PANTOPRAZOLE SODIUM- 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:

Lake Erie Medical DBA Quality Care Products LLC

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 for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. 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. Pediatric indication and usage information in pediatric patients ages 5 years and older with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.’s pantoprazole sodium delayed-release tablets. However, due to Wyeth Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartbu

Product summary:

Pantoprazole Sodium Delayed-release Tablets, USP are available containing pantoprazole sodium, USP equivalent to 20 mg or 40 mg of pantoprazole. The 20 mg tablets are dark yellow film-coated, oval, unscored tablets imprinted with M P8 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC: 55700-019-30  Bottles of 30 NDC: 55700-019-60  Bottles of 60 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: 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 using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP
(pan toe′ pra zole soe′dee um)
20 mg and 40 mg
Read this Medication Guide before you start taking pantoprazole sodium
delayed-release tablets and each
time you get a refill. There may be new information. This information
does not take the place of talking
with your doctor about your medical condition or your treatment.
What is the most important information I should know about
pantoprazole sodium delayed-release
tablets?
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:
•
Diarrhea. Pantoprazole sodium delayed-release tablets may increase
your risk of getting severe
diarrhea. This diarrhea may be caused by an infection ( Clostridium
difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain,
and fever that does not go
away.
•
Bone fractures. People who take multiple daily doses of proton pump
inhibitor medicines for a long
period of time (a year or longer) may have an increased risk of
fractures of the hip, wrist or spine.
You should take pantoprazole sodium delayed-release tablets exactly as
prescribed, at the lowest
dose possible for your treatment and for the shortest time needed.
Talk to your doctor about your
risk of bone fracture if you take pantoprazole sodium delayed-release
tablets.
Pantoprazole sodium delayed-release tablets can have other serious
side effects. See “What are the
possible side effects of pantoprazole sodium delayed-release
tablets?”
What are pantoprazole sodium delayed-release tablets?
Pantoprazole sodium delayed-release tablets are a prescription
medicine called a proton pump inhibitor
(PPI).
Pantoprazole sodium delayed-release tablets reduce the amount of acid
i

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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
TABLE TS.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
Warnings and Precautions, _Clostridium difficile_ Associated
Diarrhea (5.4) 10/2012
Warnings and Precautions, Concomitant Use of Pantoprazole
with Methotrexate (5.9) 05/2012
INDICATIONS AND USAGE
Pantoprazole is a proton pump inhibitor indicated for the following:
•
•
•
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
FREQUENCY
SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1)
40 mg
Once Daily for up to 8 wks
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1)
40 mg
Once Daily
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME (2.1)
40 mg
Twice Daily
See full prescribing information for administration instructions.
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
The most frequently occurring adverse reactions are as follows:
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
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
Syndrome. (1.3)
Adults
Adults
Adults
Delayed-release Tablets, 20 mg and 40 mg (3)
Symptomatic response does not preclude presence of gastric malignancy.
(5.1)
Atrophic gastritis has been noted with long-term therapy. (5.2)
PPI therapy may be associated with increased risk of Clostridium
difficile