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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.
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
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)
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.
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.
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
