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:

NuCare Pharmaceuticals,Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 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 capsu

Product summary:

Esomeprazole magnesium delayed-release capsules, USP 40 mg are size '3' hard gelatin white opaque colored capsule, imprinted with '187' on cap and '40 mg' on body and filled with white to slightly yellow colored pellets. They are supplied as follows: BOTTLES OF 90 NDC 68071-2919-9 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NuCare Pharmaceuticals,Inc.
----------
MEDICATION GUIDE
Esomeprazole Magnesium Delayed-Release Capsules, USP
(es"oh mep'ra zole mag nee'zee um)
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 tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including esomeprazole magnesium
delayed-release capsules, may develop
a kidney problem called acute tubulointerstitial nephritis that can
happen at any time during treatment
with esomeprazole magnesium delayed-release capsules. 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 stool 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, 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
gets worse in the sun.
Talk to your doctor about risk of these serious side effects.
Esomeprazole magnesium delayed-rel

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE
MAGNESIUM DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES.
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions,
Severe Cutaneous Adverse Reactions ( 5.5) 03/2022
Hypomagnesemia and Mineral Metabolism ( 5.9) 03/2022
INDICATIONS AND USAGE
Esomeprazole is a proton pump inhibitor (PPI).
Esomeprazole magnesium delayed-release capsules are indicated for the:
Short-term treatment in the healing of erosive esophagitis (EE) in
adults and pediatric patients 12
years to 17 years of age. ( 1.1)
Maintenance of healing of EE in adults. ( 1.2)
Short-term treatment of heartburn and other symptoms associated GERD
in adults and pediatric
patients 12 years to 17 years of age. ( 1.3)
Risk reduction of nonsteroidal anti-inflammatory drugs
(NSAID)-associated gastric ulcer in adults at risk
for developing gastric ulcers due to age (60 years and older) and/or
documented history of gastric
ulcers. ( 1.4)
_Helicobacter pylori _eradication in adult patients to reduce the risk
of duodenal ulcer recurrence in
combination with amoxicillin and clarithromycin. ( 1.5)
Long-term treatment of pathological hypersecretory conditions,
including Zollinger-Ellison syndrome in
adults. ( 1.6)
DOSAGE AND ADMINISTRATION
POPULATIONRECOMMENDED ADULT ( 2.1) AND PEDIATRIC DOSAGE ( 2.2)
HEALING OF EE (1 YEAR AND OLDER)
Adults
20 mg or 40 mg
once daily for 4 to 8 weeks; some patients may require an additional 4
to 8
weeks
12 years to
17 years
20 mg or 40 mg
once daily for 4 to 8 weeks
MAINTENANCE OF HEALING OF EE
Adults
20 mg once daily. Controlled studies do not extend beyond 6 months
TREATMENT OF SYMPTOMATIC GERD
Adults
20 mg once daily once daily for 4 wee