Obeticholic Acid INN
Composition:Obetic-5 Tablet: Each film coated tablet contains Obeticholic Acid INN 5 mg.
Obetic-10
Tablet: Each film coated tablet contains Obeticholic Acid INN 10 mg.
Indications:Obeticholic acid is indicated for the treatment of
adultpatients with primary biliary cholangitis (PBC) without cirrhosis or with
compensated cirrhosis who do not have evidence of portal hypertension, Either
in combination with Ursodeoxycholic Acid (UDCA) with an inadequate response to
UDCA or as monotherapy in patients unable to tolerate UDCA.
Dosage
and administration:
The usual starting dosage for PBC patients without cirrhosis or with
compensated cirrhosis who do not have evidence of portal hypertension who have
not achieved an adequate biochemical response to an appropriate dosage of Ursodeoxycholic Acid (UDCA) for at least 1 year or are
intolerant to UDCA follows bellow:
Start with dosage of 5mg once daily for first 3
months. After 3 months, for patients who have not achieved adequate reduction
in Alkaline phosphate (ALP) and/or total bilirubin and who are tolerating
Obeticholic Acid increase to the maximum dosage 10 mg once daily.
Management
of patient with intolerable pruritus: Add an antihistamine or bile acid binding
resin. Reduce the dosage to 5 mg every other day, for patients intolerable to 5
mg once daily, 5 mg once daily, for patients intolerant to 10 mg once daily.
Temporarily interrupt dosing for up to 2 weeks followed by restart at a reduced
dosage and titrate the dosage to 10 mg once daily based on biochemical
response. Or, as directed by the registered physician.
Use
in pregnancy and lactation:
The limited available human data on the use of obeticholicacid during pregnancy
are not sufficient to inform a drug-associated risk. There is no information on
the presence of obeticholic acid in human milk, the effects on the breast-fed
infant or the effects on milk production.
Packing: Obetic-5 Tablet: Each box contains 2 x 10's tablets in blister pack.Obetic-10 Tablet: Each box contains 1 x 10's tablets in blister pack.
