OMEPRAZOLE capsule, delayed release

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Omeprazole (UNII: KG60484QX9) (omeprazole - UNII:KG60484QX9)

Prieinama:

TYA Pharmaceuticals

INN (Tarptautinis Pavadinimas):

Omeprazole

Sudėtis:

Omeprazole 20 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 infection and duodenal ulcer disease (active or up to 1-year history) to eradicate in adults. H. pylori H. pylori Omeprazole delayed-release capsules, in combination with clarithromycin are indicated for treatment of patients with infection and duodenal ulcer disease to eradicate in adults. H. pylori H. pylori Eradication of has been shown to reduce the risk of duodenal ulcer recurrence [see and ]. H. pylori Clinical Studies (14.1) Dosage and Administration (2) Among patients who fail

Produkto santrauka:

NDC:64725-0158-1 in a BOTTLE of 100 CAPSULE, DELAYED RELEASES

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
TYA Pharmaceuticals
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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:
•
. 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. Diarrhea
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go away.
•
. 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. Bone
fractures
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 it leaves the stom

Prekės savybės

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
TYA PHARMACEUTICALS
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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 10/2012 (5.4)
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 and gastric ulcer (1.1)(1.2)
Treatment in adults and children of gastroesophageal reflux disease
(GERD) and maintenance of healing of erosive
esophagitis (1.3)(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 anaphylaxis
have occurred