Ulyses 300mg (15 Tab)

ULYSES 300MG (15 TAB) by LUPIN LTD

Name

• Brand Name: ULYSES 300MG
• Common Name: Ursodeoxycholic Acid (UDCA)

Composition

Each tablet contains Ursodeoxycholic Acid 300 mg.

Uses

ULYSES 300MG Tablet is a bile acid primarily used for the management of various liver and gallbladder conditions.

• Gallstone Dissolution: It is prescribed to dissolve cholesterol-rich gallstones and prevent their formation, particularly in overweight individuals undergoing rapid weight loss. It works by decreasing the amount of cholesterol produced by the liver, thus helping to break down existing cholesterol stones.
• Primary Biliary Cirrhosis (PBC)/Cholangitis: ULYSES 300MG is used to treat primary biliary cirrhosis, an autoimmune liver disease that progressively worsens over time, helping to protect liver cells from injury caused by toxic bile acids and improve liver function.
• Cystic Fibrosis-associated Liver Dysfunction: It is also indicated for liver dysfunction associated with cystic fibrosis, especially in children above 6 years of age.

Dosage and Administration

ULYSES 300MG Tablet should be swallowed whole after a meal, accompanied by a glass of milk or water. The dosage and duration of treatment are determined by the physician based on the patient's medical condition and body weight. It is crucial to take the medicine regularly for the entire prescribed duration, which may extend for several months or longer, even if symptoms improve or disappear. For gallstone dissolution, the usual dosage may be 8-10 mg/kg/day in 2-3 divided doses, often with the last dose at bedtime.

Side Effects

Common side effects may include:

• Abdominal pain or discomfort
• Diarrhea
• Nausea
• Vomiting
• Indigestion
• Headache
• Dizziness
• Back pain
• Rash or itching
• Hair loss
• Weakness

If diarrhea is persistent or bothersome, consult your doctor as they may advise a dose reduction or discontinuation.

Precautions

• Allergies: Do not take ULYSES 300MG if you are allergic to Ursodeoxycholic Acid or any other components of the tablet.
• Biliary Conditions: It is not recommended for patients with biliary obstructions (blocked bile ducts), swelling of the bile duct and gallbladder, gallstone pancreatitis, calcified gallstones, or gallstones larger than 20 mm.
• Liver Impairment: Use with caution in patients with severe liver problems or chronic liver disease, as it may worsen the condition. Regular monitoring of liver function and bilirubin levels may be required during treatment.
• Pregnancy and Breastfeeding: Consult your doctor before using this medicine if you are pregnant or breastfeeding.
• Drug Interactions:
  • Avoid taking antacids containing aluminum, cholestyramine, or colestipol as they can decrease the effectiveness of ULYSES 300MG.
  • Oral contraceptives, estrogenic hormones, and cholesterol-lowering agents like clofibrate may increase the risk of gallstone formation and should be avoided or discussed with your doctor.
• Children: ULYSES 300MG is generally not recommended for children below 18 years, except in specific cases of cystic fibrosis-associated liver disease in children over 6 years.
• Alcohol: Caution is advised regarding alcohol consumption while taking this medication; it is generally best to avoid it.
• Inform your doctor about any pre-existing medical conditions, rapid weight gain, frequent upper abdominal pain, or coughing up blood before starting treatment.

Storage

Store ULYSES 300MG Tablets in a cool, dry place, ideally below 30°C (some sources specify between 10°C to 25°C or 20°C to 25°C), away from direct sunlight, heat, and moisture. Keep it out of the sight and reach of children.

ULYSES 300MG contains Ursodeoxycholic Acid (UDCA) as its active ingredient. It is primarily used to treat various liver and gallbladder conditions.

What is ULYSES 300MG used for?

ULYSES 300MG is used to dissolve cholesterol gallstones in patients who prefer not to undergo surgery or are not eligible for it, and in cases of excess cholesterol in the bile. It is also prescribed for the treatment of primary biliary cholangitis (PBC), a chronic liver disease where bile ducts are damaged, and for liver and biliary disorders associated with cystic fibrosis in children aged 6 to 18 years. Additionally, it may be used to prevent gallstone formation in obese patients undergoing rapid weight loss and to treat intrahepatic cholestasis of pregnancy.

How does ULYSES 300MG work?

Ursodeoxycholic Acid (UDCA) works by several mechanisms. It helps to reduce the amount of cholesterol produced by the liver and also inhibits its absorption in the intestine, thereby decreasing cholesterol saturation in the bile. This process allows cholesterol gallstones to dissolve. Furthermore, UDCA protects liver cells from damage caused by more toxic bile acids, improves bile flow, and has immunomodulating and anti-inflammatory effects that are beneficial in cholestatic liver diseases like primary biliary cholangitis.

What is the usual dosage for ULYSES 300MG?

The dosage of ULYSES 300MG depends on the condition being treated and the patient's body weight. For gallstone dissolution, a common adult dosage is 8-12 mg/kg daily, often taken once at bedtime or in two divided doses. For primary biliary cholangitis, the typical adult dosage ranges from 12-16 mg/kg daily, usually divided into 2-4 doses for the first three months, and may then be adjusted to a single evening dose. For children with cystic fibrosis-related liver and biliary diseases, the dosage can be 20 mg/kg daily in 2-3 divided doses, potentially increasing to 30 mg/kg daily if needed. It is crucial to follow your doctor's specific instructions for dosage and duration.

What are the possible side effects of ULYSES 300MG?

Common side effects include diarrhea, abdominal discomfort or pain, nausea, and headache. These often improve over the first few days of treatment. Less common side effects can include dizziness, rash, indigestion, muscle or joint pain, and paleness. In rare cases, more serious side effects such as severe right upper abdominal pain, calcification of gallstones, or decompensation of liver cirrhosis (especially in advanced stages) have been reported. If you experience persistent or severe side effects, or symptoms of an allergic reaction like swelling of the face, eyes, lips, or tongue, or difficulty breathing, seek immediate medical attention.

Is ULYSES 300MG safe during pregnancy or breastfeeding?

During Pregnancy: Ursodeoxycholic Acid should only be used during pregnancy if clearly needed and prescribed by a doctor. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. During Breastfeeding: Ursodeoxycholic Acid is naturally present in human milk, and amounts ingested by the infant after maternal administration are typically small and not expected to cause adverse effects. It is generally considered safe for breastfeeding. However, it is advisable to consult your doctor before taking this medication while breastfeeding.

Can ULYSES 300MG be taken with other medications?

ULYSES 300MG can interact with several medications. Its absorption and effectiveness may be reduced by antacids containing aluminum hydroxide and bile acid-binding agents (like cholestyramine, colestipol, colesevelam). These should be taken at least two hours apart. Hormonal contraceptives (especially those high in estrogen) and cholesterol-lowering agents (e.g., clofibrate, fenofibrate) can decrease the effectiveness of Ursodeoxycholic Acid and may promote gallstone formation. Ursodeoxycholic Acid can also affect the absorption of certain antibiotics (e.g., ciprofloxacin, dapsone), antihypertensive agents (e.g., nitrendipine), and immunosuppressants (e.g., cyclosporine); blood levels of these medications might need monitoring and dose adjustment. Always inform your doctor or pharmacist about all other medications, supplements, and herbal remedies you are taking.

What precautions should be taken while taking ULYSES 300MG?

Inform your healthcare professional if you have any allergies to Ursodeoxycholic Acid or its ingredients. ULYSES 300MG should not be taken if you have acute inflammation of the gallbladder or bile ducts, a narrowing or blockage of bile ducts, frequent episodes of biliary colic, calcified gallstones (which don't transmit X-rays), a non-functioning gallbladder, or an active gastric or duodenal ulcer. Patients with severe liver impairment, variceal bleeding, ascites, or hepatic encephalopathy should use it with caution. Regular monitoring of liver function tests is recommended. It is also advisable to avoid foods high in calories or cholesterol. If you are taking it for gallstone dissolution and use oral hormonal contraceptives, discuss alternative contraception methods with your doctor as hormones can promote gallstone formation.

What happens if a dose of ULYSES 300MG is missed?

If you miss a dose of ULYSES 300MG, 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 ULYSES 300MG be stored?

ULYSES 300MG tablets should be stored in a cool and dry place, away from direct sunlight. Keep the medication out of the sight and reach of children. Generally, it should be stored at temperatures between 10ºC and 25ºC or below 30ºC.