PROTONIX DELAYED-RELEASE- pantoprazole sodium tablet, delayed release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Avera McKennan Hospital

Designación común internacional (DCI):

PANTOPRAZOLE SODIUM

Composición:

PANTOPRAZOLE 40 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets are indicated for: PROTONIX 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 PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. PROTONIX 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. PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reac

Resumen del producto:

How Supplied PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with PROTONIX (brown ink) on one side and are available as follows: Storage Store PROTONIX For Delayed-Release Oral Suspension and PROTONIX Delayed-Release Tablets 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] .

Estado de Autorización:

New Drug Application

Información para el usuario

PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Avera McKennan Hospital
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MEDICATION GUIDE
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
Delayed-Release Tablets
and
For Delayed-Release Oral Suspension
Read this Medication Guide before you start taking PROTONIX 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 PROTONIX?
PROTONIX may help your acid-related symptoms, but you could still have
serious stomach problems.
Talk with your doctor.
PROTONIX can cause serious side effects, including:
•
Diarrhea. PROTONIX 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 PROTONIX 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 PROTONIX.
PROTONIX can have other serious side effects. See "What are the
possible side effects of PROTONIX?"
What is PROTONIX?
PROTONIX is a prescription medicine called a proton pump inhibitor
(PPI).
PROTONIX reduces the amount of acid in your stomach.
PROTONIX 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 PROTONIX.
•
to maintain the healing of acid-related damage to the lining of the
esophagus and help prevent
return of heartburn symptoms cause

Ficha técnica

PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROTONIX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PROTONIX.
PROTONIX (PANTOPRAZOLE SODIUM) DELAYED-RELEASE TABLETS PROTONIX
(PANTOPRAZOLE SODIUM) FOR DELAYED-
RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Dosage and Administration, Recommended Dosing Schedule (2.1)
12/2014
Contraindications (4)
12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.3)
12/2014
INDICATIONS AND USAGE
PROTONIX 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)
For Delayed-Release Oral Suspension, 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)
Acute interstitial nephritis has been observed in patients taking
PPIs. (5.3)
Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g.,
longer than 3 years) may lead to m