ESOMEPRAZOLE MAGNESIUM DR- esomeprazole magnesium capsule, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Advanced Rx Pharmacy of Tennessee, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

1 INDICATIONS AND USAGE 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 Esomepra

Produkt oppsummering:

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg are white/white size ‘4’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with “I81” on body with gold tek ink. They are supplied as follows: Bottles of 30: NDC 80425-0111-01 Bottles of 60: NDC 80425-0111-02 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules product package is subdivided.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

ESOMEPRAZOLE MAGNESIUM DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE SECTION
MEDICATION GUIDE
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 ne

Preparatomtale

ESOMEPRAZOLE MAGNESIUM DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
ESOMEPRAZOLE MAGNESIUM DR 20MG CAPSULES
1. INDICATIONS AND USAGE SECTION
1 INDICATIONS AND USAGE
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