Urso 250mg Capsules Uses Side-effects Dose In Urdu
Each Urso capsule contains 250mg or 500mg of ursodeoxycholic acid (B.P specs).
Urso 250mg Capsules Uses
- Urso 250mg Capsules Uses in the following:
- dissolution of cholesterol-rich gall stones in the gallbladder. The gallstones must not be visible
on x-ray and gallbladder function must be intact despite the gallstone(s).
- chronic cholestatic liver disease.
- Symptomatic therapy of primary biliary cirrhosis is an early stage.
- Bile reflux gastritis (urso capsules250mg ).
The following daily dose is recommended for the various indications:
For dissolution of cholesterol gallstones
The daily dose amounts to 10mg per kg body weight, equivalent to:
Weight Dose by weight Dose by capsules
Urso capsules 500mg Urso capsules 250mg
up to 60kg 500mg 1 capsule or 2 capsules
61 – 80 kg 750mg 1 capsule + 1 capsule
81- 100kg 1000mg 2 capsules or 4 capsules
over 100kg 1250mg 2 capsules + 1 capsule
Swallow the capsules whole with a little fluid, do not chew. Do take the capsules regularly.
Gallstones generally take from 6 to 24 months to dissolve. if the gallstones have not
become smaller after 12 months, do not continue treatment. The result of therapy should
be monitored by ultrasonography to X-ray 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
For the treatment of primary biliary cirrhosis (PBC):
The daily dosage is 10-15 mg per kg of body weight daily. For the first 3 months of treatment.
Urso capsule dose may be taken once daily in the evening.
The recommended adult dosage for URSO 250® and URSO Forte® in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. The dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
Liver Function Tests
Liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and SBR Serum Bilurobin levels should be monitored every month for three months after the start of therapy, and every six months.
Scoring the URSO Forte Tablet
The URSO Forte scored tablet can be broken in halves to provide recommended dosage.
To break URSO Forte scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets.
Body weight (kg) Daily dose (mg/kg BW) First 3 months Subsequently
Morning Mid day Evening Evening (1x daily)
47-62 12-16 250mg 250mg 250mg 750mg
63-78 13-16 250mg 250mg 500mg 1000mg
79-93 13-16 250mg 500mg 500mg 1250mg
94-109 14-16 500mg 500mg 500mg 1500mg
Over 110 500mg 500mg 750mg 1750mg
The use of Urso capsules 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.
e.g., the itching may increase. Should this occur, therapy should first be continued with Urso capsule 250 mg
daily and the therapy gradually increased until the dose indicated in the respective dosage regimen is
For the treatment of bile reflux gastritis:
Urso capsule 250mg should normally be taken for 10-14 days. The attending physician will decide
how long treatment should be continued.
Note: it is important for the result of treatment to take the capsules regularly. liver function
parameters should be monitored several times during treatment.
Urso must not be used in :
.Acute inflammation of the gallbladder and bile ducts
.Obstruction of the biliary tract (Common bile duct or cystic duct)
.Inflammatory disorders of the large and small intestine.
Urso should not be taken where the gallbladder cannot be visualized at X-ray by patients
with calcified gallstones, disturbed contractility of the gallbladder, or frequent biliary colic.
WARNINGS AND PRECAUTIONS:
During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT)
and Y-GT should be monitored by the physician every 4 weeks, thereafter every 3 months,
Apart from allowing for identification of responders and non-responders in patients being
treated for primary biliary cirrhosis, particularly in patients with advanced-stage primary
When used for dissolution of cholesterol gallstones:
In order to assess therapeutic progress and for timely detection of any calcification of
the gallstones, depending on stone size, the gall bladder should be visualized (oral cholecystography)
with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months
after the beginning of treatment on X-ray images, or in cases of calcified gallstones, impaired
contractility of the gall bladder or frequent episodes of biliary colic.
When used for the treatment of advanced stage of primary biliary cirrhosis:
In very rare cases decompensation of cirrhosis has been observed, which partially regressed ofter
the treatment was discontinued.
Urso capsule must not be used during pregnancy unless clearly necessary. Women of
childbearing potential should be treated only if they use reliable contraception: non-hormonal
or low-estrogen oral contraceptives may increase biliary lithiasis. The possibility of pregnancy must be excluded before beginning treatment.
it is not known whether ursodeoxycholic acid passes into breast milk. Therefore, Urso
capsules should not be taken during lactation. if treatment with Urso capsules is necessary,
the infant should be weaned.
Urso Capsules SIDE EFFECTS:
The side effects are based on the following data:
Very common:(>1/10);common:(>1/100 to < 1/10); Uncommon:(>1/10,000 to <
1/100); Rare:(>1/10,000 to <1/1,000); Very rare/Not known (<1/10,000/cannot be
estimeted from available data)
Reports of pasty stools or diarrhea during ursodeoxycholic acid therapy were common in
clinical trials. Very rarely, severe right upper abdominal pain has occurred during the
treatment of primary biliary cirrhosis.
During treatment with ursodeoxycholic acid, calcification of gallstones can occur in very
rare cases. During therapy of the advanced stages of primary biliary cirrhosis in very
rare cases decompensation of hepatic cirrhosis has been observed, which partially
regressed after the treatment was discontinued.
Skin and subcutaneous disorder:
Very rarely, urticaria can occur.
Urso should not be administered concomitantly with colestyramine, colestipol, or antacids
containing aluminum hydroxide and/or smectite (aluminum oxide), because these
preparations bind ursodeoxycholic acid in the intestine and thereby inhibit its absorption
and efficacy. should the use of a preparation containing one of these substances be necessary,
it must be taken at least 2 hours before or after Urso capsules.
Urso can increase the absorption of cyclosporine from the intestine. in patients receiving ciclosporin
treatment, blood concentrations of this substance should therefore be checked by the physician and
the ciclosporin dose adjusted if necessary.
Urso can reduce the absorption of ciprofloxacin in isolated cases. Ursodeoxycholic acid has been shown
to reduce peak plasma concentrations Cmax and area under the curve( AUC) of the calcium antagonist
Nitredinpine. An interaction with a reduction of the therapeutic effect of dapsone was also reported.
Diarrhea may occur in cases of Overdose. No specific Contra- measures are necessary and the consequences of
Diarrhea should be treated Symptomatically with the restoration of fluid and electrolyte balance.