Livacol 5mg Tablet

✔️ Uses:

Primary biliary cirrhosis

✔️ How does Livacol 5mg Tablet work?

Livacol 5mg Tablet works by reducing the production and build-up of bile in the liver and also reduces the inflammation of the liver. Therefore, as a result, it helps to improve liver function.

✔️ Side Effects of Livacol 5mg Tablet

• Stomach pain
• Tiredness
• Dizziness
• Palpitations (irregular or fast heartbeat)
• Constipation
• Thyroid hormone irregularity

✔️ Quick Suggestions:

• Primary Biliary Cholangitis (PBC) predominantly affects women, although there is an increasing number of men being diagnosed with the condition.
• PBC is characterized by the chronic inflammation and eventual destruction of the small bile ducts in the liver. In the United States, it is estimated that approximately 65 out of every 100,000 women have PBC.
• This disorder typically becomes apparent during middle age, with the majority of affected individuals falling within the age range of 45 to 65 years.
• While there is no known cure for PBC, there are medications available to help manage the disease and slow down the progression of liver damage.

✔️ Indication

Livacol 5mg Tablet is used for the treatment of primary biliary cholangitis (PBC) in adults, Which is done in adult people with ursodeoxycholic acid combination, People in whom ursodeoxycholic acid has not responded adequately.

✔️ Pharmacology

Obeticholic acid is an FXR agonist, which means it activates the Farnesoid X receptor (FXR). FXR is a nuclear receptor found in various tissues, including the liver, intestine, kidney, and adipose tissue. It plays a crucial role in regulating a wide range of target genes involved in controlling:

• Bile acid synthesis and transport: FXR activation reduces the production of new bile acids (de novo synthesis) in hepatocytes (liver cells). Additionally, it enhances the transport of existing bile acids out of hepatocytes. This combined effect helps lower the exposure of hepatocytes to bile acids, which can be damaging.
• Lipid metabolism: FXR has a role in regulating the metabolism of lipids (fats), including cholesterol, in the body.
• Glucose homeostasis: FXR also influences the regulation of glucose (sugar) levels in the body, helping to maintain stable blood sugar levels.

In the context of primary biliary cholangitis (PBC), Obeticholic acid's activation of FXR can lead to a reduction in bile acid buildup within the liver and mitigate some of the harmful effects associated with PBC.

✔️ Dosage & Administration

The recommended dosing regimen for Obeticholic Acid in adults with Primary Biliary Cholangitis (PBC) is as follows:

Noncirrhotic or compensated Child-Pugh class A:

• Starting dose: 5 mg orally once daily (qDay).
• Dosage titration: If an adequate response has not been achieved after 3 months at 5 mg/day and the medication is being tolerated, increase the dose to 10 mg once daily.
• The maximum recommended dose for this category is 10 mg/day.

Child-Pugh class B or C, or prior decompensation event:

• Starting dose: 5 mg orally once weekly.
• Dosage titration: If an adequate response has not been achieved after 3 months at 5 mg once weekly and the medication is being tolerated, increase the dose to 5 mg twice weekly (at least 3 days apart).
• If necessary, the dose may be titrated up to 10 mg twice weekly (at least 3 days apart) based on response and tolerability.

✔️ Missed Dosage of Livacol 5mg Tablet

If you miss a dose of Obeticholic Acid, try to take it as soon as you remember. However, if it's close to the time for your next scheduled dose, it's best to skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

✔️ Overdose of Livacol 5mg Tablet

In the event of a suspected overdose of Obeticholic Acid, do not exceed the prescribed dose. Contact your doctor immediately for further guidance and medical advice.

✔️ Interaction

• Some medicines can affect the way Obiholic Tablet works or this Tablet itself can reduce the effectiveness of other medicines taken at the same time.
• Tell your doctor about all medicines, supplements or herbals you are currently taking or might take to avoid any possible interaction.
• The use of Obiholic Tablet with bile acid binding resins (cholestyramine, colestipol, colesevelam) may reduce the effectiveness of this Tablet.
• Particular care should be taken if you are using medicines to treat asthma/chronic obstructive pulmonary disorder (theophylline), muscle cramps (tizanidine), and blood clots (warfarin).

✔️ Contraindications

You should not take Livacol 5mg Tablet if:

• You are allergic to obeticholic acid or any other ingredient of the tablet.
• You have a complete blockage of the bile ducts in your liver or gallbladder.

✔️ Pregnancy & Lactation

The little human data on Obeticholic Acid consumption during pregnancy is insufficient to establish a drug-associated danger. There is no information on Obeticholic Acid's presence in human milk, its effects on breastfed infants, or its impact on milk production.

✔️ Precautions & Warnings

Allergic Reactions: Do not take Livacol 5mg Tablet if you are allergic to any of its components. If you experience severe itching that is difficult to tolerate, inform your doctor.

Biliary Tract Blockage: This medication is not suitable if you have a complete blockage of the biliary tract, which includes the liver, bile ducts, and gall bladder. Your doctor will consider your medical history and condition before prescribing Livacol 5mg Tablet.

Pregnancy and Breastfeeding: If you are pregnant or breastfeeding, it is essential to consult your doctor before using the Livacol 5mg Tablet. Your doctor can assess the potential risks and benefits in your specific situation.

Not for Children or Adolescents: Livacol 5mg Tablet is not recommended for use in children or adolescents. It should only be used in adults.

Dizziness: This medication may cause dizziness as a side effect. If you experience dizziness while taking Livacol 5mg Tablet, exercise caution, especially when driving or operating heavy machinery.

Seek Immediate Medical Attention: Consult a doctor immediately if you experience any of the following symptoms or conditions while taking Livacol 5mg Tablet:

• Yellowing of the skin or eyes
• Black or tarry stools
• Dark urine
• Coughing up or vomiting blood
• Confusion
• Slurred speech
• Mood swings
• Anxiety
• Swelling in and around the stomach

✔️ Storage Conditions

• Store in a cool and dry place away from direct sunlight.
• Keep out of reach of children and pets.