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:

Proficient Rx LP

INN (International Name):

Esomeprazole Magnesium

Composition:

Esomeprazole 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Healing of Erosive Esophagitis 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 erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered.   In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.   Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.   Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GER

Product summary:

Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to brown colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 60's, and 90's. Bottles of 30 NDC 63187-964-30 Bottles of 60 NDC 63187-964-60 Bottles of 90 NDC 63187-964-90 Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided. 

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
Proficient Rx LP
----------
Esomeprazole Magnesium Delayed-Release Capsules, USP
(es" oh mep' ra zole mag nee' zee um)
Read the Medication Guide that comes with esomeprazole magnesium
delayed-release capsules before you
start taking esomeprazole magnesium delayed-release capsules 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
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:
1.
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including esomeprazole magnesium delayed-release
capsules, may develop a kidney
problem called acute interstitial nephritis that can happen at any
time during treatment with
esomeprazole magnesium delayed-release capsules. Call your doctor if
you have a decrease in the
amount that you urinate or if you have blood in your urine.
2.
Diarrhea. Esomeprazole magnesium delayed-release capsules 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.
1.
Bone fractures. People who take multiple daily doses of PPI 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
esomeprazole magnesium delayed-release capsules 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

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
PROFICIENT RX LP
----------
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)
RECENT MAJOR CHANGES
Warnings and Precautions, Atrophic Gastritis (5.2) removed. 10/2016
Warnings and Precautions, Cutaneous and Systemic 10/2016
Lupus Erythematosus (5.5)
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsule USP is a proton pump
inhibitor indicated for the
following:
1.
2.
3.
DOSAGE AND ADMINISTRATION INDICATION
DOSE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
12 to 17 years
1 to 11 years
20 mg or 40mg
20 mg or 40 mg
10 mg or 20 mg
Once daily for 4 to 8 weeks
Once daily for up to 8 weeks
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
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
2.
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis have
occurred) (4)
WARNINGS AND PRECAUTIONS
1.
2.
3.
4.
5.
Treatment of gastroesophageal reflux disease (GERD) (1.1)
Risk reduction of NSAID-associated gastric ulcer (1.2)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome (1.4)
Esomeprazole magnesium Delayed-Release Capsules: 20 mg and 40 mg (3)
Gastric Malignancy:In adults, symptomatic response does not preclude
the presence of gastric
malignancy.