ESOMEPRAZOLE MAGNESIUM capsule, delayed release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

थमां उपलब्ध:

Torrent Pharmaceuticals Limited

INN (इंटरनेशनल नाम):

ESOMEPRAZOLE MAGNESIUM

रचना:

ESOMEPRAZOLE 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 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 capsules are indicated for short

उत्पाद समीक्षा:

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, are size '4' hard gelatin capsule having yellow cap and pink body imprinted as '20 mg' on the body with white ink and '1154' on the cap with black ink, containing off white to cream colored pellets. They are supplied as follows: Bottles of 30                                  NDC 13668-154-30 Bottles of 90                                  NDC 13668-154-90 Bottles of 500                                NDC 13668-154-05 Bottles of 1,000                              NDC 13668-154-10 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, are size '2' hard gelatin capsule having pink cap and body, imprinted as '40 mg' on the body and '1155' on the cap with white ink, containing off white to cream colored pellets. They are supplied as follows: Bottles of 30                                  NDC 13668-155-30   Bottles of 90                                  NDC 13668-155-90 Bottles of 500                                NDC 13668-155-05 Bottles of 1,000                              NDC 13668-155-10 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, USP container tightly closed. Dispense in a tight container with a child-resistant closure.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Torrent Pharmaceuticals Limited
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MEDICATION GUIDE
Esomeprazole Magnesium (ee so MEP ra zol mag NEE zee um)
Delayed-Release Capsules, USP
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 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,
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 your risk of these serious side effects.
Esomeprazole magnesium de

उत्पाद विशेषताएं

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
TORRENT PHARMACEUTICALS LIMITED
----------
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)
INDICATIONS AND USAGE
Esomeprazole magnesium 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
POPULATIONS
RECOMMENDED 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 weeks some patients
may require an additional 4 weeks
12 years to 17 years
20 mg once daily for 4 weeks
RISK REDUCTION OF NSAID-ASSOCIATED
GASTRI