HIGHLIGHTS OF PRESCRIBING INFORMATION

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

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 thera

Product summary:

Omeprazole delayed-release capsules, USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. 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: Bottles of 1000 (NDC 42291-572-10) Omeprazole delayed-release capsules, USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied as follows: Bottles of 1000 (NDC 42291-573-10) Storage Store omeprazole delayed-release capsules in a tight container protected from light and moisture. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AvKARE
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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:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including omeprazole, may develop a kidney problem
called acute interstitial
nephritis that can happen at any time during treatment with
omeprazole. Call your doctor if you have
a decrease in the amount that you urinate or if you have blood in your
urine.
•
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.
•
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 proton PPI medicines,
including omeprazole, may develop certain types of lupus erythematosus
or

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
RX ONLY
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 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 1 year of age and older
( 1.4)
Treatment of erosive esophagitis (EE) due to acid-mediated GERD in
patients 1 month of age and older
( 1.5)
Maintenance of healing of EE due to acid-mediated GERD in patients 1
year 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
Recurrence
_Triple Therapy_:
Omeprazole
20 mg
Each drug twice daily for 10 days ( 2.1)*
Amoxicillin
1000 mg
Clarithromycin
500 mg
_Dual Therapy:_
Omeprazole
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 1 year of age and older (
2.2)
EE due to Acid-Mediated
GERD
20 mg once daily for 4 to 8 weeks ( 2.1)*** See full prescribing
information
for weigh