OMEPRAZOLE capsule, delayed release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NuCare Pharmaceuticals,Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 a

Povzetek izdelek:

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 68071-4024-3 Bottles 30 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]..

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

NuCare Pharmaceuticals,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 pr

Lastnosti izdelka

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
NUCARE PHARMACEUTICALS,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
1. 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:
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
20 mg
Each drug twice daily for
10 days (2.1)*
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Omeprazole
40 mg once daily for 14 days**
Clarithromycin
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)*** See full prescribing
informatio