ESOMEPRAZOLE MAGNESIUM granule, delayed release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Zydus Pharmaceuticals USA Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 weeks) o

Resumen del producto:

Esomeprazole magnesium for delayed-release oral suspension, 20 mg or 40 mg - unit dose packet contains white to pale brown esomeprazole pellets and pale red to red inactive granules. Esomeprazole magnesium for delayed-release oral suspension unit dose packets are supplied as follows: NDC 68382-848-94 unit dose child-resistant packages of 30: 20 mg packets NDC 68382-849-94 unit dose child-resistant packages of 30: 40 mg packets Storage Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Zydus Pharmaceuticals USA Inc.
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SPL MEDGUIDE
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.
•
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 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 on your cheeks or arms that gets
worse in the
sun.
Talk

Ficha técnica

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED
RELEASE
ZYDUS PHARMACEUTICALS USA INC.
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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 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)
Esomeprazole magnesium for delayed-release oral suspension is
indicated for the:
Short-term treatment in the healing of EE in pediatric patients 1 year
to 11 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)
Short-term treatment of heartburn and other symptoms associated with
GERD in pediatric patients 1
year to 11 years of age. (1.3)
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