Version May 2024
Interstitial cystitis: Oral: 100 mg 3 times daily.
Note: Patients should be re-evaluated after 3 months; therapy may continue for an additional 3 months if there has been no improvement and if there are no therapy-limiting side effects. The risks and benefits of continued use beyond 6 months in patients who have not responded is not yet known.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, hepatic impairment may affect pharmacokinetics; use with caution.
Refer to adult dosing.
Interstitial cystitis: Adolescents ≥16 years: Oral: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, hepatic impairment may affect pharmacokinetics; use with caution.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Dermatologic: Alopecia (4%), diaphoresis (1%), skin rash (3%)
Endocrine & metabolic: Increased gamma-glutamyl transferase (≤1%), increased lactate dehydrogenase (≤1%)
Gastrointestinal: Abdominal pain (2%), diarrhea (4%), dyspepsia (1% to 2%), nausea (4%)
Hematologic & oncologic: Rectal hemorrhage (6%)
Hepatic: Abnormal liver function (1%), increased serum alkaline phosphatase (≤1%), increased serum transaminase (≤1%)
Nervous system: Depression (≤2%), dizziness (1%), emotional lability (≤2%), headache (3%), insomnia (1%)
<1%:
Dermatologic: Ecchymoses, pruritus, skin photosensitivity, urticaria
Gastrointestinal: Anorexia, colitis, constipation, esophagitis, flatulence, gastritis, gingival hemorrhage, oral mucosa ulcer, vomiting
Hematologic & oncologic: Anemia, leukopenia, prolonged partial thromboplastin time, prolonged prothrombin time, thrombocytopenia
Hypersensitivity: Hypersensitivity reaction
Ophthalmic: Amblyopia, conjunctivitis, optic neuritis, retinal hemorrhage
Otic: Tinnitus
Respiratory: Dyspnea, epistaxis, pharyngitis, rhinitis
Postmarketing: Ophthalmic: Macular degeneration (McGwin 2022), maculopathy (including pigmentary maculopathy with long-term use) (Pearce 2018; McGwin 2022), retinal pigment changes, retinal toxicity (including retinal dystrophy and injury) (McGwin 2022)
Hypersensitivity to pentosan polysulfate sodium, structurally related compounds (low-molecular-weight heparins or heparin), or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): History of any macular pathology.
Concerns related to adverse effects:
• Bleeding: Pentosan polysulfate is a low-molecular weight heparin-like compound with anticoagulant and fibrinolytic effects, therefore, bleeding complications (such as ecchymosis, epistaxis, and gum bleeding) may occur. Patients undergoing invasive procedures or having signs or symptoms of underlying coagulopathies or other increased risk of bleeding (eg, receiving heparin, warfarin, thrombolytics, NSAIDs, or high dose aspirin) should be evaluated prior to use.
• Ocular effects: Pigmentary changes in the retina, including pigmentary maculopathy, have been reported with long-term use (≥3 years), but may occur with a shorter duration of use; cumulative dose may be a risk factor. Use with caution in patients with retinal pigment changes from other causes. Obtain a detailed ophthalmologic history prior to initiation of therapy; consider genetic testing in patients with a family history of hereditary pattern dystrophy. Retinal exams, including ocular coherence tomography and auto-fluorescence imaging, are recommended for all patients within 6 months of initiating therapy and periodically during treatment. A comprehensive baseline retinal exam, including color fundoscopic photography, ocular coherence tomography, and auto-fluorescence imaging, is recommended before initiating therapy in patients with preexisting ophthalmologic conditions. Risks and benefits of continuing treatment should be reevaluated if pigmentary changes in the retina develop; changes may be irreversible. Follow-up retinal examinations should be continued since retinal and vision changes may progress after discontinuation of therapy.
Disease-related concerns:
• Aneurysm: Carefully evaluate patients with aneurysm before initiating therapy.
• Bleeding disorders: Carefully evaluate patients with hemophilia and/or thrombocytopenia before initiating therapy.
• Gastrointestinal disease: Carefully evaluate patients with gastrointestinal ulcerations, polyps, and/or diverticula before initiating therapy.
• Heparin-induced thrombocytopenia: Use with caution in patients with a history of heparin-induced thrombocytopenia.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
Special populations:
• Pediatric: Safety and efficacy have not been established in children <16 years of age.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Elmiron: 100 mg [contains fd&c blue #1 (brill blue) aluminum lake, fd&c blue #2 (indigo carm) aluminum lake, fd&c red #40(allura red ac)aluminum lake, quinoline (d&c yellow #10) aluminum lake]
No
Capsules (Elmiron Oral)
100 mg (per each): $13.10
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Elmiron: 100 mg
Administer with water 1 hour before or 2 hours after meals.
Oral: Administer with water 1 hour before or 2 hours after meals.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Elmiron: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020193s015lbl.pdf#page=11
Interstitial cystitis: Relief of bladder pain or discomfort due to interstitial cystitis
Pentosan may be confused with pentostatin
Elmiron may be confused with Imuran
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): Pentosan Polysulfate Sodium may enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Risk C: Monitor therapy
Anticoagulants: Pentosan Polysulfate Sodium may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
No adverse events were noted in animal reproduction studies; however, reversible limb bud abnormalities were noted during in vitro animal studies. Use with caution and only if clearly needed during pregnancy. Based on limited data, pentosan polysulfate does not appear to cross the placenta.
It is not known if pentosan polysulfate sodium is excreted in breast milk. The manufacturer recommends that caution be exercised when administering pentosan polysulfate sodium to nursing women.
Perform retinal exams for all patients within 6 months of initiating therapy and periodically during treatment; baseline retinal exam in patients with preexisting ophthalmologic conditions before initiating therapy.
Although pentosan polysulfate sodium is a low-molecular weight heparinoid, it is not known whether these properties play a role in its mechanism of action in treating interstitial cystitis; the drug appears to adhere to the bladder wall mucosa where it may act as a buffer to protect the tissues from irritating substances in the urine.
Absorption: ~6%
Metabolism: Hepatic and splenic via partial desulfation; partial depolymerization occurs in the renal parenchyma; saturable
Half-life elimination: 20-27 hours
Time to peak, serum: 2 hours (range: 0.6-120 hours)
Excretion: Feces (58% to 84%, as unchanged drug); urine (6%, primarily as metabolites)
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
