Pronunciation:

lan-SOE-pra-zole

Brand Names:

• Prevacid
• Prevacid SoluTab

Dosage Forms:

• Packet
• Capsule, Delayed Release
• Tablet Disintegrating, Delayed Release

Classifications:

Therapeutic—

Antiulcer

Pharmacologic—

Proton Pump Inhibitor

Uses of This Medicine:

Lansoprazole 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.

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

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

There is no specific information comparing the use of oral lansoprazole in children less than 1 year of age with use in other age groups. It is safe to use oral lansoprazole to treat heartburn and erosive esophagitis 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 injection in children with use in other age groups.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir
• Dasatinib
• Delavirdine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 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 this medicine 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 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 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 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 into the stomach within 15 minutes
  • Refill the syringe with approximately 5 mL of water, shake gently and administer any remaining contents

Take this medicine 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 this medicine.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (delayed-release capsule, delayed-release oral suspension, or delayed-release orally disintegrating tablet):
  • 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.
• For injection dosage form:
  • To treat erosive esophagitis in patients who 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 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular intervals. 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 may need medical attention.

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

More common

Diarrhea

skin rash or itching

Less common

Abdominal or stomach pain

increased or decreased appetite

joint pain

nausea

vomiting

Rare

Anxiety

cold or flu-like symptoms

constipation

increased cough

mental depression

muscle pain

rectal bleeding

unusual bleeding or bruising

Incidence not known

Abdominal tenderness

back, leg or stomach 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 swallowing

fast heartbeat

fatigue

fever

general body swelling

high fever

hives

indigestion

loss of appetite

lower back or side pain

nosebleeds

painful or difficult urination

pains in stomach, side or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

red irritated eyes

pinpoint red spots on skin

red skin lesions, often with a purple 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 painful glands

tightness in chest

unusual tiredness or weakness

wheezing

yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 or unpleasant (after)taste

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

feeling faint, dizzy, or light-headedness

feeling of heat or warmth

flushing or redness of skin, especially on face and neck

heartburn

indigestion

mild diarrhea

mild headache

mild vomiting

stomach discomfort, upset or pain

sweating

Incidence not known

Difficulty in speaking

decrease in frequency of urination

decrease in urine volume

decrease in passing urine [dribbling]

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.