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pentosan polysulfate sodium (Rx)Brand and Other Names:Elmiron

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 100mg
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Interstitial Cystitis

Indicated for bladder pain associated with interstitial cystitis

100 mg PO q8hr

Administration: 1 hour before or 2 hours after meals with water

Reassess every 3 Months

Sickle Cell Disease (Orphan)

Orphan indication sponsors

  • Vanguard Therapeutics, Inc; Eagle Trace Dr; Half Moon Bay, CA 94019
  • TRF Pharma, Inc; 863 Mitten Road; Burlingame, CA 94010

Mucopolysaccharidosis (Orphan)

Brand name: Lysosan

Orphan designation for treatment of MPS type VI

Sponsor

  • Plexcera Therapeutics, LLC; 4445 North Highway A1A, Suite 241; Vero Beach, FL 32963

<16 years: Safety and efficacy not established

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Adverse Effects

1-10%

Alopecia (4%)

Diarrhea (4%)

Nausea (4%)

Headache (3%)

Abdominal pain (2%)

Indigestion (2%)

Postmarketing Reports

Rectal hemorrhage

Elevated LFTs

Anemia

Leukopenia

Partial thromboplastin time increased

Prothrombin time increased

Thrombocytopenia

Optic neuritis

Retinal hemorrhage

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Warnings

Contraindications

Hypersensitivity

Cautions

Hepatic or splenic disorders

Bleeding diathesis

Risk of alopecia

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: not known if excreted in breast milk, use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Low molecular weight heparin-like compound; elicits weak anticoagulant (1/15 activity of heparin) and fibrinolytic effects

MOA in cystitis unknown; drug appears to attach to the bladder wall mucosa where it may act as a buffer to protect tissues from irritating substances in the urine

Pharmacokinetics

Absorption: 6%

Half-Life, Elimination: 4.8 hr

Distribution: Uroepithelium of the genitourinary tract with lesser amounts found in the liver, spleen, lung, skin, periosteum, and bone marrow

Metabolism: Spleen and liver; partial depolymerization in the kidney to a large number of metabolites

Excretion: Feces (58% as unchanged drug) Urine (6% primarily as metabolites)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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