ESOMEPRAZOLE MAGNESIUM DR- 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:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Healing of Erosive Esophagitis (EE) Adults 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 EE in adults. 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. 1.2 Maintenance of Healing of EE Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 1.3 Treatment of Symptomatic GERD Adults Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GE

Product summary:

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40 mg, are size 3 capsule with pink opaque cap imprinted with 'RB67' and pink opaque body imprinted with '40 mg' in black ink containing off-white to brownish colored beads. They are supplied as follows: Bottles of 30 Capsules NDC: 80425-0183-01 For bottle of 30's Store at 20 - 25° C (68 - 77° F) [See USP Controlled Room Temperature.] This package is child-resistant. Keep out of reach of children. 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 DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Advanced Rx Pharmacy of Tennessee, LLC
----------
MEDICATION GUIDE
Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um)
Delayed-Release Capsules, USP
Rx only
What is the most important information I should know about
esomeprazole magnesium delayed-release
capsules, USP?
Esomeprazole magnesium delayed-release capsules, USP may help your
acid-related symptoms, but you
could still have serious stomach problems. Talk with your doctor.
Esomeprazole magnesium delayed-release capsules, USP can cause serious
side effects, including:
•A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump inhibitor
(PPI) medicines, including esomeprazole magnesium delayed-release
capsules, USP, may develop a kidney
problem called acute tubulointerstitial nephritis that can happen at
any time during treatment with
esomeprazole magnesium delayed-release capsules, USP. Call your doctor
right away if you have a decrease
in the amount that you urinate or if you have blood in your urine.
•Diarrhea caused by an infection (Clostridium difficile) in your
intestines.
Call your doctor right away if you have watery stools or stomach pain
that does not go away. You may or
may not have a fever.
•Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in people who
take multiple daily doses of PPI medicines and for a long period of
time (a year or longer). Tell your doctor if
you have a bone fracture, especially in the hip, wrist, or spine.
•Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body's immune
cells attack other cells or organs in the body). Some people who take
PPI medicines, including esomeprazole
magnesium delayed-release capsules, USP, may develop certain types of
lupus erythematosus or have
worsening of the lupus they already have. Call your doctor right away
if you have new or worsening joint
pain or a rash on your cheeks or arms that

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM DR- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
ESOMEPRAZOLE MAGNESIUM DR 40MG CAPSULES
1. INDICATIONS AND USAGE
1.1 Healing of Erosive Esophagitis (EE)
Adults
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 EE in adults. 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.
Pediatric Patients 12 Years to 17 Years of Age
Esomeprazole magnesium delayed-release capsules are indicated for the
short-term
treatment (4 to 8 weeks) for the healing of EE in pediatric patients
12 years to 17 years
of age.
1.2 Maintenance of Healing of EE
Esomeprazole magnesium delayed-release capsules are indicated for the
maintenance of
healing of EE in adults. Controlled studies do not extend beyond 6
months.
1.3 Treatment of Symptomatic GERD
Adults
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.
Pediatric Patients 12 Years to 17 Years of Age
Esomeprazole magnesium delayed-release capsules are indicated for
short-term
treatment (4 weeks) of heartburn and other symptoms associated with
GERD in
pediatric patients 12 years to 17 years of age.
1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs
(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 adult
patients at risk for developing gastric ulcers. Patients are
considered to be at risk due to
their age (60 years and older) and/or documented history of gastric
ulcers. Controlled
studies do not extend beyond 6 months.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal
Ulcer Recurrence
Eradicatio