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:

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 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 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 contraind

Product summary:

Pantoprazole sodium delayed-release tablets, USP are supplied as follows: 20 mg - Each enteric coated, yellow, elliptical, biconvex, delayed-release tablet imprinted with Actavis logo“” and “20” on one side contains 22.6 mg of pantoprazole sodium sesquihydrate, USP equivalent to 20 mg pantoprazole. Tablets are supplied in bottles of 30 (NDC 63187-042-30), in bottles of 60 (NDC 63187-042-60) and 90 (NDC 63187-042-90). Storage Store 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]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
Proficient Rx LP
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MEDICATION GUIDE
Pantoprazole (pan-TOE-pra-zole) Sodium Delayed-Release Tablets, USP
Rx Only
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:
•
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 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.
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 tablets reduce the amount of acid
in your stomach.
Pantoprazole sodium delayed-release tabl

Summary of Product characteristics

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
PROFICIENT RX LP
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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
TABLE TS.
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release is a proton pump inhibitor
indicated for the following:
•
•
•
DOSAGE AND ADMINISTRATION
INDIC ATIO N 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
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
•
•
•
•
•
ADVERSE REACTIONS
The most frequently occurring adverse reactions are as follows:
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ACTAVIS AT
1-800-432-8534 OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
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 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