DEXLANSOPRAZOLE DELAYED RELEASE- dexlansoprazole capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. Dexlansoprazole delayed-release capsules are 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. Dexlansoprazole delayed-release capsules are 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. - Dexlansoprazole delayed-release capsules are 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 dexlansoprazole delaye

Product summary:

Product: 50090-5944 NDC: 50090-5944-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-5944-1 90 CAPSULE, DELAYED RELEASE in a BOTTLE

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

A-S Medication Solutions
----------
MEDICATION GUIDE
DEXLANSOPRAZOLE
(DEX LAN SOE PRA ZOL)
DELAYED-RELEASE CAPSULES, FOR ORAL USE
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: 5/2023
Read this Medication Guide before you start taking dexlansoprazole
delayed-release capsules 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
dexlansoprazole delayed-release
capsules?
Dexlansoprazole delayed-release capsules may help your acid-related
symptoms, but you could still have
serious stomach problems. Talk with your doctor.
Dexlansoprazole delayed-release capsules can cause serious side
effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including dexlansoprazole delayed-release
capsules, 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. Dexlansoprazole delayed-release capsules 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 dexlansoprazole delayed-release capsules 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 dexlansoprazole delayed-release capsules.
•
Certain types of lupu

Summary of Product characteristics

DEXLANSOPRAZOLE DELAYED RELEASE- DEXLANSOPRAZOLE CAPSULE, DELAYED
RELEASE
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXLANSOPRAZOLE
DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES.
DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995 (LANSOPRAZOLE)
INDICATIONS AND USAGE
Dexlansoprazole delayed-release capsules are 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
dexlansoprazole delayed-release
capsules 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
dexlansoprazole delayed-release capsules
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 osteoporosis-related fractures