ESOMEPRAZOLE MAGNESIUM granule, for suspension, extended release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Cipla USA Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Adults Esomeprazole magnesium for delayed release oral suspension is 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 for delayed release oral suspension may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium for delayed release oral suspension is 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. Pediatric Patients 1 Year to 11 Years of Age   Esomeprazole magnesium for delayed release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age. Pediatric Patients 1 Month to Less Than 1 Year of Age Esomeprazole magnesium for delayed release oral suspension is indicated for short-term treatment (up to 6 week

Produkto santrauka:

Esomeprazole magnesium For Delayed Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. Esomeprazole magnesium for delayed release oral suspension unit dose packets are supplied as follows: NDC 69097-527-34 unit dose packages of 30: 10 mg esomeprazole packets Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM GRANULE, FOR
SUSPENSION, EXTENDED
RELEASE
Cipla USA Inc.
----------
MEDICATION GUIDE
Esomeprazole magnesium (es-oh-MEP-ra-zole mag-NEE-zee-um) For Delayed
Release Oral Suspension
What is the most important information I should know about
Esomeprazole magnesium For Delayed
Release Oral Suspension?
Esomeprazole magnesium For Delayed Release Oral Suspension may help
your acid-related symptoms,
but you could still have serious stomach problems. Talk with your
doctor.
Esomeprazole magnesium For Delayed Release Oral Suspension 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 For
Delayed Release Oral
Suspension, may develop a kidney problem called acute
tubulointerstitial nephritis that can happen
at any time during treatment with Esomeprazole magnesium For Delayed
Release Oral
Suspension. Call your doctor right away if you have a decrease in the
amount that you urinate or if
you have blood in your urine.
•
Diarrheacaused 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 For Delayed Release Oral Suspension,
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

Prekės savybės

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM GRANULE, FOR
SUSPENSION, EXTENDED RELEASE
CIPLA USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE
MAGNESIUM FOR DELAYED RELEASE ORAL SUSPENSION SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR ESOMEPRAZOLE MAGNESIUM FOR DELAYED RELEASE
ORAL
SUSPENSION.
ESOMEPRAZOLE MAGNESIUM FOR DELAYED RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
INDICATIONS AND USAGE
Esomeprazole magnesium for delayed release oral suspension is a proton
pump inhibitor (PPI).
Esomeprazole magnesium for delayed release oral suspension is
indicated for the:
Short-term treatment in the healing of erosive esophagitis (EE) in
adults and pediatric patients 1 year
to 17 years of age and of EE due to acid-mediated GERD in pediatric
patients 1 month to less than 1
year 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 1 year 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
POPULATION
RECOMMENDED ADULT (2.1) AND
PEDIATRIC DOSAGE (2.2)
HEALING OF EE (1 YEAR AND OLDER)
EE DUE TO ACID-MEDIATED GERD (1 MONTH TO LESS THAN 1 YEAR)
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
1 month to 11
years
see full prescribing information for weight-based dosing and duration
of treatment (2.2)