Obetic
Generic Name
Obeticholic Acid
Manufacturer
Intercept Pharmaceuticals
Country
USA
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
obetic 10 mg tablet | ৳ 55.00 | ৳ 550.00 |
Description
Overview of the medicine
Obetic 10 mg Tablet contains Obeticholic Acid, a farnesoid X receptor (FXR) agonist, used to treat primary biliary cholangitis (PBC) in adults. It works by decreasing the production of bile acids in the liver and increasing their removal.
Uses & Indications
Dosage
Adults
Initial dose is 5 mg once daily. If tolerated, the dose may be increased to 10 mg once daily after 6 months. Take with or without food.
Elderly
No specific dose adjustment is required based on age.
Renal_impairment
No dose adjustment needed for mild to moderate renal impairment. For severe renal impairment, consult a physician.
Hepatic_impairment
For moderate to severe hepatic impairment (Child-Pugh B or C), dosage adjustments are necessary. Initial dose: 5 mg twice weekly. If tolerated, may increase to 10 mg twice weekly.
How to Take
Take orally once daily, with or without food. Swallow the tablet whole with water.
Mechanism of Action
Obeticholic acid is a potent and selective agonist for the farnesoid X receptor (FXR), a nuclear receptor expressed in the liver and intestine. Activation of FXR downregulates bile acid synthesis and transport, thereby reducing the hepatocellular exposure to bile acids.
Pharmacokinetics
Onset
Not acutely acting; therapeutic effects observed with chronic use over weeks to months.
Excretion
Primarily excreted via feces (>80%), with minimal urinary excretion.
Half life
Approximately 2-5 hours (unconjugated obeticholic acid); conjugated forms have longer half-lives.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations (Cmax) reached within 1.5 hours.
Metabolism
Undergoes extensive first-pass and enterohepatic recirculation. Metabolized primarily via conjugation with glycine or taurine.
Side Effects
Contraindications
- Complete biliary obstruction.
- Hypersensitivity to Obeticholic Acid or any component of the formulation.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin. Monitor INR and adjust warfarin dose as needed.
CYP1A2 Substrates (e.g., Theophylline, Tizanidine)
Obeticholic acid may increase exposure to CYP1A2 substrates. Monitor and adjust doses of sensitive CYP1A2 substrates.
Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol, Colesevelam)
May reduce the absorption of obeticholic acid. Administer obeticholic acid at least 4-6 hours before or 4-6 hours after taking a bile acid sequestrant.
Storage
Store at room temperature (20-25°C), away from moisture and direct light. Keep out of reach of children.
Overdose
In case of overdose, seek emergency medical attention. Symptoms may include worsening of known side effects such as severe pruritus or gastrointestinal disturbances. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. It is unknown if obeticholic acid is excreted in human milk. Exercise caution when administered to a nursing woman.
Side Effects
Contraindications
- Complete biliary obstruction.
- Hypersensitivity to Obeticholic Acid or any component of the formulation.
Drug Interactions
Warfarin
May enhance the anticoagulant effect of warfarin. Monitor INR and adjust warfarin dose as needed.
CYP1A2 Substrates (e.g., Theophylline, Tizanidine)
Obeticholic acid may increase exposure to CYP1A2 substrates. Monitor and adjust doses of sensitive CYP1A2 substrates.
Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol, Colesevelam)
May reduce the absorption of obeticholic acid. Administer obeticholic acid at least 4-6 hours before or 4-6 hours after taking a bile acid sequestrant.
Storage
Store at room temperature (20-25°C), away from moisture and direct light. Keep out of reach of children.
Overdose
In case of overdose, seek emergency medical attention. Symptoms may include worsening of known side effects such as severe pruritus or gastrointestinal disturbances. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. It is unknown if obeticholic acid is excreted in human milk. Exercise caution when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Refer to the expiry date on the packaging, typically 2-3 years from manufacturing.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patent protected
Clinical Trials
Key clinical trials include the POISE trial, which demonstrated efficacy in improving biochemical markers in patients with PBC who had an inadequate response to or were intolerant of UDCA.
Lab Monitoring
- Liver function tests (ALT, AST, total bilirubin, alkaline phosphatase) should be monitored at baseline and periodically during treatment.
- INR should be monitored for patients on warfarin.
Doctor Notes
- Carefully monitor liver function tests (ALT, AST, ALP, total bilirubin) at baseline and during treatment, especially when escalating dose or in patients with hepatic impairment.
- Manage pruritus proactively. Consider antipruritic agents if needed.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Report any new or worsening itching to your doctor immediately.
- Do not stop taking Obetic without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Obetic may cause dizziness in some patients. Patients should be advised to exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Maintain a healthy diet and lifestyle.
- Avoid alcohol consumption as it can worsen liver conditions.
- Manage pruritus with over-the-counter remedies as advised by your doctor.
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