PANTOPRAZOLE SODIUM tablet, delayed release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

PANTOPRAZOLE SODIUM (UNII: 6871619Q5X) (PANTOPRAZOLE - UNII:D8TST4O562)

Disponible depuis:

DirectRX

DCI (Dénomination commune internationale):

PANTOPRAZOLE SODIUM

Composition:

PANTOPRAZOLE 40 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Pantoprazole sodium delayed-release tablets are indicated for: 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) 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 tablets may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established. 1.2 Maintenance of Healing of Erosive Esophagitis 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. 1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellis

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PANTOPRAZOLE SODIUM- PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE
DIRECTRX
----------
PANTOPRAZOLE SODIUM
INDICATIONS & USAGE SECTION
Pantoprazole sodium delayed-release tablets are indicated for:
1.1 Short-Term Treatment of Erosive Esophagitis Associated With
Gastroesophageal Reflux Disease
(GERD)
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
tablets may be considered. Safety of
treatment beyond 8 weeks in pediatric patients has not been
established.
1.2 Maintenance of Healing of Erosive Esophagitis
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.
1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
Pantoprazole sodium delayed-release tablets are indicated for the
long-term treatment of pathological
hypersecretory conditions, including Zollinger-Ellison syndrome.
DOSAGE & ADMINISTRATION SECTION
2.1 Recommended Dosing Schedule
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
Indication
Dose Frequency
Short-Term Treatment of Erosive Esophagitis Associated With GERD
Adults
40
mg
Once
daily for
up to 8
weeks*
Children (5 years and older)
≥ 15 kg to <40 kg
≥ 40 kg
20
mg
40
mg
Once
daily for
up to 8
weeks
Maintenance of Healing of Erosive Esophagitis
Adults
40
mg
Once
daily†
Pathological Hypersecretory Conditions Including Zollinger-Ellison
Syndrome
*For adult patients who have not healed after 8 weeks of treatment, an