DEXLANSOPRAZOLE capsule, delayed release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Par Pharmaceutical, Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Dexlansoprazole Delayed-Release Capsules, 30 mg, are opaque, white with “par” imprinted on the cap and “147” imprinted on the body. NDC Number            Size 49884-147-11            Bottle of 30 Dexlansoprazole Delayed-Release Capsules, 60 mg, are opaque, green with "par" imprinted on the cap and "148" imprinted on the body. NDC  N umber             Size 49884-148-11              Bottle of 30 49884-148-09              Bottle of 90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Par Pharmaceutical, Inc.
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MEDICATION GUIDE
Dexlansoprazole (DEX lan SOE pra zol)
Delayed-Release Capsules, for oral use
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.
Dexlansoprazole delayed-release capsules, 60 mg contain FD&C Yellow #
5 (tartrazine) which may cause allergic-type reactions
(including bronchial asthma) in certain susceptible persons. Although
the overall incidence of FD&C Yellow # 5 (tartrazine)
sensitivity in the general population is low, it is frequently seen in
patients who also have aspirin hypersensitivity.
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 dexlan

Valmisteyhteenveto

DEXLANSOPRAZOLE- DEXLANSOPRAZOLE CAPSULE, DELAYED RELEASE
PAR PHARMACEUTICAL, INC.
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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)
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions (5.5) 03/2022
Hypomagnesemia and Mineral Metabolism (5.8) 03/2022
INDICATIONS AND USAGE
Dexlansoprazole 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
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 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