ESOMEPRAZOLE MAGNESIUM capsule, delayed release pellets

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Tersedia dari:

Lannett Company, Inc.

INN (Nama Internasional):

ESOMEPRAZOLE MAGNESIUM

Komposisi:

ESOMEPRAZOLE 20 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Adults Esomeprazole Magnesium Delayed-release Capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of Esomeprazole Magnesium Delayed-release Capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole Magnesium Delayed-release Capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. Pediatric Patients 1 Year to 11 Years of Age Esomeprazole Magnesium is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age. Esomeprazole Magnesium Delayed-release Capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. Adults Esomeprazole Magnesium Delayed-release Capsules are indicated for

Ringkasan produk:

Esomeprazole Magnesium Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows: NDC 62175-820-32 unit of use bottles of 30 NDC 62175-820-46 unit of use bottles of 90 NDC 62175-820-43 bottles of 1000 Esomeprazole Magnesium Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows: NDC 62175-840-32 unit of use bottles of 30 NDC 62175-840-46 unit of use bottles of 90 NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep Esomeprazole Magnesium Delayed-release Capsules container tightly closed. Dispense in a tight container if the Esomeprazole Magnesium Delayed-release Capsules product package is subdivided.

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Lannett Company, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
www.lannett.com/med-guide/esomeprazole
Esomeprazole Magnesium
(es” oh mep’ ra zole mag nee’ zee um)
Delayed-release Capsules, USP
What is the most important information I should know about
Esomeprazole Magnesium Delayed-release
Capsules?
Esomeprazole Magnesium Delayed-release Capsules may help your
acid-related symptoms, but you could
still have serious stomach problems. Talk with your doctor.
Esomeprazole Magnesium 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 Esomeprazole Magnesium
Delayed-release Capsules, may
develop a kidney problem called acute tubulointerstitial nephritis
that can happen at any time during
treatment with Esomeprazole Magnesium Delayed-release Capsules. 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 caused by an infection (Clostridium difficile) in your
intestines. Call your doctor right away
if you have watery stools or stomach pain that does not go away. You
may or may not have a fever.
•
Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in people
who take
multiple daily doses of PPI medicines and for a long period of time (a
year or longer). Tell your
doctor if you have a bone fracture, especially in the hip, wrist, or
spine.
•
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,
including Esomeprazole Magnesium Delayed-release Capsules, 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 or a rash on your cheeks or arms that
gets worse in the sun.
Talk to

Karakteristik produk

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE PELLETS
LANNETT COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE
MAGNESIUM DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES.
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
INDICATIONS AND USAGE
Esomeprazole Magnesium Delayed-release Capsules is a proton pump
inhibitor (PPI).
Esomeprazole Magnesium Delayed-release Capsules are indicated for the:
Short-term treatment in the healing of erosive esophagitis (EE) in
adults and pediatric patients 12
years to 17 years of age. (1.1)
Maintenance of healing of EE in adults. (1.2)
Short-term treatment of heartburn and other symptoms associated GERD
in adults and pediatric
patients 12 years to 17 years of age. (1.3)
Risk reduction of nonsteroidal anti-inflammatory drugs
(NSAID)-associated gastric ulcer in adults at risk
for developing gastric ulcers due to age (60 years and older) and/or
documented history of gastric
ulcers. (1.4)
_Helicobacter pylori _eradication in adult patients to reduce the risk
of duodenal ulcer recurrence in
combination with amoxicillin and clarithromycin. (1.5)
Long-term treatment of pathological hypersecretory conditions,
including Zollinger-Ellison syndrome in
adults. (1.6)
DOSAGE AND ADMINISTRATION
POPULATION
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE (1 YEAR AND OLDER)
Adults
20 mg or 40 mg once daily for 4 to 8 weeks; some patients may require
an additional 4
to 8 weeks
12 years to 17
years
20 mg or 40 mg once daily for 4 to 8 weeks
1 year to 11
years
see full prescribing information for weight-based dosing and duration
of treatment (2.2)
MAINTENANCE OF HEALING OF EE
Adults
20 mg once daily. Controlled studies do not extend beyond 6 months
TREATMENT OF SYMPTOMATIC GERD
Adults
20 mg once daily for 4 weeks some patients ma