ESOMEPRAZOLE MAGNESIUM D/R- 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:

DirectRX

INN (International Name):

Esomeprazole Magnesium

Composition:

ESOMEPRAZOLE 40 mg

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 (

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM D/R- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
DIRECTRX
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ESOMEPRAZOLE MAGNESIUM
INDICATIONS & USAGE SECTION
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.
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Esomeprazole magnesium delayed-release capsule USP is indicated for
the long-term treatment of
pathological hypersecretory conditions, including Zollinger-Ellison
Syndrome.
DOSAGE & ADMINISTRATION SECTION
Esomeprazole magnesium is supplied as delayed-release capsules for
oral administ