Pantoprazole Sodium DR

40mg

Product Details

Product Name:
Pantoprazole Sodium DR
Strength:
40mg
Count:
90
NDC:
42291-765-90
Class:
Rx
Brand Name(s):
Protonix
Imprint Code:
ING151
Color(s):
YELLOW (light yellowish)
Shape:
OVAL (oblong)
Score:
no score
Case Count:
Inactive Ingredients:
lactose monohydrate, hypromellose, crospovidone, talc, calcium stearate, povidone, propylene glycol, titanium dioxide, ferric oxide yellow, methacrylic acid and ethyl acrylate copolymer, and triethyl citrate. The tablets are imprinted with black ink containing iron oxide black, propylene glycol, and hypromellose. Pantoprazole sodium delayed-release tablets USP, 40 mg complies with USP dissolution test 3.
Indications and Usage:

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

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 (EE). 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 EE 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 (ZE) Syndrome.

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