OMEPRAZOLE/SODIUM BICARBONATE- omeprazole and sodium bicarbonate powder, for suspension

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9), SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

थमां उपलब्ध:

Bryant Ranch Prepack

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Omeprazole and sodium bicarbonate for oral suspension are indicated in adults for the: - short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. - short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. o The efficacy of omeprazole and sodium bicarbonate for oral suspension used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazol

उत्पाद समीक्षा:

Omeprazole and sodium bicarbonate is supplied as: Omeprazole and Sodium Bicarbonate for Oral Suspension is a white to off white, granular powder packaged in individual dose packets. Each packet contains 40 mg omeprazole and 1680 mg sodium bicarbonate. NDC: 63629-2243-1: Cartons of 30: 40 mg/1680 mg unit dose packets Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

OMEPRAZOLE/SODIUM BICARBONATE- OMEPRAZOLE AND SODIUM
BICARBONATE POWDER, FOR SUSPENSION
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE AND
SODIUM BICARBONATE FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION.
OMPERAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Contraindications (4) 09/2019
INDICATIONS AND USAGE
Omeprazole and sodium bicarbonate for oral suspension is a proton pump
inhibitor (PPI) (1)
Omeprazole and sodium bicarbonate for oral suspension is indicated in
adults for: (1)
Treatment of active duodenal ulcer (1) (1)
Treatment of active benign gastric ulcer (1) (1)
Treatment of erosive esophagitis (EE) due to acid-mediated
gastroesophageal reflux disease (GERD)
(1) (1)
Maintenance of healing of EE (1) (1)
Omeprazole and sodium bicarbonate for oral suspension is indicated in
adults for: (1)
Reduction of risk of upper gastrointestinal (GI) bleeding in
critically ill patients (1)
DOSAGE AND ADMINISTRATION
(2)
INDICATION (2)
RECOMMENDED ADULT DOSAGE (2)
OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION (2)
Active Duodenal Ulcer (2)
20 mg once daily for 4 weeks; some patients may require an
additional 4 weeks (2)
Active Benign Gastric Ulcer (2)
40 mg once daily for 4 to 8 weeks (2)
Treatment of Symptomatic GERD (2)
20 mg once daily for up to 4 weeks (2)
Treatment of EE due to Acid-Mediated
GERD (2)
20 mg once daily for 4 to 8 weeks* (2)
Maintenance of Healing of EE due to
Acid-Mediated GERD (2)
20 mg once daily** (2)
40 MG OMEPRAZOLE AND SODIUM BICARBONATE FOR ORAL SUSPENSION (2)
Reduction of Risk of Upper GI Bleeding in
Critically Ill Patients (2)
40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg
once daily thereafter for 14 days (2)
* an additional 4 weeks of treatment may be given if no response; if
recurrence additional 4 to 8-week
courses may be considere