Lansoprazole

Lansoprazole
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Lansoprazole is a gastrointestinal, anti-ulcer agent that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Duodenal ulcer disease, Dual therapy - Helicobacter pylori gastrointestinal tract infection, Dual therapy

• Dosing Information

• Dosage

Duodenal ulcer disease, Short-term treatment of active disease and maintenance of healed ulcers

• Dosing Information

• Dosage

Duodenal ulcer disease, Triple therapy - Helicobacter pylori gastrointestinal tract infection, Triple therapy

• Dosing Information

• Dosage

Erosive esophagitisView additional information.

• Dosing Information

• Dosage

Erosive esophagitis, Maintenance

• Dosing Information

• Dosage

Gastric ulcer, short-term treatment of active ulcerView additional information.

• Dosing Information

• Dosage

Gastric ulcer; Prophylaxis - NSAID-associated gastropathy

• Dosing Information

• Dosage

Gastric ulcer - NSAID-associated gastropathy, Treatment

• Dosing Information

• Dosage

Gastroesophageal reflux disease

• Dosing Information

• Dosage

Zollinger-Ellison syndrome

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Lansoprazole in adult patients.

Non–Guideline-Supported Use

Duodenal ulcer disease, Quadruple therapy - Helicobacter pylori gastrointestinal tract infection, Quadruple therapy

• Dosing Information

• Dosage

Gastric ulcer, Maintenance

Heartburn

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lansoprazole in adult patients.

Barrett's esophagusView additional information. Duodenal ulcer disease, Quadruple therapy - Helicobacter pylori gastrointestinal tract infection, Quadruple therapyView additional information.

   Gastric ulcer, MaintenanceView additional information.

   HeartburnView additional information.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Erosive esophagitis(1 yr and older)

• Dosing Information

• Dosage

Gastroesophageal reflux disease ( 1 year and older (oral formulation))

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Lansoprazole in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Lansoprazole in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Allergy alert: Do not use if you are allergic to lansoprazole

Do not use

   if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. 

Ask a doctor before use if you have

   liver disease 
   had heartburn over 3 months. This may be a sign of a more serious condition. 
   heartburn with lightheadedness, sweating or dizziness 
   chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness 
   frequent chest pain 
   frequent wheezing, particularly with heartburn 
   unexplained weight loss 
   nausea or vomiting 
   stomach pain 

Ask a doctor or pharmacist before use if you are taking

   warfarin (blood-thinning medicine) 
   prescription antifungal or anti-yeast medicines 
   digoxin (heart medicine) 
   theophylline (asthma medicine) 
   tacrolimus (immune system medicine) 
   atazanavir (medicine for HIV infection) 

Stop use and ask a doctor if

   your heartburn continues or worsens 
   you need to take this product for more than 14 days 
   you need to take more than 1 course of treatment every 4 months 
   you get diarrhea 

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Lansoprazole in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Lansoprazole in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lansoprazole in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Lansoprazole during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Lansoprazole with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Lansoprazole with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Lansoprazole with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Lansoprazole with respect to specific gender populations.

Race

There is no FDA guidance on the use of Lansoprazole with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Lansoprazole in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Lansoprazole in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Lansoprazole in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Lansoprazole in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Lansoprazole in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Lansoprazole in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Lansoprazole in the drug label.

Pharmacology

Mechanism of Action

Structure

File:Lansoprazole01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Lansoprazole in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Lansoprazole in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Lansoprazole in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Lansoprazole in the drug label.

How Supplied

Storage

There is limited information regarding Lansoprazole Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

adults 18 years of age and older

   this product is to be used once a day (every 24 hours), every day for 14 days 
   it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 

14-Day Course of Treatment

   swallow 1 capsule with a glass of water before eating in the morning 
   take every day for 14 days 
   do not take more than 1 capsule a day 
   swallow whole. Do not crush or chew capsules. 
   do not use for more than 14 days unless directed by your doctor 

Repeated 14-Day Courses (if needed)

   you may repeat a 14-day course every 4 months 
   do not take for more than 14 days or more often than every 4 months unless directed by a doctor 
   children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition. 

Other information

   read the directions, warnings and package insert before use 
   keep the carton and package insert. They contain important information. 
   store at 20-25°C (68-77°F) 
   keep product out of high heat and humidity 
   protect product from moisture

Precautions with Alcohol

• Alcohol-Lansoprazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Prevacid, Prevacid I.V., Prevacid SoluTab, First - Lansoprazole

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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