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:

H.J. Harkins Company, Inc.

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. In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD. 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) o

Product summary:

Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink and are supplied in bottles of 30’s. Bottles of 30 NDC 76519-1173-03 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
H.J. Harkins Company, Inc.
----------
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 fractur

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
H.J. HARKINS COMPANY, INC.
----------
1173 ESOMEPRAZOLE MG DR 40MG
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.
In infants 1 month to less than 1 year, esomeprazole magnesium
delayed-release capsules are indicated
for short-term treatment (up to 6 weeks) of erosive esophagitis due to
acid-mediated GERD.
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, are indicated for the treatment of patients with H.
pylori infection and duodenal ulcer
disease