OMEPRAZOLE capsule, delayed release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Omeprazole (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9)

Commercializzato da:

Dr. Reddy's Laboratories Limited

INN (Nome Internazionale):

Omeprazole

Composizione:

Omeprazole 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.   Triple 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.   Dual Therapy 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.   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, susce

Dettagli prodotto:

Omeprazole delayed-release capsules USP, 10 mg are off-white to pale yellow, spherical, enteric coated pellets filled in size '4' hard gelatin capsule shells with opaque purple colored cap and opaque yellow colored body imprinted, 'OMERPAZOLE' 10 mg on cap and 'R643' on body with black ink and are supplied in bottles of 30's, 100's, 500's and unit dose package of 100 (10 x 10).   Bottles of 30 NDC 55111-643-30 Bottles of 100 NDC 55111-643-01 Bottles of 500 NDC 55111-643-05 Unit dose package of 100 (10 x 10) NDC 55111-643-78   Omeprazole delayed-release capsules USP, 20 mg are off-white to pale yellow, spherical, enteric coated pellets filled in size '2' hard gelatin capsule shells with opaque purple colored cap and opaque grey colored body,imprinted 'OMEPRAZOLE' 20 mg on cap and 'R644' on body with black ink and are supplied in bottles of 30's, 100's, 500's, 1000's and unit dose package of 7 (7 x 1).   Bottles of 30 NDC 55111-644-30 Bottles of 100 NDC 55111-644-01 Bottles of 500 NDC 55111-644-05 Bottles of 1000 NDC 55111-644-10 Unit dose package of 7 (7 x 1) NDC 55111-644-77   Omeprazole delayed-release capsules USP, 40 mg are off-white to pale yellow, spherical, enteric coated pellets filled in size '1' hard gelatin capsule shells with opaque yellow colored cap and opaque purple colored body, imprinted 'OMEPRAZOLE' 40 mg on cap and 'R645' on body with black ink and are supplied in bottles of 30's, 100's, 500's, and unit dose package of 100 (10 x 10).   Bottles of 30 NDC 55111-645-30 NDC 55111-645-34 Bottles of 100 NDC 55111-645-01 Bottles of 500 NDC 55111-645-05 Unit dose package of 100 (10 x 10) NDC 55111-645-78     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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
Dr. Reddy's Laboratories Limited
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MEDICATION GUIDE
Omeprazole (oh mep' ra zole) Delayed-Release Capsules, USP
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?
You should take omeprazole delayed-release capsules exactly as
prescribed, at the lowest dose possible
and for the shortest time needed.
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 tubulointerstitial nephritis).
Some people who take proton pump
inhibitor (PPI) medicines, including omeprazole delayed-release
capsules, may develop a kidney problem
called acute tubulointerstitial nephritis that can happen at any time
during treatment with omeprazole
delayed-release capsules. Call your doctor right away 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 omepra

Scheda tecnica

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
DR. REDDY'S LABORATORIES LIMITED
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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
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 2 years of age and older
(1.4)
• Maintenance of healing of EE due to acid-mediated GERD in patients
2 years of age and older (1.6)
• Pathologic hypersecretory conditions in adults (1.7)
DOSAGE AND ADMINISTRATION
Indication
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 Gastric Ulcer
40 mg once daily for 4 to 8 weeks (2.1)
Symptomatic GERD
20 mg once daily for up to 4 weeks (2.1) See full prescribing
information for weight based dosing in pediatric patients 2
years of age and older (2.2)
EE due to Acid-Mediated
GERD
20 mg once daily for 4 to 8 weeks (2.1)***
Maintenance of Healing of
EE due to Acid-Mediated
GERD
20 mg once daily (2.1)**** See full prescribing information
for weight based dosing in pediatric patients 2 years of age
and older (2.2)
Pathol