ESOMEPRAZOLE STRONTIUM- esomeprazole strontium capsule, delayed release

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

ParaPRO LLC

INN (International Name):

ESOMEPRAZOLE STRONTIUM

রচনা:

ESOMEPRAZOLE 24.65 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults 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. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer 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 devel

পণ্য সারাংশ:

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. It is available as follows: Unit of use bottles of 30 NDC 52246-200-30 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. It is available as follows: Unit of use bottles of 30 NDC 52246-400-30 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.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

ESOMEPRAZOLE STRONTIUM- ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED
RELEASE
PARAPRO LLC
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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)
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps (5.12) 06/2018
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
INDIC ATIO N
DO SE
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
*Studied for 12 months for Maintenance of Healing of Erosive
Esophagitis
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
In adults, symptomatic response does not preclude the presence of
gastric malignancy. Consider