OMEPRAZOLE- omeprazole capsule, delayed release

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Blenheim Pharmacal, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Omeprazole Delayed-Release Capsules, USP are available in the following strengths: 10 mg, 20 mg or 40 mg. The 10 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a dark green opaque body axially printed with MYLAN over 5211 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 0378-5211-93 bottles of 30 capsules 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 0378-6150-93 bottles of 30 capsules NDC 0378-6150-01 bottles of 100 capsules NDC 0378-6150-10 bottles of 1000 capsules The 40 mg capsule is a hard-shell gelatin capsule with a dark green opaque cap and a light-blue opaque body axially printed with MYLAN over 5222 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 0378-5222-93 bottles of 30 capsules NDC 0378-5222-05 bottles of 500 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
Blenheim Pharmacal, Inc.
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MEDICATION GUIDE
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
(oh mep′ ra zole)
10 mg, 20 mg and 40 mg
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

Αρχείο Π.Χ.Π.

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
BLENHEIM PHARMACAL, 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 FOR ORAL USE
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions: Interactions with Diagnostic Investigations
for Neuroendocrine Tumors ( 5.10) 03/2014
Indications and Usage: Treatment of Gastroesophageal Reflux Disease
(GERD) (adults and pediatric patients) ( 1.3)
12/2014
Dosage and Administration: Maintenance of Healing of Erosive
Esophagitis ( 2.5) 12/2014
Warnings and Precautions: Acute Interstitial Nephritis ( 5.3) 12/2014
Warnings and Precautions: Cyanocobalamin (vitamin B-12) Deficiency (
5.4) 12/2014
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)
Pathologic Hypersecretory Conditions ( 1.5)
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