PANTOPRAZOLE SODIUM tablet, delayed release PANTOPRAZOLE SODIUM DR- 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:

DIRECT RX

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: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) 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 delayed-release tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis 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. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellis

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 0093-0011-98). 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 0093-0012-98). 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
PANTOPRAZOLE SODIUM DR- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
DIRECT RX
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Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um) Delayed-Release
Tablets USP
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, 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 of lup

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
PANTOPRAZOLE SODIUM DR- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
DIRECT RX
----------
PANTOPRAZOLE SODIUM
Pantoprazole sodium delayed-release tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With
Gastroesophageal Reflux Disease
(GERD)
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 delayed-release
tablets may be considered. Safety of
treatment beyond 8 weeks in pediatric patients has not been
established.
1.2 Maintenance of Healing of Erosive Esophagitis
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.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the
long-term treatment of pathological
hypersecretory conditions, including Zollinger-Ellison syndrome.
2.1 Recommended Dosing Schedule
Pantoprazole sodium is supplied as delayed-release tablets. The
recommended dosages are outlined in
Table 1.
Table 1: Recommended Dosing Schedule for Pantoprazole Sodium
Delayed-Release Tablets
*
For 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.
†
Controlled studies did not extend beyond 12 months
‡
Dosage regimens should be adjusted to individual patient needs and
should continue for as long as
clinically indicated. Doses up to 240 mg daily have been administered.
Indication
Dose
Frequency
Short-Term Treatment of Eros