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:

Mylan Pharmaceuticals Inc.

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 10 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. 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. 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 are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If

Product summary:

Omeprazole Delayed-Release Capsules, USP are available containing 10 mg, 20 mg or 40 mg of omeprazole, USP. The 10 mg capsules are hard-shell gelatin capsules with a dark green opaque cap and a dark green opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 5211 in white ink both on the cap and the body. They are available as follows: NDC 0378-5211-93 bottles of 30 capsules The 20 mg capsules are hard-shell gelatin capsules with a dark green opaque cap and a blue-green opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 6150 in white ink both on the cap and the body. 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 capsules are hard-shell gelatin capsules with a dark green opaque cap and a light-blue opaque body filled with white to off-white beads. The capsule is axially printed with MYLAN over 5222 in white ink both on the cap and the body. 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Pharmaceuticals 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:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump
inhibitor (PPI) medicines, including omeprazole delayed-release
capsules, may develop a kidney
problem called acute interstitial nephritis that can happen at any
time during treatment with
omeprazole delayed-release capsules. Call your doctor 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 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 PPI

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
MYLAN PHARMACEUTICALS INC.
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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
Warnings and Precautions, Fundic Gland Polyps (5.12) 5/2018
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor (PPI) indicated for the:
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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
Amoxicillin
Clarithromycin
20 mg
1000 mg
500 mg
Each drug twice daily for 10 days (2.1)*
_Dual Therapy:_
Omeprazole Delayed-Release Capsules
Clarithromycin
40 mg once daily for 14 days**
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 prescribing information for weight based dosing in
pediatric patients 1 month of age and older (2.2)
Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once
daily (2.1)****
See full prescribing information for weight based dosing in
pediatric patients 1 year of age and older (2.2)
Pathological Hypersecretory Conditions
Starting dose is 60 mg once daily (varies with individual
patient, see full prescribing information) as long as clinically
indicated (2.1)
* if ulcer present, continue omeprazole delayed-release capsules 20 mg
once daily for an additional 1