Lansoprazole

Lansoprazole
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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Overview

Lansoprazole is a gastrointestinal, anti-ulcer agent that is FDA approved for the treatment of duodenal ulcer disease, erosive esophagitis, erosive esophagitis- maintanance, short-term treatment of active gastric ulcer, gastric ulcer - NSAID-associated gastropathy, gastroesophageal reflux disease, Zollinger-Ellison syndrome and for prophylaxis of gastric ulcer. Common adverse reactions include abdominal pain, constipation, diarrhea, nausea, headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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

• Dosing Information

• Helicobacter pylori gastrointestinal tract infection, Dual therapy: dual therapy is not recommended due to the increasing resistance rates in Helicobacter pylori infections

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

• Dosing Information

• Treatment of active ulcer, 15 mg ORALLY once daily up to 4 weeks

• Maintenance of healed ulcer, 15 mg ORALLY once daily

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

• Dosing Information

• 30 mg ORALLY twice daily in combination with amoxicillin 1 gram ORALLY twice daily and clarithromycin 500 mg ORALLY twice daily for 10 to 14 days

• 30 mg ORALLY twice daily in combination with metronidazole 500 mg ORALLY twice daily and clarithromycin 500 mg ORALLY twice daily for 10 to 14 days

Erosive esophagitis

• Dosing Information

• 30 mg ORALLY once daily for 8 to 16 weeks; another 8 weeks for recurrence may be considered

Erosive esophagitis, Maintenance

• Dosing Information

• 15 mg ORALLY once daily

Gastric ulcer, short-term treatment of active ulcer

• Dosing Information

• 30 mg ORALLY once daily up to 8 weeks

Gastric ulcer; Prophylaxis - NSAID-associated gastropathy

• Dosing Information

• 15 mg ORALLY once daily up to 12 weeks

Gastric ulcer - NSAID-associated gastropathy, Treatment

• Dosing Information

• 30 mg ORALLY once daily for 8 weeks

Gastroesophageal reflux disease

• Dosing Information

• 15 mg ORALLY once daily up to 8 weeks

Zollinger-Ellison syndrome

• Dosing Information

• 60 mg ORALLY once daily up to 90 mg twice daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

• Helicobacter pylori gastrointestinal tract infection, Quadruple therapy: (quadruple therapy) lansoprazole 30 mg ORALLY twice daily, metronidazole 250 mg ORALLY four times a day, bismuth subsalicylate 525 mg ORALLY four times a day and tetracycline 500 mg ORALLY four times a day for 10 to 14 days

Gastric ulcer, Maintenance

Heartburn

• Dosing Information

• 15 mg ORALLY once a day for 14 days

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Erosive esophagitis(1 yr and older)

• Dosing Information

• 1 to 11 years of age, weight 30 kg or less, 15 mg ORALLY once daily for up to 12 weeks, may increase dose up to 30 mg twice daily if symptoms persist after 2 or more weeks of treatment

• 1 to 11 years of age, weight more than 30 kg, 30 mg ORALLY once daily for up to 12 weeks, may increase dose up to 30 mg twice daily if symptoms persist after 2 or more weeks of treatment

• 12 years of age and older, 30 mg ORALLY once daily for up to 8 weeks

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

• • Dosing Information

• 1 to 11 years of age, weight greater than 30 kg, 30 mg ORALLY once daily for up to 12 wk, may increase dose up to 30 mg twice daily if symptoms persist after 2 or more weeks of treatment

• 12 years of age and older, 15 mg once daily for up to 8 weeks

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Condition1

Warnings

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 Lansoprazole Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Lansoprazole Drug Interactions in the drug label.

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

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

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Lansoprazole overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

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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