OMEPRAZOLE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Prilosec
• Zegerid

In Canada?

• Losec

Category

• Gastric acid pump inhibitor
• antiulcer agent

Description

Omeprazole (o-MEP-ra-zole) is used to treat certain conditions in which there istoo much acid in the stomach. It is used to treat gastric and duodenal ulcersand gastroesophageal reflux disease, a condition in which the acid in thestomach washes back up into the esophagus. Sometimes omeprazole is used incombination with antibiotics to treat ulcers associated with infection causedby the H. pylori bacteria (germ).

Omeprazole is also used to treat Zollinger-Ellison disease, a conditionin which the stomach produces too much acid.

Omeprazole is also used to treat dyspepsia, a condition that causes sourstomach, belching, heart burn, or indigestion.

In addition, omeprazole is used to prevent upper gastrointestinal tractbleeding in seriously ill patients.

Omeprazole works by decreasing the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

Oral
• Delayed-release capsules (U.S.)
• Powder for oral suspension (U.S.)
• Delayed-release tablets (Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For omeprazole, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to omeprazole. Also tell your health care professional ifyou are allergic to any other substances, such as foods, preservatives, ordyes.

Pregnancy?Studies have not been done in humans. However, studiesin animals have shown that omeprazole may cause harm to the fetus. Beforetaking this medicine, make sure your doctor knows if you are pregnant or ifyou may become pregnant.

Breast-feeding?Omeprazole passes into human breast milk and thismedicine has been shown to cause unwanted effects, such as tumors and cancer,in animals. It may be necessary for you to take another medicine or to stopbreast-feeding during treatment. Be sure you have discussed the risks andbenefits of the medicine with your doctor.

Children?There is no specific information comparing the useof omeprazole in children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof omeprazole in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingomeprazole, it is especially important that your health care professionalknow if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Diazepam (e.g., Valium) or
• Phenytoin (e.g., Dilantin)
• Warfarin (e.g., Coumadin)?Use with omeprazole may cause highblood levels of these medicines, which may increase the chance of side effects

Other medical problems?The presence of other medicalproblems may affect the use of omeprazole. Make sure you tell your doctorif you have any other medical problems, especially:

• Liver disease or a history of liver disease?This conditionmay cause omeprazole to build up in the body

Proper Use of This Medicine

Take omeprazole capsules immediately before a meal, preferablyin the morning. Omeprazole tablets may be takenwith food or on an empty stomach. Take omeprazole powderfor oral suspension on an empty stomach at least 1 hour before a meal.For patients receiving continuous feeding through a tube, feeding should betemporarily stopped about 3 hours before and 1 hour after administration ofomeprazole powder for oral suspension.

It may take several days before this medicine begins to relieve stomachpain. To help relieve this pain, antacids may be taken with omeprazole, unlessyour doctor has told you not to use them.

Swallow the capsule and tablet forms of omeprazole whole. Do not open the capsule. Do not crush,break, or chew the capsule or the tablet.

To use the powder for oral suspension:

• Empty packet of powder into a small cup containing 2 tablespoonsof water
• Do not use other liquids or foods
• Stir well and drink immediately
• Refill cup with water and drink

Take this medicine for the full time of treatment,even if you begin to feel better. Also, keep your appointments withyour doctor for check-ups so that your doctor will be better able to tellyou when to stop taking this medicine.

Dosing?The dose of omeprazole will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of omeprazole. If your dose is different,do not change it unless your doctor tells you to do so.

• For oral dosage forms (capsules, tablets):
  • To treat dyspepsia:
    • Adults?20 milligrams (mg) taken once a day for four weeks. Patients may respond adequately to 10 mg once daily, so individual dose adjustmentmay be considered.
    • Children?Use and dose must be determined by your doctor.
  • To treat gastroesophageal reflux disease (GERD):
    • Adults?20 milligrams (mg) taken once a day for four to eightweeks. Or your doctor may tell you to take 40 mg a day for certain conditions.Also, your doctor may want you to take omeprazole for more than eight weeksfor certain conditions.
    • Children?Use and dose must be determined by your doctor.
  • To treat conditions in which the stomach produces too much acid:
    • Adults?60 mg taken once a day. Your doctor may change the doseas needed. Your treatment may be continued for as long as it is needed.
    • Children?Use and dose must be determined by your doctor.
  • To treat duodenal ulcers:
    • Adults?20 mg taken once a day. Or your doctor may tell youto take 40 mg a day for certain conditions.
    • Children?Use and dose must be determined by your doctor.
  • To treat gastric ulcers:
    • Adults?40 mg taken once a day for four to eight weeks.
    • Children?Use and dose must be determined by your doctor.
  • To treat ulcers related to infection with H. pylori:
    • Adults?40 mg once a day, taken along with clarithromycin 500mg three times a day, for the first fourteen days. For days 15 through 28,omeprazole 20 mg taken once a day.
    • Children?Use and dose must be determined by your doctor.

• For oral dosage form (powder for suspension):
  • To prevent upper gastrointestinal tract bleeding in seriously illpatients:
    • Adults?The first day: 40 milligrams (mg) for the first dose;then after 6 to 8 hours, a second 40 mg dose. After the first day: 40 mg oncea day for up to 14 days.
    • Children?Use and dose must be determined by your doctor.
  • To treat duodenal ulcer:
    • Adults?20 milligrams (mg) taken once a day for four to eightweeks.
    • Children?Use and dose must be determined by your doctor.
  • To treat gastric ulcers:
    • Adults?40 mg taken once a day for four to eight weeks.
    • Children?Use and dose must be determined by your doctor.
  • To treat gastroesophageal reflux disease (GERD) for erosive esophagitis:
    • Adults?20 mg taken once a day for four to eight weeks.
    • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regularvisits. If your condition does not improve, or if it becomes worse,check with your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

Rare

Back, leg, or stomach pain; bleedingor crusting sores on lips; blisters; bloody or cloudy urine; chills; continuing ulcers or sores in mouth; difficult, burning, or painful urination; fever; frequent urge to urinate; general feelingof discomfort or illness; joint pain; loss of appetite; muscle aches or cramps; pain; red or irritatedeyes; redness, tenderness, itching, burning, or peelingof skin; skin rash or itching; sore throat ; sores, ulcers, or white spots on lips,in mouth, or on genitals; unusual bleeding or bruising; unusual tiredness or weakness

Symptoms of overdose

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Abdominal or stomach pain

Less common

Back pain; body aches or pain; chest pain; constipation; cough; diarrhea or loose stools; difficulty in breathing; dizziness; ear congestion; gas; headache; heartburn; lossof voice; muscle pain; nasal congestion; nausea and vomiting; runny nose; skin rash or itching; sneezing; unusual drowsiness; unusual tiredness

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.