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USP DI Vol. II - LANSOPRAZOLE (Systemic)

LANSOPRAZOLE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Prevacid
  • Prevacid I.V.

In Canada?

  • Prevacid

Category

  • Gastric acid pump inhibitor
  • antiulcer agent

Description

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

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

Lansoprazole 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. and Canada)
  • Delayed-release oral suspension (U.S.)
  • Delayed-release orally disintegrating tablets (U.S.)
    Parenteral
  • Injection (U.S.)


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 lansoprazole, thefollowing should be considered:

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

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

Breast-feeding?Lansoprazole may pass into the breast milk. Sincethis medicine 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-feedingduring treatment. Be sure you have discussed the risks and benefits of themedicine with your doctor.

Children?There is no specific information comparing the useof oral lansoprazole in children less than 1 year of age with use in otherage groups. It is safe to use oral lansoprazole to treat heartburn and erosiveesophagitis in people between 1 and 17 years of age.

Studies on lansoprazole for injection have been done only in adult patients,and there is no specific information comparing use of lansoprazole for injectionin children with use in other age groups.

Older adults?In studies done to date that have included olderadults, lansoprazole did not cause different side effects or problems thanit did in younger adults.

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 takinglansoprazole, it is especially important that your health care professionalknow if you are taking any of the following:

  • Sucralfate (e.g., Carafate)?Oral lansoprazole shouldbe taken at least 30 minutes before sucralfate so that lansoprazole will beproperly absorbed
  • Warfarin (e.g., Coumadin)?May increase your chance of bleedingside effects. Your doctor may test your blood after you start lansoprazoleand after you stop lansoprazole.

Proper Use of This Medicine

Take oral 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 thecapsule whole, you may open it and sprinkle the granules contained in thecapsule on one tablespoonful of applesauce and swallow it immediately; oryou 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 crushthe granules.

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

For Delayed-Release Orally Disintegrating Tablets: Do not chew. Place on tongue and allow to disintegrate, with or withoutwater, until particles can be swallowed

  • If you are using this medicine 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 mixturewithin 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 this medicine 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 intothe stomach within 15 minutes
    • Refill the syringe with approximately 5 mL of water, shake gentlyand administer any remaining contents

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 lansoprazole will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe 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 lengthof time you take the medicine depend on the medical problem for which youare taking lansoprazole.

  • For oral dosage form (delayed-releasecapsule, delayed-release oral suspension, or delayed-release orally disintegratingtablet):
    • To treat gastroesophageal reflux disease (GERD):
      • Adults?15 to 30 mg once a day, preferably taken in the morningbefore a meal.
      • Children less than 1 year of age? Use and dose must be determinedby your doctor
      • Children 1 to 18 years of age?15 to 30 mg once daily for 8to 12 weeks
    • To treat duodenal ulcers:
      • Adults?At first, 15 milligrams (mg) once a day, preferablytaken in the morning before a meal. Your doctor may increase your dose ifneeded.
      • Children up to 18 years of age?Use and dose must be determinedby your doctor.
    • To treat duodenal ulcers related to infection with H.pylori:
      • Adults?30 mg plus amoxicillin 1000 mg (1 gram) plus clarithromycin500 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 amoxicillin1000 mg (1 gram) before meals three times a day for fourteen days.
      • Children up to 18 years of age?Use and dose must be determinedby your doctor.
    • To treat gastric ulcers:
      • Adults?15 to 30 mg once a day, preferably taken in the morningbefore a meal.
      • Children up to 18 years of age?Use and dose must be determinedby your doctor.
    • To treat conditions in which the stomach produces too much acid:
      • Adults?At first, 60 mg once a day, preferably taken in themorning before a meal. Your doctor may increase your dose if needed.
      • Children up to 18 years of age?Use and dose must be determinedby your doctor.
  • For injection dosage form:
    • To treat erosive esophagitis in patients you cannot take oral lansoprazole:
      • Adults?30 mg once a day injected into a vein.
      • 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 regularintervals. If your condition does not improve, or if it becomes worse,discuss this 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:

    More common

      Diarrhea; skin rash or itching

    Less common

      Abdominal or stomach pain; increasedor decreased appetite; joint pain; nausea; vomiting

    Rare

      Anxiety; cold or flu-like symptoms; constipation; increased cough; mental depression; muscle pain; rectal bleeding; unusual bleeding orbruising

    Incidence not known

      abdominal tenderness; back, leg, orstomach pains; bleeding gums; blistering, peeling, loosening of skin; bloating; bloody, black, or tarry stools; change in mental status; chest pain; chills; clay colored stools; constipation; cough or hoarseness; dark or bloody urine; difficulty breathing; difficulty speaking; difficulty swallowing; fast heartbeat; fatigue; fever; general body swelling; high fever; hives; indigestion; lossof appetite; lower back or side pain; nosebleeds; painful or difficult urination; pains in stomach, side, or abdomen, possibly radiatingto the back; pale skin; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; red irritated eyes; pinpointred spots on skin; red skin lesions, often with apurple center; seizures; shortness of breath; sore throat; sores, ulcers, or white spots on lips or in mouth; swelling of feet or lower legs; swollen or painfulglands; tightness in chest; unusual tiredness or weakness; wheezing; yellowing of the eyes or skin

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

    More common

      Dizziness; headache

    Less common

      bleeding, blistering, burning, coldness, discoloration of skin,feeling of pressure, hives, infection, inflammation, itching, lumps, numbness,pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling,ulceration, or warmth at injection site; mild nausea

    Rare

      acid or sour stomach; bad, unusual orunpleasant (after)taste; belching; burning, crawling, itching, numbness, prickling, "pins and needles" , or tinglingfeelings; change in taste; feeling faint, dizzy, or light-headedness; feelingof warmth or heat; flushing or redness of skin, especiallyon face and neck; heartburn; indigestion; mild diarrhea; mild headache; mild vomiting; stomach discomfort, upset or pain; sweating

    Incidence not known

      difficulty in speaking; decrease infrequency of urination; decrease in urine volume; difficulty in passing urine [dribbling]

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.


Revised: 08/25/2005