PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Unit Dose Services

INN (الاسم الدولي):

PANTOPRAZOLE SODIUM

تركيب:

PANTOPRAZOLE 20 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Pantoprazole Sodium Delayed-Release Tablets are indicated for: Pantoprazole Sodium Delayed-Release Tablet 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 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 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 Delayed-Release Tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome. •  Pantoprazole Sodium Delayed-Release Tablets are contraindica

ملخص المنتج:

Product: 50436-0712 NDC: 50436-0712-2 60 TABLET, DELAYED RELEASE in a BOTTLE

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Unit Dose Services
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MEDICATION GUIDE
Pantoprazole Sodium Delayed-Release Tablets USP
(pan toe' pra zole soe' dee um)
What is the most important information I should know about
pantoprazole sodium delayed-release tablets?
You should take pantoprazole sodium delayed-release tablets exactly as
prescribed, at the lowest dose
possible and for the shortest time needed.
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 sodium delayed-release tablets, 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 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 delayed-release tablet, 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 in the sun.
Ta

خصائص المنتج

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
UNIT DOSE SERVICES
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps (5.9) 06/2018
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablet is a proton pump inhibitor
(PPI) 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
(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)
≥ 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
*Controlled studies did not extend beyond 12 months
See full prescribing information for administration instructions (2)
DOSAGE FORMS AND STRENGTHS
•Delayed-Release Tablets: 20 mg and 40 mg ( 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 diagonostic testing. (
5.1)
• Acute Interstitial Nephritis:Observed in patients taking PPIs. (
5.2)
• _Clostridium difficile-Associated Diarrhea:_