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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 .
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.
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.