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:

Bryant Ranch Prepack

Designación común internacional (DCI):

PANTOPRAZOLE SODIUM

Composición:

PANTOPRAZOLE 40 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium delayed-release tablets are 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 sodium delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole sodium delayed-release tablets are 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 sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole sodium delayed-release tablets are contra

Resumen del producto:

Product: 63629-6533 NDC: 63629-6533-1 30 TABLET, DELAYED RELEASE in a BOTTLE

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um) Delayed-Release
Tablets USP
Read this Medication Guide before you start taking pantoprazole sodium
delayed-release tablets 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 sodium delayed-release
tablets?
Pantoprazole sodium delayed-release tablets may help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Pantoprazole sodium delayed-release tablets can cause serious side
effects, including:
•
A type of kidney problem (acute interstitial nephritis). Some people
who take proton pump inhibitor
(PPI) medicines, including pantoprazole, may develop a kidney problem
called acute interstitial
nephritis that can happen at any time during treatment with
pantoprazole sodium delayed-release
tablets. Call your doctor if you have a decrease in the amount that
you urinate or if you have blood
in your urine.
•
Diarrhea. Pantoprazole sodium delayed-release tablets 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
pantoprazole sodium delayed-release tablets 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 sodium delayed-release tablets.
•
Certain types of lupus erythematosus. Lupus erythematosus is

Ficha técnica

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
BRYANT RANCH PREPACK
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Atrophic Gastritis removed (5.2)
10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus
(5.5)
10/2016
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are a proton pump
inhibitor indicated for the following:
•
•
•
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
•
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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)
Controlled studies did not extend beyond 12 months
*
Delayed-Release Tablets, 20 mg and 40 mg (3)
In adults, symptomatic response does not preclude presence of gastric
malignancy. Consider additional follow-up and
diagnostic testing. (5.1)
Acute interstitial nephritis has been observed in patients taking
PPIs. (5.2)
PPI therapy may be associated with