NEXIUM- 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:

Cardinal Health

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Healing of Erosive Esophagitis NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. 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. In infants 1 month to less than 1 year, NEXIUM is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD. Maintenance of Healing of Erosive Esophagitis NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patient

Product summary:

NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows: NDC 0186-5020-31 unit of use bottles of 30 NDC 0186-5022-28 unit dose packages of 100 NDC 0186-5020-54 bottles of 90 NDC 0186-5020-82 bottles of 1000 NEXIUM Delayed-Release Capsules, 40 mg, 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 0186-5040-31 unit of use bottles of 30 NDC 0186-5042-28 unit dose packages of 100 NDC 0186-5040-54 bottles of 90 NDC 0186-5040-82 bottles of 1000 NDC 0186-5040-35 unit of use bottles of 30 NDC 0186-5042-25 unit dose packages of 100 NDC 0186-5040-55 bottles of 90 NDC 0186-5040-85 bottles of 1000 NEXIUM 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. NEXIUM unit dose packets are supplied as follows: NDC 0186-4025-01 unit dose packages of 30: 2.5 mg packets NDC 0186-4050-01 unit dose packages of 30: 5 mg packets NDC 0186-4010–01 unit dose packages of 30: 10 mg packets NDC 0186-4020–01 unit dose packages of 30: 20 mg packets NDC 0186-4040–01 unit dose packages of 30: 40 mg packets 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.

Authorization status:

New Drug Application

Patient Information leaflet

NEXIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
Cardinal Health
----------
MEDICATION GUIDE
NEXIUM® (nex-e-um)
(esomeprazole magnesium)
Delayed-Release Capsules
NEXIUM® (nex-e-um)
(esomeprazole magnesium)
For Delayed-Release
Oral Suspension
Read the Medication Guide that comes with NEXIUM before you start
taking NEXIUM and each time
you get a refill. There may be new information. This information does
not take the place of talking with
your doctor about your medical condition or your treatment.
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:
•
Diarrhea. NEXIUM may increase your risk of getting severe diarrhea.
This diarrhea may be caused
by an infection (Clostridium difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go
away.
•
Bone fractures. People who take multiple daily doses of Proton Pump
Inhibitor medicines for a long
period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist, or spine.
You should take NEXIUM exactly as prescribed, at the lowest dose
possible for your treatment and
for the shortest time needed. Talk to your doctor about your risk of
bone fracture if you take
NEXIUM.
NEXIUM can have other serious side effects. See “ What are the
possible side effects of
NEXIUM?”
What is NEXIUM?
NEXIUM is a prescription medicine called a proton pump inhibitor
(PPI). NEXIUM reduces the amount
of acid in your stomach.
NEXIUM is used in adults:
•
for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux
disease (GERD). NEXIUM may
also be prescribed to heal acid-related damage to the lining of the
esophagus (erosive esophagitis),
and to help continue this healing.
•
GERD happens when acid in your stomach backs up into the tube
(esophagus) that connects your
mouth to your stomach. This may cause a

Summary of Product characteristics

NEXIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
CARDINAL HEALTH
----------
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, Interaction with Clopidogrel (5.4) 10/2012
Warnings and Precautions, Clostridium difficile associated diarrhea
(5.3) 09/2012
Warnings and Precautions, Concomitant use of NEXIUM with Methotrexate
(5.9) 01/2012
Indications and Usage, Treatment of GERD (1.1) 12/2011
Dosage and Administration (2) 12/2011
INDICATIONS AND USAGE
NEXIUM is a proton pump inhibitor indicated for the following:
•
•
•
•
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
20 mg or 40 mg
Once daily for 4 to 8 weeks
12 to 17 years
20 mg or 40 mg
Once daily for up to 8 weeks
1 to 11 years
10 mg or 20 mg
Once daily for up to 8 weeks
1 month to less than 1 year: 2.5 mg, 5 mg or 10 mg (based on weight).
Once daily, up to 6 weeks for erosive esophagitis
(EE) due to acid-mediated GERD only.
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
20 mg or 40 mg
Once daily for up to 6 months
_H. PYLORI_ ERADICATION_ (Triple Therapy):_
NEXIUM
40 mg
Once daily for 10 days
Amoxicillin
1000 mg
Twice daily for 10 days
Clarithromycin
500 mg
Twice daily for 10 days
PATHOLOGICAL HYPERSECRETORY CONDITIONS
40 mg
Twice daily
See full prescribing information for administration options (2)
Patients with severe liver impairment-do not exceed dose of 20 mg (2)
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis have occurred) (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•Treatment of gastroesophageal reflux disease (GERD) (1.1)
•Risk re