OMEPRAZOLE- omeprazole capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Omeprazole (UNII: KG60484QX9) (omeprazole - UNII:KG60484QX9)

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

Omeprazole

Composition:

Omeprazole 20 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, 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’                                                                                                                                                                                             20 mg and on body ‘R158’ with black ink. The capsules are supplied in bottles of; Bottle of 14 - 68788-1554-4 Bottle of 20 - 68788-1554-2 Bottle of 30 - 68788-1554-3 Bottle of 60 - 68788-1554-6 Bottle of 90 - 68788-1554-9 Bottle of 100 - 68788-1554-1 Bottle of 120 - 68788-1554-8 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
Preferred Pharmaceuticals, 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 ce

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
PREFERRED PHARMACEUTICALS, 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 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
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