Dosing & Uses
Dosage Forms & Strengths
capsule
- 100mg
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
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
Pigmentary changes in the retina
Warnings
Contraindications
Hypersensitivity
Cautions
Alopecia is associated with pentosan polysulfate and with heparin products; alopecia began within the first 4 weeks of treatment in clinical trials; ninety-seven percent (97%) of cases of alopecia reported were alopecia areata, limited to a single area on the scalp
The drug has not been studied in patients with hepatic insufficiency; because there is evidence of hepatic contribution to elimination of drug, hepatic impairment may have an impact on pharmacokinetics of the drug; exercise caution when using drug in this patient population
Retinal pigmentary changes
- Pigmentary changes in retina, reported as pigmentary maculopathy, identified with long-term use of drug
- Although most cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use; while the etiology is unclear, cumulative dose appears to be a risk factor
- Visual symptoms in reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision
- Visual consequences of pigmentary changes are not fully characterized
- Use caution in patients with retinal pigment changes from other causes in which examination findings may confound appropriate diagnosis, follow-up, and treatment
- Obtain detailed ophthalmologic history in all patients prior to starting treatment; consider testing if there is a family history of hereditary pattern dystrophy, genetic
- For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy
- A baseline retinal examination (including OCT and autofluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment; if pigmentary changes in retina develop, re-evaluate risks and benefits of continuing treatment, since these changes may be irreversible
- Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment
Anticoagulant effects
- The drug is a weak anticoagulant (1/15 the activity of heparin) At a daily dose of 300 mg (n=128), rectal hemorrhage was reported as an adverse event in 6.3% of patients
- Bleeding complications of ecchymosis, epistaxis, and gum hemorrhage reported
- Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to other therapies such as coumarin anticoagulants, heparin, tPA, streptokinase, high dose aspirin, or nonsteroidal anti-inflammatory drugs) should be evaluated for hemorrhage.
- Patients with diseases such as aneurysms, thrombocytopenia, hemophilia, gastrointestinal ulcerations, polyps, or diverticula should be carefully evaluated before starting therapy
- Exercise caution when administering therapy in patients who have a history of heparin-induced thrombocytopenia
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.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)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Elmiron oral - | 100 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
pentosan polysulfate sodium oral
PENTOSAN POLYSULFATE SODIUM - ORAL
(PEN-toe-san paw-lee-SULL-fate SO-dee-um)
COMMON BRAND NAME(S): Elmiron
USES: This medication is used to treat pain/discomfort from a certain bladder disorder (interstitial cystitis). It may work by forming a layer on the bladder wall and protecting it from harmful/irritating substances in the urine. It is also a weak "blood thinner" and may increase the risk of bruising/bleeding (such as bleeding from the nose/gums).
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking pentosan polysulfate sodium and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth at least 1 hour before or 2 hours after meals as directed by your doctor, usually 3 times daily.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Do not increase your dose or take this medication more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Tell your doctor if your condition worsens or does not improve after 3 months.
SIDE EFFECTS: Diarrhea, hair loss, nausea, headache, stomach upset, or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: unusual bruising/bleeding (such as blood in stool), vision changes (such as blurred vision), eye pain, mental/mood changes, heartburn, discomfort when swallowing, tiredness, fast/pounding heartbeat, shortness of breath.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking pentosan polysulfate sodium, tell your doctor or pharmacist if you are allergic to it; or to heparin or low molecular weight heparin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders (such as hemophilia, thrombocytopenia), blood vessel disorders (such as aneurysm), eye disorders, liver disease, spleen disorders, stomach/intestinal disorders (such as stomach ulcers, polyps, diverticula).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin, heparin, tenecteplase, abciximab, clopidogrel, ticlopidine), mifepristone, sulfinpyrazone.Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, naproxen, ketorolac) that may increase your risk for side effects if taken together with this medication. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day). Ask your doctor or pharmacist for more details.This medication may interfere with certain laboratory tests (including prothrombin time/INR, factor Xa levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unusual bruising/bleeding, nausea/vomiting.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as eye exams, liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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