OMEPRAZOLE- omeprazole capsule, delayed release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Lake Erie Medical DBA Quality Care Products LLC

INN (Algemene Internationale Benaming):

OMEPRAZOLE

Samenstelling:

OMEPRAZOLE 40 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 Delayed-Release Capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In p

Product samenvatting:

Omeprazole Delayed-Release Capsules, 10 mg, are opaque white cap and opaque white body capsules imprinted with "KU" and "114" in black ink. They are supplied as follows: Bottles of 30 NDC 62175-114-32 Bottles of 100 NDC 62175-114-37 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: Bottles of 30 NDC 62175-118-32 Bottles of 100 NDC 62175-118-37 Bottles of 1000 NDC 62175-118-43 Omeprazole Delayed-Release Capsules, 40 mg, are opaque gold cap and opaque gold body capsules imprinted with "KU" and "136" in black ink. They are supplied as follows: Bottles of 30 NDC 62175-136-32 Bottles of 100 NDC 62175-136-37 Bottles of 1000 NDC 62175-136-43 Storage Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Dispense in a tight and light-resistant container.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 USP.
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS
Bone Fracture (5.3)
09/2010
WARNINGS AND PRECAUTIONS
Diminished anti-platelet activity of clopidogrel (5.4)
01/2011
WARNINGS AND PRECAUTIONS
Hypomagnesemia (5.7)
06/2011
WARNINGS AND PRECAUTIONS
Concomitant Use of Omeprazole Delayed-Release
Capsules with St. John's Wort or rifampin (5.8)
Interactions with Diagnostic Investigations for
Neuroendocrine Tumors (5.9)
06/2011
INDICATIONS AND USAGE
Omeprazole Delayed-Release Capsules are a proton pump inhibitor
indicated for:
Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2).
Treatment in adults and children of gastroesophageal reflux disease
(GERD) (1.3) and maintenance of healing of
erosive esophagitis (1.4).
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
TREATMENT OF
AC TIVE
DUODENAL ULCER
(2.1)
20 mg (2)
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:_
Ome prazole
De laye d-Re le ase
Capsule s
20 mg
Each drug twice
daily for 10 days
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Ome prazole
De laye d-Re le ase
Capsule s
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
MAINTENANCE OF
HEALING OF
ERO SIVE
ESO PHAG ITIS
(2.5)
20 mg
Once daily
PATHO LO G IC AL
HYPE RSE C RE TO RY
CO NDITIO NS
(2.6 )
60 mg (varies