DESTONE Ursodeoxycholic Acid 250mg Capsule 1's
RXDRUG-DRP-4978-02-1pc
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Features
Brand
Destone
Full Details
Dosage Strength
250 mg
Drug Ingredients
- Ursodeoxycholic Acid
Drug Packaging
Capsule 1's
Generic Name
Ursodeoxycholic Acid
Dosage Form
Capsule
Registration Number
DRP-4978-02
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
It is used for the dissolution of cholesterol-rich gallstones in patients with functioning gallbladders. It is also used in the treatment of primary biliary cirrhosis and primary sclerosing cholangitis.
Dosage/Direction for Use
The daily dose for the following indications are for the dissolution of cholesterol gallstones, approx. 10 mg per kg body weight equivalent to: Up to 60 kg: 2 capsules.
Up to 80 kg: 3 capsules.
Up to 100 kg: 4 capsules.
Over 100 kg: 5 capsules.
For the treatment of biliary reflux gastritis: 1 capsule daily at bedtime.
For the symptomatic treatment of primary biliary cirrhosis: The daily dose depends on the body weight of the patient and lies between 2 and 6 capsules (approx. 10-15 mg of Ursodeoxycholic acid per kg body weight).
Up to 80 kg: 3 capsules.
Up to 100 kg: 4 capsules.
Over 100 kg: 5 capsules.
For the treatment of biliary reflux gastritis: 1 capsule daily at bedtime.
For the symptomatic treatment of primary biliary cirrhosis: The daily dose depends on the body weight of the patient and lies between 2 and 6 capsules (approx. 10-15 mg of Ursodeoxycholic acid per kg body weight).
Overdosage
Diarrhoea may occur in cases of overdose. In general, other symptoms of overdose are unlikely because the absorption of UDCA decreases with increasing dose and therefore more is excreted with the faeces.
No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
Additional information on special populations: Long-term, high-dose UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with higher rates of serious adverse events.
No specific counter-measures are necessary and the consequences of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
Additional information on special populations: Long-term, high-dose UDCA therapy (28-30 mg/kg/day) in patients with primary sclerosing cholangitis (off-label use) was associated with higher rates of serious adverse events.
Administration
Should be taken with food.
Contraindications
Do not administer to the following patients: with hypersensitivity to its components; with complete obstruction of biliary tract (choleretic actions may aggravate the symptoms); with fulminant hepatitis; with radiopaque calcifying cholelith; with nonfunctioning cholecyst or acute cholecystitis; Pregnant women or women suspected of being pregnant; Pediatric patients; with renal disease; with gastric ulcers (acute gastroduodenal ulcers); with colitis or enteritis such as Crohn's disease.
Special Precautions
The following patients should consult with a physician, dentist or pharmacist before taking this drug.
Patients with severe pancreatic disease (It may cause underlying disease).
Patients with cholelithiasis in bile duct (cholestasis may occur due to choleretic actions).
Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplantation.
Ursodeoxycholic acid should not be given to patients with peptic ulcer disease, inflammatory bowel disease, or chronic liver disease. Its use should be avoided in pregnancy.
General Precautions: Regularly check the level of liver enzyme (ALT, AST, γ-GT, ALP, total bilirubin).
There is a faint chance that an overdose causes a severe adverse event. If necessary, perform liver function test.
There is no evidence that dose adjustment in geriatric patients is necessary. The appropriate cautions should be exercised such as reducing the dose because the physical function in elderly patients generally declines.
Patients with severe pancreatic disease (It may cause underlying disease).
Patients with cholelithiasis in bile duct (cholestasis may occur due to choleretic actions).
Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplantation.
Ursodeoxycholic acid should not be given to patients with peptic ulcer disease, inflammatory bowel disease, or chronic liver disease. Its use should be avoided in pregnancy.
General Precautions: Regularly check the level of liver enzyme (ALT, AST, γ-GT, ALP, total bilirubin).
There is a faint chance that an overdose causes a severe adverse event. If necessary, perform liver function test.
There is no evidence that dose adjustment in geriatric patients is necessary. The appropriate cautions should be exercised such as reducing the dose because the physical function in elderly patients generally declines.
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amounts of data from the use of UDCA in pregnant women. Studies in animals have shown reproductive toxicity during the early phase of gestation. Ursodeoxycholic acid capsules must not be used during pregnancy unless clearly necessary.
Women of childbearing potential: Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal contraceptives or low-oestrogen oral contraceptives are recommended. However, in patients taking Ursodeoxycholic acid for dissolution of gallstones, 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.
Breastfeeding: It is not known whether Ursodeoxycholic acid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ursodeoxycholic acid is administered to a nursing mother.
Women of childbearing potential: Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal contraceptives or low-oestrogen oral contraceptives are recommended. However, in patients taking Ursodeoxycholic acid for dissolution of gallstones, 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.
Breastfeeding: It is not known whether Ursodeoxycholic acid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ursodeoxycholic acid is administered to a nursing mother.
Adverse Reactions
Discontinue administration and consult with a physician, dentist or pharmacist.
Digestive: sometimes pasty stools, diarrhea, vomit, nausea, rarely abdominal pain, constipation, heartburn and epigastric distress.
Hypersensitivity: sometimes, itch, rarely, rash.
Interstitial pneumonia: fever, cough, dyspnea, interstitial pneumonia accompanying chest X-ray abnormality.
Others: Rarely, general malaise, dizziness, calcification of cholelithiasis, increase in ALT, ALP, AST, γ-GT, decrease of leukocyte.
Digestive: sometimes pasty stools, diarrhea, vomit, nausea, rarely abdominal pain, constipation, heartburn and epigastric distress.
Hypersensitivity: sometimes, itch, rarely, rash.
Interstitial pneumonia: fever, cough, dyspnea, interstitial pneumonia accompanying chest X-ray abnormality.
Others: Rarely, general malaise, dizziness, calcification of cholelithiasis, increase in ALT, ALP, AST, γ-GT, decrease of leukocyte.
Drug Interactions
Concurrent administration of oral hypoglycemic agent (Tolbutamide) with this drug should be cautiously administered to diabetic patients because it may increase the effect of oral hypoglycemic agent.
The following reduce the absorption of this drug: Cholestyramine, colestipol, charcoal, aluminum hydroxide and magnesium-based antacid, 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. It can affect the absorption of ciclosporin and ciprofloxacin.
Cholesterol-reducing drugs in bile (eg. oral contraceptives containing estrogens) or cholesterol-reducing drugs in serum (eg. clofibrate).
Drugs which induce liver injury.
The following reduce the absorption of this drug: Cholestyramine, colestipol, charcoal, aluminum hydroxide and magnesium-based antacid, 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. It can affect the absorption of ciclosporin and ciprofloxacin.
Cholesterol-reducing drugs in bile (eg. oral contraceptives containing estrogens) or cholesterol-reducing drugs in serum (eg. clofibrate).
Drugs which induce liver injury.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: After oral administration of unconjugated UDCA, 30-60% of the dose is passively absorbed in the small and large intestines and undergoes efficient hepatic uptake (> 60% of the absorbed dose) and conjugation in the liver with glycine (to a lesser extent with taurine). Because colonic absorption may account for as much as 20% of an ingested dose, unconjugated UDCA is also absorbed in patients who have had ileal resections, as long as high oral doses (4 g/day) of UDCA are administered. Conjugated UDCA is then secreted into the biliary tree and intestine where it undergoes efficient enterohepatic circulation with active reabsorption in the terminal ileum. Under continuous oral treatment at pharmacological doses (10-15 mg/kg/day) UDCA becomes the predominant bile acid in the liver and the systematic circulation, comprising 40-60% of the circulating bile acid pool.
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 faeces and the rest absorbed and mainly conjugated and sulfated by the liver before excretion in the faeces. However, in comparison with chenodeoxycholic acid, less ursodeoxycholic acid undergoes such bacterial degradation.
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 faeces and the rest absorbed and mainly conjugated and sulfated by the liver before excretion in the faeces. However, in comparison with chenodeoxycholic acid, less ursodeoxycholic acid undergoes such bacterial degradation.
MedsGo Class
Cholagogues, Cholelitholytics & Hepatic Protectors
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