PANTOPRAZOLE SODIUM tablet, delayed release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)

Verfügbar ab:

ReadyMeds

INN (Internationale Bezeichnung):

PANTOPRAZOLE SODIUM

Zusammensetzung:

PANTOPRAZOLE 40 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months. Pantoprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole Sodium Delayed-Release Tablets is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11) ] or any substi

Produktbesonderheiten:

How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg white, oval biconvex delayed-release tablets imprinted in black ink with "KU" and "181" on one side and are available as follows: Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white, oval biconvex delayed-release tablets imprinted in black ink with "KU" on one side and "180" on the other side and are available as follows: Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature ].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
ReadyMeds
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MEDICATION GUIDE
Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP
CIA77568D
Rev. 4E 01/2014
Read this Medication Guide before you start taking Pantoprazole 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
Pantoprazole?
Pantoprazole may help your acid-related symptoms, but you could still
have serious stomach problems.
Talk with your doctor.
Pantoprazole can cause serious side effects, including:
•
Diarrhea. Pantoprazole 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 Pantoprazole 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 Pantoprazole.
Pantoprazole can have other serious side effects. See "What are the
possible side effects of
Pantoprazole?"
What is Pantoprazole?
Pantoprazole is a prescription medicine called a proton pump inhibitor
(PPI).
Pantoprazole reduces the amount of acid in your stomach.
Pantoprazole is used in adults:
•
for up to 8 weeks to heal acid-related damage to the lining of the
esophagus (erosive esophagitis or
EE) and to relieve symptoms caused by gastroesophageal reflux disease
(GERD). If needed, your
doctor may decide to prescribe another 8 weeks of Pantoprazole.
•
to maintain healing of acid-related damage to the lining of the
esophagus and help prevent return
of heart

Fachinformation

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
READYMEDS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM DELAYED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PANTOPRAZOLE SODIUM DELAYED-RELEASE
TABLETS.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Pantoprazole is a proton pump inhibitor indicated for the following:
Short-Term Treatment of Erosive Esophagitis Associated with
Gastroesophageal Reflux Disease (GERD) (1.1)
Maintenance of Healing of Erosive Esophagitis (1.2)
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome (1.3)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
FREQUENCY
SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1)
Adults
40 mg
Once Daily for up to 8 wks
Children (5 years and older)
≥ 15 kg to < 40 kg
20 mg
Once Daily for up to 8 wks
≥ 40 kg
40 mg
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1)
Adults
40 mg
Once Daily
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME (2.1)
Adults
40 mg
Twice Daily
See full prescribing information for administration instructions
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets, 20 mg and 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles (4)
WARNINGS AND PRECAUTIONS
Symptomatic response does not preclude presence of gastric malignancy
(5.1)
Atrophic gastritis has been noted with long-term therapy (5.2)
PPI therapy may be associated with increased risk of _Clostridium
difficile_ associated diarrhea (5.4)
Bone Fracture: Long-term and multiple daily dose PPI therapy may be
associated with an increased risk for
osteoporosis-related fractures of the hip, wrist or spine (5.5)
Hypomagnesemia has been reported rarely with prolonged treatment with
PPIs (5.6)
ADVERSE REACTIONS
The most frequently occurring adverse reactions are