OMEPRAZOLE DELAYED-RELEASE- omeprazole capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DOH CENTRAL PHARMACY

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ther

Product summary:

Omeprazole delayed-release capsules USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink.   Omeprazole delayed-release capsules USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink.  Omeprazole delayed-release capsules USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store omeprazole delayed-release capsules in a tight container protected from light and moisture.   Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OMEPRAZOLE DELAYED-RELEASE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE DELAYED-RELEASE . SEE FULL
PRESCRIBING INFORMATION FOR OMEPRAZOLE DELAYED-RELEASE . INITIAL U.S.
APPROVAL 1989
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:
• 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 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 PATIENTS (1 TO 16 YEARS OF
AGE) (2.7) (2)
GERD (2)
AND MAINTENANCE OF HEALING OF
EROSIVE ESOPHAGITIS (2)
Weight (2)
5 < 1