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Pentosan Polysulfate Sodium

Latest prescription information about Pentosan Polysulfate Sodium. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Pentosan Polysulfate Sodium
Pronunciation : PEN-toe-san pol-ee-SUL-fate SOE-dee-um
Therapeutic Classification : Cystitis Agents
Trade Name(s): 
India- Comfora.
International- Elmiron.
Why it is prescribed (Indications) : 
This medication is a semi-synthetically produced heparin-like macro molecular carbohydrate derivative, prescribed for interstitial cystitis or painful bladder syndrome (IC/PBS).  
When it is not to be taken (Contraindications): Hypersensitivity.

Pregnancy Category :

A B C D X
Category B : Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Dosage & When it is to be taken : 
The recommended dose is 300 mg/day taken as one 100 mg capsule orally three times daily.
How it should be taken : 
It comes as a capsule to take by mouth, at least 1 hour before meals or 2 hours after meals.
Warnings and Precautions : 
* Caution should be exercised in patients with history of aneurysm, hemophilia, ulcers, low platelet count, an intestinal blockage, liver or spleen disease, any allergy, who are taking other medication, during pregnancy and breastfeeding.
* It may cause increased bleeding, avoid bruising or injury.
Side Effects : 
Serious- Abdominal pain, diarrhea and dehydration.
Central Nervous System - Sleeplessness, headache, severe emotional lability, depression, night blindness, dizziness and hyperactivity.
Gastrointestinal- Nausea, diarrhea, indigestion, jaundice and vomiting.
Skin- Rash, itching, tears, nose inflammation and increased sweating.
Miscellaneous- Absence of menstrual periods, joint pain and vaginal inflammation.
Other Precautions : 
*Avoid excess dosage.
Storage Conditions : 
Store it at controlled room temperature 15°-30°C.

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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