PANTOPRAZOLE SODIUM- pantoprazole tablet, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bryant Ranch Prepack

INN (International Name):

PANTOPRAZOLE SODIUM

Sammensetning:

PANTOPRAZOLE 20 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 delayed-release tablets are contraindi

Produkt oppsummering:

How Supplied Pantoprazole sodium delayed-release tablets USP, 20 mg, are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A6” with black ink on one side and plain on the other side. NDC: 71335-0291-1: 60 Tablets in a BOTTLE NDC: 71335-0291-2: 30 Tablets in a BOTTLE NDC: 71335-0291-3: 90 Tablets in a BOTTLE NDC: 71335-0291-4: 56 Tablets in a BOTTLE NDC: 71335-0291-5: 28 Tablets in a BOTTLE NDC: 71335-0291-6: 10 Tablets in a BOTTLE NDC: 71335-0291-7: 120 Tablets in a BOTTLE NDC: 71335-0291-8: 180 Tablets in a BOTTLE Storage Store pantoprazole sodium delayed-release tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Bryant Ranch Prepack
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MEDICATION GUIDE
Pantoprazole Sodium (pan toe’ pra zole soe’ dee um)
Delayed-Release Tablets
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 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

Preparatomtale

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
BRYANT RANCH PREPACK
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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,
Severe Cutaneous Adverse Reactions (5.5) 03/2022
Hypomagnesemia and Mineral Metabolism (5.8) 03/2022
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are 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
DOSAGE FORMS AND STRENGTHS
Delayed-Release Tablets: 20 mg and 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
p