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:

Direct Rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) 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. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer Esomeprazole magnesium

Product summary:

Esomeprazole magnesium delayed-release capsules USP, 20 mg are White opaque size '4' hard gelatin capsule imprinted with ''H'' on cap and 'E2' on body filled with off white to pale yellow pellets. NDC 72189-318-30 bottles of 30 NDC 72189-318-90 bottles of 90 NDC 72189-318-10 bottles of 1000 Esomeprazole magnesium delayed-release capsules USP, 40 mg are white opaque size '3' hard gelatin capsule imprinted with ''H'' on cap and 'E3' on body filled with off white to pale yellow pellets. NDC 72189-318-30 bottles of 30 NDC 72189-318-90 bottles of 90 NDC 72189-318-10 bottles of 1000

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Direct Rx
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Esomeprazole Magnesium Delayed-Release Capsules, USP
(es'' oh mep' ra zole mag nee' zee um)
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
about your risk of bone fracture if
you take esomeprazole magnesium delayed-release capsules.
• Certain t

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
DIRECT RX
----------
ESOMEPRAZOLE
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
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.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules are 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.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
Triple Therapy (esomeprazole magnesium delayed-release capsules plus
amoxicillin and
clarithromycin): Esomeprazole magnesium delayed-release capsules, in
combination with
amoxicillin and clarithromycin, is indicated for the treatment of
patients with H. pylori
infection and duodenal ulcer disease (active or history of within the
past 5 years) to
eradicate H. pylori. Eradication of H. pylori has been shown to reduce
the risk of
duodenal ulcer recurrence [see Dosage and Administration (2) and
Clinical Studies (14)].
In pa