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:

Dispensing Solutions, 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 4 weeks. Some patients may require an additional 4 weeks of 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 one year history) to eradicate H. pylori in adults. 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. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)]. 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 pati

Product summary:

Omeprazole Delayed-Release Capsules, USP The 20 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a blue-green opaque body axially printed with MYLAN over 6150 in white ink both on the cap and the body. The capsule is filled with white to off-white beads. They are available as follows: NDC 66336-0706-30 bottles of 30 capsules 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
Dispensing Solutions, Inc.
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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:
•
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 proton pump
inhibitor 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.
Omeprazole delayed-release capsules can have other serious side
effects. See “What are the possible side
effects of omeprazole delayed-release capsules?”
What are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules are a prescription medicine called
a proton pump inhibitor (PPI).
Omeprazole delayed-release capsules reduce the amount of acid in your
stomach.
Omeprazole delayed-release capsules are used in adults:
•
for up to 8 weeks for the healing of duodenal ulcers. The duodenal
area is the area where food
pass

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
DISPENSING SOLUTIONS, 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: Interaction with Clopidogrel (5.4) 10/2012
Warnings and Precautions: _Clostridium difficile _Associated 09/2012
Diarrhea (5.3)
Warnings and Precautions: Concomitant Use of Omeprazole 01/2012
with Methotrexate (5.9)
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for:
Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2)
Treatment in adults and children of gastroesophageal reflux disease
(GERD) (1.3) and maintenance of healing of
erosive esophagitis (1.4)
The safety and effectiveness of omeprazole in pediatric patients < 1
year of age have not been established. (8.4)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
OMEPRAZOLE DOSE
FREQUENCY
TREATMENT OF ACTIVE DUODENAL ULCER
(2.1)
20 mg
Once daily for 4 weeks. Some patients
may require an additional 4 weeks
_H. PYLORI_ ERADICATION TO REDUCE THE
RISK OF DUODENAL ULCER RECURRENCE
(2.2)
_Triple Therapy:_
Ome prazole
20 mg
Each drug twice
Amoxicillin
1000 mg
daily for 10 days
Clarithromycin
500 mg
_Dual Therapy:_
Ome prazole
40 mg
Once daily for 14 days
Clarithromycin
500 mg
Three times daily for 14 days
GASTRIC ULCER (2.3)
40 mg
Once daily for 4 to 8 weeks
GERD (2.4)
20 mg
Once daily for 4 to 8 weeks
MAINTENANCE OF HEALING OF EROSIVE
ESOPHAGITIS (2.5)
20 mg
Once daily
PATHOLOGICAL HYPERSECRETORY
CONDITIONS (2.6)
60 mg (varies with individual patient) Once daily
PEDIATRIC PATIENTS (2 TO 16 YEARS OF
AGE) (2.7)
Weight Dose
GERD AND
10 < 20 kg 10 mg
Once daily
MAINTENANCE OF
≥ 20 kg 20 mg
HEALING OF EROSIVE
ESO PHAG ITIS
DOSAGE FORMS AND STRENGTHS
Omeprazole Delayed-Release Capsules, 10 mg, 20 mg and 40 mg (3)
C