PANTOPRAZOLE SODIUM granule, delayed release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Sun Pharmaceutical Industries, Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Pantoprazole sodium for delayed-release oral suspension is indicated for: Pantoprazole sodium for delayed-release oral suspension 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 pantoprazole sodium for delayed-release oral suspension may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole sodium for delayed-release oral suspension 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. Pantoprazole sodium for delayed-release oral suspension is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome. - Pan

製品概要:

How Supplied 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. Pantoprazole sodium for delayed-release oral suspension is supplied as child-resistant sachets as follows: NDC 62756-071-64, unit-dose carton of 30. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] .

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um)
for Delayed-Release Oral Suspension
What
is
the
most
important
information
I
should
know
about
pantoprazole
sodium
for
delayed-release
oral
suspension?
You should take pantoprazole sodium for delayed-release oral
suspension exactly as prescribed, at the lowest dose possible and for
the shortest
time
needed.
Pantoprazole sodium for delayed-release oral suspension may help your
acid-related symptoms, but you could still have serious stomach
problems.
Talk
with
your
doctor.
Pantoprazole sodium for delayed-release oral suspension can cause
serious side effects, including:
•
A type of kidney problem (acute tubulointerstitial nephritis). Some
people who take proton pump inhibitor (PPI) medicines, including
pantoprazole sodium for delayed-release oral suspension, may develop a
kidney problem called acute tubulointerstitial nephritis that can
happen at any time during treatment with pantoprazole sodium for
delayed-release oral suspension. 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
pantoprazole sodium for delayed-release oral suspension,
may develop

製品の特徴

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM
FOR DELAYED-RELEASE ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR PANTOPRAZOLE SODIUM FOR DELAYED-RELEASE ORAL
SUSPENSION.
PANTOPRAZOLE SODIUM FOR DELAYED-RELEASE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Pantoprazole sodium is a proton pump inhibitor (PPI) indicated for the
following: (1)
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)
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)
≥ 40 kg
40 mg
Once Daily for up to 8 wks
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
For Delayed-Release Oral Suspension: 40 mg pantoprazole (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to any component of the
formulation or to substituted
benzimidazoles (4)
Patients receiving rilpivirine-containing products (4,7)
WARNINGS AND PRECAUTIONS
Gastric Malignancy: In adults, symptomatic response does not preclude
presence of gastric
malignancy. Consider additional follow-up and diagnostic testing.
(5.1)
Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate
patients. (5.2)
_Clostridium difficile_-Associated Diarrhea: PPI therapy may be
associated with increased risk of
_Clostridium difficile_-associated diarrhea. (5.3)
Bone Fracture: Long-term and multiple dail