OMEPRAZOLE capsule, delayed release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Rebel Distributors Corp

INN (Rahvusvaheline Nimetus):

Omeprazole

Koostis:

Omeprazole 10 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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, 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, 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 with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In pa

Toote kokkuvõte:

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 body ‘R157’ with black ink. The capsules are supplied in bottles of 60 and 120.                                                                                   Bottles of 60                                                                  NDC 42254-043-60        Bottles of 120                                                                NDC 42254-043-72          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 bottles of 30, 100, 1000 and unit-dose packages of 10 x 10.                                                                                       Bottles of 7                                                                   NDC 42254-053-07   Bottles of 14                                                                  NDC 42254-053-14 Bottles of 30                                                                  NDC 42254-053-30      Bottles of 60                                                                NDC 42254-053-60         Bottles of 90                                                               NDC 42254-053-90         Bottles of 120                                                               NDC 42254-053-72               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].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
REBEL DISTRIBUTORS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEPRAZOLE DELAYED-RELEASE CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SEE FULL PRESCRIBING INFORMATION FOR USE
INITIAL U.S. APPROVAL: 2007
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 is a proton pump inhibitor indicated for: (2)
The safety and effectiveness of omeprazole in pediatric patients < 1
year of age have not been established. (8.4) (2)
DOSAGE AND ADMINISTRATION
INDICATION (3)
OMEPRAZOLE DOSE (3)
FREQUENCY (3)
SHORT-TERM TREATMENT
OF ACTIVE DUODENAL
ULCER (2.1) (3)
20 mg (3)
Once daily for 4 weeks. Some patients
may require an additional 4 weeks (3)
_H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.2) (3)
_Triple Therapy:_ (3)
Omeprazole (3)
20 mg (3)
Each drug twice daily for 10 days (3)
Amoxicillin (3)
1000 mg (3)
Clarithromycin (3)
500 mg (3)
_Dual Therapy:_ (3)
Omeprazole (3)
40 mg (3)
Once daily for 14 days (3)
Clarithromycin (3)
500 mg (3)
Three times daily for 14 days (3)
GASTRIC ULCER (2.3) (3)
40 mg (3)
Once daily for 4 to 8 weeks (3)
GERD (2.4) (3)
20 mg (3)
Once daily for 4 to 8 weeks (3)
MAINTENANCE OF HEALING
OF EROSIVE ESOPHAGITIS
(2.5) (3)
20 mg (3)
Once daily (3)
PATHO LO G IC AL
HYPE RSE C RE TO RY
CONDITIONS (2.6) (3)
60 mg (varies with individual patient) (3)
Once daily (3)
PEDIATRIC PATIENTS (2 TO
16 YEARS OF AGE) (2.7)
(3)
GERD (3)
AND MAINTENANCE OF
HEALING OF EROSIVE
ESOPHAGITIS (3)
Weight (3)
10 < 20 kg (3)
> 20 kg (3)
Dose (3)
10 mg (3)
20 mg (3)
Once daily (3)
DOSAGE FORMS AND STRENGTHS
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 o