Tridelta

A white coloured, biconvex, round, uncoated tablet, with break line on one side and plain on other side.
Each uncoated tablet contains: Ursodeoxycholic Acid USP 300 mg.
Excipients/Inactive Ingredients: q.s.

Bile Salt.
Pharmacology: Pharmacodynamics: Mechanism of action: Ursodeoxycholic acid reduces the ratio of cholesterol to bile salts plus phospholipids in bile, causing desaturation of cholesterol saturated bile. The exact mechanism of action has not been fully elucidated.
Pharmacokinetics: Ursodeoxycholic acid is absorbed from the gastrointestinal tract and undergoes enterohepatic recycling. It is partly conjugated in the liver before being excreted into the bile. Under the influence of intestinal bacteria, the free and conjugated forms undergo 7α-dehydroxylation to lithocholic acid, some of which is excreted directly in the feces. The rest is absorbed and mainly conjugated and sulfated by the liver before excretion in the feces. However, in comparison with chenodeoxycholic acid, less Ursodeoxycholic acid undergoes such bacterial degradation.

Ursodeoxycholic acid tablets are indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of small to medium sized radiolucent, cholesterol-rich gallstones in patients with a functioning gallbladder.

Ursodeoxycholic acid tablets are for oral administration. To be taken with a drink of water.
Primary Biliary Cirrhosis: Adults and Elderly: 10-15 mg Ursodeoxycholic acid (UDCA) per kg per day in two to four divided doses.
Children: Dosage should be related to body weight.
Dissolution of gallstones: Adults and Elderly: The usual dose is 6-12 mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15 mg/kg/day in obese patients, if necessary.
The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued for three months after the apparent dissolution of the stone(s).
Children: Dosage should be related to body weight. Or as prescribed by the physician.

Diarrhea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of Ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the feces.
No specific counter-measures are necessary and the consequences of diarrhea should be treated symptomatically with restoration of fluid and electrolyte balance.

Ursodeoxycholic acid should not be used in patients with: Radio-opaque calcified gallstones.
Acute inflammation of the gallbladder or biliary tract.
Occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct).
Frequent episodes of biliary colic.
Impaired contractility of the gallbladder.
Hypersensitivity to bile acids or any excipients of the formulations.
Who are pregnant or breastfeeding, or in women who may become pregnant.
Chronic liver disease, peptic ulcers or in those with inflammatory diseases of the small intestine and colon.

Ursodeoxycholic acid should be taken under medical supervision.
During the first 3 months of treatment, the liver function parameters AST (SGOT), ALT (SGPT) and γ-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, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis.
When used for the 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 gallbladder 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.
If the gallbladder cannot be visualized on X-ray images, or in cases of calcified gallstones, impaired contractility of the gallbladder or frequent episodes of biliary colic, Ursodeoxycholic acid should not be used.
When used for treatment of advanced stage of primary biliary cirrhosis: In very rare cases, decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.
If diarrhea occurs, the dose must be reduced and in cases of persistent diarrhea, the therapy should be discontinued. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption should not take this medicine.

Pregnancy: There are no adequate data on the use of Ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of a teratogenic effect during the early phase of gestation. Ursodeoxycholic acid must not be used during pregnancy unless clearly necessary.
Lactation: There are no clinical data available on the safety of Ursodeoxycholic acid in women who are breastfeeding. Therefore, Ursodeoxycholic acid is not recommended in this patients group.
Women of childbearing potential: Women of childbearing potential should be treated with Ursodeoxycholic acid, only if they practice reliable contraception: Non-hormonal contraceptives or oral contraceptives with low oestrogen dose are recommended. However, in patients taking Ursodeoxycholic acid for dissolving gallstones an effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis.
The possibility of a pregnancy must be excluded before beginning treatment.
Fertility: Animal studies did not show an influence of Ursodeoxycholic acid on fertility. Human data on fertility treatment with Ursodeoxycholic acid are not available.

The evaluation of undesirable effects is based on the following frequency data: Very common (>1/10); Common (>1/100 to <1/10); Uncommon (>1/1,000 to <1/100); Rare (>1/10,000 to <1/1,000); Very rare/Not known (<1/10,000 / cannot be estimated from available data).
Gastrointestinal disorders: In clinical trials, reports of pasty stools or diarrhea during Ursodeoxycholic acid therapy were common.
Very rarely, severe right upper abdominal pain has occurred during the treatment of primary biliary cirrhosis. Ursodeoxycholic acid may give rise to nausea and vomiting. The frequency of these effects are not known.
Hepatobiliary disorders: During treatment with Ursodeoxycholic acid, calcification of gallstones can occur in very rare cases making them unable to be dissolved by bile acid therapy and resulting in surgery for some patients.
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 disorders: Very rarely, urticaria can occur.
Ursodeoxycholic acid may give rise to pruritus. The frequency of this effect is not known.

Ursodeoxycholic acid should not be administered concomitantly with charcoal, cholestyramine, 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 Ursodeoxycholic acid.
Ursodeoxycholic acid can increase the absorption of Cyclosporine from the intestine. In patients receiving Cyclosporine treatment, blood concentrations of this substance should therefore be checked by the physician and the Cyclosporine dose adjusted if necessary.
In isolated cases, Ursodeoxycholic acid can reduce the absorption of Ciprofloxacin.
Ursodeoxycholic acid has been shown to reduce the plasma peak concentrations (Cmax) and the area under the curve (AUC) of the calcium antagonist Nitrendipine. An interaction with a reduction of the therapeutic effect of Dapsone was also reported.
These observations together with in vitro findings could indicate a potential for Ursodeoxycholic acid to induce cytochrome P450 3A enzymes. Controlled clinical trials have shown, however, that Ursodeoxycholic acid does not have a relevant inductive effect on cytochrome P450 3A enzymes.
Oral contraceptives, estrogenic hormones and blood cholesterol lowering agents such as Clofibrate may increase biliary lithiasis, which is a counter effect to Ursodeoxycholic acid used for dissolution of gallstones.

Store at temperatures not exceeding 25°C.
Shelf Life: 36 months from the date of manufacturing.

Cholagogues, Cholelitholytics & Hepatic Protectors

A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.

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