Obetohep 5 Mg Tablet (10 Tab)

OBETOHEP 5 MG TABLET

Name:

• Brand Name: Obetohep 5 mg Tablet
• Common Name: Obeticholic Acid

Composition: Each tablet contains Obeticholic Acid 5 mg as the active ingredient.

Uses: Obetohep 5 mg Tablet is primarily used in the treatment and management of primary biliary cholangitis (PBC), also known as primary biliary cirrhosis. It helps to improve liver function by reducing the production and build-up of bile acids in the liver and increasing their removal, thereby preventing their toxic effects and reducing inflammation. It can be prescribed alone or in combination with ursodiol. Other reported uses include liver health maintenance, pediatric primary biliary cirrhosis, cholestatic liver diseases, alcoholic fatty liver disease, and non-alcoholic fatty liver disease.

Dosage and Administration: Obetohep 5 mg Tablet is typically taken orally once daily, with or without food. It should be swallowed whole with a glass of water, without chewing or crushing. For consistency, it is advisable to take the medicine at the same time each day. The usual starting dose is 5 mg once daily, which may be increased to 10 mg once daily after 3 months based on patient response and tolerability. It is crucial to follow the doctor's instructions carefully and not to alter the dosage without consulting a healthcare professional. If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose; in such cases, skip the missed dose and continue with the regular schedule. Do not double the dose.

Side Effects: Common side effects include:

• Itching (pruritus)
• Fatigue
• Rash
• Mouth or throat pain (oropharyngeal pain)
• Dizziness
• Constipation
• Joint pain
• Abdominal discomfort/pain
• Swelling of hands, feet, ankles, or lower legs (peripheral edema)
• Fast or irregular heartbeat (palpitations)
• Fever
• Eczema
• Thyroid disorders

More serious side effects or worsening of existing side effects should be reported to a doctor immediately.

Precautions:

• Pregnancy: Consult a doctor before taking Obetohep 5 mg Tablet if pregnant or planning to become pregnant, as information on its use during pregnancy is limited, and caution is advised.
• Breastfeeding: Breastfeeding mothers should consult their doctor, as it is not known if Obeticholic acid is secreted in milk.
• Alcohol: It is advisable to consult a doctor regarding alcohol consumption while taking this medication, especially for patients with liver disease.
• Liver Impairment: Use with caution in patients with severe liver disease, as dose adjustment may be needed, and it may worsen liver function. Not recommended for patients with complete biliary obstruction.
• Kidney Impairment: While no specific interactions have been reported, caution is advised in patients with severe kidney impairment.
• Drug Interactions: Inform your doctor about all other medications being taken. Specific interactions include:
  • Bile acid binding resins (e.g., cholestyramine, colestipol, colesevelam): Should be taken at least 4-6 hours before or after Obetohep 5 mg Tablet to avoid reduced efficacy.
  • Warfarin: May decrease INR levels in patients.
  • Cyclosporine: May increase levels of Obetohep in the blood.
  • Rifampin: May decrease levels of Obetohep in the blood.
  • Theophylline and Tizanidine: Co-administration may lead to increased exposure.
• Children: Obetohep 5 mg Tablet is generally not recommended for children or adolescents.
• Driving: Obetohep 5 mg Tablet may cause dizziness, so caution should be exercised when driving or operating machinery.

Storage: Store Obetohep 5 mg Tablet in a cool and dry place, below 30°C. Protect from excess moisture and direct sunlight. Keep out of reach of children.

OBETOHEP 5 MG TABLET (10 TAB) by ALKEM LABORATORIES LTD. - Frequently Asked Questions

What is OBETOHEP 5 MG Tablet used for?

OBETOHEP 5 MG Tablet, containing Obeticholic Acid, is primarily used for the treatment of primary biliary cholangitis (PBC), a chronic liver disease that gradually damages the bile ducts in the liver. It can be used alone or in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response or are intolerant to UDCA. This medication helps to improve liver function and can prevent or delay liver damage, especially when started in the early stages of the disease.

How does OBETOHEP 5 MG Tablet work?

OBETOHEP 5 MG Tablet works by activating the farnesoid X receptor (FXR), a natural receptor found in the liver that plays a crucial role in regulating bile acid synthesis and transport, lipid metabolism, and inflammation. By activating FXR, Obeticholic acid reduces the production and accumulation of bile acids in the liver, increases their removal, and modulates inflammatory mediators, thereby improving bile flow and reducing liver inflammation and fibrosis.

What is the usual dosage for OBETOHEP 5 MG Tablet?

The usual dosage for OBETOHEP 5 MG Tablet is typically one tablet (5 mg) taken orally once daily. It can be taken with or without food, but it is recommended to take it regularly at evenly spaced intervals, ideally at the same time each day, as prescribed by your doctor. Do not break, crush, or chew the tablet; swallow it whole with a glass of water. Your doctor will determine the most suitable dose based on your condition and response to treatment.

What are the possible side effects of OBETOHEP 5 MG Tablet?

Common side effects of OBETOHEP 5 MG Tablet may include itching (pruritus), fatigue, rash, throat pain, dizziness, constipation, and joint pain. Other reported side effects include abdominal discomfort or pain, oropharyngeal pain, peripheral edema, palpitations, fever, eczema, and thyroid disorders. If you experience any persistent or worsening side effects, consult your doctor.

Is OBETOHEP 5 MG Tablet safe during pregnancy or breastfeeding?

Information regarding the use of OBETOHEP 5 MG Tablet during pregnancy and breastfeeding is limited. It is generally advised to consult your doctor if you are pregnant, planning to become pregnant, or are breastfeeding, as caution is recommended. Your doctor will assess the potential risks and benefits to decide if the medicine can be taken.

Can OBETOHEP 5 MG Tablet be taken with other medications?

OBETOHEP 5 MG Tablet can interact with certain other medications. For example, co-administration with warfarin may decrease INR levels, requiring dose adjustments. It may also increase the exposure to medicines that are CYP1A2 substrates, such as theophylline and tizanidine. Bile acid binding resins like cholestyramine, colestipol, and colesevelam can reduce the efficacy of Obeticholic acid, so it's advisable to administer these medicines with a time gap of at least 4 to 6 hours. Always inform your doctor about all other medicines you are taking to avoid potential interactions.

What precautions should be taken while using OBETOHEP 5 MG Tablet?

It is important to inform your doctor about any existing medical conditions, especially liver problems like decompensated cirrhosis, jaundice, or complete biliary obstruction, as the medicine is not recommended in these cases. Regular monitoring of liver function is essential during treatment. Alcohol consumption should be avoided or limited, especially if you have liver disease, as it may interact with the medication and worsen your condition. If you experience severe itching, consult your doctor. This medicine is generally not recommended for children or adolescents.

What happens if a dose of OBETOHEP 5 MG Tablet is missed?

If you miss a dose of OBETOHEP 5 MG Tablet, 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 compensate for the missed one.

How should OBETOHEP 5 MG Tablet be stored?

OBETOHEP 5 MG Tablet should be stored at room temperature (20°C to 25°C) in a cool and dry place. Keep it away from excess moisture, direct sunlight, and out of the reach of children and pets. Follow proper medical waste management protocols for its disposal.