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:

Ranbaxy 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, USP are indicated for: Pantoprazole sodium delayed-release tablets, USP 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, USP 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 is contra

Product summary:

How Supplied Pantoprazole sodium delayed-release tablets, USP 20 mg are supplied as yellow to light yellow colored, oval-shaped, biconvex, enteric-coated tablets, imprinted with ‘RA33 ’ on one side and plain on the other side and are available as follows: NDC 63304-967-90 Bottles of 90 NDC 63304-967-10 Bottles of 1000 NDC 63304-967-77 Blister pack of 100 Pantoprazole sodium delayed-release tablets, USP 40 mg are supplied as yellow to light yellow colored, oval-shaped, biconvex, enteric-coated tablets, imprinted with ‘RA34 ’ on one side and plain on the other side and are available as follows: NDC 63304-968-90 Bottles of 90 NDC 63304-968-10 Bottles of 1000 NDC 63304-968-77 Blister pack of 100 Storage Store pantoprazole sodium delayed-release tablets, USP at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Ranbaxy Pharmaceuticals Inc.
----------
SPL MEDGUIDE SECTION
MEDICATION GUIDE
PANTOPRAZOLE SODIUM (pan toe' pra zole soe' dee um) DELAYED-RELEASE
TABLETS, USP
Rx only
Read this Medication Guide before you start taking pantoprazole sodium
delayed-release tablets, USP 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,
USP?
Pantoprazole sodium delayed-release tablets, USP may help your
acid-related symptoms, but you could
still have serious stomach problems. Talk with your doctor.
Pantoprazole sodium delayed-release tablets, USP can cause serious
side effects, including:
•
Diarrhea. Pantoprazole sodium delayed-release tablets, USP 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 delayed-release tablets, USP
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, USP.
Pantoprazole sodium delayed-release tablets, USP can have other
serious side effects. See “What are the
possible side effects of pantoprazole sodium delayed-release tablets,
USP?”
What are pantoprazole sodium delayed-release tablets, USP?
Pantoprazole sodium delayed-release tablets, USP are a prescription
medicine called a proton pump
inhibitor (PPI).
Pantoprazole sodium delaye

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
RANBAXY PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANTOPRAZOLE SODIUM DELAYED-RELEASE
TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR PANTOPRAZOLE SODIUM DELAYED-
RELEASE TABLETS, USP.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP, FOR ORAL
ADMINISTRATION
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 tablets, USP are a proton pump
inhibitor indicated for the following: (1)
•
•
•
DOSAGE AND ADMINISTRATION
INDICATION (2)
DOSE (2)
FREQUENCY (2)
SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD (2.1)
(2)
Adults (2)
40 mg (2)
Once Daily for up to 8 wks (2)
Children (5 years and older) ≥ 15 kg to < 40 kg (2)
20 mg (2)
Once Daily for up to 8 wks (2)
≥ 40 kg (2)
40 mg (2)
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2.1) (2)
Adults (2)
40 mg (2)
Once Daily*** (2)
PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME (2.1) (2)
Adults (2)
40 mg (2)
Twice Daily (2)
*Controlled studies did not extend beyond 12 months (2)
See full prescribing information for administration instructions (2)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation or to
substituted benzimidazoles (4) (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most frequently occurring adverse reactions are as follows: (6)
•
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)
Symptomatic re