OMEPRAZOLE capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Buy It Now

Patient Information leaflet (PIL)

26-07-2020

Summary of Product characteristics (SPC)

26-07-2020

Active ingredient:

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

Available from:

Clinical Solutions Wholesale

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. 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. Omeprazole delayed-release capsules, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate

Product summary:

Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘3’ hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap ‘OMEPRAZOLE’ 10 mg and on body ‘R157’ with black ink. The capsules are supplied in bottles of 30, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-157-30 Bottles of 100 NDC 55111-157-01 Bottles of 1000 NDC 55111-157-10 Unit-dose packages of 100 (10 x 10) NDC 55111-157-78 Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘2’ hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap ‘OMEPRAZOLE’ 20 mg and on body ‘R158’ with black ink. The capsules are supplied in bottles of 30, 90, 100, 1000 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-158-30 Bottles of 90 NDC 55111-158-90 Bottles of 100 NDC 55111-158-01 Bottles of 1000 NDC 55111-158-10 Unit-dose packages of 100 (10 x 10) NDC 55111-158-78 Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap ‘OMEPRAZOLE’ 40 mg and on body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 100, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-159-30 Bottles of 100 NDC 55111-159-01 Bottles of 500 NDC 55111-159-05 Unit-dose packages of 100 (10 x 10) NDC 55111-159-78 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) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
Clinical Solutions Wholesale
----------
MEDICATION GUIDE
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
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:
1.
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.
1.
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 is omeprazole delayed-release capsule?
Omeprazole delayed-release capsule is a prescription medicine called a
proton pump inhibitor (PPI).
Omeprazole delayed-release capsules reduces the amount of acid in your
stomach.
Omeprazole delayed-release capsules are used in adults:
1.
for up to 8 weeks for the healing of duodenal ulcers. The duodenal
area is the area where food
passes when it leaves the

Read the complete document

Summary of Product characteristics

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
CLINICAL SOLUTIONS WHOLESALE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
_THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING_
_INFORMATION FOR OMEPRAZOLE. _
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
_Re f
Warnings and Precautions, Interaction with Clopidogrel (5.4) 10/2012
Warnings and Precautions, Clostridium difficile associated 09/2012
diarrhea (5.3)
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for:
1. Treatment in adults of duodenal ulcer (1.1) and gastric ulcer (1.2)
2. Treatment in adults and children of gastroesophageal reflux disease
(GERD) (1.3)C:\Documents and
Settings\p00019458\Desktop\d78b53a1-b20c-bf2f-6d08-3af72bbec957.xml -
_CE2C82EC-444E-6C8D-BE54-
7D1B1188728Eand maintenance of healing of erosive esophagitis
(1.4)C:\Documents and
Settings\p00019458\Desktop\d78b53a1-b20c-bf2f-6d08-3af72bbec957.xml -
_39B333AB-63EF-CA27-B90E-
CBFD42274F48
C:\Documents and
Settings\p00019458\Desktop\d78b53a1-b20c-bf2f-6d08-3af72bbec957.xml -
_39B333AB-63EF-CA27-
B90E-CBFD42274F48The 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 ACTIVEDUODENAL ULCER
(2.1)C:\Documents and
Se ttings\p00019458\De sktop\d78b53a1-b20c-
bf2f-6d08-3af72bbec957.xml - _8CCD4EEF-
BDF2-1C7F-55EF-38682CD96AC2
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)C:\Documents and
Settings\p00019458\Desktop\d78b53a1-b20c-bf2f-6d08-3af72bbec957.xml -
_B5D29A9F-6590-44EF-ED94-
989E08F75D1C
_Triple Therapy:_
Ome prazole
20 mg
Each drug twice daily for 10
days
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
GASTRIC ULC

Read the complete document