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:

NuCare Pharmaceuticals, Inc.

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 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 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 14 NDC 68071-3285-4 Bottles of 15 NDC 68071-3285-1 Bottles of 28 NDC 68071-3285-2 Bottles of 30 NDC 68071-3285-3 Bottles of 60 NDC 68071-3285-6 Bottles of 90 NDC 68071-3285-9 Bottles of 180 NDC 68071-3285-8 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 from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NuCare Pharmaceuticals, Inc.
----------
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 lu

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
NUCARE PHARMACEUTICALS, 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
Indications and Usage, Treatment of Erosive Esophagitis (EE) due to
Acid-Mediated GERD ( 1.5) 02/2016
Dosage and Administration, Recommended Pediatric Dosage Regimen by
Indication ( 2.2) 02/2016
Contraindications ( 4) 02/2016
Warnings and Precautions, Atrophic Gastritis ( 5.2) removed 10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (
5.5) 10/2016
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
INDIC ATIO N
RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE ( 2.2)
Treatment of Active Duodenal
Ulce r
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_:
Ome prazole
20 mg
Each drug twice daily for 10 days ( 2.1)*
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 ( 2.1)
Active Benign Gastric Ulcer
40 mg once daily for 4 to 8 weeks