In the U.S.—

In Canada—

• Gastric acid pump inhibitor
• antiulcer agent

Lansoprazole (lan-SOE-pra-zole ) is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers and gastroesophageal reflux disease (GERD), a condition in which the acid in the stomach washes back up into the esophagus. Sometimes lansoprazole is used in combination with antibiotics to treat ulcers associated with infection caused by the H. pylori bacteria (germ).

Lansoprazole is also used to treat Zollinger-Ellison disease, a condition in which the stomach produces too much acid.

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

PREVACID is available only with your doctor's prescription.

Oral
• Delayed-release capsules (U.S. and Canada)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to lansoprazole. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies have not been done in humans. However, studies in animals have not shown that lansoprazole causes harm to the fetus.

Breast-feeding—Lansoprazole may pass into the breast milk. Since PREVACID has been shown to cause unwanted effects such as tumors in animals, it may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—There is no specific information comparing the use of lansoprazole in children less than 1 year of age with use in other age groups. It is safe to use this drug to treat heartburn and erosive esophagitis in people between 1 and 17 years of age.

Older adults—In studies done to date that have included older adults, lansoprazole did not cause different side effects or problems than it did in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking lansoprazole, it is especially important that your health care professional know if you are taking any of the following:

• Sucralfate (e.g., Carafate)—Lansoprazole should be taken at least 30 minutes before sucralfate so that lansoprazole will be properly absorbed

Take lansoprazole before a meal, preferably in the morning.

For Delayed-Release Capsules: Swallow the capsule whole. Do not crush, break, or chew the capsule. If you cannot swallow the capsule whole, you may open it and sprinkle the granules contained in the capsule on one tablespoonful of applesauce and swallow it immediately; or you may mix the granules in some fruit or vegetable juice and drink it immediately. Juices you may use include apple, cranberry, grape, orange, pineapple, prune, tomato, and V-8 vegetable juice. Do not chew or crush the granules.

For Delayed-Release Oral Suspension: Empty the packet contents into a container containing 2 tablespoons of water. Stir well and drink immediately. If any of the content remains after drinking, add more water and drink immediately. If you have enteral administration tubes, do not take PREVACID through them.

For Delayed-Release Orally Disintegrating Tablets: Do not chew. Place on tongue and allow to disintegrate, with or without water, until particles can be swallowed

• If you are using PREVACID with an Oral Syringe:
  • Place a 15 mg tablet in oral syringe and fill with 4 mL of water, or place a 30 mg tablet in oral syringe and fill with 10 mL of water
  • Shake gently
  • After medicine mixes completely with the water, take the mixture within 15 minutes
  • Refill the syringe with 2 mL (5 mL for the 30 mg tablet) of water, shake gently and take any remaining contents
• If you are using PREVACID with a Nasogastric Tube:
  • Place a 15 mg tablet in oral syringe and fill with 4 mL of water, or place a 30 mg tablet in oral syringe and fill with 10 mL of water
  • Shake gently
  • After tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes
  • Refill the syringe with approximately 5 mL of water, shake gently and administer any remaining contents

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

Dosing—

The dose of lansoprazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lansoprazole. If your dose is different, do not change it unless your doctor tells you to do so.

The number of doses you take each day and the length of time you take the medicine depend on the medical problem for which you are taking lansoprazole.

• For oral dosage form (delayed-release capsule):
  • To treat gastroesophageal reflux disease (GERD):
    • Adults—15 to 30 mg once a day, preferably taken in the morning before a meal.
    • Children less than 1 year of age— Use and dose must be determined by your doctor
    • Children 1 to 18 years of age—15 to 30 mg once daily for 8 to 12 weeks
  • To treat duodenal ulcers:
    • Adults—At first, 15 milligrams (mg) once a day, preferably taken in the morning before a meal. Your doctor may increase your dose if needed.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.
  • To treat duodenal ulcers related to infection with H. pylori:
    • Adults—30 mg plus amoxicillin 1000 mg (1 gram) plus clarithromycin 500 mg, taken together before meals twice a day for ten to fourteen days. Alternatively, your doctor may want you to take lansoprazole 30 mg plus amoxicillin 1000 mg (1 gram) before meals three times a day for fourteen days.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.
  • To treat gastric ulcers:
    • Adults—15 to 30 mg once a day, preferably taken in the morning before a meal.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.
  • To treat conditions in which the stomach produces too much acid:
    • Adults—At first, 60 mg once a day, preferably taken in the morning before a meal. Your doctor may increase your dose if needed.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of PREVACID, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store PREVACID:

• 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 other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.