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:

Lannett Company, Inc.

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Omeprazole Delayed-Release Capsules is 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, is 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 is 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 is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility

Product summary:

Storage Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store at 20° - 25°C (68° - 77°F) (See USP Controlled Room Temperature). Dispense in a tight and light-resistant container, as described in USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Lannett Company, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at:
www.lannett.com/med-guide/omeprazole
Omeprazole (oh mep’ ra zole) Delayed-Release Capsules, USP
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?
You should take Omeprazole Delayed-Release Capsules exactly as
prescribed, at the lowest dose
possible and for the shortest time needed.
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 tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including Omeprazole Delayed-Release
Capsules, may develop a
kidney problem called acute tubulointerstitial nephritis that can
happen at any time during
treatment with Omeprazole Delayed-Release Capsules. Call your doctor
right away 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
fr

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
LANNETT COMPANY, 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 USP
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2)
11/2020
INDICATIONS AND USAGE
Omeprazole Delayed-Release Capsules 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 year 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 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 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 pres