PANTOPRAZOLE SODIUM DELAYED-RELEASE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Lifestar Pharma LLC

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Pantoprazole sodium delayed-release tablets are indicated for: Pantoprazole sodium 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 is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome. - Pantoprazole sodium is contraindicated in patients with known hypersensitivity to any component of the formul

ملخص المنتج:

Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as light brown to brown, round, biconvex, delayed-release tablets imprinted with 'L9' on one side and plain on other side containing 40 mg pantoprazole and are available as follows: Storage Store pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature.]

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Lifestar Pharma LLC
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SPL MEDGUIDE
Dispense with Medication Guide available at:
www.lifestarpharma.com/medguide/pantoprazolesodiumtablets.pdf
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 tubulointerstitial nephritis). Some
people who
take proton pump inhibitor (PPI) medicines, including pantoprazole
sodium
delayed-release tablets, may develop a kidney problem called acute
tubulointerstitial 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
tablets, may develop certain types of lupus erythematosus or have
worsening of
the lupus they already

خصائص المنتج

PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM DELAYED-
RELEASE TABLET
LIFESTAR PHARMA LLC
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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
INDICATIONS AND USAGE
Pantoprazole sodium 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 weeks
Children (5 years and older)
≥15 kg to < 40 kg
20 mg
Once Daily for up to 8 weeks
≥ 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 (2)
See full prescribing information for administration instructions (2)
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 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 diarr