OMEPRAZOLE DELAYED-RELEASE- omeprazole capsule, delayed release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Ranbaxy Laboratories Inc.

INN (nume internaţional):

OMEPRAZOLE

Compoziție:

OMEPRAZOLE 40 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Omeprazole delayed-release capsules is 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.

Rezumat produs:

Omeprazole delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethystcolored capsules, coded 1740 on cap and 40 mg on the body. They are supplied as follows: NDC 63304-445-30 unit of use bottles of 30 NDC 63304-445-01 bottles of 100 NDC 63304-445-10 bottles of 1000. Storage 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).

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

OMEPRAZOLE DELAYED-RELEASE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
RANBAXY LABORATORIES INC.
----------
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
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: (1)
• Treatment of duodenal ulcer in adults (1.1) (1)
• Treatment of gastric ulcer in adults (1.2) (1)
• Treatment of gastroesophageal reflux disease (GERD) in pediatric
patients and adults (1.3) (1)
• Maintenance of healing of erosive esophagitis in pediatric
patients and adults (1.4) (1)
• Treatment of pathological hypersecretory conditions in adults
(1.5) (1)
The safety and effectiveness of omeprazole delayed-release capsules in
pediatric patients < 1 year of age have not been
established. (8.4) (1)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
OMEPRAZOLE DOSE
Fre que ncy
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:_
Ome prazole
20 mg
Each drug twice daily for 10 days
Amoxicillin
1000 mg
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 (1 TO 16 YEARS OF AGE)
(2.7)GERDand Maintenance of Healing of Erosive
Esophagitis
Weight 5 < 10 kg
10 < 2