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:

Northwind Pharmaceuticals, LLC

INN (International Name):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

 INDICATIONS AND USAGE Pantoprazole sodium delayed-release tablets USP are indicated for: Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) Pantoprazole sodium delayed-release tablets USP are indicated in adults 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. Maintenance of Healing of Erosive Esophagitis 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. Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Pantoprazole

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PANTOPRAZOLE SODIUM DR- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
NORTHWIND PHARMACEUTICALS, LLC
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PANTOPRAZOLE SODIUM DR 40 MG
INDICATIONS AND USAGE
INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets USP are indicated for:
Short-Term Treatment of Erosive Esophagitis Associated With
Gastroesophageal Reflux Disease
(GERD)
Pantoprazole sodium delayed-release tablets USP are indicated in
adults 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.
Maintenance of Healing of Erosive Esophagitis
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.
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Pantoprazole sodium delayed-release tablets USP are indicated for the
long-term treatment of
pathological hypersecretory conditions, including Zollinger-Ellison
syndrome.
DOSAGE AND ADMINISTRATION
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.
†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 EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD
Adults 40 mg Once daily for up
to 8 weeks*
Children (5 Yea