URSO 200mg 100Tabs
WHAT IS URSO 200 MG?
Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis.
Ursodiol is used to treat primary biliary cirrhosis.
Ursodiol capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol capsules are not for treating gallstones that are calcified
Ursodiol may also be used for purposes not listed in this medication guide.
URSO 200 MG INDICATIONS
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
1. Urso 200 mg is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Urso 200 mg beyond 24 months is not established.
2. Ursa 200 mg is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
HOW SHOULD I USE URSO 200 MG
Use Urso 200 mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Urso 200 mg by mouth with food or milk.
Do not take an antacid that has aluminum in it or a bile acid sequestrant (eg, cholestyramine, colestipol) within 1 hour before or 2 hours after you take Ursa 200 mg.
If you miss a dose of Urso 200 mg, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Urso 200 mg.
USES OF URSO 200 MG IN DETAILS
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Ursodiol is a bile acid used to dissolve gallstones in patients who do not want surgery or cannot have surgery to remove gallstones. Ursodiol is also used to prevent the formation of gallstones in overweight patients who are undergoing rapid weight loss.
URSO 200 MG DESCRIPTION
Urso 200 mg is a bile acid which is physiologically synthesized in the human liver and is also formed by bacteria in the large intestine. It is present in human bile making up 1.4-4% of the biliary bile acids. Urso 200 mg is an epimer of chenodeoxycholic acid; it differs from this bile acid only in the configuration of the hydroxyl group in the C7-position.
URSO 200 MG DOSAGE
Tablet: Cholestatic Liver Disease and Dissolution of Cholesterol Gallstones: Approximately 10 mg/kg body weight/day equivalent to: Up to 60 kg: 2 tablets; up to 80 kg: 3 tablets; up to 100 kg: 4 tablets; >100 kg: 5 tablets.
Treatment of Biliary Reflux Gastritis: 1 tablet daily.
Symptomatic Treatment of Primary Biliary Cirrhosis: The daily dose depends on the body weight of the patient and lies between 2 and 6 tablets (approximately 10-15 mg/kg body weight).
The following method of taking of the capsules is recommended: See table 1.
Tablet: There are no age restrictions on the use of Urso 200 mg film-coated tablet. For patients weighing <47 kg or patients who are unable to swallow Urso 200 mg tablet 500 mg, Urso 200 mg tablet are available.
The following daily dose is recommended for the various
Indications: Dissolution of Cholesterol Gallstones: Approximately Urso 200 mg 10 mg/kg body weight, equivalent to: Up to 60 kg: 1 tablet, 61-80 kg: 1½ tablet, 81-100 kg: 2 tablet, >100 kg: 2½ tablet.
The tablets should be swallowed whole with some liquid in the evening at bedtime. They must be taken regularly.
The time required for the dissolution of gallstones is generally 6-24 months. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued.
The success of the treatment should be checked by means of ultrasound or x-ray examination every 6 months. At the follow-up examinations, a check should be made to see whether calcification of the stones has occurred in the meantime. Should this be the case, the treatment must be ended.
Symptomatic Treatment of Primary Biliary Cirrhosis (PBC): The daily dose depends on body weight and ranges from 1½ to 3½ tablets (ursodeoxycholic acid 14±2 mg/kg of body weight). For the first 3 months of treatment, Urso 200 mg tablet should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening.
The use of Urso 200 mg tablet in primary biliary cirrhosis may be continued indefinitely.
In patients with primary biliary cirrhosis, in rare cases, the clinical symptoms may worsen at the beginning of treatment eg, the itching may increase. In this event, therapy should first be continued with ½ an Urso 200 mg film-coated tablet 500 mg or 1 Urso 200 mg tablet (containing Urso 200 mg ) daily and the dose then gradually increased (weekly increase of the daily dose by 1 Urso 200 mg tablet) until the dose indicated in the respective dosage regimen is reached again.
URSO 200 MG INTERACTIONS
Urso 200 mg should not be administered concomitantly with cholestyramine, colestipol or antacids containing aluminum hydroxide and/or smectite (aluminum oxide), because these preparations bind Urso 200 mg in the intestine and thereby inhibits its absorption and efficacy. Should the use of a preparation containing one of these active ingredients concomitantly be necessary, it must be taken at least 2 hrs before or after Urso 200 mg.
Urso 200 mg can increase the absorption of ciclosporin from the intestine. In patients receiving ciclosporin treatment, blood concentrations of this substance should therefore be checked by physician and the ciclosporin dose adjusted if necessary.
In isolated cases, Urso 200 mg can reduce the absorption of ciprofloxacin.
Tablet: Urso 200 mg has been shown to reduce peak plasma concentrations (Cmax) and area under the curve (AUC) of the calcium antagonist nitrendipine.
An interaction with a reduction of the therapeutic effects of dapsone was also reported.
These observations, together with in vitro findings could indicate a potential for Urso 200 mg to induce cytochrome P450 (CYP450) 3A enzymes. Controlled clinical studies have shown, however, that Ursa 200 mg does not have a relevant inductive effect on CYP450 3A enzymes.
Estrogenic hormones and blood cholesterol-lowering agents eg, clofibrate may increase biliary lithiasis, which is a counter-effect to Urso 200 mg used for dissolution of gallstones.
What is Urso (ursodiol)?
Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis.
Ursodiol is used to treat primary biliary cirrhosis.
Ursodiol capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol capsules are not for treating gallstones that are calcified
Ursodiol may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Urso (ursodiol)?
You should not use ursodiol if you have an obstruction in your liver or gallbladder.
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What should I discuss with my healthcare provider before taking Urso (ursodiol)?
You should not use ursodiol if you are allergic to it, or if you have an obstruction in your liver or gallbladder.
To make sure ursodiol is safe for you, tell your doctor if:
•you have been coughing up blood; or
•you have gained weight rapidly, especially in your face and midsection.
FDA pregnancy category B. Ursodiol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether ursodiol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Urso (ursodiol)?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take the ursodiol tablet with food.
You may need to break a tablet in half to get your correct dose. Each tablet is scored in the middle and should break apart easily.
Swallow the tablet piece whole with a glass of water. A broken tablet can have a bitter taste.
Use ursodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
To treat gallstones, you may have to take ursodiol for several months before your gallstones dissolve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Not all gallstones completely dissolve with ursodiol treatment, and you may develop new gallstones within 5 years after treatment. Talk to your doctor about your specific risks.
While using ursodiol, you may need gallbladder ultrasound exams, or frequent blood tests to check your liver function. Your doctor may also want to check your liver function every 6 months after you stop using ursodiol.
Store at room temperature away from moisture and heat. Tablets that are broken in half can be kept at room temperature for up to 28 days.
If you split your tablets, keep them separate from any whole tablets.
