Ursodeoxycholic Acid (URSODELIC) 300mg Tablet 30’s

About Ursodeoxycholic Acid (URSODELIC) 300mg Tablet

Ursodeoxycholic Acid (URSODELIC) 300mg Tablet contain Ursodeoxycholic acid (UDCA), a naturally occurring bile acid that helps in the treatment of liver-related disorders. UDCA is used to improve liver function by promoting the flow of bile and reducing the amount of toxic bile acids in the liver. It is commonly used to treat certain types of liver diseases, including gallstones and cholestatic liver diseases. 

Indications:

Ursodeoxycholic Acid (URSODELIC) 300mg Tablet is indicated for the following conditions:

• Primary Biliary Cholangitis (PBC): A chronic liver disease where the bile ducts are damaged, leading to liver dysfunction.
• Gallstones: Specifically, cholesterol gallstones in patients who cannot undergo surgery (non-surgical treatment option).
• Cholestatic Liver Disease: Conditions where bile flow is impaired, such as in progressive familial intrahepatic cholestasis (PFIC).
• Cirrhosis (in certain cases where it is prescribed to prevent further liver damage).
• Non-alcoholic fatty liver disease (NAFLD) and conditions that lead to bile acid malabsorption.

Dosage:

The general dosage of Ursodeoxycholic Acid (URSODELIC) 300mg Tablet can vary based on the specific condition being treated. The usual dosage recommendations are as follows:

• For Primary Biliary Cholangitis (PBC):
  • Adults: The usual starting dose is 13-15mg/kg/day. The daily dose is divided into 2-3 doses, depending on the doctor’s recommendation.
  • Example: For a 70kg adult, this would be approximately 1-2 capsules (250mg) per dose, taken 2-3 times daily.
• For Gallstones:
  • Adults: The recommended dose is generally 10-15mg/kg/day of Ursodeoxycholic acid, divided into two to three doses.
  • Treatment usually continues for 6 to 12 months until the stones are dissolved or symptoms improve.
• For Cholestatic Liver Disease:
  • The dose varies depending on the severity and specific condition, with typical doses ranging from 10-15mg/kg/day, divided into 2-3 doses per day.
• For other liver diseases, dosing is typically based on body weight, and your healthcare provider will determine the exact dose.

Note: Always follow your healthcare provider’s instructions for dosage and treatment duration.

Side Effects:

While Ursodeoxycholic Acid (URSODELIC) 300mg Tablet is generally well-tolerated, side effects can occur. Common side effects include:

• Gastrointestinal issues: Diarrhea, nausea, bloating, abdominal pain, or indigestion.
• Headache.
• Dizziness or fatigue.
• Skin rash.
• Itching (pruritus).
• Changes in liver enzyme levels, which can be monitored through blood tests.

Serious side effects of Ursodeoxycholic Acid (URSODELIC) 300mg Tablet are rare and include:

• Liver problems: Although UDCA is used to treat liver disorders, in rare cases, it can cause or worsen liver dysfunction.
• Severe allergic reactions: Difficulty breathing, swelling of the face or throat, rash, or hives.
• Chest pain or unusual heart symptoms.

If you experience any of these serious side effects, discontinue use and seek immediate medical attention.

Contraindications:

Ursodeoxycholic Acid (URSODELIC) 300mg Tablet should be avoided in the following cases:

• Hypersensitivity to Ursodeoxycholic acid or any of the inactive ingredients in the capsule.
• Severe liver impairment: If you have decompensated cirrhosis or liver failure, UDCA may not be suitable.
• Gallbladder disease: In patients who are unable to empty their gallbladder or have bile duct obstructions (unless these conditions are surgically corrected).
• Acute liver conditions: Ursodeoxycholic acid is not recommended in cases of active liver inflammation (e.g., acute viral hepatitis).
• Pregnancy: There is limited data on the safety of Ursodeoxycholic acid during pregnancy. It should only be used if absolutely necessary and prescribed by a healthcare provider.
• Breastfeeding: Caution is advised, as it is not known whether Ursodeoxycholic acid is excreted in breast milk.

Precautions for Ursodeoxycholic Acid (URSODELIC) 300mg Tablet:

• Regular liver function tests: Your healthcare provider may require regular monitoring of liver enzymes and other tests to ensure that the medication is working as intended and that there are no adverse effects on liver function.
• Gallbladder surgery: If you have had gallbladder surgery, consult your doctor before taking Ursodeoxycholic acid.

Storage:

• Store Ursodeoxycholic Acid (URSODELIC) 300mg Tablet at room temperature (15°C to 25°C).
• Keep the tablets in the original packaging to protect them from light and moisture.
• Keep out of reach of children.

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