PANTOPRAZOLE SODIUM tablet, delayed release

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

AvPAK

INN (Isem Internazzjonali):

PANTOPRAZOLE SODIUM

Kompożizzjoni:

PANTOPRAZOLE 20 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole 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 may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. Pantoprazole 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 is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome. - Pantoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may includ

Sommarju tal-prodott:

How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 40 mg white, oval biconvex delayed-release tablets debossed with "17" on one side and are available as follows: Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white, oval biconvex delayed-release tablets imprinted in black ink with "KU" on one side and "180" on the other side and are available as follows: Dispensed in Unit Dose Package. For Institutional Use Only. Storage Store Pantoprazole Sodium Delayed-Release Tablets, USP 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].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
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MEDICATION GUIDE
Pantoprazole (pan-TOE-pruh-zole) Sodium Delayed-Release Tablets, USP
What is the most important information I should know about
Pantoprazole?
You should take Pantoprazole exactly as prescribed, at the lowest dose
possible and for the shortest time
needed.
Pantoprazole may help your acid-related symptoms, but you could still
have serious stomach problems. Talk
with your doctor.
Pantoprazole 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, may develop a kidney problem
called acute interstitial
nephritis that can happen at any time during treatment with
Pantoprazole. 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 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, 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.
Talk to your doctor about your risk of these serious side effects.
Pantoprazole can have other serious side effects. See “What are the
possible side effects of Pantoprazole?”
Wha

Karatteristiċi tal-prodott

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP
RX ONLY
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 (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
See full prescribing information for administration instructions
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
_Clostridi