Ulyses Sr 450

ULYSES SR 450 by LUPIN LTD

Name

• Common Name: Ursodeoxycholic Acid
• Brand Name: ULYSES SR 450, ULYSES 450mg Tablet SR, ULYSES-SR 450 Tablet

Composition

ULYSES SR 450 contains Ursodeoxycholic Acid (450mg) as its active ingredient, formulated for sustained release.

Uses

ULYSES SR 450 is prescribed for various liver and gallbladder conditions:

• Gallstones: It is used to dissolve certain cholesterol gallstones in the gallbladder and prevent their formation. It works by reducing cholesterol production in the liver and breaking down cholesterol in bile, aiding in the dissolution of existing stones and preventing new ones.
• Primary Biliary Cirrhosis (PBC) / Primary Biliary Cholangitis: This medication treats this type of liver disease, which involves damage to bile ducts, by improving bile flow and protecting liver cells.
• Cystic Fibrosis related Liver Disease: It is used to manage liver and biliary diseases associated with cystic fibrosis in children aged 6 years and older.
• Gallstone Prevention: It can also prevent gallstone formation in obese individuals undergoing rapid weight loss.

Dosage and Administration

• Swallow the tablet whole after a meal, accompanied by a glass of milk or water. Do not crush or chew the tablet.
• The dosage is determined by your doctor based on the specific condition being treated and your body weight.
• Take the medication regularly for the duration prescribed by your doctor, which may be several months or longer, even if symptoms improve.

Side Effects

Common side effects may include:

• Abdominal pain or discomfort
• Diarrhea
• Nausea
• Rash or itching
• Hair loss
• Dizziness, indigestion, or weakness

If you experience severe side effects such as allergic reactions (e.g., severe rash, swelling) or worsening liver symptoms, seek immediate medical attention. Diarrhea, if persistent or containing blood, should be reported to your doctor.

Precautions

• Inform your doctor about any allergies to bile acids or any other components of the medicine.
• Before starting treatment, disclose any existing conditions such as inflammation of the gallbladder or bile ducts, frequent upper abdominal pain, coughing up blood, or rapid weight gain.
• ULYSES SR 450 should not be taken if you have acute inflammation of the gallbladder or bile ducts, narrowing or blockage of bile ducts, biliary colic, calcified gallstones (not visible on X-ray), a gallbladder that cannot properly constrict, or an active gastric or duodenal ulcer.
• Hormonal birth control pills may increase gallstone production and should be discontinued.
• Inform your doctor about all other medications you are taking, as ULYSES SR 450 can interact with certain drugs, including antacids containing aluminum hydroxide, bile acid sequestrants (e.g., cholestyramine), clofibrate, estrogens, ciprofloxacin, and nitrendipine.
• Your doctor may recommend regular ultrasound scans or blood tests to monitor liver function during treatment.
• Avoid alcohol consumption as it may increase sleepiness and potentially lead to liver damage.
• Use in pregnant or breastfeeding women should only be as prescribed by a doctor.
• Children aged 6 and older may use this medicine under specialist supervision.

Storage

Store ULYSES SR 450 in a cool and dry place, away from direct sunlight. Keep it out of sight and reach of children. The medication should be stored below 30°C, or specifically between 10ºC and 25ºC.

Frequently Asked Questions about ULYSES SR 450

ULYSES SR 450 is a medication manufactured by Lupin Ltd. and contains Ursodeoxycholic Acid (UDCA) as its active ingredient. It is primarily used to treat various liver and gallbladder conditions.

What is ULYSES SR 450 used for?

ULYSES SR 450 is primarily used to dissolve gallstones that are mainly composed of cholesterol and are not visible on X-rays, particularly in patients with a functioning gallbladder. It is also prescribed for the management of primary biliary cirrhosis (PBC), a chronic liver disease where the immune system damages bile ducts. Additionally, it can be used to treat liver dysfunction associated with cystic fibrosis in children aged 6 to 18 years.

How does ULYSES SR 450 work?

ULYSES SR 450 works by increasing the bile flow through the liver and protecting liver cells. It helps reduce cholesterol secretion into bile by inhibiting its absorption in the gut and suppressing its synthesis in the liver, thereby decreasing cholesterol levels in the bile. This action helps dissolve existing cholesterol gallstones and prevents the formation of new ones. It also has immunomodulating and anti-inflammatory properties that improve bile flow in PBC and protect liver cells from injury caused by toxic bile acids.

What is the usual dosage for ULYSES SR 450?

The dosage of ULYSES SR 450 depends on the condition being treated and your body weight, and it should always be determined by a doctor. It is typically taken once daily, often at bedtime, or in 2 to 3 divided doses throughout the day, spaced at 6-hour intervals (e.g., 8 a.m., 2 p.m., and 8 p.m.). The tablet should be swallowed whole after a meal with a glass of milk or water.

What are the possible side effects of ULYSES SR 450?

Common side effects may include abdominal pain or discomfort, diarrhea, nausea, headache, dizziness, hair loss, and rash. Not everyone experiences these side effects, and most are temporary. If side effects persist or worsen, it is important to inform your doctor. Persistent diarrhea may warrant discontinuing the therapy.

Is ULYSES SR 450 safe during pregnancy or breastfeeding?

ULYSES SR 450 should be used during pregnancy only if clearly considered necessary by a doctor, and if the benefits to the mother outweigh the risks to the fetus. It is generally considered safe for breastfeeding mothers to take Ursodeoxycholic Acid, but it can pass into breast milk, so it's advisable to monitor the baby closely for any signs of side effects like diarrhea, vomiting, or poor weight gain. Non-hormonal contraceptive measures or low estrogen oral contraceptive pills are recommended for women of childbearing age during treatment, as hormonal pills can increase gallstone production.

Can ULYSES SR 450 be taken with other medications?

ULYSES SR 450 can interact with several medications. It is crucial to inform your doctor about all medicines you are taking, including over-the-counter drugs and supplements.

• Avoid taking hormonal birth control pills as they can increase gallstone formation.
• Antacids containing aluminum hydroxide and cholesterol-lowering medicines like cholestyramine or colestipol can reduce the efficacy of ULYSES SR 450, so they should be taken with at least a 2-hour gap.
• Clofibrate and oestrogens can increase the risk of gallstones when taken with ULYSES SR 450.
• ULYSES SR 450 may increase the absorption of ciprofloxacin and nitrendipine.
• It may interact with immunosuppressants like Ciclosporin.

What precautions should be taken?

Before taking ULYSES SR 450, inform your doctor if you have an inflammation of the gallbladder or bile ducts, frequent cramp-like pain in your upper abdomen, have been coughing up blood, or have rapidly gained weight. Regular ultrasound scans and frequent blood tests may be necessary to monitor your liver function during treatment. Avoid a high-cholesterol diet as it may affect the medicine's effectiveness. If you experience persistent diarrhea, consult your doctor immediately.

What happens if a dose is missed?

If you miss a dose of ULYSES SR 450, 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 ULYSES SR 450 be stored?

ULYSES SR 450 tablets should be stored in a cool and dry place, protected from direct sunlight, moisture, and heat. Keep it away from children and pets. Discard any unused or expired medicine properly; do not flush it down the toilet or throw it into the drain.