Rx Item-Elmiron 100Mg pentosan polysulfate Cap 100 By J O M Pharma

Clinical Information
Gen. Code and Des.
21175 pentosan polysulfate sodium ORAL CAPSULE 100 MG
GCN and Des.
41229 pentosan polysulfate sodium ORAL CAPSULE 100 MG
Strength
100MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
92560000 PROTECTIVE AGENTS
Active Ingredients
4395 pentosan polysulfate sodium 140207938
Inactive Ingredients
10138 blue dye
10141 red dye
10143 yellow dye
2549 gelatin 9000708





ELMIRON- pentosan polysulfate sodium capsule, gelatin coated
Janssen Pharmaceuticals, Inc.

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:

Chemical Structure
(click image for full-size original)


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. ELMIRON Indications and Usage

ELMIRON� (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis.

RX ITEM-Elmiron 100Mg Cap 100 By J O M P
item No.:RX003780 NDC No.50458009801 50458-098-01 5045809801 UPC No.:350458098013 NDC No. 50458-0098-01 UPC/GTIN No. 3-50458-09801-3 MPN 9801

Elmiron 100Mg Cap 100 By J O M Pharma
BRAND: ELMIRON NDC: 50458-0098-01,50458009801 UPC: 3-50458-09801-3,350458098013 J/O/M Pharma Services

PENTOSAN POLYSULFATE SODI
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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