low levels of vitamin B12 in your body, osteoporosis (a condition in which the bones become thin and weak and break easily); an autoimmune disease (condition in which the body attacks its own organs, causing swelling and loss of function) such as systemic lupus erythematosus; or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking esomeprazole, call your doctor.
• talk to your doctor about the risks and benefits of taking esomeprazole if you are 65 years of age or older. Do not take this medication for a longer period of time than recommended on the product label or by your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Esomeprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea, diarrhea; gas; constipation
• dry mouth
• drowsiness
• in men, difficulty achieving or maintaining an erection

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately, or get emergency medical help:

• blisters, peeling, or bleeding skin; sores on the lips, nose, mouth, or genitals; swollen glands; shortness of breath; fever; or flu-like symptoms
• rash; hives; itching; swelling of the eyes, face, lips, mouth, throat, or tongue; difficulty breathing or swallowing; or hoarseness
• irregular, fast, or pounding heartbeat; muscle spasms; uncontrollable shaking of a part of the body; excessive tiredness; lightheadedness; dizziness; or seizures
• severe diarrhea with watery stools, stomach pain, or fever that does not go away
• new or worsening joint pain; rash on cheeks or arms that is sensitive to sunlight
• increased or decreased urination, blood in urine, fatigue, nausea, loss of appetite, fever, rash, or joint pain

People who take proton pump inhibitors such as esomeprazole may be more likely to fracture their wrists, hips, or spine than people who do not take one of these medications. People who take proton pump inhibitors may also develop fundic gland polyps (a type of growth on the stomach lining). These risks are highest in people who take high doses of one of these medications or take them for one year or longer. Talk to your doctor about the risk of taking esomeprazole.

Esomeprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• confusion
• drowsiness
• blurred vision
• fast heartbeat
• nausea
• sweating
• flushing
• headache
• dry mouth

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking esomeprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Nexium^®
• Nexium^® 24HR

• Vimovo^® (containing Esomeprazole, Naproxen)^¶