PANTOPRAZOLE SODIUM DELAYED-RELEASE- 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:

Aphena Pharma Solutions - Tennessee, LLC

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. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium 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 erosive esophagitis 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. Pantoprazole Sodium Delayed-Release Tablets are contraindicated in patients wi

Product summary:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. How Supplied Pantoprazole Sodium Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with P40 (brown ink) on one side and are available as follows: Pantoprazole Sodium Delayed-Release Tablets are supplied as 20 mg yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side and are available as follows: Storage Store Pantoprazole Sodium Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature] .

Authorization status:

New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET,
DELAYED
RELEASE
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Pantoprazole sodium
Delayed-Release Tablets
Read this Medication Guide before you start taking pantoprazole sodium
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?
Pantoprazole sodium may help your acid-related symptoms, but you could
still have serious stomach
problems. Talk with your doctor.
Pantoprazole sodium can cause serious side effects, including:
•
Diarrhea. Pantoprazole sodium 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 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.
Pantoprazole sodium can have other serious side effects. See "What are
the possible side effects of
pantoprazole sodium?"
What is pantoprazole sodium?
Pantoprazole sodium is a prescription medicine called a proton pump
inhibitor (PPI).
Pantoprazole sodium reduces the amount of acid in your stomach.
Pantoprazole sodium is used in adults:
•
for up to 8 weeks to heal acid-related damage to the lining of the
esophagus (erosive esophagitis or
EE) and to relieve symptoms caused by gastroesophageal reflux disease
(GERD). If needed, your
doctor may decide to prescribe another 8 weeks of pantoprazole sodium.
•
to maintain

Summary of Product characteristics

PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET,
DELAYED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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
T ABLE TS.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Pantoprazole sodium is a proton pump inhibitor 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
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 (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles (4)
WARNINGS AND PRECAUTIONS
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 _associated diarrhea. (5.4)
Bone Fracture: Long-term and multiple daily dose PPI therapy may be
associated with an increased risk for
osteoporosis-related fractures of the hip, wrist or spine. (5.5)
Hypomagnesemia has been reported rarely with prolonged treatment with
PPIs (5.6)
ADVERSE REACTIONS
The most freq