ELMIRON pentosan polysulfate sodium capsule gelatin coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

PENTOSAN POLYSULFATE SODIUM (UNII: 914032762Y) (PENTOSAN POLYSULFATE - UNII:F59P8B75R4)

Sẵn có từ:

Cardinal Health

INN (Tên quốc tế):

PENTOSAN POLYSULFATE SODIUM

Thành phần:

PENTOSAN POLYSULFATE SODIUM 100 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

ELMIRON- PENTOSAN POLYSULFATE SODIUM CAPSULE, GELATIN COATED
CARDINAL HEALTH
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ELMIRON -100 MG
(PENTOSAN POLYSULFATE SODIUM)
CAPS ULES
PRESCRIBING INFORMATION
DESCRIPTION
Pentosan polysulfate sodium is a semi-synthetically produced
heparin-like macromolecular
carbohydrate derivative, which chemically and structurally resembles
glycosaminoglycans. It is a white
odorless powder, slightly hygroscopic and soluble in water to 50% at
pH 6. It has a molecular weight
of 4000 to 6000 Dalton with the following structural formula:
ELMIRON is supplied in white opaque hard gelatin capsules containing
100 mg pentosan polysulfate
sodium, microcrystalline cellulose, and magnesium stearate. It also
contains pharmaceutical glaze
(modified) in SD-45, synthetic black iron oxide, FD&C Blue No. 2
aluminum lake, FD&C Red No. 40
aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Yellow No. 10
aluminum lake, n-butyl alcohol,
propylene glycol, SDA-3A alcohol, and titanium dioxide. It is
formulated for oral use.
CLINICAL PHARMACOLOGY
GENERAL
Pentosan polysulfate sodium is a low molecular weight heparin-like
compound. It has anticoagulant and
fibrinolytic effects. The mechanism of action of pentosan polysulfate
sodium in interstitial cystitis is not
known.
PHARMACOKINETICS
ABS ORPTION
In a clinical pharmacology study in which healthy female volunteers
received a single oral 300 or 450
mg dose of pentosan polysulfate sodium containing radiolabeled drug as
a solution under fasted
conditions, maximal levels of plasma radioactivity were seen
approximately at a median of 2 hours
(range 0.6-120 hours) after dosing. Based on urinary excretion of
radioactivity, a mean of
approximately 6% of a radiolabeled oral dose of pentosan polysulfate
sodium is absorbed and reaches
the systemic circulation.
_FOOD EFFECTS_
In clinical trials, ELMIRON was administered with water 1 hour before
or 2 hours after meals; the
effect of food on absorption of pentosan polysulfate sodium is not
known.
DIS TRIBUTION
Preclinical studies with parenterally administere