OMEPRAZOLE capsule, delayed release

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mas Management Group, Inc.

INN (Rahvusvaheline Nimetus):

OMEPRAZOLE

Koostis:

OMEPRAZOLE 20 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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) 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. p

Toote kokkuvõte:

Omeprazole delayed-release capsules USP, 20 mg, are size ‘2’ two piece hard gelatin capsule with light blue to blue body with “G” imprinting in black ink and light blue to blue cap with “G231” imprinting in black ink. The capsules are filled with white to off-white pellets. They are supplied as follows: NDC 69677-180-30 bottles of 30 NDC 69677-180-60 bottles of 60 NDC 69677-180-90 bottles of 90 NDC 69677-180-01 bottles of 120 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); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]..

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

Mas Management Group, 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 pro

Toote omadused

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
MAS MANAGEMENT GROUP, 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
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 delayed-release capsules are a proton pump inhibitor (PPI)
indicated for the: (1)
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 FORMS AND STRENGTHS
Omeprazole delayed-release capsules: 10 mg, 20 mg, and 40 mg. ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to substituted benzimidazoles or
any component of the formulation. ( 4)
Patients receiving rilpivirine-containing products. ( 4, 7)
Refer to the Contraindications section of the prescribing information
for clarithromycin and amoxicillin, when
administered in combination with omeprazole. ( 4)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response does not preclude
the presence of gastric malignancy. Consider
additional follow-up and diagnostic testing. ( 5.1)
Acute Interstitial Nephritis: Observed in patients taking PPIs. ( 5.2)
Clostridium difficile-Associated Diarrhea: PPI therapy may be
associated with increased risk. ( 5.3)
Bone Fracture: Long-term and multiple daily dose PPI