Ursofalk 500mg 1 Tablet
₱102.50
| Generic Name | Ursodeoxycholic Acid |
| Strength | 500 mg |
| Indication/Usage | For the dissolution of cholesterol-rich gallstones in the bladder and for the treatment of biliary reflux gastritis and cholestatic liver disease. For the symptomatic treatment of primary biliary cirrhosis (PBC), in patients without decompensated hepatic cirrhosis. |
| Dosage and Administration | For dissolution of cholesterol gallstones Approx. 10 mg of ursodeoxycholic acid per kg of body weight, equivalent to: up to 60 kg 1 film-coated tablet 61-80 kg 1½ film-coated tablets 81-100 kg 2 film-coated tablets over 100 kg 2½ film-coated tablets The film-coated 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. For the symptomatic treatment of primary biliary cirrhosis (PBC) The daily dose depends on body weight and ranges from 1½ to 3½ film-coated tablets (14 ± 2 mg of ursodeoxycholic acid per kg of body weight). For the first 3 months of treatment, Ursofalk® 500mg film-coated tablets should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening. For more information, please refer to package insert. |
| Warning and Precautions | Ursofalk® 500mg film-coated tablets should be taken under medical supervision. During the first 3 months of treatment, liver function parameters AST (SGOT), ALT (SGPT) and .-GT should be monitored by the physician every 4 weeks, thereafter every 3 months. Apart from allowing for identification of responders or non-responders in patients being treated for primary biliary cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis. 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 visualised (oral cholecystography) with overview and occlusion views in standing and supine positions (ultrasound control) 6-10 months after the beginning of treatment. If the gall bladder cannot be visualised on X-ray images, or in cases of calcified gallstones, impaired contractility of the gall bladder or frequent episodes of biliary colic, Ursofalk® 500mg film-coated tablets should not be used. When used for treatment of the advanced stages of primary biliary cirrhosis: In very rare cases decompensation of the hepatic cirrhosis has been observed; which partially regressed after the treatment discontinued. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued. Female patients taking Ursofalk® 500mg film-coated tablets for dissolution of gallstones should use an effective non-hormonal method of contraception, since hormonal contraceptives may increase biliary lithiasis. In patients with PBC, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this case the dose of Ursofalk® should be reduced to one Ursofalk® 250mg capsule daily and then gradually increased again as described in section “Dosage and mode of administration”. Long-term, high-dose UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis was associated with higher rates of serious adverse events. |
| Drug Interaction | Ursofalk® 500mg film-coated tablets should not be administered concomitantly with colestyramine, colestipol or antacids containing aluminium hydroxide and/or smectite (aluminium 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 Ursofalk® 500mg film-coated tablets. Ursofalk® 500mg film-coated tablets can affect the absorption of ciclosporin 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. In isolated cases, Ursofalk® 500mg film-coated tablets can reduce the absorption of ciprofloxacin. Oestrogenic hormones and blood cholesterol lowering agents such as clofibrate increase hepatic cholesterol secretion and may therefore encourage biliary lithiasis, which is a counter-effect to UDCA used for dissolution of gallstones. |
| Requires Prescription? (Yes or No) | Yes |
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