OMEPRAZOLE- omeprazole capsule, delayed release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NCS HealthCare of KY, Inc dba Vangard Labs

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Omeprazole delayed-release capsules, USP 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 [seeCLINICAL STUDIES ( 14.1 ) andDOSAGE 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

Proizvod sažetak:

Omeprazole delayed-release capsules USP, 10 mg, are light brown cap and light brown body, each imprinted with "OME 10".  Omeprazole delayed-release capsules USP, 20 mg, are white cap and white body, each imprinted with "OME 20".They are supplied as follows: NDC 0615-7933-39, blisterpacks of 30 capsules  NDC 0615-7933-31, blisterpacks of 31 capsules  NDC 0615-7933-05, blisterpacks of 15 capsules  NDC 0615-7933-14, blisterpacks of 14 capsules Omeprazole delayed-release capsules USP, 40 mg are white opaque colored cap, light brown colored body, hypromellose capsules, coded OME 40 on cap and body.  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). [See USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
Omeprazole Delayed-Release Capsules, USP
(oh-MEE-pray-zole)
Read this Medication Guide before you start taking omeprazole
delayed-release capsules and each time you
get a refill. There may be new information. This information does not
take the place of talking with your
doctor about your medical condition or your treatment.
What is the most important information I should know about omeprazole
delayed-release capsules?
Omeprazole delayed-release capsules may help your acid-related
symptoms, but you could still have serious
stomach problems. Talk with your doctor.
Omeprazole delayed-release capsules can cause serious side effects,
including:
•
•Diarrhea. Omeprazole delayed-release capsules may increase your
risk of getting severe diarrhea.
This diarrhea may be caused by an infection (Clostridium difficile) in
your intestines.
•
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go away.
•
•Bone fractures. People who take multiple daily doses of proton pump
inhibitor medicines for a long
period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist, or spine.
You should take omeprazole delayed-release capsules exactly as
prescribed, at the lowest dose
possible for your treatment and for the shortest time needed. Talk to
your doctor about your risk of
bone fracture if you take omeprazole delayed-release capsules.
Omeprazole delayed-release capsules can have other serious side
effects. See “What are the possible side
effects of omeprazole delayed-release capsules?”
What are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules are a prescription medicine called
a proton pump inhibitor (PPI).
Omeprazole delayed-release capsules reduces the amount of acid in your
stomach.
Omeprazole delayed-release capsules are used in adults:
•
•for up to 8 weeks for the healing of duodenal ulcers. The duodenal
a

Svojstava lijeka

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
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, FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions, Interactions with Diagnostic
Investigations for Neuroendocrine Tumors (5.8) 03/2014
Indications and Usage, Treatment of Gastroesophageal Reflux
Disease (GERD) (adults and pediatric patients) (1.3) 12/2014
Dosage and Administration, Maintenance of Healing of Erosive
Esophagitis (2.5) 12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014
Warnings and Precautions, Cyanocobalamin (vitamin B-12)
Deficiency (5.4) 12/2014
INDICATIONS AND USAGE
Omeprazole delayed-release capsule, USP 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)
•Pathologic Hypersecretory Conditions (1.5)
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 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*