PANTOPRAZOLE SODIUM- pantoprazole 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:

Proficient Rx LP

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pantoprazole Sodium Delayed-Release Tablets, USP are indicated for: Pantoprazole Sodium Delayed-Release Tablet, USP is 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, USP 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 USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Pantoprazole Sodium Delayed-Release Tablets are contraindicat

Product summary:

How Supplied Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg yellow to pale yellow, oval, biconvex, delayed-release tablets imprinted “H125” on one side with black ink and plain on the other side. They are supplied as follows:         Bottles of 30 tablets                                             NDC 63187-831-30        Bottles of 60 tablets                                              NDC 63187-831-60        Bottles of 90 tablets                                              NDC 63187-831-90 Storage Store pantoprazole sodium delayed-release tablets, USP 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 TABLET, DELAYED RELEASE
Proficient Rx LP
----------
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 sodiumdelayed-release tablets may help your acid-related
symptoms, but you could still
have serious stomach problems. Talk with your doctor.
Pantoprazole sodiumdelayed-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
offractures 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 tablet.
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 tablet reduces the amount of acid
in your stomach.
Pantoprazole sodium delayed-release tablets a

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
PROFICIENT RX LP
----------
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
Dosage and Administration, Recommended Dosing Schedule (2.1) 12/2014
Contraindications (4) 12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablet, USP 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
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
*Controlled studies did not extend beyond 12 months
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
• Symptomatic response does not preclude presence of gastric
malignancy (5.1)
• Atrophic gastritis has been noted with long-term therapy (5.2)
• Acute gastritis has been observed in patients taking PPIs. (5.3)
• Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use
(e.g., longer than 3 years) may lead to m