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Written By Santoshini Reddy G , M Pharmacy
Reviewed By Bayyarapu Mahesh Kumar , M Pharmacy
Last Updated Oct 30, 2024 | 5:52 AM IST

Ursodox-300 Tablet is used to treat gallstones, primary biliary cholangitis (an autoimmune disease of the liver), excess cholesterol in bile and children above 6 years with biliary and liver diseases caused by cystic fibrosis. It contains Ursodeoxycholic acid, which helps decrease the production of cholesterol in the blood, thereby dissolving gall bladder stones composed mainly of cholesterol. It has a protective effect on the liver cells. Thus, it protects from injury caused by toxic bile acids and improves liver function. In some cases, you may experience certain common side effects such as abdominal discomfort, abdominal pain, diarrhoea, nausea, rash, dizziness, indigestion and weakness. Before taking this medicine, you should tell your doctor if you are allergic to any of its components or if you are pregnant/breastfeeding, and about all the medications you are taking and pre-existing medical conditions.

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Manufacturer/Marketer

Signova Pharma

Consume Type

ORAL

Return Policy

Not Returnable

Expires on or after

Jan-27

for this medicine

About Ursodox-300 Tablet

Ursodox-300 Tablet belongs to a group of medicines called biliary agents or gallstone dissolution agents. These agents are used to treat gallstones, primary biliary cholangitis (an autoimmune disease of the liver), excess cholesterol in the bile, and children above 6 years old with biliary and liver diseases caused by cystic fibrosis. 

Ursodox-300 Tablet contains ursodeoxycholic acid, which is a naturally occurring bile acid. Ursodox-300 Tablet helps decrease the production of cholesterol in the blood, thereby dissolving gallbladder stones composed mainly of cholesterol. Ursodox-300 Tablet has a protective effect on the liver cells from injury caused by toxic bile acids and improves liver function.

Take Ursodox-300 Tablet with food. You are advised to take Ursodox-300 Tablet as long as your doctor has prescribed it for you, depending on your medical condition. In some cases, you may experience certain common side effects such as abdominal discomfort, abdominal pain, diarrhoea, nausea, rash, dizziness, indigestion and weakness. Most of these side effects do not require medical attention and will resolve gradually over time. However, you are advised to talk to your doctor if you experience these side effects persistently.

Inform your doctor before taking Ursodox-300 Tablet if you have variceal bleeding (high blood pressure in portal veins), ascites (excess abdominal fluid), liver encephalopathy or liver disease. Do not take Ursodox-300 Tablet if you are pregnant or breastfeeding unless prescribed. Ursodox-300 Tablet can be given to children above 6 years if prescribed by the doctor. Avoid consuming alcohol along with Ursodox-300 Tablet as it could lead to increased drowsiness and liver damage. Keep your doctor informed about your health condition and medicines to rule out any side effects.

Uses of Ursodox-300 Tablet

Treatment of Gall stones, primary biliary cholangitis and biliary and liver diseases caused by cystic fibrosis.

Medicinal Benefits

Ursodox-300 Tablet contains ursodeoxycholic acid, which is a naturally occurring bile acid. It belongs to a group of medicines called the biliary agent or gallstone dissolution agents used to treat gallstones, primary biliary cholangitis (an autoimmune disease of the liver), excess cholesterol in bile children above 6 years with biliary and liver diseases caused by cystic fibrosis. Ursodox-300 Tablet breaks down the cholesterol that has formed into gall bladder stones, thereby dissolving the stones. Ursodox-300 Tablet has a protective effect on the liver cells and the immune system, thereby improving liver function. Ursodox-300 Tablet decreases the amount of cholesterol produced by the liver and absorbed by the intestine. In patients with primary biliary cirrhosis, Ursodox-300 Tablet increases the bile flow.

Directions for Use

Tablet/Capsule: Swallow it as a whole with a glass of water; do not chew, or crush the tablet/capsule.Syrup/Suspension/Drops: Take the prescribed dose by mouth using the measuring cup/dosing syringe/dropper; shake the pack well before each use.Dispersible tablet: Disperse the tablet in water and consume it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of Ursodox-300 Tablet

  • Abdominal discomfort
  • Abdominal pain
  • Diarrhoea
  • Nausea
  • Fever
  • Cough
  • Rash
  • Dizziness
  • Indigestion
  • Black or tarry stools
  • Frequent and painful urination
  • Weakness

Drug Warnings

Do not take Ursodox-300 Tablet if you are allergic to any of its contents, if you have inflammation of gall bladder and bile ducts, narrowing or blockage of bile ducts, biliary colic, calcified gallstones, improper constriction of the gallbladder, gastric or duodenal ulcer. Inform your doctor before taking Ursodox-300 Tablet if you have variceal bleeding (high blood pressure in portal veins), ascites (excess abdominal fluid), liver encephalopathy or liver disease. Consult your doctor before taking Ursodox-300 Tablet with other medicines as Ursodox-300 Tablet might reduce the absorption of antibiotics (ciprofloxacin and dapsone) and antihypertensive agents (nitrendipine), increase the effect of immunosuppressants (cyclosporine), oral contraceptives (oestrogen) and cholesterol-lowering agents (clofibrate) might promote the formation of gallstones. Do not take Ursodox-300 Tablet if you are pregnant or breastfeeding unless prescribed. Ursodox-300 Tablet can be given to children above 6 years if prescribed by the doctor. Avoid consuming alcohol along with Ursodox-300 Tablet as it could lead to increased drowsiness and liver damage. Keep your doctor informed about your health condition and medicines to rule out any unpleasant side effects.

Drug Interactions

Drug-Drug Interactions: Ursodox-300 Tablet may interact with antibiotics (ciprofloxacin and dapsone), antihypertensive agents (nitrendipine), immunosuppressants (cyclosporine), hormones (oestrogen), and antacids (aluminium hydroxide, aluminium carbonate, magaldrate).

Drug-Food Interactions: No interactions found/established.

Drug-Disease Interactions: Inform your doctor if you have biliary obstruction and liver impairment, variceal bleeding (high blood pressure in portal veins), ascites (excess abdominal fluid), or liver encephalopathy.

Drug-Drug Interactions Checker List

  • CIPROFLOXACIN
  • DAPSONE
  • CYCLOSPORINE
  • ESTROGEN
  • ALUMINUM HYDROXIDE
  • ALUMINUM CARBONATE
  • NITRENDIPINE
  • MAGALDRATE

Habit Forming

No

Diet & Lifestyle Advise

  • Include foods such as bell peppers, citrus fruits, leafy vegetables, tomatoes, milk, fish, low-fat dairy, beans, nuts, lentils, tofu and tempeh in your diet.
  • Eat a healthy, well-balanced diet, which includes fruits and vegetables.
  • Foods rich in vitamins B and C and calcium are good for the gallbladder.
  • Plant-based protein foods such as beans, nuts, lentils, tofu and tempeh help prevent gallbladder disease.
  • Avoid high-fat, trans-fat and processed foods.
  • White bread, white pasta and sugars should be avoided.
  • Avoid tobacco and alcohol consumption.

Special Advise

  • Your doctor may recommend regular liver function tests to monitor liver function and the progress of treatment.
  • Ursodox-300 Tablet may rarely cause thinning and hair loss. If there is excessive hair loss, consult your doctor for further advice.

Disease/Condition Glossary

Primary biliary cholangitis: Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is an autoimmune disease caused by bile duct damage in the liver. Bile ducts are the small channels which carry the bile (digestive fluid) from the liver to the small intestine, where it breaks down fats and aids in its absorption. Biliary cirrhosis causes a build-up of bile in the liver, which leads to liver damage.
Gallbladder stones: Gallbladder is a small organ located below the liver that stores bile and helps with digestion. Excess cholesterol in bile leads to the formation of gallstones. Gallstones can cause pain in the abdomen, dark urine and stools, indigestion, diarrhoea, nausea and vomiting.
Cystic fibrosis: It is a hereditary disease that affects the digestive system and lungs. In this condition, the body produces a thick and sticky fluid that obstructs the pancreas and clogs the lungs.

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Alcohol

Unsafe

Avoid consumption of alcohol while taking Ursodox-300 Tablet as it may cause increased dizziness and liver damage.

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Pregnancy

Caution

Ursodox-300 Tablet belongs to pregnancy category B. Please consult your doctor if you have any concerns regarding this. Your doctor will prescribe only if the benefits outweigh the risks.

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Breast Feeding

Caution

Consult your doctor before taking Ursodox-300 Tablet ; your doctor will decide whether breastfeeding mothers can take Ursodox-300 Tablet or not.

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Driving

Caution

Ursodox-300 Tablet does not affect your ability to drive. However, you are advised to be cautious while driving if you experience dizziness.

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Liver

Caution

Dose adjustment may be needed in patients with liver impairment. Please consult your doctor if you have a liver impairment or any concerns regarding this.

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Kidney

Caution

Dose adjustment may be needed in patients with kidney impairment. Please consult your doctor if you have kidney impairment or any concerns regarding this.

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Children

Caution

Ursodox-300 Tablet can be given to children with caution above 6 years and only if prescribed by the doctor.

Country of origin

India

Manufacturer/Marketer address

House No-44, Ground Floor, Barthakur Mill Road, Ulubari, Guwahati, Kamrup,Assam -781007
Other Info - URS0093

Author Details

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FAQs

Ursodox-300 Tablet is used to treat gallstones, primary biliary cholangitis (an autoimmune disease of the liver), excess cholesterol in bile and children above 6 years with biliary and liver diseases caused by cystic fibrosis.
Ursodox-300 Tablet works in decreasing the production of cholesterol and by dissolving the cholesterol in bile, thereby preventing the formation of gallstones. Ursodox-300 Tablet decreases the toxic levels of bile acids that accumulate in primary biliary cirrhosis.
Do not discontinue Ursodox-300 Tablet without consulting your doctor. To treat your condition effectually, continue taking Ursodox-300 Tablet for as long as prescribed. Do not be reluctant to speak with your doctor if you have any difficulty taking Ursodox-300 Tablet .
Diarrhoea might be a side-effect of Ursodox-300 Tablet . Drink lots of fluids and eat food rich in fibre if you experience diarrhoea. If you find blood in stools (tarry stools) or if you experience excess diarrhoea, consult your doctor. Do not take anti-diarrheal medicine on your own.
Avoid taking aluminium-containing antacids along with Ursodox-300 Tablet , as they might interfere with its absorption. Maintain a gap of 2 hours between both.
Ursodox-300 Tablet might reduce the absorption of antibiotics (ciprofloxacin and dapsone) and antihypertensive agents (nitrendipine). Ursodox-300 Tablet might increase the effect of immunosuppressants (cyclosporine). Cholesterol-lowering agents (clofibrate) might promote the formation of gallstones. Inform your doctor before taking Ursodox-300 Tablet with other medicines to avoid unpleasant side effects.
Oral contraceptives (oestrogen) might promote the formation of gallstones. Consult your doctor if you have any concerns regarding this, your doctor may advise other contraception methods.
There is no evidence that Ursodox-300 Tablet affects fertility. Please consult the doctor if you have any concerns regarding this.
Ursodox-300 Tablet should be given to paediatric patients only if prescribed by the doctor. It may be used in children above 6 years with liver and biliary diseases caused by cystic fibrosis.
The doctor will determine when to take Ursodox-300 Tablet based on your condition. Ursodox-300 Tablet should be taken after a meal with a glass of milk or a small snack. Take the prescribed number of tablets distributed throughout the day as advised by the physician.
Yes, Ursodox-300 Tablet is safe to use if prescribed by the doctor. Like all medicines, Ursodox-300 Tablet may also cause side effects in some people. However, if any of the side effects are bothersome, please consult the doctor.
Ursodox-300 Tablet has a protective effect on the liver cells from injury caused by toxic bile acids and improves liver function.
Ursodox-300 Tablet may cause weight gain in some people. Consult the doctor if you notice rapid weight gain, especially in your face and midsection.
Avoid taking other medicines concomitantly with Ursodox-300 Tablet as it might reduce or intensify the effect of other medicines. Colestyramine and colestipol should be taken 2 hours before or after Ursodox-300 Tablet . Consult your doctor before taking Ursodox-300 Tablet with other medicines as Ursodox-300 Tablet might reduce the absorption of antibiotics (ciprofloxacin and dapsone) and antihypertensive agents (nitrendipine), increase the effect of immunosuppressants (cyclosporine), oral contraceptives (oestrogen) and cholesterol-lowering agents (clofibrate) might promote the formation of gallstones.

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