DEXILANT- dexlansoprazole capsule, delayed release

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

DEXLANSOPRAZOLE (UNII: UYE4T5I70X) (DEXLANSOPRAZOLE - UNII:UYE4T5I70X)

Dostupné z:

A-S Medication Solutions

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

DEXILANT is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. DEXILANT is indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. DEXILANT is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks. - DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11)] . Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6)] . - PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products [see Drug Interactions (7)] . Risk Summary There are no studies with dexlansoprazole us

Prehľad produktov:

Product: 50090-4374 NDC: 50090-4374-0 90 CAPSULE, DELAYED RELEASE in a BOTTLE

Stav Autorizácia:

New Drug Application

Príbalový leták

A-S Medication Solutions
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Revised: 11/2020
MEDICATION GUIDE
DEXILANT (decks-i-launt) (dexlansoprazole)
delayed-release capsules, for oral use
Read this Medication Guide before you start taking DEXILANT and each
time you get a refill. There may
be new information. This information does not take the place of
talking to your doctor about your medical
condition or your treatment.
What is the most important information that I should know about
DEXILANT?
DEXILANT may help your acid-related symptoms, but you could still have
serious stomach problems. Talk
with your doctor.
DEXILANT can cause serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including DEXILANT, may develop a kidney
problem called acute
tubulointerstitial nephritis, that can happen at any time during
treatment with PPI medicines. Call
your doctor right away if you have a decrease in the amount that you
urinate or if you have blood in
your urine.
•
Diarrhea. DEXILANT may increase your risk of getting severe diarrhea.
This diarrhea may be
caused by an infection (Clostridium difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go away.
•
Bone fractures. People who take multiple daily doses of PPI medicines
for a long period of time (a
year or longer) may have an increased risk of fractures of the hip,
wrist or spine. You should take
DEXILANT exactly as prescribed, at the lowest dose possible for your
treatment and for the shortest
time needed. Talk to your doctor about your risk of bone fracture if
you take DEXILANT.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body's
immune cells attack other cells or organs in the body). Some people
who take PPI medicines may
develop certain types of lupus erythematosus or have worsening of the
lupus they already have. Call
your doctor right away if you have new or worsening joint pain

Súhrn charakteristických

DEXILANT- DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXILANT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXILANT.
DEXILANT (DEXLANSOPRAZOLE) DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995 (LANSOPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions,
Acute Tubulointerstitial Nephritis (5.2)
11/2020
Risk of Heart Valve Thickening in Pediatric Patients Less than Two
Years of Age (5.11)
9/2020
INDICATIONS AND USAGE
DEXILANT is a proton pump inhibitor (PPI) indicated in patients 12
years of age and older for:
Healing of all grades of erosive esophagitis (EE). (1.1)
Maintenance of healed EE and relief of heartburn. (1.2)
Treatment of symptomatic non-erosive gastroesophageal reflux disease
(GERD). (1.3)
DOSAGE AND ADMINISTRATION
Recommended dosage in patients 12 years of age and older:
See full prescribing information for complete dosing information for
DEXILANT by indication and age
group and dosage adjustment in patients with hepatic impairment. (2.1,
2.2)
Administration Instructions (2.3):
Take without regard to food.
Swallow whole; do not chew.
See full prescribing information for alternative administration
options.
DOSAGE FORMS AND STRENGTHS
Delayed-release capsules: 30 mg and 60 mg. (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to any component of the
formulation. (4)
Patients receiving rilpivirine-containing products. (4, 7)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response with DEXILANT does
not preclude the presence of
gastric malignancy. Consider additional follow-up and diagnostic
testing. (5.1)
Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate
patients. (5.2)
_Clostridium difficile_-Associated Diarrhea: PPI therapy may be
associated with increased risk. (5.3)
Bone Fracture: Long-term and multiple daily dose PPI therapy may be
associated with an increased risk
for osteoporosi