Prevacid lansoprazole

Get an overview of PREVACID (lansoprazole capsule, delayed release), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Prevacid can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Prevacid.

Drug Basics

Brand Name: Prevacid

Generic Name: LANSOPRAZOLE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: CAPSULE, DELAYED RELEASE

Data Current As Of: 2018-10-05

indications & usage

short-term treatment of active duodenal ulcer

PREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)].

h. pylori eradication to reduce the risk of duodenal ulcer recurrence

Triple Therapy: PREVACID/amoxicillin/clarithromycin

PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].

Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual Therapy: PREVACID/amoxicillin

PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].

Please refer to the full prescribing information for amoxicillin.

maintenance of healed duodenal ulcers

PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies (14)].

short-term treatment of active benign gastric ulcer

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14)].

healing of nsaid-associated gastric ulcer

PREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [see Clinical Studies (14)].

risk reduction of nsaid-associated gastric ulcer

PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies (14)].

gastroesophageal reflux disease (gerd)

Short-Term Treatment of Symptomatic GERD

PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14)].

Short-Term Treatment of Erosive Esophagitis

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered [see Clinical Studies (14)].

maintenance of healing of erosive esophagitis (ee)

PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [see Clinical Studies (14)].

pathological hypersecretory conditions including zollinger-ellison syndrome (zes)

PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14)].

patient counseling information

[See FDA-Approved Patient Labeling]

Patient should be informed of the following:

Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (5.3)].

Information for Patients

PREVACID is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below [see Dosage and Administration (2.3)].

  • PREVACID should be taken before eating.
  • PREVACID products SHOULD NOT BE CRUSHED OR CHEWED.
  • Phenylketonurics: Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.

Administration Options

1. PREVACID Delayed-Release Capsules – Oral Administration

  • PREVACID Delayed-Release Capsules should be swallowed whole.
  • Alternatively, for patients who have difficulty swallowing capsules, PREVACID Delayed-Release Capsules can be opened and administered as follows:
    • Open capsule.
    • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
    • Swallow immediately.
  • PREVACID Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
    • Open capsule.
    • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
    • Mix briefly.
    • Swallow immediately.
    • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

PREVACID Delayed-Release Capsules – Nasogastric Tube (≥16 French) Administration

  • For patients who have a nasogastric tube in place, PREVACID Delayed-Release Capsules can be administered as follows:
    • Open capsule.
    • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
    • Inject through the nasogastric tube into the stomach.
    • Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

2. PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets

  • PREVACID SoluTab should not be broken or cut.
  • PREVACID SoluTab should not be chewed.
    • Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
    • The tablet typically disintegrates in less than 1 minute.
    • Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be delivered in two different ways.


    PREVACID SoluTab – Oral Syringe

    • For administration via oral syringe, PREVACID SoluTab can be administered as follows:
      • Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
      • Shake gently to allow for a quick dispersal.
      • After the tablet has dispersed, administer the contents within 15 minutes.
      • Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.

    PREVACID SoluTab – Nasogastric Tube (≥8 French) Administration

    • For administration via a nasogastric tube, PREVACID SoluTab can be administered as follows:
      • Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.
      • Shake gently to allow for a quick dispersal.
      • After the 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 flush the nasogastric tube.

FDA-Approved Patient Labeling

Patient Information

PREVACID (prev-ǎ-sid)
(lansoprazole)
Delayed-Release Capsules
and
PREVACID SoluTab (prev-ǎ-sid sol-ū-tab)
(lansoprazole)
Delayed-Release Orally Disintegrating Tablets

Read this Patient Information that comes with PREVACID before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is PREVACID?

PREVACID is a prescription medicine called a proton pump inhibitor (PPI). PREVACID reduces the amount of acid in your stomach.

PREVACID is used in adults:

  • for 4 weeks to heal ulcers in the first part of the small bowel (duodenal ulcers).
  • along with certain antibiotics to treat a stomach infection called Helicobacter pylori.
  • for continued healing of duodenal ulcers.
  • for up to 8 weeks to heal stomach ulcers.
  • for up to 8 weeks to heal stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
  • for reducing the risk of stomach ulcers in some people taking NSAIDs.
  • for up to 8 weeks for the relief of heartburn and other symptoms of gastroesophageal reflux disease (GERD).

    GERD happens when acid from your stomach enters the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping. In some cases, acid can damage the lining of your esophagus. This damage is called erosive esophagitis.

  • for 8 weeks to heal the acid-related damage to the lining of the esophagus (called erosive esophagitis) and to relieve symptoms, such as heartburn pain. If needed, your doctor may prescribe an additional 8 weeks of PREVACID.
  • for continued healing of erosive esophagitis.
  • for the long-term treatment of conditions where your stomach makes too much acid. This includes a condition called Zollinger-Ellison syndrome.

PREVACID is used in children and adolescents (ages 1 to 17):

  • for up to 12 weeks to treat GERD and erosive esophagitis in children 1 to 11 years old.
  • for up to 8 weeks to treat GERD and erosive esophagitis in adolescents 12 to 17 years old.

PREVACID is not effective for symptoms of GERD in children under the age of 1 year.

PREVACID may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Who should not take PREVACID?

  • Do not take PREVACID if you are allergic to PREVACID or any of its ingredients. See the end of this leaflet for a complete list of ingredients in PREVACID.

What should I tell my doctor before taking PREVACID?

Before you take PREVACID, tell your doctor if you:

  • have been told that you have low magnesium levels in your blood.
  • have liver problems
  • have phenylketonuria. PREVACID SoluTab contains aspartame.
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if PREVACID will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or planning to breast-feed. You and your doctor should decide if you will take PREVACID or breast-feed. You should not do both without first talking with your doctor.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

PREVACID may affect how other medicines work, and other medicines may affect how PREVACID works.

Especially tell your doctor if you take:

  • ampicillin sodium (Unasyn) or ampicillin trihydrate (Principen)
  • atazanavir (Reyataz)
  • digoxin (Lanoxin)
  • a product that contains iron
  • ketoconazole (Nizoral)
  • warfarin (Coumadin, Jantoven)
  • tacrolimus (Prograf)
  • theophylline (Theo-24, Elixophyllin, Theochron, Theolair)
  • methotrexate

Ask your doctor or pharmacist if you are not sure if your medicine is listed above.

How should I take PREVACID?

  • Take PREVACID exactly as prescribed by your doctor.
  • Do not change your dose or stop taking PREVACID without talking to your doctor first.
  • You should take PREVACID before eating.
  • PREVACID Delayed-Release Capsules:
    • You should swallow PREVACID Delayed-Release Capsules whole.
    • Do not crush or chew PREVACID Delayed-Release Capsules.
    • If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with certain foods or juices. See "Patient Instruction for Use" at the end of this leaflet for instructions on how to take PREVACID capsules with certain foods and juices.
    • See "Patient Instruction for Use" at the end of this leaflet for instructions on how to mix and give PREVACID capsules through a nasogastric tube.
  • PREVACID SoluTab:
    • is a tablet that melts in your mouth with or without water.
    • Do not break, cut or chew the tablets.
    • See "Patient Instruction for Use" at the end of this leaflet for instructions on how to mix and give PREVACID SoluTab tablets through a syringe and nasogastric tube.
  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time. If you are not sure about dosing, call your doctor. If you take too much PREVACID, call your doctor right away.

What are the possible side effects of PREVACID?

The most common side effects of PREVACID in adults and children include:

  • diarrhea
  • stomach pain
  • nausea
  • constipation
  • headache
  • dizziness

Other side effects

  • Serious allergic reactions. Tell your doctor if you get any of the following symptoms with PREVACID.
    • rash
    • face swelling
    • throat tightness
    • difficulty breathing

Your doctor may stop PREVACID if these symptoms happen.

  • Bone Fractures. People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine.
  • Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms:

  • seizures
  • dizziness
  • abnormal or fast heartbeat
  • jitteriness
  • jerking movements or shaking (tremors)
  • muscle weakness
  • spasms of the hands and feet
  • cramps or muscle aches
  • spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking PREVACID, or during treatment; if you will be taking PREVACID for a long period of time.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of PREVACID. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

How should I store PREVACID?

  • Store PREVACID at room temperature between 59°F to 86°F (15°C to 30°C).

Keep PREVACID and all medicines out of the reach of children.

General information about PREVACID

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information Leaflet. Do not use PREVACID for conditions for which it was not prescribed. Do not give PREVACID to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information Leaflet provides a summary of the most important information about PREVACID. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

For more information go to www.PREVACID.com or call 1-877-825-3327.

What are the ingredients in PREVACID?

Active ingredient: lansoprazole.

Inactive ingredients in PREVACID Delayed-Release Capsules:

Sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40.

In addition PREVACID 15 mg Capsule only: FD&C Green No. 3.

Inactive ingredients in PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets:

Mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartame, glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.

PREVACID SoluTab contains phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet.

Patient Instructions for Use

PREVACID (prev-ǎ-sid)
(lansoprazole)
Delayed-Release Capsules
and
PREVACID SoluTab (prev-ǎ-sid sol-ū-tab)
(lansoprazole)
Delayed-Release Orally Disintegrating Tablets

PREVACID Delayed-Release Capsules

  • Swallow PREVACID Delayed-Release Capsules whole. Do not crush or chew them.
  • You should take PREVACID before eating.
  • PREVACID Delayed-Release Capsule with certain food:
    You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
  • 1 Open the capsule.
  • 2 Sprinkle the granules on 1 tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
  • 3 Swallow right away.
  • PREVACID Delayed-Release Capsule with certain juices:
    You can only use apple juice, orange juice or tomato juice.
  • 1 Open the capsule.
  • 2 Sprinkle the granules into 60 mL ( about ¼ cup) of either apple juice, orange juice or tomato juice.
  • 3 Stir.
  • 4 Swallow right away.
  • 5 To make sure that the entire dose is taken, rinse the glass with 1/2 cup or more of juice to get out any leftover granules. Swallow the juice right away.
  • PREVACID Delayed-Release Capsules through a nasogastric tube (NG tube) 16 French or larger, as prescribed by your doctor:
    You can only use apple juice.
  • 1 Open the capsule and empty the granules into a syringe.
  • 2 Do not break or crush the granules.
  • 3 Mix with 40 mL of apple juice. Do not use other liquids.
  • 4 Attach the syringe to the NG tube and give the medicine in the syringe through the NG tube into the stomach.
  • 5 After giving the granules, flush the NG tube with more apple juice to clear the tube.

PREVACID should not be used in foods or liquids not listed above.

  • PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets
  • 1 Do not chew, crush, cut or break tablets.
  • 2 Put the tablet on the tongue and let it dissolve, with or without water.
  • 3 Swallow after the tablet dissolves.
  • 4 The tablet usually dissolves in less than 1 minute.
  • PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets with an oral syringe:
  • 1 Put a 15 mg tablet in an oral syringe and add 4 mL of water, or put a 30 mg tablet in an oral syringe and add 10 mL of water.
  • 2 Shake the syringe gently to dissolve the tablet quickly.
  • 3 After the tablet has dissolved, give the mixture within 15 minutes.
  • 4 To make sure that the entire dose is taken, refill the syringe with about 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and give the water in the syringe.
  • PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets through a nasogastric tube (NG tube) 8 French or larger, as prescribed by your doctor:
  • 1 Put a 15 mg tablet in a syringe and add 4 mL of water, or put a 30 mg tablet in a syringe and add 10 mL of water.
  • 2 Shake the syringe gently to dissolve the tablet quickly.
  • 3 After the tablet has dissolved, give the mixture in the syringe through the NG tube into the stomach within 15 minutes.
  • 4 Refill the syringe with about 5 mL of water, shake gently, and flush the NG tube.

How should I store PREVACID?

  • Store PREVACID at room temperature between 59°F to 86°F (15°C to 30°C).

Keep PREVACID and all medicines out of the reach of children.

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

PREVACID is a trademark registered in the U.S. Patent and Trademark Office and SoluTab is a trademark of Takeda Pharmaceuticals U.S.A., Inc. and used under license by Takeda Pharmaceuticals America, Inc.

All other trademark names are the property of their respective owners.

©1995 - 2012 Takeda Pharmaceuticals America, Inc.

PRV012 R42 May 2012

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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