NEXIUM- esomeprazole magnesium capsule, delayed release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

REMEDYREPACK INC.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Adults NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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 NEXIUM may be considered. Pediatric Patients 12 Years to 17 Years of Age NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension 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. Pediatric Patients 1 Year to 11 Years of Age NEXIUM 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 NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediat

Rezumat produs:

NEXIUM Delayed-Release Capsules, 40 mg esomeprazole, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows: NDC: 70518-2038-00 PACKAGING: 20 in 1 BOTTLE PLASTIC Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM delayed-release capsules container tightly closed. Dispense in a tight container if the NEXIUM delayed-release capsules product package is subdivided. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statutul autorizaţiei:

New Drug Application

Prospect

REMEDYREPACK INC.
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MEDICATION GUIDE
NEXIUM ® (nex-e-um) NEXIUM ® (nex-e-um)
(esomeprazole magnesium) (esomeprazole magnesium)
delayed-release capsules, for oral use for delayed-release oral
suspension
What is the most important information I should know about NEXIUM?
NEXIUM may help your acid-related symptoms, but you could still have
serious stomach problems. Talk
with your doctor.
NEXIUM can cause serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including NEXIUM, may develop a kidney
problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with NEXIUM. 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 NEXIUM, 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.
NEXIUM can have other serious side effects. See “ What are the
possible side effects of NEXIUM?”
What is NEXIUM?
A prescription medicine called a proton pump inhibitor (PPI) used to
reduce the amount

Caracteristicilor produsului

NEXIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NEXIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NEXIUM.
NEXIUM (ESOMEPRAZOLE MAGNESIUM) DELAYED-RELEASE CAPSULES, FOR ORAL USE
NEXIUM (ESOMEPRAZOLE MAGNESIUM) FOR DELAYED-RELEASE ORAL SUSPENSION
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
NEXIUM is a proton pump inhibitor (PPI).
NEXIUM delayed-release capsules and NEXIUM 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)
NEXIUM 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)