ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sunshine Lake Pharma Co., Ltd.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsule 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 esomeprazole magnesium delayed-release capsule may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsule is 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 capsule 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. Esomeprazole magnesium delayed-release capsule is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patien

Product summary:

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are white or almost white capsules, with “S1” imprinted on the cap of shell, the contents of capsules is white or off-white pellets. They are supplied as follows: NDC 48792-7843-1 bottles of 60 Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are white or almost white capsules, with “S2” imprinted on the cap of shell, the contents of capsules is white or off-white pellets. They are supplied as follows: NDC 48792-7842-1 bottles of 60 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 USP container tightly closed. Dispense in a tight container if the Esomeprazole Magnesium Delayed-Release Capsules USP product package is subdivided.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Sunshine Lake Pharma Co., Ltd.
----------
MEDICATION GUIDE
Esomeprazole (ES-oh-MEP-ra-zole) Magnesium
(mag-NEE-zee-um)
Delayed-Release Capsules
Read the Medication Guide that comes with esomeprazole magnesium
delayed-release capsules before
you start taking esomeprazole magnesium delayed-release capsules 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?
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 interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including esomeprazole magnesium
delayed-release capsules, may
develop a kidney problem called acute interstitial nephritis that can
happen at any time during
treatment with esomeprazole magnesium delayed-release capsules. 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 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 exactly as prescribed,
at the lowest dose
possible for your treatment and for the shortest time needed. Talk to
your doctor abou

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
SUNSHINE LAKE PHARMA CO., LTD.
----------
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
1. Warnings and Precautions, Atrophic Gastritis (5.2) removed 10/2016
2. Warnings and Precautions, Cutaneous and Systemic Lupus
Erythematosus (5.5) 10/2016
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsule is a 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
INDIC ATIO N
DO SE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
20 mg or 40 mg
Once daily for 4 to 8 weeks
12 to 17 years
20 mg or 40 mg
Once daily for up to 8 weeks
1 to 11 years
10 mg or 20 mg
Once daily for up to 8 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
20 mg or 40 mg
Once daily for up to 6 months
_H. PYLORI_ ERADICATION _(Triple Therapy):_
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
40 mg
Twice daily
See full prescribing information for administration options. (2)
Patients with severe liver impairment-do not exceed dose of 20 mg. (2)
DOSAGE FORMS AND STRENGTHS
Esomeprazole Magnesium Delayed-Release Capsules, USP: 20 mg and 40 mg.
( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis have occurred). (4)
WARNINGS AND PR