OMEPRAZOLE- omeprazole capsule, delayed release

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Mylan Institutional Inc.

INN (इंटरनेशनल नाम):

OMEPRAZOLE

रचना:

OMEPRAZOLE 20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. 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. 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 patients who fail therapy, susceptibility testing should be done. If

उत्पाद समीक्षा:

Omeprazole Delayed-Release Capsules, USP are available containing 20 mg of omeprazole, USP. The 20 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a blue-green opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6150 in white ink both on the cap and the body. They are available as follows: NDC 51079-007-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. PHARMACIST: Dispense a Medication Guide with each prescription.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Mylan Institutional Inc.
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MEDICATION GUIDE
Omeprazole Delayed-Release Capsules, USP
(oh mep' ra 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:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including omeprazole delayed-release
capsules, may develop a kidney
problem called acute interstitial nephritis that can happen at any
time during treatment with
omeprazole delayed-release capsules. Call your doctor if you have a
decrease in the amount that
you urinate or if you have blood in your urine.
•
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 PPI 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.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the
body’s immune cells attack other cells or organs in the body). Some
people who take PPI
m

उत्पाद विशेषताएं

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
MYLAN INSTITUTIONAL INC.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Indications and Usage, Treatment of Erosive Esophagitis (EE) due to
Acid-Mediated GERD ( 1.5) 02/2016
Dosage and Administration, Recommended Pediatric Dosage Regimen by
Indication ( 2.2) 02/2016
Contraindications ( 4) 02/2016
Warnings and Precautions, Atrophic Gastritis (5.2) removed 10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (
5.5) 10/2016
INDICATIONS AND USAGE
Omeprazole is 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 1 year of age and older ( 1.4)
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in
patients 1 month of age and older ( 1.5)
Maintenance of healing of EE due to acid-mediated GERD in patients 1
year 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
Amoxicillin
Clarithromycin
20 mg
1000 mg
500 mg
Each drug twice daily for 10 days ( 2.1)*
_Dual Therapy:_
Omeprazole Delayed-Release Capsules
Clarithromycin
40 mg once daily for 14 days**
500 mg three times daily for 14 days ( 2.1)
Active Benign Ga