OMEPRAZOLE capsule, delayed release pellets

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Golden State Medical Supply, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple 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. Dual Therapy 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. Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance

Povzetek izdelek:

Omeprazole Delayed-release Capsules USP, 40 mg are HPMC capsules with lavender cap and white body, filled with white to grayish pellets, imprinted with “TEVA” on the cap and “5294” on the body. They are supplied as follows: Bottles of 90 (NDC 60429-974-90), and 500 (NDC 60429-974-05). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light and moisture.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Revised: 12/2019
Document Id: 99769ef2-433f-9a24-e053-2995a90adf8e
34391-3
Set id: 9df708e0-aa16-4fad-bc1d-82a7316d24b5
Version: 3
Effective Time: 20191211
Golden State Medical Supply, Inc.

Lastnosti izdelka

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEPRAZOLE DELAYED-RELEASE CAPSULES
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.
OMEPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps ( 5.12) 01/2018
INDICATIONS AND USAGE
Omeprazole delayed-release capsules are a proton pump inhibitor (PPI)
indicated for the:
Treatment of active duodenal ulcer in adults ( 1.1)
Eradication of _Helicobacter pylori_ to reduce the risk of duodenal
ulcer recurrence in adults ( 1.2)
Treatment of active benign gastric ulcer in adults ( 1.3)
Treatment of symptomatic gastroesophageal reflux disease (GERD) in
patients 2 years of age and older ( 1.4)
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in
patients 2 years of age and older ( 1.5)
Maintenance of healing of EE due to acid-mediated GERD in patients 2
years of age and older ( 1.6)
Pathologic hypersecretory conditions in adults ( 1.7)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
RECOMMENDED ADULT ( 2.1) AND PEDIATRIC DOSAGE ( 2.2)
Treatment of Active Duodenal Ulcer
20 mg once daily for 4 weeks; some patients may require an
additional 4 weeks ( 2.1)
_H. pylori_ Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
_Triple Therapy:_
Omeprazole delayed-release capsules
20 mg
Each drug twice daily for 10
days ( 2.1)
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Omeprazole delayed-release capsules
40 mg once daily for 14 days
Clarithromycin
500 mg three times daily for 14 days ( 2.1)
Active Benign Gastric Ulcer
40 mg once daily for 4 to 8 weeks ( 2.1)
Symptomatic GERD
20 mg once daily for up to 4 weeks ( 2.1) See full prescribing
information for weight based dosing in pediatric patients 2
years of age and older ( 2.2)
EE due to Acid