OMEPRAZOLE - omeprazole capsule, delayed release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lake Erie Medical DBA Quality Care Products LLC

INN (Tarptautinis Pavadinimas):

OMEPRAZOLE

Sudėtis:

OMEPRAZOLE 20 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within 4 weeks. Some patients may require an additional 4 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 one 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 pati

Produkto santrauka:

Omeprazole Delayed-Release Capsules, USP are available in the following strength: 20 mg. 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. They are supplied as follows: 35356-811-30 Bottle of 30 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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, USP
INITIAL U.S. APPROVAL: 1989
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for:
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)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
OMEPRAZOLE DOSE
FREQUENCY
TREATMENT OF ACTIVE DUODENAL
ULCER (2.1)
20 mg
Once daily for 4 weeks. Some patients
may require an additional 4 weeks
_H. PYLORI_ ERADICATION TO REDUCE THE
RISK OF DUODENAL ULCER RECURRENCE
(2.2)
_Triple Therapy:_
Ome prazole
20 mg
Each drug twice
Amoxicillin
1000 mg
daily for 10 days
Clarithromycin
500 mg
_Dual Therapy:_
Ome prazole
40 mg
Once daily for 14 days
Clarithromycin
500 mg
Three times daily for 14 days
GASTRIC ULCER (2.3)
40 mg
Once daily for 4 to 8 weeks
GERD (2.4)
20 mg
Once daily for 4 to 8 weeks
MAINTENANCE OF HEALING OF EROSIVE
ESOPHAGITIS (2.5)
20 mg
Once daily
PATHOLOGICAL HYPERSECRETORY
CONDITIONS (2.6)
60 mg (varies with individual
patie nt)
Once daily
PEDIATRIC PATIENTS (2 TO 16 YEARS OF
AGE) (2.7) GERD AND MAINTENANCE
OF HEALING OF EROSIVE ESOPHAGITIS
We ight
10 < 20 kg
≥ 20 kg
Dose
10 mg
20 mg
Once daily
DOSAGE FORMS AND STRENGTHS
Omeprazole Delayed-Release Capsules, 10 mg, 20 mg and 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or
substituted benzimidazoles (angioedema and anaphylaxis
have occurred) (4)
WARNINGS AND PRECAUTIONS
Symptomatic response does not preclude the presence of gastric