PHARMAPURERX ESOMEP-EZS- esomeprazole magnesium kit

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Dostopno od:

PureTek Corporation

INN (mednarodno ime):

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

Sestava:

ESOMEPRAZOLE 20 mg

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium Delayed-Release Capsules may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole Magnesium Delayed-Release Capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole Magnesium Delayed-Release Capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. Esomeprazole Magnesium Delayed-Release Capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy

Povzetek izdelek:

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “ ” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules. NDC 0093- 6450 -56 bottle of 30 NDC 0093- 6450 -98 bottle of 90 NDC 0093- 6450 -10 bottle of 1000 Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “ ” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules. NDC 0093- 6451 -56 bottle of 30 NDC 0093- 6451 -98 bottle of 90 NDC 0093- 6451 -10 bottle of 1000 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP CONTAINER TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status dovoljenje:

unapproved drug other

Navodilo za uporabo

PHARMAPURERX ESOMEP-EZS- ESOMEPRAZOLE MAGNESIUM
PureTek Corporation
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
----------
MEDICATION GUIDE
Esomeprazole (ES-oh-MEP-ra-zole) Magnesium (mag-NEE-zee-um)
Delayed-Release Capsules
Read the Medication Guide that comes with esomeprazole magnesium
delayed-release capsules before
you start taking esomeprazole magnesium 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
esomeprazole magnesium delayed-release
capsules?
Esomeprazole magnesium delayed-release capsules may help your
acid-related symptoms, but you could
still have serious stomach problems. Talk with your doctor.
Esomeprazole magnesium delayed-release capsules can cause serious side
effects, including:
• A type of kidney problem (acute interstitial nephritis). Some
people who take proton pump inhibitor
(PPI) medicines, including esomeprazole magnesium delayed-release
capsules, may develop a kidney
problem called acute interstitial nephritis that can happen at any
time during treatment with esomeprazole
magnesium delayed-release capsules. Call your doctor if you have a
decrease in the amount that you
urinate or if you have blood in your urine.
• Diarrhea. Esomeprazole magnesium 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 esomeprazole
magnesium delaye

Lastnosti izdelka

PHARMAPURERX ESOMEP-EZS- ESOMEPRAZOLE MAGNESIUM
PURETEK CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PHARMAPURERX ESOMEP-EZS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE
MAGNESIUM DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES.
ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions, Atrophic Gastritis ( 5.2) removed 10/2016
Warnings and Precautions, Cutaneous and Systemic 10/2016
Lupus Erythematosus ( 5.5)
INDICATIONS AND USAGE
Esomeprazole Magnesium Delayed-Release Capsules are a proton pump
inhibitor indicated for the
following:
Treatment of gastroesophageal reflux disease (GERD). ( 1.1)
Risk reduction of NSAID-associated gastric ulcer. ( 1.2)
_H. pylori _eradication to reduce the risk of duodenal ulcer
recurrence. ( 1.3)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome. ( 1.4)
DOSAGE AND ADMINISTRATION
INDICATION
DOSE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
20 mg or 40 mg Once daily for 4 to 8 weeks
12 to 17 years
20 mg or 40 mg Once daily for up to 8 weeks
1 to 11 years
10 mg or 20 mg Once daily for up to 8 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
20 mg or 40 mg Once daily for up to 6 months
_H. PYLORI _ERADICATION _(Triple Therapy):_
Esomeprazole Magnesium Delayed-Release Capsules 40 mg
Once daily for 10 days
Amoxicillin
1000 mg
Twice daily for 10 days
Clarithromycin
500 mg
Twice daily for 10 days
PATHOLOGICAL HYPERSECRETORY CONDITIONS
40 mg
Twice daily
See full prescribing information for administration options. ( 2)
Patients with severe liver impairment-do not exceed dose of 20 mg. (
2)
DOSAGE FORMS AND STRENGTHS
Esomeprazole Magnesium De