PANTOPRAZOLE SODIUM tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

REMEDYREPACK INC.

INN (שם בינלאומי):

PANTOPRAZOLE SODIUM

הרכב:

PANTOPRAZOLE 20 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 (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 is contraindicated in patients with k

leaflet_short:

How Supplied Pantoprazole sodium delayed-release tablets, USP are supplied as 20 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "96" printed with brown ink on the other side. They are available as follows: Bottles of 30                                                          NDC 13668-096-30 Bottles of 90                                                          NDC 13668-096-90 Bottles of 500                                                        NDC 13668-096-05 100 Unit Dose Tablets                                           NDC 13668-096-74 Pantoprazole sodium delayed-release tablets, USP are supplied as 40 mg white to pale yellow colored, oval shape, biconvex, enteric-coated tablets, plain on one side and "97" printed with brown ink on the other side. They are available as follows: Bottles of 30                                                       NDC 13668-429-30 Bottles of 90                                                       NDC 13668-429-90 Bottles of 500                                                     NDC 13668-429-05 80 Unit Dose Tablets                                          NDC 13668-429-77 Storage Store 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].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
REMEDYREPACK INC.
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MEDICATION GUIDE
MEDICATION GUIDE
Pantoprazole sodium (pan TOE pra zole SO-dee-um) delayed-release
tablets, USP
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 tablets,
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 worse

מאפייני מוצר

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
REMEDYREPACK INC.
----------
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 is a proton pump inhibitor indicated (PPI) 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 (2)
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 diagnostic testing. ( 5.1)
Acute Interstitial Nephritis: Observed in patients taking PPIs. ( 5.2)
_Clostridium difficile-Associated Diarrhea:_ PPI therapy may be
associated with increased risk of