NEXIUM- esomeprazole magnesium capsule, delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Lake Erie Medical DBA Quality Care Products LLC

ІПН (Міжнародна Ім'я):

ESOMEPRAZOLE MAGNESIUM

Склад:

ESOMEPRAZOLE 40 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Healing of Erosive Esophagitis NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. 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. Maintenance of Healing of Erosive Esophagitis NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months. T

Огляд продуктів:

NEXIUM Delayed-Release Capsules, 20 mg, 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 0186-5022-28 unit dose packages of 100 NDC 0186-5020-54 bottles of 90 NDC 0186-5020-82 bottles of 1000 NEXIUM Delayed-Release Capsules, 40 mg, 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 0186-5042-28 unit dose packages of 100 NDC 0186-5040-54 bottles of 90 NDC 0186-5040-82 bottles of 1000 NDC 0186-5040-35 unit of use bottles of 30 NDC 0186-5042-25 unit dose packages of 100 NDC 0186-5040-55 bottles of 90 NDC 0186-5040-85 bottles of 1000 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 0186-4010–01 unit dose packages of 30: 10 mg packets NDC 0186-4020–01 unit dose packages of 30: 20 mg packets NDC 0186-4040–01 unit dose packages of 30: 40 mg 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. NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies. ©AstraZeneca 2010

Статус Авторизація:

New Drug Application

інформаційний буклет

NEXIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
NEXIUM® (nex-e-um)
(esomeprazole magnesium)
Delayed-Release Capsules
NEXIUM® (nex-e-um)
(esomeprazole magnesium)
For Delayed-Release
Oral Suspension
Read the Medication Guide that comes with NEXIUM before you start
taking NEXIUM and each time
you get a refill. There may be new information. This information does
not take the place of talking with
your doctor about your medical condition or your treatment.
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 interstitial nephritis). Some
people who take proton pump inhibitor
(PPI) medicines, including NEXIUM, may develop a kidney problem called
acute interstitial nephritis
that can happen at any time during treatment with NEXIUM. Call your
doctor if you have a decrease in
the amount that you urinate or if you have blood in your urine. •
Diarrhea. NEXIUM 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 NEXIUM
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 NEXIUM.
• 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 erythe

Характеристики продукта

NEXIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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
NEXIUM (ESOMEPRAZOLE MAGNESIUM) FOR DELAYED-RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS 08/2010
Bone Fracture (5.3)
INDICATIONS AND USAGE
NEXIUM is a proton pump inhibitor indicated for the following: (1)
Treatment of gastroesophageal reflux disease (GERD) (1.1) (1)
Risk reduction of NSAID-associated gastric ulcer (1.2) (1)
_H. pylori _eradication to reduce the risk of duodenal ulcer
recurrence (1.3) (1)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome (1.4) (1)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD) (2)
Adults (2)
20 mg or 40 mg (2) Once daily for 4 to 8 weeks (2)
12 to 17 years (2)
20 mg or 40 mg (2) Once daily for up to 8 weeks (2)
1 to 11 years (2)
10 mg or 20 mg (2) Once daily for up to 8 weeks (2)
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER (2)
20 mg or 40 mg (2) Once daily for up to 6 months (2)
_H. PYLORI_ ERADICATION_ (Triple Therapy):_ (2)
(2)
NEXIUM (2)
40 mg (2)
Once daily for 10 days (2)
Amoxicillin (2)
1000 mg (2)
Twice daily for 10 days (2)
Clarithromycin (2)
500 mg (2)
Twice daily for 10 days (2)
PATHOLOGICAL HYPERSECRETORY CONDITIONS (2) 40 mg (2)
Twice daily (2)
See full prescribing information for administration options (2) (2)
DOSAGE FORMS AND STRENGTHS
NEXIUM Delayed-Release Capsules, 20 mg and 40 mg (3) (3)
NEXIUM For Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg
(3) (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to any component of the
formulation or to substituted benzimidazoles (angioedema
and anaphylaxis have occurred) (4) (4)
WARNINGS AND PRECAUTIONS
Symptomatic resp