PANTOPRAZOLE SODIUM tablet, delayed release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Aphena Pharma Solutions - Tennessee, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 contra

Resumen del producto:

How Supplied Pantoprazole Sodium Delayed-Release Tablets USP, 20 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘51’ with brown ink on one side and plain on other side.                      Bottles of 90                                                        NDC 66993-067-85                                                                                             Cartons of 100 (10 x 10) Unit-dose Tablets         NDC 66993-067-80 Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg are yellow colored, oval shaped, biconvex, enteric-coated tablets imprinted with ‘I’ and ‘52’ with brown ink on one side and plain on other side.                      Bottles of 90                                                        NDC 66993-068-85                      Cartons of 100 (10 x 10) Unit-dose Tablets         NDC 66993-068-80 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

PANTOPRAZOLE SODIUM - PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Aphena Pharma Solutions - Tennessee, LLC
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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 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

Ficha técnica

PANTOPRAZOLE SODIUM - PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, 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
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps (5.9) 06/2018
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
* Controlled studies did not extend beyond 12 months
See full prescribing information for administration instructions
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
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 Interstitial Nephritis: Observed in patients taking PPIs. (5.2)
_Clostridium difficile-_Associated Diarrhea: