OMEPRAZOLE capsule, delayed release pellets

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)

Tilgjengelig fra:

Contract Pharmacy Services-PA

INN (International Name):

OMEPRAZOLE

Sammensetning:

OMEPRAZOLE 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Omeprazole Delayed-Release Capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole Delayed-Release Capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. Omeprazole Delayed-Release Capsules, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2) ]. Among patients who fail therapy, omeprazole with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy,

Produkt oppsummering:

Omeprazole Delayed-Release Capsules, 20 mg, are opaque white cap and opaque gold body capsules imprinted with “KU” and “118” in black ink. They are supplied as follows: Blisters of 30 Capsules NDC 67046-520-30 Blisters of 60 Capsules NDC 67046-520-60 Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
CONTRACT PHARMACY SERVICES-PA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE DELAYED-RELEASE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OMEPRAZOLE DELAYED-RELEASE CAPSULES.
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage, Treatment of Gastroesophageal Reflux Disease
(1.3) 03/2008
Dosage and Administration, Pediatric Patients (2.7) 03/2008
INDICATIONS AND USAGE
Omeprazole Delayed-Release Capsules are a proton pump inhibitor
indicated for:
Treatment of duodenal ulcer in adults (1.1)
Treatment of gastric ulcer in adults (1.2)
Treatment of gastroesophageal reflux disease (GERD) in pediatric
patients and adults (1.3)
Maintenance of healing of erosive esophagitis in pediatric patients
and adults (1.4)
Treatment of pathological hypersecretory conditions in adults (1.5)
The safety and effectiveness of Omeprazole Delayed-Release Capsules in
pediatric patients < 1 year of age have not been
established. (8.4)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
OMEPRAZOLE DOSE
FREQUENCY
SHORT-TERM TREATMENT OF ACTIVE
DUO DENAL
ULCER (2.1)
20 mg
Once daily for 4 weeks. Some patients
may require an additional 4 weeks
_H. PYLORI _ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.2)
_Triple Therapy:_
Omeprazole Delayed-Release Capsules
20 mg
Each drug twice daily for 10 days
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Omeprazole Delayed-Release Capsules
40 mg
Once daily for 14 days
Clarithromycin
500 mg
Three times daily for 14 days
GASTRIC ULCER (2.3)
40 mg
Once daily for 4 to 8 weeks
GERD (2.4)
20 mg
Once daily for 4 to 8 weeks
MAINTENANCE OF HEALING OF EROSIVE
ESOPHAGITIS (2.5)
20 mg
Once daily
PATHOLOGICAL HYPERSECRETORY CONDITIONS
(2.6 )
60 mg (varies with
individual patient)
Once daily
PEDIATRIC PATIENTS (2
TO 16 YEARS OF AGE) (2.7)
GERD
AND MAINTENANCE OF HEALING OF
EROSIVE ESOPHAGITIS
Weight Dose
10 < 20 kg 10 mg
≥ 20 kg 20