ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Healing of Erosive Esophagitis 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 erosive esophagitis. 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. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium delayed-release capsules are 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. Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy

Produkt oppsummering:

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40 mg, are size 3 capsule with pink opaque cap imprinted with RB67 and pink opaque body imprinted with 40 mg in black ink containing off-white to brownish colored beads. They are supplied as follows: NDC 68071-2241-4 BOTTLES OF 14 Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature.] This package is child-resistant. Keep out of reach of children. For bottle of 1000's: Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature.] Keep esomeprazole magnesium delayed-release capsules, USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules, USP product package is subdivided.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um)
Delayed-Release Capsules, USP
Rx only
Read the Medication Guide that comes with esomeprazole magnesium
delayed-release capsules, USP before
you start taking esomeprazole magnesium delayed-release capsules, USP
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
esomeprazole magnesium delayed-release
capsules, USP?
Esomeprazole magnesium delayed-release capsules, USP may help your
acid-related symptoms, but you
could still have serious stomach problems. Talk with your doctor.
Esomeprazole magnesium delayed-release capsules, USP can cause serious
side effects, including:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including esomeprazole magnesium delayed-release
capsules, USP, may develop a
kidney problem called acute interstitial nephritis that can happen at
any time during treatment with
esomeprazole magnesium delayed-release capsules, USP. Call your doctor
if you have a decrease in
the amount that you urinate or if you have blood in your urine.
•
Diarrhea. Esomeprazole magnesium delayed-release capsules, USP 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
esomeprazole magnesium delayed-release capsules, USP 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

Preparatomtale

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
NUCARE PHARMACEUTICALS,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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps ( 5.12) 06/2018
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsules are proton pump
inhibitor indicated for the
following:
Treatment of gastroesophageal reflux disease (GERD). (1.1)
Risk reduction of NSAID-associated gastric ulcer. (1.2)
_H. pylori _eradication to reduce the risk of duodenal ulcer
recurrence. (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome. (1.4)
DOSAGE AND ADMINISTRATION
1. INDICATION DOSE 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)
Esomeprazole magnesium
delayed-release capsules (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)
Patients with severe liver impairment-do not exceed dose of 20 mg. (2)
(2)
DOSAGE FORMS AND STRENGTHS
Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg. (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis ha