Urso 500mg (Ursodeoxycholic Acid) - Generic

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URSODIL SR is the international generic and equivalent of Urso

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Urso  500mg  (Ursodeoxycholic Acid) - Generic


What is Generic Urso(Ursodeoxycholic Acid)?
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 small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol is also used to treat primary biliary cirrhosis.Ursodiol is not for treating gallstones that are calcified.Ursodiol may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Generic Urso  (Ursodeoxycholic Acid)?
Before taking ursodiol, tell your doctor if you are also taking cholestyramine (Questran), colestipol (Colestid), or estrogens (birth control pills or hormone replacement).Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb ursodiol.
To treat gallstones, you may have to take ursodiol for several months, and not all gallstones may completely dissolve. Many people who use this medicine will develop gallstones again within 5 years after treatment with ursodiol. Talk to your doctor about your specific risks for repeated gallstones.
To be sure this medication is helping your condition, your doctor may perform ultrasound examinations of your gallbladder on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.
 


What should I discuss with my healthcare provider before taking Generic Urso  (Ursodeoxycholic Acid)?
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have liver disease.FDA pregnancy category B. This medication is not expected to be harmful to 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. Do not use this medication without telling your doctor if you are breast-feeding a baby.
To treat gallstones, you may have to take ursodiol for several months, and not all gallstones may completely dissolve. Many people who use this medicine will develop gallstones again within 5 years after treatment with ursodiol. Talk to your doctor about your specific risks for repeated gallstones.


How should I take Generic Urso  (Ursodeoxycholic Acid)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label.Take each dose with a full glass of water. The medication can be taken with meals unless your doctor tells you otherwise.
To be sure this medication is helping your condition, your doctor may perform ultrasound examinations of your gallbladder on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.It may take several months of taking ursodiol before your gallstones dissolve. Take this medication for the entire length of time prescribed by your doctor.
It is important to take ursodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.Store ursodiol at room temperature away from heat, moisture, and light.


What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.An overdose of ursodiol is likely to cause diarrhea.


What should I avoid while taking Generic Urso  (Ursodeoxycholic Acid)?
Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb ursodiol.Generic Urso  (Ursodeoxycholic Acid) side effectsGet emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Other less serious side effects are more likely to occur, such as:
    * fever, chills, body aches, flu symptoms;    


    * stomach pain, nausea, diarrhea, constipation;    


    * dizziness, tired feeling;    


    * back pain;    


    * runny or stuffy nose, cold symptoms; or    


    * headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. 


What other drugs will affect Generic Urso  (Ursodeoxycholic Acid)?
Before taking ursodiol, tell your doctor if you are using any of the following drugs:
    * cholestyramine (Questran);    


    * colestipol (Colestid);    


    * estrogens (birth control pills or hormone replacement); or    


   * antacids that contain aluminum, such as Rolaids, Mylanta, or Maalox).
If you are using any of these drugs, you may not be able to use ursodiol or you may need dosage adjustments or special tests during treatment.There may be other drugs not listed that can affect ursodiol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.


Generic Name Ursodeoxycholic Acid
Search Name Urso Generic 500mg Tab
Supply Name URSODIL SR
Brand Generic GENERIC
Presentation Blister in Box
Dosage Tab
USA Brand Urso
Manufacture Revenbhel Healthcare
Strength 500mg
Search Terms Urso ,URSODIL SR ,Ursodeoxycholic Acid
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to ursodiol: oral capsule, oral tablet

Along with its needed effects, ursodiol (the active ingredient contained in Urso) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ursodiol:

More common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- dizziness
- fast heartbeat
- frequent urge to urinate
- indigestion
- lower back or side pain
- severe nausea
- skin rash or itching over the entire body
- stomach pain
- vomiting
- weakness

Less common
- Black, tarry stools
- chest pain
- chills or fever
- cough
- pinpoint red spots on the skin
- severe or continuing stomach pain
- sore throat or swollen glands
- sores, ulcers, or white spots on the lips or in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness

Incidence not known
- Clay-colored stools
- dark urine
- difficulty with swallowing
- headache
- hives or welts
- hoarseness
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- nausea
- redness of the skin
- slow or irregular breathing
- tightness in the chest
- unpleasant breath odor
- yellow eyes or skin

Some side effects of ursodiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
- Back pain
- body aches or pain
- congestion
- constipation
- general feeling of discomfort or illness
- heartburn
- loss of voice
- muscle aches
- muscle or bone pain
- pain, swelling, or redness in the joints
- runny nose
- sweating
- trouble sleeping

Less common
- Diarrhea

Rare
- Worsening psoriasis

Incidence not known
- Acid or sour stomach
- belching bloating or swelling of face, arms, hands, lower legs, or feet
- difficulty with moving
- rapid weight gain
- stomach discomfort or upset
- tingling of the hands or feet
- unusual weight gain or loss
USUAL ADULT DOSE FOR BILIARY CIRRHOSIS

Tablets: 13 to 15 mg/kg/day orally in 2 to 4 divided doses with food

Comments:
-Dose should be adjusted according to patient's need at physician's discretion.

Approved indication: For treatment of patients with primary biliary cirrhosis

USUAL ADULT DOSE FOR GALLBLADDER DISEASE

Capsules:
Gallbladder stone dissolution: 8 to 10 mg/kg/day orally in 2 or 3 divided doses
Gallstone prevention: 300 mg orally twice a day

Comments:
-Ultrasound images of gallbladder recommended at 6-month intervals for first year of therapy to monitor gallstone response. If gallstones appear to have dissolved, therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months.
-Most patients who eventually achieve complete stone dissolution show partial or complete dissolution at the first on-treatment reevaluation.
-If partial stone dissolution is not seen by 12 months of therapy, likelihood of success is greatly reduced.
-Safety of use beyond 24 months is not established.

Approved indications:
-For dissolution of gallstones in patients with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter who are not candidates for cholecystectomy due to increased surgical risk (e.g., systemic disease, advanced age, idiosyncratic reaction to general anesthesia) or who refuse surgery
-For gallstone prevention in obese patients undergoing rapid weight loss

USUAL PEDIATRIC DOSE FOR GALLBLADDER DISEASE

(Not approved by FDA)

Some experts recommend:
Parenteral nutrition-induced cholestasis in neonates:
Treatment: 30 mg/kg/day orally in 3 divided doses; some centers divide in 2 daily doses

Prevention:
With initiation of parenteral nutrition: 5 mg/kg/day orally in 4 divided doses beginning on day of life 3
With initiation of enteral feeding: Increase dose to 10 mg/kg/day orally in 4 divided doses.
When full enteral feedings reached: Increase dose to 20 mg/kg/day orally in 4 divided doses.

Biliary atresia:
Infants: 10 to 15 mg/kg orally once a day

Treatment of TPN-induced cholestasis:
Infants and children: 30 mg/kg/day orally in 3 divided doses

Improvement in the hepatic metabolism of essential fatty acids in cystic fibrosis:
Children: 30 mg/kg/day orally in 2 divided doses

RENAL DOSE ADJUSTMENTS

Data not available

LIVER DOSE ADJUSTMENTS

Data not available

PRECAUTIONS

Consult WARNINGS section for dosing related precautions.

DIALYSIS

Data not available

OTHER COMMENTS

Administration advice:
-The 500 mg scored tablet may be broken in halves to provide recommended dose; segments should be swallowed unchewed with water due to bitter taste.

Storage requirements:
-Half-tablets (500 mg scored tablets broken in half): May be used for up to 28 days when stored in current packaging (bottles) at 20C to 25C (68F to 77F); should be stored separately from whole tablets.

Monitoring:
-Hepatic: For capsules, monitor AST and ALT (start of therapy and thereafter as clinically indicated); for tablets, monitor bilirubin levels and liver function tests, including gamma-glutamyltransferase, alkaline phosphatase, AST, ALT (every month for 3 months after start of therapy then every 6 months thereafter)