OMEPRAZOLE- omeprazole capsule, delayed release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

A-S Medication Solutions

INN (Nama Internasional):

OMEPRAZOLE

Komposisi:

OMEPRAZOLE 20 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Product: 50090-2023 NDC: 50090-2023-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2023-2 15 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2023-3 60 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2023-4 20 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2023-5 90 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2023-6 200 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2023-7 180 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2023-8 7 CAPSULE, DELAYED RELEASE in a BOTTLE Product: 50090-2067 NDC: 50090-2067-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2067-1 60 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-2067-2 90 CAPSULE, DELAYED RELEASE in a BOTTLE

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
A-S Medication Solutions
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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

Karakteristik produk

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
A-S MEDICATION SOLUTIONS
----------
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
INDICATIONS AND USAGE
Omeprazole delayed-release capsules are a proton pump inhibitor (PPI)
indicated for the:
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
INDICATION
Treatment of Active Duodenal Ulcer
_H. pylori_ Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
_Triple Therapy:_
Ome prazole
Each drug twice daily for 10
days (2.1)*
Amoxicillin
Clarithromycin
_Dual Therapy:_
Ome prazole
Clarithromycin
Active Benign Gastric Ulcer
Symptomatic GERD
Warnings and Precautions, Cutaneous and Systemic Lupus
Erythematosus (5.5) 10/2016
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
1000 mg
500 mg
40 mg once daily for 14 days**
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)
* if ulcer present, continue Omeprazole 20 mg once daily for an
additional 18 days.
** if ulce