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:

Aurobindo Pharma 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 patient

Dettagli prodotto:

Omeprazole Delayed-Release Capsules USP, 10 mg are pink/pink size ‘3’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on pink cap and ‘65’ on pink body with black ink.             Bottles of 30                                       NDC 59651-001-30             Bottles of 100                                     NDC 59651-001-01             Bottles of 1,000                                  NDC 59651-001-99             3 x 10 Unit-dose Capsules                  NDC 59651-001-03             10 x 10 Unit-dose Capsules                NDC 59651-001-78 Omeprazole Delayed-Release Capsules USP, 20 mg are reddish brown/pink size ‘1’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on reddish brown cap and ‘67’ on pink body with black ink.             Bottles of 30                                       NDC 59651-002-30             Bottles of 90                                       NDC 59651-002-90             Bottles of 100                                     NDC 59651-002-01             Bottles of 500                                     NDC 59651-002-05             Bottles of 1,000                                  NDC 59651-002-99             3 x 10 Unit-dose Capsules                  NDC 59651-002-03             10 x 10 Unit-dose Capsules                NDC 59651-002-78 Omeprazole Delayed-Release Capsules USP, 40 mg are reddish brown/reddish brown size ‘0’ hard gelatin capsule filled with white to off-white enteric-coated granules and imprinted with ‘E’ on reddish brown cap and ‘69’ on reddish brown body with black ink.             Bottles of 30                                       NDC 59651-003-30             Bottles of 90                                       NDC 59651-003-90             Bottles of 100                                     NDC 59651-003-01             Bottles of 500                                     NDC 59651-003-05             Bottles of 1,000                                  NDC 59651-003-99             3 x 10 Unit-dose Capsules                  NDC 59651-003-03             10 x 10 Unit-dose Capsules                NDC 59651-003-78 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
Aurobindo Pharma Limited
----------
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?
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 omeprazole de

Scheda tecnica

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
AUROBINDO PHARMA LIMITED
----------
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
* if ulcer present, continue omeprazole delayed-release capsules 20 mg
once daily for an additional 18
days.
** if ulcer present, continue omeprazole delayed-release capsules 20
mg once daily for an additional 14
days.
*** an additional 4 weeks of treatment may be given if no response; if
recurrence additional 4 to 8 week
courses may be considered.
**** studied for 12 months. Reduce the dosage to 10 mg once daily for
patients with hepatic impairment
(Child-Pugh Class A, B, or C) and Asian patients (8.6, 8.7)
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
20 mg
Each drug twice daily for 10 days
(2.1)*
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 (2.1)
Active Benign G