Ocabile 5 Mg Tab

OCABILE 5 MG TABLET

OCABILE 5 MG Tablet, manufactured by Torrent Pharmaceuticals Ltd., is a medication primarily used in the management of chronic liver conditions.

• Name

  • Common Name: Ocabile 5 Tablet
  • Brand Name: OCABILE 5 MG TAB by TORRENT PHARMACEUTICALS LTD

• Composition

  • Active Ingredient: Each tablet contains 5 mg of Obeticholic acid.

• Uses OCABILE 5 MG Tablet is mainly prescribed for the treatment of Primary Biliary Cholangitis (PBC), also known as Primary Biliary Cirrhosis. This chronic autoimmune liver disease involves damage to the bile ducts in the liver. The medication works by activating the Farnesoid X receptor (FXR), which helps in:

  • Reducing the production and build-up of bile acids in the liver.
  • Promoting bile flow and increasing the removal of bile from the liver.
  • Reducing liver inflammation and preventing scarring.
  • Supporting overall liver function and reducing bile toxicity. It may also help regulate lipid and glucose metabolism.

• Dosage and Administration

  • OCABILE 5 MG Tablet is for oral administration and is typically taken once daily, with or without food.
  • It should be swallowed whole with water, without chewing, crushing, or breaking the tablet.
  • Patients should follow the dosage and schedule prescribed by their doctor, taking it regularly at evenly spaced intervals, preferably at the same time each day to aid remembrance.
  • The full course of medication should be completed as directed by the healthcare provider, even if symptoms improve.

• Side Effects Common side effects may include:

  • Itching (pruritus)
  • Fatigue/Tiredness
  • Abdominal pain/discomfort
  • Dizziness
  • Constipation
  • Rash
  • Joint pain
  • Throat pain
  • Peripheral edema (swelling in limbs)
  • Palpitations (abnormal heartbeat)
  • Eczema
  • Thyroid disorders Seek immediate medical attention if serious symptoms like yellowing of skin/eyes, dark urine, black/tarry stools, coughing/vomiting blood, confusion, slurred speech, mood swings, anxiety, or swelling in and around the stomach occur.

• Precautions

  • Allergies: Do not take if allergic to Obeticholic acid or any other ingredient.
  • Biliary Tract Blockage: Contraindicated in individuals with complete blockage of the biliary tract (liver, bile ducts, and gallbladder).
  • Pregnancy and Breastfeeding: Use with caution during pregnancy and breastfeeding; consult a doctor as limited information is available.
  • Children and Adolescents: Not recommended for use in children or adolescents.
  • Driving: May cause dizziness, so caution is advised while driving or operating machinery.
  • Liver Impairment: Close monitoring of liver function is essential, especially if there are other liver conditions, and dose adjustment may be needed.
  • Drug Interactions: Inform your doctor about all medications, including non-prescription drugs, herbals, and supplements. Particular care should be taken with bile acid binding resins (e.g., cholestyramine), theophylline, tizanidine, and warfarin, as interactions may occur.
  • Alcohol: Avoid or limit alcohol consumption as it may exacerbate liver issues.
  • Diet and Lifestyle: Maintain a healthy, well-balanced diet, avoid high-fat/trans-fat/processed foods, white bread, white pasta, and sugars. Avoid tobacco consumption.

• Storage

  • Store in a cool and dry place, away from direct sunlight.
  • Keep out of reach and sight of children.
  • Store at temperatures between 10ºC to 25ºC or below 30ºC.
  • Protect from moisture and light.

OCABILE 5 MG TAB by TORRENT PHARMACEUTICALS LTD, containing the active ingredient Obeticholic Acid, is a medication primarily used to manage a chronic liver condition called Primary Biliary Cholangitis (PBC). It works by helping to regulate bile acid levels in the liver, thereby reducing inflammation and slowing disease progression.

Here are some frequently asked questions about OCABILE 5 MG TAB:

What is OCABILE 5 MG TAB used for?

OCABILE 5 MG TAB is used to treat Primary Biliary Cholangitis (PBC) in adults. It can be prescribed in combination with ursodeoxycholic acid (UDCA) for adults who haven't responded adequately to UDCA, or as a standalone therapy for those who cannot tolerate UDCA. The medication aims to improve liver function, reduce liver inflammation and fibrosis, and slow down the progression of liver damage.

How does OCABILE 5 MG TAB work?

OCABILE 5 MG TAB's active ingredient, Obeticholic Acid, acts as a farnesoid X receptor (FXR) agonist. FXR is a protein found in the liver and intestine that plays a key role in regulating bile acid, inflammatory, fibrotic, and metabolic pathways. By activating FXR, the medication decreases the synthesis of bile acids in the liver, promotes their removal, and reduces their toxic accumulation, which helps protect liver cells from damage.

What is the usual dosage for OCABILE 5 MG TAB?

The recommended starting dose is typically 5 mg once daily for the first three months. If, after three months, there isn't a sufficient reduction in certain liver markers (like alkaline phosphatase and/or total bilirubin) and the medication is well-tolerated, your doctor may increase the dose to a maximum of 10 mg once daily. It can be taken orally with or without food.

What are the possible side effects of OCABILE 5 MG TAB?

Common side effects include itching (pruritus), fatigue, stomach pain or abdominal discomfort, rash, dizziness, constipation, and joint pain. More serious side effects can include worsening of liver disease or liver failure, especially in patients with existing cirrhosis. Allergic reactions are also possible. It can also cause changes in cholesterol levels, including decreased HDL-C and increased LDL-C.

Is OCABILE 5 MG TAB safe during pregnancy or breastfeeding?

There is insufficient human safety data to recommend OCABILE 5 MG TAB during pregnancy, although animal studies have not shown it to cause birth defects. It is generally not recommended during pregnancy, and you should inform your doctor if you are pregnant or plan to become pregnant. For breastfeeding, use with caution, and always consult your doctor.

Can OCABILE 5 MG TAB be taken with other medications?

OCABILE 5 MG TAB can interact with several medications.

• Bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) can reduce the absorption and effectiveness of OCABILE 5 MG TAB, so it should be taken at least 4 hours before or 4 hours after these medications.
• Warfarin (a blood thinner) may have its effects altered, so your doctor may need to monitor your International Normalized Ratio (INR) and adjust the warfarin dose.
• CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline, tizanidine) may have increased exposure when taken with OCABILE 5 MG TAB, requiring therapeutic monitoring.
• Bile salt efflux pump (BSEP) inhibitors (e.g., cyclosporine) should generally be avoided or used with caution as they can lead to bile salt accumulation in the liver. Always inform your doctor about all prescription, over-the-counter medications, vitamins, and herbal supplements you are taking.

What precautions should be taken while taking OCABILE 5 MG TAB?

OCABILE 5 MG TAB is contraindicated if you have a complete blockage of the bile ducts or if you have decompensated cirrhosis (Child-Pugh B or C) or a history of hepatic decompensation events. Close monitoring of liver function is crucial during treatment due to the risk of worsening liver disease or liver failure. If you experience severe itching, your doctor might suggest management strategies such as dose reduction or temporary interruption. Regular monitoring of cholesterol levels may also be necessary. Do not stop taking the medication without consulting your doctor.

What happens if a dose of OCABILE 5 MG TAB is missed?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should OCABILE 5 MG TAB be stored?

OCABILE 5 MG TAB should be stored in a closed container at room temperature. Keep it away from excessive heat, moisture, and direct light. Ensure it is kept out of the reach of children.