OMEPRAZOLE capsule, delayed release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Adı):

OMEPRAZOLE

Kompozisyon:

OMEPRAZOLE 20 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patien

Ürün özeti:

Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’                                                                                                                                                                                                10 mg      and on body ‘R157’ with black ink. Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’                                                                                                    20 mg and body ‘R158’ with black ink. The capsules are supplied in blisterpacks of 30, 31, and 15                                                                                      Blisterpacks of 30                                                                  NDC 0615-2305-39       Blisterpacks of 31                                                                  NDC 0615-2305-31        Blisterpacks of 15                                                                  NDC 0615-2305-05    Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel ’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’                                                                                                  40 mg   and body ‘R159’ with black ink.  The capsules are supplied in blisterpacks of 30 and 15.                                                                                       Blisterpacks of 30                                                              NDC 0615-2302-39       Blisterpacks of 15                                                              NDC 0615-2302-05        Storage           Store  delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OMEPRAZOLE.
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
"INITIAL U.S. APPROVAL:".1989
RECENT MAJOR CHANGES
Warnings and Precautions, Hypomagnesemia (5.7) 06/2011
Warnings and Precautions, 06/2011
Comcomitant Use of omeprazole with St John’s Wort or rifampin (5.8)
Interactions with Diagnostic Investigations for Neuroendocrine Tumors
(5.9)
Warnings and Precautions,
Concomitant use of Omeprazole with Methotrexate (5.10) 01/2012
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for: (1)
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 in pediatric patients < 1
year of age have not been established. (8.4) (1)
DOSAGE AND ADMINISTRATION
INDICATION (2)
OMEPRAZOLE DOSE (2)
FREQUENCY (2)
SHORT-TERM TREATMENT OF ACTIVE
DUODENAL ULCER (2.1) (2)
20 mg (2)
Once daily for 4 weeks. Some patients may require
an additional 4 weeks (2)
_H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.2) (2)
_Triple Therapy:_ (2)
Omeprazole (2)
20 mg (2)
Each drug twice daily for 10 days (2)
Amoxicillin (2)
1000 mg (2)
Clarithromycin (2)
500 mg (2)
_Dual Therapy:_ (2)
Omeprazole (2)
40 mg (2)
Once daily for 14 days (2)
Clarithromycin (2)
500 mg (2)
Three times daily for 14 days (2)
GASTRIC ULCER (2.3) (2)
40 mg (2)
Once daily for 4 to 8 weeks (2)
GERD (2.4) (2)
20 mg (2)
Once daily for 4 to 8 weeks (2)
MAINTENANCE OF HEALING OF EROSIVE
ESOPHAGITIS (2.5) (2)
20 mg (2)
Once daily (2)
PATHOLOGICAL HYPERSECRETORY
CONDITIONS (2.6) (2)
60 mg (varies with
individual patient) (2)
Once daily (2)
PEDIATRIC PATI