Prilosec

GENERIC NAME: OMEPRAZOLE (o-MEP-ra-zole)

COMMON USES: This medicine is a proton pump inhibitor (PPI) used to treat ulcers, heartburn, gastroesophageal reflux, or Zollinger-Ellison syndrome. It works by blocking acid production in the stomach. This medicine may be used in combination with antibiotics (e.g., amoxicillin, clarithromycin) to treat certain types of ulcers. It may also be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. SWALLOW WHOLE. DO NOT chew, crush, or open the capsule. If you have difficulty swallowing this medicine whole, the capsule may be opened and the contents sprinkled onto cool applesauce and taken as directed. Do not chew the food/medicine mixture or make-up a supply in advance. Doing so may destroy the drug and/or increase side effects. After taking the drug/applesauce mixture, drink a glass of cool water to ensure complete swallowing of the medicine. Take this medicine by mouth at least 1 hour before a meal, unless otherwise directed by your doctor. This medicine may be taken with antacids if your doctor has instructed you to take antacids. Use this medicine regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container, away from heat, light, and moisture. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TAKING THIS MEDICINE even if you feel better. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or use this medicine for longer than prescribed without checking with your doctor. DO NOT STOP USING THIS MEDICINE without first checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure laboratory personnel and your doctors know you use this medicine. This medicine may cause drowsiness or dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. CONTACT YOUR DOCTOR IF YOU HAVE ANY SYMPTOMS OF A BLEEDING ULCER, such as black, tarry stools or vomit that looks like coffee grounds, or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing. THIS MEDICINE MAY INCREASE THE RISK of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use this medicine in high doses, for longer than a year, or if you are older than 50 years old. Contact your doctor if you have any questions about this information. LOW BLOOD MAGNESIUM LEVELS HAVE BEEN REPORTED RARELY in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking this medicine for a long time or if you take certain other medicines (eg, digoxin, diuretics such as furosemide or hydrochlorothiazide), your doctor will perform lab test to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures). BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN ASIAN PATIENTS because the risk of side effects may be increased in these patients. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while using this medicine include diarrhea, dizziness, gas, headache, nausea, stomach pain, or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bone pain; chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; severe diarrhea; severe stomach pain or cramps; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual tiredness; vision changes; or yellowing of the eyes or skin. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking dasatinib, certain HIV protease inhibitors (eg, atazanavir, nelfinavir), rifampin, or St. John's wort. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking ampicillins, anticoagulants (eg, warfarin), azole antifungals (eg, ketoconazole, voriconazole), benzodiazepines (eg, diazepam), cilostazol, clopidogrel, cyclosporine, digoxin, disulfiram, diuretics (eg, furosemide, hydrochlorothiazide), ginkgo biloba, HIV protease inhibitors (eg, saquinavir), iron, mycophenolate, phenytoin, tacrolimus, or tyrosine kinase inhibitors (eg, dasatinib, erlotinib). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including liver problems, stomach or bowel cancer, low blood magnesium levels, allergies, pregnancy, or breast-feeding. Tell your doctor if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition). Contact your doctor or pharmacist if you have any questions about taking this medicine.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include confusion, drowsiness, flushing, nausea, vomiting, severe headache, unusual sweating, blurred vision, or unusually fast heartbeat.

ADDITIONAL INFORMATION: If you are taking this medicine for gastric ulcers or reflux disease, your symptoms should improve within 4 to 8 weeks. If your symptoms do not improve or if they become worse, contact your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.