Obexa 10mg Tablet 1 Strip

✔️

✔️ Dosage & Administration

Pre-treatment Assessment:
Before starting therapy, assess for:

Decompensated cirrhosis (Child-Pugh Class B/C)

Previous hepatic decompensation

Portal hypertension (e.g., ascites, varices, low platelets)

Obexa is contraindicated in such cases.

Recommended Dosage:

Start at 5 mg once daily for 3 months.

If necessary and tolerated, increase to 10 mg once daily based on liver function tests (ALP and bilirubin).

• Pediatrics: Not established for children.
• Elderly (65+ years): No major safety differences noted, but increased sensitivity is possible.
• Hepatic Impairment: Contraindicated in decompensated liver disease or portal hypertension due tothe risk of serious hepatic side effects.

✔️ Managing Severe Pruritus:

Consider adding antihistamines or bile acid sequestrants.

Modify dose:
• 5 mg every other day (if 5 mg daily is not tolerated)
• 5 mg daily (if 10 mg daily is intolerable)

Interrupt therapy temporarily (up to 2 weeks) and resume at a lower dose if needed.

✔️ Monitoring:

• Regularly monitor liver biochemistry and signs of worsening PBC.
• Patients with cirrhosis or concurrent liver disease should be watched closely for portal hypertension or hepatic decompensation.
• Discontinue if evidence of liver failure, biliary obstruction, or severe hepatic events arises.

✔️ Side Effects

Common adverse effects include:

Itching (pruritus)

Fatigue

Abdominal discomfort

Others: rash, joint pain, throat irritation, dizziness, constipation, thyroid irregularities, and skin inflammation (eczema)

✔️ Drug Interactions

• Bile Acid Binding Agents (e.g., cholestyramine) may interfere with Obexa absorption. Space doses by at least 4 hours.
• Warfarin May reduce INR. Monitor and adjust warfarin dose.
• CYP1A2 Substrates (e.g., theophylline): Obexa may elevate their blood levels. Therapeutic drug monitoring is advised.
• BSEP Inhibitors (e.g., cyclosporine): Concomitant use may raise hepatic bile salt accumulation. Use with caution and monitor liver function.

✔️ Contraindications

Decompensated cirrhosis or history of liver decompensation

Portal hypertension in compensated cirrhosis

Complete bile duct obstruction

✔️ Use in Pregnancy and Lactation

Pregnancy:
Limited human data. Animal studies show no harm at high doses. Use only if needed.

Lactation:
Unknown if excreted in breast milk. Weigh the benefits of breastfeeding against the mother's treatment needs and potential risk to the infant.

✔️ Precautions & Warnings

Liver Complications in Cirrhosis:
Liver failure and decompensation, some fatal or requiring transplant, have occurred, especially in cirrhotic patients. Risk increases with higher doses or pre-existing liver issues. Monitor liver function closely.

Severe Itching:
Occurs in up to 23% of patients at the 10 mg dose. It can severely affect daily life. Consider dose adjustment, symptomatic treatment, or interruption of therapy.

HDL-C Reduction:
Obexa may lower HDL (good cholesterol). Monitor lipid levels, particularly in long-term use or when treatment response is poor.

✔️ Overdose

Higher-than-recommended doses (25–50 mg) have led to liver-related side effects. If overdose occurs, provide supportive treatment and monitor liver function closely.

✔️ Storage

Store below 30°C, in a dry, dark place. Keep away from the child