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:

Contract Pharmacy Services-PA

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 (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. - Pantoprazole sodium delayed-release tablets are contraindicated

Product summary:

How Supplied 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 the following: NDC 67046-534-07 blisterpacks of 7 NDC 67046-534-14 blisterpacks of 14 NDC 67046-534-15 blisterpacks of 15 NDC 67046-534-20 blisterpacks of 20 NDC 67046-534-21 blisterpacks of 21 NDC 67046-534-28 blisterpacks of 28 NDC 67046-534-30 blisterpacks of 30 NDC 67046-534-60 blisterpacks of 60 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

Contract Pharmacy Services-PA
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MEDICATION GUIDE
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:
1.
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.
2.
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.
3.
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.
4.
Certain types of lupus erythematosus. Lupus erythematosus is an
autoimmune disorder (the
body’s immune cells attack ot

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
CONTRACT PHARMACY SERVICES-PA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
534 PANTOPRAZOLE 40 MG
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:
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
Patients with known hypersensitivity to any component of the
formulation or to substituted benzimidazoles ( 4)
Patients receiving rilpivirine-containing products ( 4)
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: Observed in patients taking PPIs. ( 5.2)