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:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

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. 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 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 clarithromyc

Product summary:

Omeprazole delayed-release capsules, USP, 20 mg, are opaque, hard gelatin, white-colored capsules, coded in black ink "OM" on the cap and "20" on the body. They are supplied as follows: NDC 70934-433-14 bottles of 14 NDC 70934-433-30 bottles of 30 NDC 70934-433-60 bottles of 60 NDC 70934-433-90 bottles of 90 Storage Store Omeprazole delayed-release capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
Denton Pharma, Inc. dba Northwind Pharmaceuticals
----------
MEDICATION GUIDE
OMEPRAZOLE (OH MEP' RA 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?
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 (tubulointerstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including Omeprazole delayed-release
capsules, may develop a kidney
problem called 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 fracture if
you ta

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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 ADMINISTRATION
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, USP, 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 Ulcers
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 ol