OMEPRAZOLE capsule, delayed release

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Glenmark Pharmaceuticals Inc., USA

ИНН (Международная Имя):

OMEPRAZOLE

состав:

OMEPRAZOLE 10 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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, 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. 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 is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibilit

Обзор продуктов:

Omeprazole Delayed-Release Capsules, USP 10 mg are size ‘3’ two piece hard gelatin capsules with a light blue to blue body with “G” imprinted in black ink and an orange cap with “G230” imprinted in black ink. The capsules are filled with white to off-white pellets. They are supplied as follows: Bottles of 30 with child-resistant closure, NDC 68462-395-30 Bottles of 90 with child-resistant closure, NDC 68462-395-90 Bottles of 100 with child-resistant closure, NDC 68462-395-01 Bottles of 1000, NDC 68462-395-10 Omeprazole Delayed-Release Capsules, USP 20 mg are size ‘2’ two piece hard gelatin capsules with a light blue to blue body with “G” imprinted in black ink and a light blue to blue cap with “G231” imprinted in black ink. The capsules are filled with white to off-white pellets. They are supplied as follows: Bottles of 30 with child-resistant closure, NDC 68462-396-30 Bottles of 90 with child-resistant closure, NDC 68462-396-90 Bottles of 100 with child-resistant closure, NDC 68462-396-01 Bottles of 1000, NDC 68462-396-10 Omeprazole Delayed-Release Capsules, USP 40 mg are size ‘1’ two piece hard gelatin capsules with an orange body with ‘G’ imprinted in black ink and light blue to blue cap with ‘G232’ imprinted in black ink. The capsules are filled with white to off-white pellets. They are supplied as follows: Bottles of 30 with child-resistant closure, NDC 68462-397-30 Bottles of 90 with child-resistant closure, NDC 68462-397-90 Bottles of 100 with child-resistant closure, NDC 68462-397-01 Bottles of 1000, NDC 68462-397-10 Storage Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

Glenmark Pharmaceuticals Inc., USA
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MEDICATION GUIDE
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 delayed-release capsules

Характеристики продукта

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
GLENMARK PHARMACEUTICALS INC., USA
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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
Warnings and precautions, Severe Cutaneous Adverse Reactions (5.5)
12/2021
Warnings and precautions, Hypomagnesemia and Mineral Metabolism (5.9)
12/2021
INDICATIONS AND USAGE
•
•
•
•
•
•
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DOSAGE AND ADMINISTRATION
INDICATION
Treatment of Active Duodenal Ulcer
_H. pylori_ Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
_Triple Therapy:_
Omeprazole
Each drug twice daily for
10 days (2.1)
Amoxicillin
Clarithromycin
_Dual Therapy:_
Omeprazole
Clarithromycin
Active Benign Gastric Ulcer
Symptomatic GERD
EE due to Acid-Mediated GERD
Omeprazole delayed-release capsules are 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)
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE
(2.2)
20 mg once daily for 4 weeks; some patients may require an
additional 4 weeks (2.1)
20 mg
_1_
1000 mg
500 mg
40 mg once daily for 14 days
_2_
500 mg three times daily for 14 days (2.1)
40 mg once daily for 4 to 8 weeks (2.1)
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)
20 mg once daily for 4 to 8 weeks (2.1) See full prescribing
information f