ESOMEPRAZOLE MAGNESIUM capsule, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)

זמין מ:

DIRECT RX

INN (שם בינלאומי):

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

הרכב:

ESOMEPRAZOLE 40 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP 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-R

leaflet_short:

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “logo“ and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules. NDC 0093-6450-56 bottle of 30 NDC 0093-6450-98 bottle of 90 NDC 0093-6450-10 bottle of 1000 Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “logo“ and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules. NDC 0093-6451-56 bottle of 30 NDC 0093-6451-98 bottle of 90 NDC 0093-6451-10 bottle of 1000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP CONTAINER TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
DIRECT RX
----------
SPL MEDGUIDE SECTION
Esomeprazole (ES-oh-MEP-ra-zole) Magnesium (mag-NEE-zee-um)
Delayed-Release Capsules USP
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:
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 Proton Pump
Inhibitor 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.
Esomeprazole magnesium delayed-release capsules can have other serious
side effects. See “What are the
possible side effects of esomeprazole magnesium delayed-release
capsules?”
What are esomeprazole magnesium delayed-release capsules?
Esomeprazole magnesium delayed-release capsules are a prescription
medicine called a proton pump
inhibitor (PPI). Esomeprazo

מאפייני מוצר

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
DIRECT RX
----------
ESOMEPRAZOLE MAGNESIUM
INDICATIONS & USAGE SECTION
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules USP 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 USP 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 USP 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 USP
plus amoxicillin
and clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules
USP, 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 [