OMEPRAZOLE capsule, delayed release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

State of Florida DOH Central Pharmacy

INN (nume internaţional):

OMEPRAZOLE

Compoziție:

OMEPRAZOLE 20 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 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

Rezumat produs:

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. 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. 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.  They are supplied by State of Florida DOH Central Pharmacy as follows: Storage          Protect from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
State of Florida DOH Central Pharmacy
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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:
•
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 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:
•
for up to 8 weeks for the healing of duodenal ulcers. The duodenal
area is the area where food
passes when i

Caracteristicilor produsului

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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
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:
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 ACTIVEDUODENAL 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 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 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)
We ight
Dose
GERD
10 < 20 kg
10 mg
Once daily
AND MAINTENANCE OF
≥ 20 kg
20 mg
HEALING OF EROSIVE ESOPHAGITIS
DOSAGE FORMS AND STRENGTHS
Omeprazole delayed-release capsules, 10 mg, 20 mg and 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or
substituted benzimidazoles (angioedema and anap