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:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole delayed-release capsules USP 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. Omeprazole delayed-release capsules USP 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. Omeprazole delayed-release capsules USP in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1)and Dosage and Administration (2)] . Among patients who fail therapy, omeprazole delayed-release capsules USP with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
Proficient Rx LP
----------
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:
•
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 proton pump
inhibitor 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.
Omeprazole delayed-release capsules can have other serious side
effects. See “What are the possible side
effects of omeprazole delayed-release capsules?”
What are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules are a prescription medicine called
a proton pump inhibitor (PPI).
Omeprazole reduces the amount of acid in your stomach.
Omeprazole delayed-release capsules are used in adults:
•
for up to 8 weeks for the healing of duodenal ulcers. The duodenal
area is the area where food
passes when it leaves the stomach.
•

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE DELAYED-RELEASE CAPSULES USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OMEPRAZOLE DELAYED-RELEASE CAPSULES USP.
OMEPRAZOLE DELAYED-RELEASE CAPSULES USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions, Interactions with Diagnostic Investigations
for Neuroendocrine Tumors (5.8) 03/2014
Indications and Usage, Treatment of Gastroesophageal Reflux Disease
(GERD) (adults and pediatric patients) (1.3)
12/2014
Dosage and Administration, Maintenance of Healing of Erosive
Esophagitis (2.5) 12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014
Warnings and Precautions, Cyanocobalamin (vitamin B-12) Deficiency
(5.4) 12/2014
INDICATIONS AND USAGE
Omeprazole delayed-release capsule USP is a proton pump inhibitor
indicated for:
• Treatment in adults of duodenal ulcer (1.1) and gastric ulcer
(1.2)
• Treatment in adults and children of gastroesophageal reflux
disease (GERD) (1.3) and maintenance of healing of erosive
esophagitis (1.4)
• Pathologic Hypersecretory Conditions (1.5)
The safety and effectiveness of omeprazole in pediatric patients <1
year of age have not been established. (8.4)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
OMEPRAZOLE DOSE
FREQUENCY
TREATMENT OF ACTIVE DUODENAL ULCER (2.1)
20 mg
Once daily for 4
weeks. Some
patients may
require an
additional 4
weeks
_H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.2)
_Triple Therapy:_
Ome prazole
Amoxicillin
Clarithromycin
20 mg
1000 mg
500 mg
Each drug twice daily for 10 days
_Dual Therapy_:
Ome prazole
40 mg
Once daily for 14 days
Clarithromycin
500 mg
Three times daily for
14 days
GASTRIC ULCER (2.3)
40 mg
Once daily for 4 to 8
weeks
GERD (2.4)
20 mg
Once daily for 4 to 8 weeks
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
(2.5)
20 mg
Once daily
PATHOLOGICAL HYPERSECRETORY