esomeprazole, Nexium

GENERIC NAME: esomeprazole

BRAND NAME: Nexium

DRUG CLASS AND MECHANISM: Esomeprazole is in a class of drugs called proton pump inhibitors (PPIs) which block the production of acid by the stomach. Other drugs in the same class include omeprazole (Prilosec),lansoprazole (Prevacid), rabeprazole (Aciphex) and pantoprazole (Protonix). Chemically, esomeprazole is very similar to omeprazole. Proton pump inhibitors are used for the treatment of conditions such as stomach and duodenal ulcers, gastroesophageal reflux disease (GERD) and the Zollinger-Ellison syndrome which all are caused by stomach acid. Esomeprazole, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal. Esomeprazole was approved by the FDA in February 2001. GENERIC: No PRESCRIPTION: Yes PREPARATIONS: Capsules: 20 and 40 mg. Intravenous: 20 and 40 mg; Powder for Oral Suspension: 10 mg, 20 mg, 40 mg STORAGE: Store at room temperature, 15-30 C (59-86 F) in a tightly closed container. PRESCRIBED FOR: Esomeprazole is approved for the treatment of gastroesophageal reflux disease (GERD) and in combination with amoxicillinand clarithromycin (Biaxin) for the treatment of patients with ulcers and H. pylori infection. It also is used for reducing the risk of gastric ulcersassociated with NSAIDs and the treatment of Zollinger-Ellison syndrome. Esomeprazole also is approved for short term use in children ages 1-11 for GERD.

GENERIC NAME: esomeprazole

BRAND NAME: Nexium

DRUG CLASS AND MECHANISM: Esomeprazole is in a class of drugs called proton pump inhibitors (PPIs) which block the production of acid by the stomach. Other drugs in the same class include omeprazole (Prilosec),lansoprazole (Prevacid), rabeprazole (Aciphex) and pantoprazole (Protonix). Chemically, esomeprazole is very similar to omeprazole. Proton pump inhibitors are used for the treatment of conditions such as stomach and duodenal ulcers, gastroesophageal reflux disease (GERD) and the Zollinger-Ellison syndrome which all are caused by stomach acid. Esomeprazole, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal. Esomeprazole was approved by the FDA in February 2001. GENERIC: No PRESCRIPTION: Yes

PREPARATIONS: Capsules: 20 and 40 mg. Intravenous: 20 and 40 mg; Powder for Oral Suspension: 10 mg, 20 mg, 40 mg STORAGE: Store at room temperature, 15-30 C (59-86 F) in a tightly closed container. PRESCRIBED FOR: Esomeprazole is approved for the treatment of gastroesophageal reflux disease (GERD) and in combination with amoxicillinand clarithromycin (Biaxin) for the treatment of patients with ulcers and H. pylori infection. It also is used for reducing the risk of gastric ulcersassociated with NSAIDs and the treatment of Zollinger-Ellison syndrome. Esomeprazole also is approved for short term use in children ages 1-11 for GERD.

esomeprazole, Nexium (cont.)

Pharmacy Author: Omudhome Ogbru, PharmD Medical and Pharmacy Editor: Jay W. Marks, MD

Through unknown mechanisms, esomeprazole may increase blood levels ofsaquinavir (Invirase, Fortovase) and reduce blood levels of nelfinavir(Viracept) and atazanavir (Reyataz), Therefore, nelfinavir or atazanavir should not be administered with esomeprazole, and physicians should consider reducing the dose of saquinavir in order to avoid side effects from saquinavir. Clopidogrel (Plavix) is converted to its active form by enzymes in the liver. Esomeprazole reduces the activity of these enzymes and potentially can reduce the activity of clopidogrel. Esomeprazole should not be used with clopidogrel. Esomeprazole increases the concentration of cilostazol (Pletal) and its metabolites. The dose of cilostazol should be reduced from 100 mg twice daily to 50 mg twice daily when given with esomeprazole. PREGNANCY: Use of esomeprazole in pregnant women has not been adequately evaluated. NURSING MOTHERS: Esomeprazole has not been adequately studied innursing women. SIDE EFFECTS: Esomeprazole, like other PPIs, is well-tolerated. The most common side effects are diarrhea, nausea, vomiting, headaches, rash anddizziness. Nervousness, abnormal heartbeat, muscle pain, weakness, leg cramps, and water retention occur infrequently. High doses and long-term use (1 year or longer) may increase the risk ofosteoporosis-related fractures of the hip, wrist, or spine. Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated. USES: Esomeprazole is used to treat stomach and throat (esophagus) problems caused by too much stomach acid (e.g., acid reflux or GERD, erosive esophagitis, Zollinger-Ellison syndrome). It works by blocking acid production in the stomach. Decreasing extra stomach acid can help relieve symptoms such as heartburn, difficulty swallowing, persistent cough, and trouble sleeping. It can also prevent conditions caused by serious acid damage to your digestive system (e.g.,

ulcers, cancer of the esophagus).Esomeprazole may also be used to prevent ulcers caused by the long-term use of certain drugs for pain or swelling (nonsteroidal anti-inflammatory drugs-NSAIDs). In addition, this medication may be used with antibiotics to treat certain types of ulcers caused by bacterial infection. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using esomeprazole and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth at least 1 hour before a meal, usually once daily or as directed by your doctor. This medication may also be given through a tube into the stomach (nasogastric or gastric tube).If you are taking this medication by mouth, empty the contents of the medication packet into a container with 1 tablespoon (half an ounce or 15 milliliters) of water. Stir the mixture well and leave it for 2 to 3 minutes to thicken. Stir again and drink all of the mixture within 30 minutes. If any medication remains in the container, add more water, stir, and drink immediately to make sure you take the entire dose. Do not crush or chew the medication granules. Doing so may destroy the drug and/or increase side effects.If you are giving this medication through a nasogastric or gastric tube, consult your health care professional for detailed instructions on how to properly mix and give it.If needed, antacids may be taken along with this medication.The dosage and length of treatment is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the full prescribed time, even if you are feeling better.Tell your doctor if your condition persists or worsens. SIDE EFFECTS: Headache, diarrhea, nausea, gas, stomach pain,constipation, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because 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 immediately if any of these unlikely but serious side effects occur: signs of a lung infection called pneumonia (e.g., fever, cough, trouble breathing).Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, persistent nausea, vomiting, unusual tiredness, dark urine, yellowing eyes/skin, signs of vitamin B12 deficiency in people taking this medication for longer than 3 years (e.g., unusual weakness, sore tongue, numbness or tingling of the hands/feet).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 esomeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., lansoprazole, omeprazole); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, other stomach problems (e.g., tumors).Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn combined with lightheadedness/sweating/dizziness, chest pain or shoulder/jaw pain (especially with trouble

breathing), pain spreading to arms/neck/shoulders, unexplained weight loss.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Based on information for similar drugs, this medication may pass into breast milk. Breastfeeding while using this drug is not recommended. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious interactions may occur: atazanavir,nelfinavir.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting esomeprazole.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cilostazol,warfarin, HIV drugs (such as saquinavir).Some products need stomach acid so that the body can absorb them properly (such as ampicillin, iron supplements, calcium supplements, dasatinib, azole antifungals includingketoconazole). Esomeprazole decreases stomach acid, so it may change how well these other products work. Before using esomeprazole, consult your doctor or pharmacist about the other medications you take and for advice on how to reduce or avoid these types of interactions.Based on information for similar drugs, esomeprazole may increase the amount ofdigoxin that is absorbed into your blood. If you take digoxin, consult your doctor or pharmacist for details.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, extreme sweating, blurred vision, unusually fast heartbeat. NOTES: Do not share this medication with others.Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.