ESOMEPRAZOLE STRONTIUM capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESOMEPRAZOLE STRONTIUM (UNII: C5N25H3803) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

ESOMEPRAZOLE STRONTIUM

Composition:

ESOMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Healing of Erosive Esophagitis Esomeprazole strontium 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 esomeprazole strontium may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Esomeprazole strontium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk either due to their age (≥60) and/or documented history of gastric ul

Product summary:

Esomeprazole strontium delayed-release capsules, 24.65 mg (equivalent to 20 mg of esomeprazole), are hard capsules with light pink cap and body containing off-white to pale brown granules with HMP 20 printed in black ink. They are available as follows: Unit of use bottles of 30         NDC 53746-955-03 Esomeprazole strontium delayed-release capsules, 49.3 mg (equivalent to 40 mg of esomeprazole), are hard capsules with dark pink cap and body containing off-white to pale brown granules with HMP 40 printed in black ink. They are available as follows: Unit of use bottles of 30         NDC 53746-957-03 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep esomeprazole strontium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole strontium delayed-release capsules product package is subdivided.

Authorization status:

New Drug Application

Patient Information leaflet

ESOMEPRAZOLE STRONTIUM- ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED
RELEASE
Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
ESOMEPRAZOLE STRONTIUM (es-o-mep-ra-zol stron-tee-um)
delayed-release capsules
Read the Medication Guide that comes with esomeprazole strontium
before you start taking esomeprazole
strontium 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 strontium?
Esomeprazole strontium may help your acid-related symptoms, but you
could still have serious stomach
problems. Talk with your doctor.
Esomeprazole strontium can cause serious side effects, including:
•
Diarrhea. Esomeprazole strontium 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 esomeprazole strontium 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 esomeprazole strontium.
Esomeprazole strontium can have other serious side effects. See
“What are the possible side effects of
esomeprazole strontium?”
What is esomeprazole strontium?
Esomeprazole strontium is a prescription medicine called a proton pump
inhibitor (PPI).
Esomeprazole strontium reduces the amount of acid in your stomach.
Esomeprazole strontium is used in adults:
•
for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux
disease (GERD). Esomeprazole
strontium may also be prescribed to heal acid-related damage to the
lining of the

Summary of Product characteristics

ESOMEPRAZOLE STRONTIUM- ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED
RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE
STRONTIUM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ESOMEPRAZOLE
STRONTIUM.
ESOMEPRAZOLE STRONTIUM DELAYED-RELEASE CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
INDICATIONS AND USAGE
Esomeprazole strontium is a proton pump inhibitor indicated for adults
for:
Treatment of gastroesophageal reflux disease (GERD) (1.1)
Risk reduction of NSAID-associated gastric ulcer (1.2)
_H. pylori_ eradication to reduce the risk of duodenal ulcer
recurrence (1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome (1.4)
DOSAGE AND ADMINISTRATION
INDICATION
DOSE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
24.65 or 49.3 mg
Once daily for 4-8 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
Adults
24.65 or 49.3
mg
Once daily for up to 6
months
_H. PYLORI_ ERADICATION (TRIPLE THERAPY) IN ADULTS:
Esomeprazole
strontium
49.3 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
Adults
49.3 mg
Twice daily
See full prescribing information for full dosage and administration
(2)
Patients with severe liver impairment: do not exceed dose of 24.65 mg
(2)
DOSAGE FORMS AND STRENGTHS
_Delayed-Release Capsules (3):_
24.65 mg of esomeprazole strontium (equivalent to 20 mg of
esomeprazole)
49.3 mg of esomeprazole strontium (equivalent to 40 mg of
esomeprazole)
CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis have
occurred) (4)
WARNINGS AND PRECAUTIONS
Symptomatic response does not preclude the presence of gastric
malignancy (5.1)
Atrophic gastritis has been noted with long-term omeprazole therapy
(5.2)
PPI therapy may be associated with increased risk of _Clostridium
diffi