Ursokem-300 (Ursodeoxycholic Acid)

Ursokem-300 general information

What is Ursokem-300 used for?

Ursokem tablets 300mg are used to treat cholestatic disease of liver, which is the build-up of bile in the liver due to impaired formation of bile by the liver and reduced flow of bile out of the liver.  This is caused by primary biliary cirrhosis (destruction of the bile ducts, thought to be an autoimmune disease) and primary sclerosing cholangitis (inflammation of the bile ducts) and can result in the formation of gallstones in the liver itself before the bile is released.  Bile is produced by the liver and comprises cholesterol, fatty acids, bile salts (formed from bile acids and glycine or taurine amino acids) and the pigment bilirubin, which is a breakdown product of red blood cells.  Bile passes through the bile duct into the gall bladder where it is stored, until it is released into the small intestine when food is ingested, to aid the digestion of fat in the diet.  The release of cholesterol into bile is also a means of eliminating excess cholesterol.  Normally bile contains sufficient bile acids to dissolve the cholesterol, however, if the bile has high cholesterol content, too much bilirubin or too little bile salt content, the cholesterol may form crystals in the gall bladder and eventually turn into gall stones.  Impaired or delayed emptying of the gall bladder causes bile to become concentrated and this also contributes to the formation of gall stones.  Ursokem-300 dissolves cholesterol gallstones and is effective for small gallstones that do not require surgery or when surgery is not an option.  Ursokem-300 is not suitable for other types of gallstones such as pigment gallstones.

How does Ursokem-300 work?

Ursokem tablets 300mg contain ursodeoxycholic acid (also known as ursodiol), which is a secondary bile acid that is produced by metabolism by intestinal bacteria from primary bile acids added to bile in the liver.  Ursodeoxycholic acid in Ursokem-300 suppresses the formation of cholesterol by the liver and also reduces the amount of cholesterol absorbed by the intestine, which regulates the body’s cholesterol levels.  Ursodeoxycholic acid also acts as a surfactant (detergent) and works by dispersing cholesterol into small droplets or micelles, so that the cholesterol becomes solubilised and can be metabolised more easily.  This property of Ursodeoxycholic acid in Ursokem-300 helps break down small gallstones that have a high cholesterol content and do not need surgery to remove them.  Dissolution of gallstones is slow and can take months or years of treatment.

What does Ursokem-300 contain?

Ursokem-300 contains the active ingredient ursodeoxycholic acid, a secondary bile acid used to dissolve gallstones. 

Treating gallstones with Ursokem-300

Ursokem tablets 300mg contain ursodeoxycholic acid that is used to break up small cholesterol-based gallstones that can form in the liver and in the gall bladder.  Gallstones in the liver are the result of build-up of bile in the liver due to impaired formation of bile by the liver and reduced flow of bile out of the liver.  Gallstones in the gall bladder is caused by bile that has high cholesterol content, too much bilirubin or too little bile salt content, and as a result the cholesterol forms crystals in the gall bladder and eventually turn into gallstones.  Gallstones can also be due to impaired or delayed emptying of the gall bladder. which causes bile to become concentrated.  Bile is produced by the liver and comprises cholesterol, fatty acids, bile salts (formed from bile acids and glycine or taurine amino acids) and the pigment bilirubin, which is a breakdown product of red blood cells.  Bile passes through the bile duct into the gall bladder where it is stored, until it is released into the small intestine when food is ingested, to aid the digestion of fat in the diet by dispersing cholesterol into small droplets or micelles so that it can be metabolised more easily.  Ursodeoxycholic acid in Ursokem-300 works in the same way so that the cholesterol in gallstones becomes solubilised and this helps break up the gallstone.  Ursokem 300 helps relieve symptoms of gallstones which vary depending on the size and location of the gallstones. There may be no symptoms at all or severe symptoms including acute abdominal pain, jaundice (yellowing of the skin and whites of the eyes) and fever.  Ursokem-300 is only suitable for treatment of small cholesterol-based gallstones and not for other types of gallstones such as pigment gallstones.  

What are the side effects of Ursokem-300?

The most commonly reported side effects when taking Ursokem-300 include: nausea, vomiting, diarrhoea, back pain, dizziness, heartburn, hair loss, upper respiratory tract infection.

When should Ursokem-300 not be used?

You should not use Ursokem-300 if you:

• are allergic to ursodeoxycholic acid or any ingredients in Ursokem-300
• are pregnant or are breastfeeding
• are over 65 years without discussion with your doctor
• have calcified cholesterol, radio-opaque or radiolucent bile pigment stones
• should be referred for surgery to remove the gallbladder (cholecystectomy) for conditions including unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis or biliary-gastrointestinal fistula
• are taking medicines that interact with Ursokem-300, including bile sequestering agents cholestyramine and colestipol for high cholesterol, aluminium-based antacids, oestrogens, oral contraceptives and clofibrate a lipid-lowering agent

What medications interact with Ursokem-300?

Several medications interact with Ursokem-300 and should either not be taken while you are taking Ursokem-300 or only after discussion and instruction from your doctor:

• Drugs that counteract  the effect of Ursokem-300: oestrogens, oral contraceptives and clofibrate a lipid-lowering agent, by increasing hepatic cholesterol secretion, and encouraging cholesterol gallstone formation
• Drugs that affect Ursokem-300: Bile sequestering agents cholestyramine and colestipol for high cholesterol, aluminium-based antacids,

How should Ursokem-300 be taken?

You should take your Ursokem-300 tablets once daily swallowed whole with a glass of water and with a meal.  The dose you take depends on your condition and your doctor’s recommendation.  If you are taking bile acid binding resins, you should take your Ursokem-300 either 2-3hours before or 4 hours after the doses of resins.  You should continue to take you Ursokem-300 for as long as recommended by your doctor

How long should you take Ursokem-300?

You should continue to take you Ursokem-300 for as long as recommended by your doctor

Missed dose of Ursokem-300

If you miss a dose of Ursokem-300 take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Ursokem-300 be stored?

You should store your Ursokem-300 below 25°C in a cool dry place.