OMEPRAZOLE capsule delayed release pellets

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Omeprazole (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9)

Dostupno od:

KAISER FOUNDATION HOSPITALS

INN (International ime):

Omeprazole

Sastav:

Omeprazole 40 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
KAISER FOUNDATION HOSPITALS
----------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 DUODENAL ULCER (ADULTS)
Omeprazole delayed-release capsules USP 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 USP in combination with
clarithromycin and amoxicillin, is
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 USP in combination with
clarithromycin is 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
USP with clarithromycin is
more likely to be associated with the development of clarithromycin
resistance as compared with triple
therapy. In patients who fail therapy, susceptibility testing should
be done. If resistance to
clarithromycin is demonstrated or susceptibility testing is not
possible, alternative antimicrobial therapy
should be instituted. [_See Microbiology section (12.4)_], and the
clarithromycin package insert,
Microbiology section.)
1.2 GASTRIC ULCER (ADULTS)
Omeprazole delayed-release capsules USP are indicated for short-term
treatment (4 to 8 weeks) of
active benign gastric ulcer in adults. [_See Clinical Studies (14.2)_]
1.3 TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD) (ADULTS AND
PEDIATRIC PATIENTS)
_Symptomatic GERD_
Omeprazole delayed-release capsules USP are indicated for the
treatment of heartburn and other
symptoms associated with GERD in pediatric patients and adults.
_Erosive Esophagitis_
Omeprazole delayed-release caps