ESOMEPRAZOLE MAGNEISUM D/R capsule, delayed release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Tilgængelig fra:

Direct_Rx

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole magnesium is 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 may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium is 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. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer Esomeprazole magnesium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID

Produkt oversigt:

Esomeprazole magnesium delayed-release capsules, USP 20 mg, are hard gelatin capsule shell, Dark blue opaque cap & body imprinted with "ESO" on cap and "20" on the body in golden yellow ink. They are supplied as follows: bottles of 30 bottles of 90 bottles of 500 bottles of 1000 Unit-Dose Blister Packages of 100 (10×10) Esomeprazole magnesium delayed-release capsules, USP 40 mg, are hard gelatin capsule shell, Dark blue opaque cap & body imprinted with "ESO" on cap and "40" on the body in golden yellow ink.They are supplied as follows: bottles of 30 bottles of 90 bottles of 500 bottles of 1000 Unit-Dose Blister Packages of 100 (10×10) Store at 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules, USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules, USP product package is subdivided.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ESOMEPRAZOLE MAGNEISUM D/R- ESOMEPRAZOLE MAGNEISUM D/R CAPSULE,
DELAYED RELEASE
Direct_Rx
----------
Esomeprazole magnesium delayed-release capsules, USP
(es ″ oh mep′ ra zole mag nee′ zee um)
Read the Medication Guide that comes with esomeprazole magnesium
delayed-release capsules, USP
before you start taking esomeprazole magnesium delayed-release
capsules, USP 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, USP?
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, may develop a
kidney problem called acute
interstitial nephritis that can happen at any time during treatment
with Esomeprazole magnesium. 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 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 esomeprazole magnesium 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 es

Produktets egenskaber

ESOMEPRAZOLE MAGNEISUM D/R- ESOMEPRAZOLE MAGNEISUM D/R CAPSULE,
DELAYED RELEASE
DIRECT_RX
----------
ESOMEPRAZOLE MAGNEISUM D/R
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole magnesium is 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
may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium is indicated to maintain symptom resolution and
healing of erosive
esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole magnesium is 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.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium is indicated for the reduction in the
occurrence of gastric ulcers associated
with continuous NSAID therapy in patients at risk for developing
gastric ulcers. Patients are considered
to be at risk due to their age (> 60) and/or documented history of
gastric ulcers. Controlled studies do
not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer
Recurrence
Triple Therapy (esomeprazole magnesium plus amoxicillin and
clarithromycin): esomeprazole
magnesium, in combination with amoxicillin and clarithromycin, is
indicated for the treatment of patients
with H. pylori infection and duodenal ulcer disease (active or history
of within the past 5 years) to
eradicate H. pylori. Eradication of H. pylori has been shown to reduce
the risk of duodenal ulcer
recurrence [see Dosage and Administration (2) and Clinical Studies
(14)].
In patients who fail therapy, susceptibility testing should be done.
If resistance to clarithromycin is
demonstrated or susceptibility testing is not possible, alte