Interacting drugs- summary
           
+Urosidil-

Antacids
 Aluminium based antacids adsorb bile acids in vitro and interfere
 with the action of urodiol by reducing absorption.

Bile acids sequestrants
Cholestyramine and colestipol may interfere with the action of
ursodiol by reducing its absorption.

Clofibrate  /  Estrogens /  Oral contraceptives
 These agents (and perhaps other lipid-lowering drugs) increase hepatic-                        
 cholestrol secretion and encourage choleterol gallstone formation and
  hence counteract the effectiveness of urosidol    

Dissolution of gall stones in patients with radiolucent, noncalcified gall bladder stones.

Interacting drugs- summary

 +Urosidil

Antacids decr Aluminium based antacids adsorb bile acids in vitro and interfere with the action of urodiol by reducing absorption.

Bile acids seques- decr Cholestyramine and colestipol may interfere with the action of trants ursodiol by reducing its absorption.

Dissolution of gall stones in patients with radiolucent, noncalcified gall bladder stones.

Interacting drugs- summary

 +Urosidil

Antacids decr Aluminium based antacids adsorb bile acids in vitro and interfere with the action of urodiol by reducing absorption.

Bile acids seques- decr Cholestyramine and colestipol may interfere with the action of trants ursodiol by reducing its absorption.

GI- Nausea, vomiting, dyspepsia, metallic taste, abdominal pain, cholecystis, constipation, stomatitis, flatulence.

Dermatologic- Pruritus, rash, urticaria, dry skin.eweating, hairthinning, . One patient with pre-erxiting psorasis apparently developed exacerbation ofitching which remitred on withdrawl of the drug.

Miscellaneous- Headache, fatigue, anxiety, depression, sleep disorder, arthalgia, myalgia, cough, back pain,rhinitis.

URSODIOL(ursodeoxycholic acid) will not dissolve calcified gall stones,radiopaque stones or radioulcent bile pigment stones.

Hence patients with such stones are not candidates for ursodil. Patients with compelling reasons for cholesystectomy including unremitting acute cholecystis, cholangitis,biliary obstruction,gallstone pancreatitis or biliary-gastrointestinal fistula are not candidates for ursidol therapy.

Special precautions:

Hepatic effects- Ursidol therapy has not been associated with livewr damage. Patients with significant abnormalities in liver tests at any point should be monitored frequently, evaluate carefully for worsening gall stone disease which in the controlled clinical stidies has been the only identified cause of significant liver test abnormality.

Warnings

Length of therapy- Safety for use of ursodiaol beyoong 24 months is not established.

Gallbladder nonvisualization- Nonvisualizing gallbladder by oral cholecytogram prior to the initiation of therapy is not a contraindication to ursodiol therapy. However, gallbladder nonvisulization developing during ursodiol treatment predicts failure of complete stone dissolution and therapy should be discontinued.

 Carconogenesis- Bile acids might be involved in the pathogenesis of human colon cancer in patients who have undergone a cholecystectomy .Direct evidence is lacking.

Pregnancy- No adequate and well controlled studies in pregnant women.The possibility that ursodiol can cause fetal harm cannot be ruled out, hence do not use during pregnancy.

Lactation- Excercise caution when urdiol is administered to a nursing mother. Children- Safety and efficay for use in children have not been established.

  Date of Approval-    2004/2008      

Indications:

Dissolution of gall stones in patients with radiolucent, noncalcified gall bladder stones.

Dosage:

Radioluscent gall bladder stones- 8 to 10 mg/kg/day given in 2 or 3 divide doses. Storage: Do not store above 86F(30C).

Overdosage- Symptoms

Diarrhea

Treatment

1. Treat symptomatically

2. Treatment includes usual supportive measures

Missed dose

1. If you miss a dose of this medicine, take it as soon as possible.

2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.

3. Do not double doses.

URSODIOL OR URSODEOXYCHOLIC ACID

1.Gallbladder stones disssolution with ursodiol requires months of therapy.

2.Complete dissolution does not occur in all patients and recurrence of stones within 5 years is known to occur

3. Allergy- tell your doctor if you are allergic to ursodiol or any other other food substances

4. Diet- it is thought that body weight and the kind of diet the patient follows may affect how fast the the stones whether new stones will form However, check with your doctor before going on any diet.

5. Pregnancy- ursodiol has not been studied in pregnant women. However, ursodiol has not shown to cause birth defects or other problems in animal studies.

6. Breast feeding- ursodiol passes into breast milk. Mothers who are taking this medicine and who wish to breast feed should discuss this with their doctor.

7. Children- no specific information available comparing use of ursodiol in childen with use in older age groups . This medicine is not expected to cause different side effects than it does in adults.

8. Other medicines- tell your doctor if you are taking any other prescriptiom medicines or OTC medicines

9. Other medical problems- telyou rdoctor if youhaveany other medical problems especially- Billiary tract infections or Pancreatitis - these conditions may make it necessary to have surgery since treatment with ursodiol would take too long

10. Dosing-dose of ursodiol will be different to different patients. Follow your doctors instructions

11. Missed dose- If you miss a dose of this medicine take it as soon as possible or double your next dose.

12. Storage- Keep out of reach of children Store away from heat and direct light Do not store unwanted or outdated medicines. Make sure that any discarded medicine is kept out of reach of children.

Pharmacology:

Ursodiol is a natural occuring bile acid found in small quantites in normal human bile. Ursodiol suppreses hepatic synthesis and cholestrol secretion,and also inhibits intestinal absorption of cholestrol.

Pharmacokinetics:

About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. After absorption ursodiol enters the potal vein and undergoes extraction from portal blood by the liver,where it is conjugated with either glycerine or taurine and then secreted into the hepatic bile products.

Not available

Pregnancy: Do not use the drug during pregnancy

Lactation: Excercise caution when using ursidol is administered to a nursing mother.

Children: Safety and efficacy for use in children have not been established