ELMIRON- pentosan polysulfate sodium capsule, gelatin coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

PENTOSAN POLYSULFATE SODIUM

Composition:

PENTOSAN POLYSULFATE SODIUM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELMIRON® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.

Product summary:

ELMIRON® is supplied in white opaque hard gelatin capsules imprinted "BNP7600" containing 100 mg pentosan polysulfate sodium. Supplied in: Store at controlled room temperature 15°–30°C (59°–86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

ELMIRON - PENTOSAN POLYSULFATE SODIUM CAPSULE, GELATIN COATED
PHYSICIANS TOTAL CARE, INC.
----------
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
Absorption
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.
Distribution
Preclinical studies with pa