OMEPRAZOLE- omeprazole capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Patient Information leaflet (PIL)

21-08-2019

Summary of Product characteristics (SPC)

21-08-2019

Active ingredient:

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

Available from:

REMEDYREPACK INC.

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

Product summary:

Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mg and on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 NDC 55111-158-34 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 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

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
REMEDYREPACK INC.
----------
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

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Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
REMEDYREPACK INC.
----------
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, Fundic Gland Polyps ( 5.12) 02/2018
INDICATIONS AND USAGE
Omeprazole is 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
Ulce r
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
Re curre nce
Triple Therapy:
Omeprazole delayed-release
capsules Amoxicillin
Clarithromycin
20 mg 1000 mg 500 mg
Each drug twice
daily for 10 days
(2.1)*
Dual Therapy:
Omeprazole delayed-release
capsules Clarithromycin
40 mg once daily for 14 days** 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)***
Maintenance of Healing of EE
due to Acid-Mediated GERD
20 mg once daily (2.1)**** See full prescribing information for
weight base

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