PANTOPRAZOLE SODIUM DELAYED-RELEASE- pantoprazole sodium tablet, delayed release

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Contract Pharmacy Services-PA

INN (Tên quốc tế):

PANTOPRAZOLE SODIUM

Thành phần:

PANTOPRAZOLE 40 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Pantoprazole sodium delayed-release tablets are indicated for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. 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 patients with gastroesophageal reflux disease (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 contraindicated in patients with known hypersensitivity to any component of the formulation.

Tóm tắt sản phẩm:

Pantoprazole sodium delayed-release tablets are supplied as 40 mg yellow oval biconvex delayed‑release tablets imprinted with PROTONIX (brown ink) on one side. They are available as follows: Store pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] United States Patent Numbers: 4,758,579; 5,997,903. Marketed by esiLederle Division of Wyeth Philadelphia, PA 19101 under license from Nycomed GmbH D78467 Konstanz, Germany W10525C006 ET02 Rev 11/08 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--02/2010--NJW

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

PANTOPRAZOLE SODIUM DELAYED-RELEASE- PANTOPRAZOLE SODIUM TABLET,
DELAYED
RELEASE
CONTRACT PHARMACY SERVICES-PA
----------
PANTOPRAZOLE SODIUM
DELAYED-RELEASE TABLETS
RX ONLY
DESCRIPTION
The active ingredient in pantoprazole sodium delayed-release tablets
is a substituted benzimidazole,
sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]
sulfinyl]-1_H_-benzimidazole
sesquihydrate, a compound that inhibits gastric acid secretion. Its
empirical formula is
C
H F N NaO S x 1.5 H O, with a molecular weight of 432.4. The
structural formula is:
Pantoprazole sodium sesquihydrate is a white to off-white crystalline
powder and is racemic.
Pantoprazole has weakly basic and acidic properties. Pantoprazole
sodium sesquihydrate is freely
soluble in water, very slightly soluble in phosphate buffer at pH 7.4,
and practically insoluble in
n hexane.
The stability of the compound in aqueous solution is pH-dependent. The
rate of degradation increases
with decreasing pH. At ambient temperature, the degradation half-life
is approximately 2.8 hours at
pH 5.0 and approximately 220 hours at pH 7.8.
Pantoprazole sodium is supplied as a delayed-release tablet for oral
administration, available in
2 strengths. Each delayed-release tablet contains 45.1 mg or 22.6 mg
of pantoprazole sodium
sesquihydrate (equivalent to 40 mg or 20 mg pantoprazole,
respectively) with the following inactive
ingredients: calcium stearate, crospovidone, hypromellose, iron oxide,
mannitol, methacrylic acid
copolymer, polysorbate 80, povidone, propylene glycol, sodium
carbonate, sodium lauryl sulfate,
titanium dioxide, and triethyl citrate. Pantoprazole Sodium Delayed
Release tablets (40 mg and 20 mg)
complies with USP dissolution test 2.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Pantoprazole sodium is prepared as an enteric-coated tablet so that
absorption of pantoprazole begins
only after the tablet leaves the stomach. Peak serum concentration (C
) and area under the serum
concentration time curve (AUC) increase in a manner proportional to
oral and intra