PEN-toe-san

Therapeutic Classification:

Pharmacologic Classification:

• Management of symptoms (bladder pain/discomfort) of chronic interstitial cystitis (IC).

• Adheres to uroepithelium, providing a protective barrier against irritating solutes in urine.
• Has anticoagulant and fibrinolytic properties.

• ↓ pain and discomfort in chronic IC.

Absorption: 6% absorbed following oral administration.

Distribution: Distributes into uroepithelium of the genitourinary tract with less found in liver, spleen, lung, skin, periosteum, and bone marrow.

Metabolism/Excretion: Metabolized by saturable enzyme systems in liver, spleen and kidney. Majority (58–84%) excreted in feces as unchanged (unabsorbed drug). Metabolites of absorbed drug are renally excreted; minimal renal excretion of unchanged drug.

Half-life: 27 hr.

(↓ symptoms)

Contraindicated in:

• Hypersensitivity.

Use Cautiously in:

• Underlying coagulopathy, concurrent medications that ↑ bleeding risk, history of aneurysms. thrombocytopenia, hemophilia, GI ulceration/bleeding, polyps, diverticula
• History of heparin-induced thrombocytopenia; risk of bleeding may be ↑
• Hepatic insufficiency
• OB: Use during pregnancy only if clearly needed
• Lactation: Safety not established in breastfeeding
• Pedi: Children <16 yr (safety and effectiveness not established).

Derm: alopecia, ecchymosis, rash.

EENT: blurred vision, epistaxis, retinal pigment changes.

GI: ↑ liver enzymes, abdominal pain, diarrhea, dyspepsia, gum bleeding, nausea, rectal bleeding.

Hemat: ↑ bleeding time, bleeding.

Neuro: dizziness, headache.

Drug-Drug:

• Concurrent use of anticoagulants, heparins, thrombolytics, high dose aspirin, or NSAIDs may ↑ risk of bleeding.

• PO (Adults): 100 mg three times daily.

• Capsules: 100 mg;

• Assess pain intensity, frequency, and duration in patient with interstitial cystitis.

• Doses of <1200 mg/day are unlikely to affect PT or PTT.
  • May cause liver function abnormalities.
  • May rarely cause anemia, ↑ PT, ↑ PTT, leukopenia, and thrombocytopenia.

• PO: Administer on an empty stomach 3 times daily, at least 1 hr before or 2 hr after meals.

• Instruct patient to take pentosan as directed, taking no more or no more frequently than prescribed. Advise patient to read Medication Guide before starting therapy and with Rx refills in case of changes.
• Inform patient of potential visual changes. Advise patient to notify health care professional if visual changes occur.
• Advise patient to notify health care professional if surgery, anticoagulant therapy (warfarin, heparin), or therapy with high doses of aspirin or NSAIDs is planned.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

• ↓ in pain and discomfort of interstitial cystitis. Reassess after 3 mo of therapy. If no improvement but no limiting adverse events are present, may be continued for 3 more mo.

Elmiron

NDC Code^*

• 50458- Janssen Pharmaceuticals, Inc.
  • 50458-098- ELMIRON
    • 50458-098-01- 100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)