PANTOPRAZOLE SODIUM- pantoprazole 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:

California Pharmaceuticals LLC

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, USP are 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) 1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) 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. 1.2 Maintenance of Healing of Erosive Esophagitis Pantoprazole sodium delayed-releas

Descriptif du produit:

How Supplied Pantoprazole sodium delayed-release tablets, USP, 40 mg, are supplied as light yellow to yellow color, oval shaped, biconvex, delayed-release tablets imprinted “A37” with black ink on one side and plain on the other side. They are available as follows: Bottles of 7     NDC 70332-300-01 Bottles of 30   NDC 70332-300-02 Storage Store pantoprazole sodium delayed-release tablets, USP 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].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

PANTOPRAZOLE SODIUM- PANTOPRAZOLE TABLET, DELAYED RELEASE
CALIFORNIA PHARMACEUTICALS LLC
----------
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS
1 INDICATIONS AND USAGE
Pantoprazole sodium delayed-release tablets, USP are 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)
1.1 SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH
GASTROESOPHAGEAL REFLUX
DISEASE (GERD)
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.
1.2 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.
1.3 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.
2 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 CONDIT