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:

Preferred Pharmaceuticals, 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 syndrome. Teratogenic Effects Pregnancy Category C  Repr

Product summary:

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. Bottle of 30 - 68788-9510-3 Bottle of 60 - 68788-9510-6 Bottle of 90 - 68788-9510-9 Bottle of 100 - 68788-9510-1 Bottle of 120 - 68788-9510-8 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
Pantoprazole Sodium Delayed-Release Tablets, USP
(pan toe' pra zole soe' dee um)
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:
•
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 if you
have a decrease in the amount
that you urinate or if you have blood in your urine.
•
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 PPI 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.
•
Certain types o

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
PREFERRED PHARMACEUTICALS, INC.
----------
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, Atrophic Gastritis removed (5.2) 10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus
Erythematosus (5.5) 10/2016
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets are a proton pump
inhibitor (PPI) indicated for the following:
•
•
•
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
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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)
Delayed-Release Tablets, 20 mg and 40 mg (3)
Patients with known hypersensitivity to any component of the
formulation or to substituted benzimidazoles (4)
Patients receiving rilpivirine-containing products (4)
Gastric Malignancy: In adults, symptomatic response does not preclude
presence of gastric malignancy. Consider
additional follow-up and diagnostic testing. (5.1)