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:

AvKARE, 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 42291-658-90). 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 42291-659-90), 500 tablets (NDC 42291-659-50) and 1000 tablets (NDC 42291-659-10). 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

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
AvKARE, Inc.
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MEDICATION GUIDE
Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um) Delayed-Release
Tablets USP
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
g

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
AVKARE, INC.
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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, Interference with Investigations for
Neuroendocrine Tumors ( 5.9) 12/2017
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
Fre que ncy
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 Interstitial Nephritis_: _Obser