ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

AstraZeneca Pharmaceuticals LP

ИНН (Международная Имя):

ESOMEPRAZOLE MAGNESIUM

состав:

ESOMEPRAZOLE 20 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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. Pediatric Patients 1 Month to Less Than 1 Year of Age Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1

Обзор продуктов:

Esomeprazole magnesium delayed-release capsules, 20 mg esomeprazole, are opaque, hard gelatin, powder blue colored capsules with “0382” and “20 mg” in black on the body. They are supplied as follows: NDC 0186-0382-30 unit of use bottles of 30 NDC 0186-0382-90 bottles of 90 Esomeprazole magnesium delayed-release capsules, 40 mg esomeprazole, are opaque, hard gelatin, powder blue colored capsules with “0384” and “40 mg” in black on the body. They are supplied as follows: NDC 0186-0384-30 unit of use bottles of 30 NDC 0186-0384-90 bottles of 90 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.

Статус Авторизация:

New Drug Application Authorized Generic

тонкая брошюра

AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
Esomeprazole Magnesium
delayed-release capsules, for oral use
What is the most important information I should know about
Esomeprazole magnesium?
Esomeprazole magnesium may help your acid-related symptoms, but you
could still have serious stomach
problems. Talk with your doctor.
Esomeprazole magnesium 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, may
develop a kidney problem called
acute tubulointerstitial nephritis that can happen at any time during
treatment with esomeprazole
magnesium. 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, 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.
Esomeprazole magnesium can have other serious side effects. See
“What are the possible side effects of
Esomeprazole magnesium?”
What is Esomeprazole magnesium?
A prescription medicine called a prot

Характеристики продукта

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
ASTRAZENECA PHARMACEUTICALS LP
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Contraindications (4) 10/2020
Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2)
11/2020
INDICATIONS AND USAGE
Esomeprazole magnesium is a proton pump inhibitor (PPI).
Esomeprazole magnesium delayed-release capsules is indicated for the:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
POPULATION
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2)
HEALING OF EE (1 YEAR AND OLDER) 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
1month 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 may require an
additional 4 weeks
12 years to 17 years
20 mg once daily for 4 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
Esomeprazole magnesium 40 mg once daily for 10 days
Amoxicillin 1000 mg twice daily for 10 days
Clarithromycin 500 mg twice daily for 10 days
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME
Adults
Starting dosage is 40 mg twice daily (varies with the individual
patient) as long as clinically indicated.
Short-term treatment in the healing o