Medindia » Medication Manual » Ursodiol

Ursodiol

Latest prescription information about Ursodiol. 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 : Ursodiol
Pronunciation : ERR-so-DIE-ole
Therapeutic Classification : Miscellaneous Gastrointestinal Products
Trade Name(s): 
International- Actigall and Urso.
Why it is prescribed (Indications) : 
This medication is a bile acid, prescribed for dissolving gallstones. It helps to dissolve the stone by reducing the amount of cholesterol released by liver into bile.
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 for adults is 8-10 mg/kg/day split into 2 or 3 doses.
How it should be taken : 
It comes as a capsule to take by mouth, with food or milk.
Warnings and Precautions : 
* Caution should be exercised in patients with history of inflammation of the bile duct, gallbladder pancreas, esophageal bleeding, who are taking other medications, children, during pregnancy and breastfeeding.
Side Effects : 
Most Common - Diarrhea, elevated liver enzyme, elevated blood glucose, peptic ulcer, skin rash, decrease in platelets.
Gastrointestinal - Abdominal discomfort, abdominal pain, constipation, diarrhea, indigestion, nausea, vomiting.
General - Uneasiness, swelling in th extremities, fever.
Metabolic - Facial swelling, hives, angioedema and laryngeal edema.
Musculoskeletal - Muscle pain.
Central Nervous system - Dizziness, headache.
Respiratory - Cough.
Skin - Hair loss, itching, rash.
Other Precautions : 
* Avoid excess dosage.
Storage Conditions : 
Store at 20°C to 25°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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