OMEPRAZOLE- omeprazole capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply, Inc.

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is 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 patients who fail therapy, susce

Product summary:

Omeprazole delayed-release capsules, USP 40 mg, are opaque, hard gelatin, dark green and light green colored capsules, imprinted “ Andrx 640 ” on cap and “ 40 mg ” on the body. They are supplied as follows: NDC 60429-899-90 NDC 60429-899-05 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Golden State Medical Supply, Inc.
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MEDICATION GUIDE
Omeprazole (o-mep-re-zol) Delayed-Release Capsules, USP
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

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEPRAZOLE DELAYED-RELEASE CAPSULES
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
Indications and Usage, Treatment of Erosive Esophagitis
02/2016
(EE) due to Acid-Mediated GERD ( 1.5)
Dosage and Administration, Recommended Pediatric Dosage
02/2016
Regimen by Indication ( 2.2)
Contraindications ( 4)
02/2016
Warnings and Precautions, Atrophic Gastritis ( 5.2) removed
10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus
10/2016
Erythematosus ( 5.5)
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 1 year of age and older ( 1.4)
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in
patients 1 month of age and older ( 1.5)
Maintenance of healing of EE due to acid-mediated GERD in patients 1
year 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