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:

Mylan Institutional Inc.

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 40 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 containing 45.10 mg of pantoprazole sodium, USP equivalent to 40 mg of pantoprazole, respectively. The 40 mg tablets are dark yellow, film-coated, oval, unscored tablets imprinted with M P9 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-051-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Mylan Institutional Inc.
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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 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

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
MYLAN INSTITUTIONAL 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
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Tubulointerstitial Nephritis ( 5.2),
11/2020
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
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
patients. ( 5.2)
_Clostridium difficile_-Associated Diarrhea: PPI therapy may be
asso