PANTOPRAZOLE SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindic

Product summary:

How Supplied Pantoprazole Sodium Delayed-Release Tablets USP are available as follows: 20 mg: Yellow, oval shaped, unscored tablets imprinted with black ink on one side of the tablet “93/11” and plain on the other side. They are available in bottles of 90 tablets (NDC 0093-0011-98). 40 mg: Yellow, oval shaped, unscored tablets imprinted with black ink on one side of the tablet “93/12” and plain on the other side. They are available in bottles of 90 tablets (NDC 0093-0012-98). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Teva Pharmaceuticals USA, Inc.
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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 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
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 the sun.
Talk to your doctor a

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
TEVA PHARMACEUTICALS USA, INC.
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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 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
*
INDIC ATIO N
DO SE
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 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: PPI therapy may be
associated with increased risk of _Clostridium difficile_-
associated diarrhea. (5.3)
Bone Fracture: Long-term and multi