PROTONIX DELAYED-RELEASE- pantoprazole sodium tablet, delayed release PROTONIX DELAYED-RELEASE- pantoprazole sodium granule, de

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

INN (International Name):

PANTOPRAZOLE SODIUM

Sammensetning:

PANTOPRAZOLE 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 (EE). 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 EE 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 (ZE) Syndrome. Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pa

Produkt oppsummering:

How Supplied PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as yellow, oval biconvex delayed-release tablets imprinted with PROTONIX (brown ink) on one side containing 40 mg pantoprazole and are available as follows: PROTONIX (pantoprazole sodium) Delayed-Release Tablets are supplied as yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side containing 20 mg pantoprazole and are available as follows: PROTONIX (pantoprazole sodium) For Delayed-Release Oral Suspension is supplied as pale yellowish to dark brownish, enteric-coated granules containing 40 mg pantoprazole in a unit-dose packet 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] .

Autorisasjon status:

New Drug Application

Informasjon til brukeren

PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
----------
MEDICATION GUIDE
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
delayed-release tablets
and
PROTONIX (pro-TAH-nix)
(pantoprazole sodium)
for delayed-release oral suspension
What is the most important information I should know about PROTONIX?
You should take PROTONIX exactly as prescribed, at the lowest dose
possible and for the shortest time
needed.
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:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump
inhibitor (PPI) medicines, including PROTONIX, may develop a kidney
problem called acute
tubulointerstitial nephritis that can happen at any time during
treatment with PROTONIX. Call
your doctor right away if you have a decrease in the amount that you
urinate or if you have blood
in your urine.
•
Diarrhea caused by an infection (Clostridium difficile) in your
intestines. Call your doctor right
away if you have watery stools or stomach pain that does not go away.
You may or may not have a
fever.
•
Bone fractures (hip, wrist, or spine). Bone fractures in the hip,
wrist, or spine may happen in people
who take multiple daily doses of PPI medicines and for a long period
of time (a year or longer).
Tell your doctor if you have a bone fracture, especially in the hip,
wrist, or spine.
•
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the body's
immune cells attack other cells or organs in the body). Some people
who take PPI medicines,
including PROTONIX, may develop certain types of lupus erythematosus
or have worsening of the
lupus they already have. Call your doctor right away if you have new
or worsening joint pain or a
rash on your cheeks or arms that gets worse

Preparatomtale

PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
PROTONIX DELAYED-RELEASE- PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE
WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.
----------
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, FOR ORAL USE
PROTONIX (PANTOPRAZOLE SODIUM) FOR DELAYED-RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
PROTONIX is a proton pump inhibitor (PPI) indicated for the following:
•
•
•
DOSAGE AND ADMINISTRATION
INDICATION
DOSE
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
•
•
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
(ZE) Syndrome (1.3)
Controlled studies did not extend beyond 12 months
*
Delayed-Release Tablets: 20 mg and 40 mg pantoprazole (3)
For Delayed-Release Oral Suspension: 40 mg pantoprazole (3)
Patients with known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles (4)
Patients receiving rilpivirine-containing products (4,7)
Gastric Malignancy: In adults, symptomatic response does not preclude
presence of gastric
malignancy. Consider additional follow-up and diagnostic testing.
(5.1)
Acute Tubulointerstiti