Livcare 5mg Tablet

Uses:

Primary biliary cirrhosis

How does Livcare 5mg Tablet work?

Obeticholic Acid works by decreasing the production of bile in the liver and promoting the removal of bile from your liver. 

Side Effects of Livcare 5mg Tablet

• Stomach pain
• Constipation
• Dizziness
• Tiredness
• Fast or irregular heartbeat
• Dry skin
• Swelling of hands and feet
• Fever

Quick Suggestions:

• Obeticholic Acid can be taken with or without food. Avoid taking more or less than the recommended dose.
• Avoid tobacco and alcohol consumption.
• Do not stop taking the medication without talking to your doctor. Your doctor may suggest tests to monitor your liver function and bilirubin levels periodically while you are taking this medicine.
• Eat a healthy balanced diet low in fat and exercise regularly to prevent gallstone formation.

Indication

Obiholic Tablet is used for the treatment of a liver disease called primary biliary cirrhosis in adults.

Pharmacology

Obeticholic acid's mechanism of action involves its interaction with the Farnesoid X receptor (FXR) in the liver and gut. FXR is a nuclear receptor that plays a critical role in regulating various metabolic processes, including bile acid synthesis, bile acid transport, lipid metabolism, and glucose regulation.

Here's a summary of how obeticholic acid's action improves liver function:

• FXR Activation: Obeticholic acid activates FXR, which is expressed in the liver, intestine, kidney, and adipose tissue.
• Reduced Bile Acid Synthesis: FXR activation suppresses de novo synthesis of bile acids within hepatocytes. This means that the liver produces fewer new bile acids.
• Increased Bile Acid Transport: FXR activation also increases the transport of existing bile acids out of hepatocytes. This promotes the elimination of bile acids from the liver.
• Reduced Bile Acid Pool: The combination of reduced synthesis and increased transport of bile acids leads to a decrease in the total bile acid pool within the liver.
• Prevention of Toxic Effects: By reducing the accumulation of bile acids within the liver, Obeticholic acid helps prevent their toxic effects on liver cells. Bile acid accumulation can contribute to liver damage.
• Improved Liver Function: Ultimately, by regulating bile acid levels and reducing hepatocyte exposure to bile acids, obeticholic acid helps improve overall liver function. This is particularly important in conditions such as primary biliary cholangitis (PBC), where bile duct damage can lead to liver impairment.

Dosage & Administration of

Obeticholic Acid is indicated for the treatment of primary biliary cholangitis (PBC) in adults. It can be used in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA for at least one year, or as monotherapy in adults who cannot tolerate UDCA.

The dosing instructions for Obeticholic Acid are important for individuals with primary biliary cholangitis (PBC) and healthcare providers to understand. The dosing can vary based on the patient's liver condition, as assessed by the Child-Pugh classification, as well as their response to the medication. Here are the key points:

Concomitant Bile-Acid Binding Resin: If a patient is taking a bile-acid binding resin, it's recommended to separate the doses of Obeticholic Acid by at least 4 hours to avoid potential interactions that may reduce Obeticholic Acid absorption and efficacy.

Child-Pugh Classification: Before initiating Obeticholic Acid, it's important to determine the patient's Child-Pugh classification. This classification system assesses the severity of liver disease and helps determine the appropriate starting dosage.

Starting Dose and Titration: The dosing recommendations are based on the patient's Child-Pugh classification:

For noncirrhotic or compensated Child-Pugh class A patients:

• Starting dose: 5 mg orally once daily (qDay)
• Dosage titration: If an adequate response is not achieved after 3 months at 5 mg/day and OBETICHOLIC ACID is well-tolerated, the dose can be increased to 10 mg qDay. The maximum dose should not exceed 10 mg/day.

For patients with Child-Pugh class B or C, or those with a prior decompensation event:

• Starting dose: 5 mg orally once weekly
• Dosage titration: If an adequate response is not achieved after 3 months at 5 mg once weekly and Obeticholic Acid is well-tolerated, the dose can be increased to 5 mg twice weekly (with at least 3 days between doses). It may be titrated further to 10 mg twice weekly based on response and tolerability.

These dosing guidelines are important for optimizing the treatment of PBC with Obeticholic Acid while considering the patient's liver condition and response to the medication.

Administration: Obeticholic Acid can be taken with or without food.

Interaction

Drug-Drug Interactions: Obeticholic Acid may interact with xanthines (theophylline), muscle relaxants (tizanidine), blood thinners (warfarin), bile acid sequestrants (cholestyramine, colestipol, colesevelam).

Drug-Food Interactions: No interactions found/established.

Drug-Disease Interactions: Inform your doctor if you have biliary obstruction, liver impairment, or lipid disorder.

Contraindications

• If you are allergic to obeticholic acid or any other ingredient of  Livcare 5mg Tablet
• If you have complete blockage of the bile ducts in your liver or gallbladder.

Pregnancy & Lactation

Livcare 5mg Tablet is not recommended for use in pregnant women and it is not known whether Livcare 5mg Tablet passes through breast milk.

Precautions & Warnings

• Allergy: It's crucial not to take Livcare 5mg Tablet if you have known allergies to any of its components.
• Biliary Tract Blockage: If you have a complete blockage of the biliary tract, which includes the liver, bile ducts, and gallbladder,  Livcare 5mg Tablet should not be used. This is because the medication affects bile acid metabolism, and a blockage can disrupt bile flow.
• Itching: If you experience severe itching that is difficult to tolerate while taking OBETICHOLIC ACID, inform your doctor. Pruritus (itching) is a known side effect that some patients may experience, and it's essential to manage this symptom.
• Pregnancy and Breastfeeding: Consult your doctor if you are pregnant or breastfeeding. The use of  Livcare 5mg Tablet during pregnancy and while breastfeeding should be carefully evaluated by a healthcare professional to assess potential risks and benefits.
• Children and Adolescents:  Livcare 5mg Tablet is not recommended for use in children or adolescents, as its safety and efficacy in this population have not been established.
• Dizziness: Be cautious when driving or operating heavy machinery if you experience dizziness while taking  Livcare 5mg Tablet.
• Symptoms of Concern: Several symptoms can be indicative of adverse reactions or complications, and you should contact your doctor if you experience any of them. These symptoms include yellowing of the skin or eyes (jaundice), black or tarry stools, dark urine, coughing up or vomiting blood, confusion, slurred speech, mood swings, anxiety, and abdominal swelling.

Storage Conditions

• Keep Livcare 5mg Tablet out of reach of children
• Store at room temperature