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:

Safecor Health, LLC

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 mg

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 [seeClinical Studies (14.1) and Dosage and Administration (2)].   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 w

Product summary:

Omeprazole delayed-release capsules, USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. They are supplied as follows:  Packaging meets USP specifications for light resistance. For Institutional Use Only The product contained in this package is from NDC# 60505-0065 Apotex Corp. Weston, FL USA 33326 Packaged and Distributed by: Safecor Health, LLC 317 New Boston Street Woburn, MA 01801 Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Questions or comments? Call 1-800-447-1006 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); 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
Safecor Health, LLC
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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:
1.
Diarrhea. Omeprazole 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.
1.
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 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 is a prescription medicine called
a proton pump inhibitor (PPI).
Omeprazole delayed-release capsules reduces the amount of acid in your
stomach. Omeprazole delayed-
release capsules are used in adults:
1.
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.
2.
with certain antibioti

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
SAFECOR HEALTH, LLC
----------
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
Omeprazole 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)
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
20 mg
Each drug twice
daily for 10 days
Amoxicillin
1000 mg
Clarithromycin
500 mg
_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
PATHO LO G IC AL
HYPE RSE C RE TO RY
CONDITIONS (2.6)
60 mg (varies with individual
patie nt)
Once daily
PEDIATRIC PATIENTS
(2 TO 16 YEARS OF AGE) (2.7)
We ight
Dose
GERD AND MAINTENANCE
OF HEALING OF EROSIVE
ESO PHAG ITIS
10 < 20 kg
10 mg
Once daily
≥ 20 kg
20 kg
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or
substituted benzimidazoles (angioedema and anaphylaxis
have occurred) (4)
WARNING