Ocabile 10mg

OCABILE 10MG by TORRENT PHARMACEUTICALS LTD

Name:

• Brand Name: Ocabile 10 Tablet
• Common Name: Obeticholic acid 10 mg

Composition:

• Active Ingredient: Obeticholic Acid 10 mg

Uses: Ocabile 10 Tablet is prescribed for the treatment of primary biliary cholangitis (PBC), also known as primary biliary cirrhosis, in adults. It is used either alone or in combination with ursodeoxycholic acid (UDCA). This chronic liver disease can lead to liver failure if left untreated. Ocabile 10 works by reducing bile acid levels in the liver, preventing the progression of liver damage, and improving overall hepatic function, especially when started in the early stages of the disease.

Dosage and Administration: Ocabile 10 Tablet should be taken orally, exactly as prescribed by a doctor. It can be taken with or without food, but it is advisable to take it at the same time each day to maintain consistency. The tablet should be swallowed whole without chewing, crushing, or breaking. It is crucial to complete the full course of medication and not to stop taking it abruptly without medical consultation.

• Typical Dosage Guidance:
  • Initial dose: 5 mg orally once a day.
  • Maintenance dose: 5 mg orally once a day. If an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin is not achieved after 3 months, the dosage may be increased to 10 mg orally once a day.
  • Maximum dose: 10 mg/day.

Side Effects: Common side effects associated with Ocabile 10 include:

• Itching (pruritus)
• Fatigue
• Rash
• Mouth or throat pain (oropharyngeal pain)
• Dizziness or lightheadedness
• Constipation
• Joint pain (arthralgia)
• Eczema
• Thyroid disorders
• Fast or irregular heartbeat (palpitations)
• Swelling of the hands or feet (peripheral edema)
• Abdominal discomfort/pain

Serious side effects, though less common, warrant immediate medical attention. These can include signs of worsening liver function such as yellowing of the skin or eyes (jaundice), dark urine, persistent nausea or vomiting, or severe abdominal pain and swelling.

Precautions:

• Liver Impairment: Caution should be exercised in patients with severe liver disease, and dose adjustment may be necessary. It is contraindicated in patients with decompensated cirrhosis, prior decompensation events, and/or compensated cirrhosis with evidence of portal hypertension.
• Pregnancy and Breastfeeding: It is important to consult a doctor before using Ocabile 10 during pregnancy or while breastfeeding, as information on its safety in these situations is limited.
• Alcohol: It is recommended to consult a doctor regarding alcohol consumption while taking this medicine, as interactions are not well-established.
• Other Conditions: Patients with a history of bile duct obstruction, excessive alcohol consumption, high cholesterol, or thyroid disease should inform their doctor before starting treatment.
• Monitoring: Regular monitoring of liver function is essential during treatment with Ocabile 10.
• Children: Not recommended for children and adolescents.

Storage: Ocabile 10 Tablet should be stored in a cool and dry place, away from direct sunlight, and kept out of the reach of children and pets. It should be stored below 30°C.

OCABILE 10MG contains obeticholic acid and is primarily used to treat primary biliary cholangitis (PBC), a chronic liver disease.

What is OCABILE 10MG used for?

OCABILE 10MG is used to treat primary biliary cholangitis (PBC), also known as primary biliary cirrhosis, in adults. This medication helps manage the disease, especially when started in its early stages, to prevent or delay liver damage. It can be used alone or in combination with other therapies like ursodeoxycholic acid (UDCA).

How does OCABILE 10MG work?

OCABILE 10MG contains obeticholic acid, which acts as a farnesoid X receptor (FXR) agonist. By activating FXR in the liver and intestines, it helps reduce the production of bile acids and increases their removal from the liver. This action decreases the toxic effects of accumulated bile acids, reduces inflammation, promotes healthy liver cell growth, and improves overall liver function.

What is the usual dosage of OCABILE 10MG?

The usual starting dose for primary biliary cholangitis is 5 mg once daily for the first three months. Based on the patient's response and tolerability, and after monitoring alkaline phosphatase (ALP) and total bilirubin levels, the dose may be increased to 10 mg once a day. The maximum recommended dose is 10 mg per day. It should be taken exactly as prescribed by your doctor, at the same time each day, with or without food.

What are the possible side effects of OCABILE 10MG?

Common side effects include severe itching (pruritus), fatigue, skin rash, throat or mouth pain, dizziness, constipation, stomach pain, joint pain (arthralgia), and eczema. Some individuals may also experience a fast or irregular heartbeat, peripheral edema, or thyroid disorders. It's crucial to inform your doctor if any side effects persist or worsen, or if you experience more serious symptoms like yellowing of the skin or eyes (jaundice), dark urine, or unusual abdominal pain, as these could indicate worsening liver problems.

Is OCABILE 10MG safe during pregnancy or breastfeeding?

There is limited information on the effects of OCABILE 10MG during pregnancy. It is generally not recommended for use in pregnant women, and you should consult your doctor if you are pregnant or planning to become pregnant. Similarly, it is not known if OCABILE 10MG passes into human breast milk. Breastfeeding mothers should consult their doctor to weigh the potential risks and benefits before using this medication.

Can OCABILE 10MG be taken with other medications?

OCABILE 10MG can interact with certain medications. The effectiveness of OCABILE 10MG may be reduced if taken concurrently with bile acid binding resins (e.g., cholestyramine, colestipol, colesevelam); it is recommended to take OCABILE at least 4 hours before or after these resins. Additionally, it can affect blood clot-treating medicines like warfarin, potentially lowering the International Normalized Ratio (INR), so monitoring and dose adjustments may be necessary. It may also increase the exposure of certain CYP1A2 substrates like theophylline. Always inform your doctor about all medicines, supplements, and herbal products you are currently taking.

What precautions should be taken with OCABILE 10MG?

Regular monitoring of liver function is essential during treatment with OCABILE 10MG. It is contraindicated in individuals with complete biliary obstruction. Caution should be exercised, and dose adjustment may be necessary for patients with severe liver disease. Inform your doctor if you have a history of high cholesterol or thyroid disease. While taking OCABILE 10MG, it's advisable to consult your doctor before consuming alcohol, as the interaction is not well-established. Managing itching, a common side effect, can involve keeping cool, using moisturizers for dry skin, and avoiding scratching.

What happens if a dose of OCABILE 10MG is missed?

If you miss a dose of OCABILE 10MG, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should OCABILE 10MG be stored?

OCABILE 10MG should be stored at room temperature, ideally between 68°F and 77°F (20°C and 25°C). It can tolerate shorter exposures to temperatures between 59°F and 86°F (15°C and 30°C). Keep it in a cool, dry place, away from direct sunlight, and out of reach of children and pets.