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:

Teva Pharmaceuticals USA, 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, 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 with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibil

Product summary:

Omeprazole Delayed-release Capsules USP, 40 mg are HPMC capsules with lavender cap and white body, filled with white to grayish pellets, imprinted with “TEVA” on the cap and “5294” on the body. They are supplied as follows: Bottles of 30 (NDC 0093-5294-56), 90 (NDC 0093-5294-98), and 1000 (NDC 0093-5294-10). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Omeprazole (oh-MEE-pray-zole) Delayed-Release Capsules
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
p

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
TEVA PHARMACEUTICALS USA, 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) 01/2018
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 2 years of age and older (1.4)
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in
patients 2 years of age and older (1.5)
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
INDIC ATIO N
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 delayed-release capsules
20 mg
Each drug twice daily for 10
days (2.1)
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Omeprazole delayed-release capsules
40 mg once daily for 14 days
Clarithromycin
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)