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 a proton pump inhibitor indicated for: The safety and effectiveness of Omeprazole Delayed-Release Capsules in pediatric patients < 1 year of age have not been established. (8.4 ) 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 Admini

Toote kokkuvõte:

Omeprazole Delayed-Release Capsules, 10 mg, are opaque white cap and opaque white body capsules imprinted with “KU” and “114” in black ink. They are supplied as follows: Bottles of 30 NDC 21695-097-30 Bottles of 60 NDC 21695-097-60 Bottles of 120 NDC 21695-097-72 Omeprazole Delayed-Release Capsules, 20 mg, are opaque white cap and opaque gold body capsules imprinted with “KU” and “118” in black ink. They are supplied as follows: Bottles of 7  NDC 21695-098-07 Bottles of 10 NDC 21695-098-10 Bottles of 14 NDC 21695-098-14 Bottles of 15 NDC 21695-098-15 Bottles of 30 NDC 21695-098-30 Bottles of 60 NDC 21695-098-60 Bottles of 90 NDC 21695-098-90 Bottles of 120 NDC 21695-098-72 Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
REBEL DISTRIBUTORS CORP.
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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.
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage, Treatment of Gastroesophageal Reflux Disease
(1.3) 03/2008
Dosage and Administration, Pediatric Patients (2.7) 03/2008
DOSAGE AND ADMINISTRATION
INDIC ATIO N
OMEPRAZOLE DOSE
FREQUENCY
SHORT-TERM 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:_
Omeprazole Delayed-Release Capsules
20 mg
Each drug twice daily for 10 days
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
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 (4)
WARNINGS AND PRECAUTIONS
Concomitant Gastric Malignancy: Symptomatic response to therapy with
Omeprazole Delayed-Release Capsules does not
preclude the presence of gastric malignancy (5.1)
Atrophic Gastritis: Has been observed in gastric corpus biopsies from
patients treated long-term with Omeprazole
Delayed-Release Capsules (5.2)
Combination Use with Clarithromycin and/or Amoxicillin: Refer to