PRILOSEC- omeprazole magnesium capsule, delayed release PRILOSEC- omeprazole magnesium granule, delayed release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK) (OMEPRAZOLE - UNII:KG60484QX9)

Dostupno od:

AstraZeneca Pharmaceuticals LP

INN (International ime):

OMEPRAZOLE MAGNESIUM

Sastav:

OMEPRAZOLE 10 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

PRILOSEC is 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 PRILOSEC 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. Dual Therapy PRILOSEC 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, PRILOSEC with clarithromycin is 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 resistance to clarithromycin is demonstrated or susceptibility testing is not pos

Proizvod sažetak:

PRILOSEC delayed-release capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as follows: NDC 0186-0606-31 unit of use bottles of 30 PRILOSEC delayed-release capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows: NDC 0186-0742-31 unit of use bottles of 30 NDC 0186-0742-82 bottles of 1000 PRILOSEC delayed-release capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows: NDC 0186-0743-31 unit of use bottles of 30 NDC 0186-0743-68 bottles of 100 PRILOSEC for delayed-release oral suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish omeprazole granules and pale yellow inactive granules. PRILOSEC unit dose packets are supplied as follows: NDC 0186-0625–01 unit dose packages of 30: 2.5 mg packets NDC 0186-0610–01 unit dose packages of 30: 10 mg packets Storage Store PRILOSEC delayed-release capsules in a tight container protected from light and moisture. Store between 15°C and 30°C (59°F and 86°F). Store PRILOSEC for delayed-release oral suspension at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F). [See USP Controlled Room Temperature.]

Status autorizacije:

New Drug Application

Uputa o lijeku

PRILOSEC- OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
PRILOSEC- OMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE
AstraZeneca Pharmaceuticals LP
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MEDICATION GUIDE
PRILOSEC® (pry-lo-sec)
(omeprazole)
delayed-release capsules
PRILOSEC® (pry-lo-sec)
(omeprazole magnesium)
for delayed-release oral suspension
Read this Medication Guide before you start taking PRILOSEC 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 PRILOSEC?
PRILOSEC may help your acid-related symptoms, but you could still have
serious stomach problems.
Talk with your doctor.
PRILOSEC can cause serious side effects, including:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including PRILOSEC, may develop a kidney problem
called acute interstitial
nephritis that can happen at any time during treatment with PRILOSEC.
Call your doctor if you
have a decrease in the amount that you urinate or if you have blood in
your urine.
•
Diarrhea. PRILOSEC 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
PRILOSEC 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 PRILOSEC.
•
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 proton PPI medicines,
including PRILOSEC, ma

Svojstava lijeka

PRILOSEC- OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE
PRILOSEC- OMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE
ASTRAZENECA PHARMACEUTICALS LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRILOSEC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PRILOSEC.
PRILOSEC (OMEPRAZOLE) DELAYED-RELEASE CAPSULES
PRILOSEC (OMEPRAZOLE MAGNESIUM) FOR DELAYED-RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Indications and Usage, Treatment of Erosive Esophagitis (EE) due to
Acid-Mediated GERD (1.5)
02/2016
Dosage and Administration, Recommended Pediatric Dosage Regimen by
Indication (2.2)
02/2016
Contraindications (4)
Warnings and Precautions, Atrophic Gastritis (5.2) removed
Warnings and Precautions, Cutaneous and Systemic Lupus
Erythematosus (5.5)
02/2016
10/2016
10/2016
INDICATIONS AND USAGE
PRILOSEC is a proton pump inhibitor (PPI) indicated for the:
•
•
•
•
•
•
•
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:_
PRILOSEC
Amoxicillin
Clarithromycin
20 mg
1000 mg
500 mg
Each drug twice daily for 10 days (2.1)*
_Dual Therapy:_
PRILOSEC
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 do