NEXIUM- esomeprazole magnesium capsule, delayed release NEXIUM- esomeprazole magnesium granule, delayed release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

AstraZeneca Pharmaceuticals LP

INN (Међународно име):

ESOMEPRAZOLE MAGNESIUM

Састав:

ESOMEPRAZOLE 20 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Adults NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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 NEXIUM may be considered. Pediatric Patients 12 Years to 17 Years of Age NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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 NEXIUM for delayed-release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age. Pediatric Patients 1 Month to Less Than 1 Year of Age NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediat

Резиме производа:

NEXIUM Delayed-Release Capsules, 20 mg esomeprazole, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows: NDC 0186-5020-31 unit of use bottles of 30 NDC 0186-5020-54 bottles of 90 NEXIUM Delayed-Release Capsules, 40 mg esomeprazole, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows: NDC 0186-5040-31 unit of use bottles of 30 NDC 0186-5040-54 bottles of 90 NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows: NDC 0186-4025-01 unit dose packages of 30: 2.5 mg esomeprazole packets NDC 0186-4050-01 unit dose packages of 30: 5 mg esomeprazole packets NDC 0186-4010–01 unit dose packages of 30: 10 mg esomeprazole packets NDC 0186-4020–01 unit dose packages of 30: 20 mg esomeprazole packets NDC 0186-4040–01 unit dose packages of 30: 40 mg esomeprazole packets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM delayed-release capsules container tightly closed. Dispense in a tight container if the NEXIUM delayed-release capsules product package is subdivided.

Статус ауторизације:

New Drug Application

Информативни летак

NEXIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
NEXIUM- ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE
AstraZeneca Pharmaceuticals LP
----------
MEDICATION GUIDE
NEXIUM® (nex-e-um) NEXIUM® (nex-e-um)
(esomeprazole magnesium) (esomeprazole magnesium)
delayed-release capsules, for oral use for delayed-release oral
suspension
What is the most important information I should know about NEXIUM?
NEXIUM may help your acid-related symptoms, but you could still have
serious stomach problems. Talk
with your doctor.
NEXIUM can cause serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including NEXIUM, may develop a kidney
problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with NEXIUM. 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
NEXIUM, 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 your doctor about your risk of these serious side effects.
NEXIUM can have other serious side effects. See “What are the
possible side effe

Карактеристике производа

NEXIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
NEXIUM- ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE
ASTRAZENECA PHARMACEUTICALS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEXIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEXIUM.
NEXIUM (ESOMEPRAZOLE MAGNESIUM) DELAYED-RELEASE CAPSULES, FOR ORAL USE
NEXIUM (ESOMEPRAZOLE MAGNESIUM) FOR DELAYED-RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
INDICATIONS AND USAGE
NEXIUM is a proton pump inhibitor (PPI).
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral
suspension are indicated for the:
•
•
•
•
•
•
NEXIUM for delayed-release oral suspension is indicated for the:
•
•
DOSAGE AND ADMINISTRATION
POPULATION
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE (1 YEAR AND OLDER)
EE DUE TO ACID-MEDIATED GERD (1 MONTH TO LESS THAN 1 YEAR)
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 month 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 once daily for 4 weeks some patients may require an
additional 4 weeks
12 years to 17 years
20 mg once daily for 4 weeks
1 year to 11 years
10 mg once daily for up to 8 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
Adults
20 mg or 40 mg once daily for up to 6 months
_H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE
Adults
NEXIUM 40 mg once daily for 10 days
®
®
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