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:

Bryant Ranch Prepack

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. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.   Triple 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.   Dual Therapy 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.   Among patients who fail therapy, omeprazole delayed-release capsules are with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail thera

Rezumat produs:

NDC: 63629-3643-1: 60 Capsules in a BOTTLE NDC: 63629-3643-2: 30 Capsules in a BOTTLE NDC: 63629-3643-3: 90 Capsules in a BOTTLE

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
Bryant Ranch Prepack
----------
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?
You should take omeprazole delayed-release capsules exactly as
prescribed, at the lowest dose possible and
for the shortest time needed.
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 tubulointerstitial nephritis).
Some people who take proton pump inhibitor
(PPI) medicines, including omeprazole delayed-release capsules, may
develop a kidney problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with omeprazole delayed-release
capsules. Call your doctor right away 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

Caracteristicilor produsului

OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE
BRYANT RANCH PREPACK
----------
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, Acute Tubulointerstitial Nephritis (5.2)
11/2020
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor (PPI) indicated for the:
• Treatment of active duodenal ulcer in adults (1.1)
• Eradication of Helicobacter pylori to reduce the risk of duodenal
ulcer recurrence in adults (1.2)
• Treatment of active benign gastric ulcer in adults (1.3)
• Treatment of symptomatic gastroesophageal reflux disease (GERD) in
patients 2 years of age and older
(1.4)
• Maintenance of healing of EE due to acid-mediated GERD in patients
2 years of age and older (1.6)
• Pathologic hypersecretory conditions in adults (1.7)
DOSAGE AND ADMINISTRATION
Indication
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 2
years of age and older (2.2)
EE due to Acid-Mediated
GERD
20 mg once daily for 4 to 8 weeks (2.1)***
Maintenance of Healing of
EE due to Acid-Mediated
GERD
20 mg once daily (2.1)**** See full prescribing information