Uroxyl 300mg Davipharm medicine for cirrhosis, melting gallstones (6 blisters x 10 tablets)
Dosage form Box of 6 blisters x 10 tablets
Specifications Ursodeoxycholic Acid
Ingredient
| Composition information | Content |
| Ursodeoxycholic Acid | 300mg |
Uses
Indications
Uroxyl 300 drug are indicated in the following cases:
Children
Pharmacological group: Gastrointestinal medicine.
Ursodeoxycholic Acid (UDCA) is a substance in the composition of bile fluid, accounting for a very small percentage (about 5%) in total bile acid. After taking the drug, this ratio increases corresponding to the dose and UCDA can become the main component of bile acid (accounting for 40-50%). Ursodeoxycholic acid (UDCA) works to reduce cholesterol in bile fluid mainly by reducing cholesterol absorption from the intestine. This effect does not affect cholesterol and bile acid biosynthesis. Cholesterol gradually dissolved from the gallbladder.
Children
Cystic fibrosis: From clinical experimental reports that last for more than 10 years, the effect of UDCA in the treatment of cystic fibrosis and liver disorders in children. There is evidence when treating with UDCA can reduce biliary lines, slow down tissue damage and even recover liver changes if treated in the early stages of the disease. UDCA should be started immediately after being diagnosed with disease to optimize treatment effect.
pharmacokinetic
absorption
UDCA is absorbed from the digestive tract. UDCA is present in plasma for 10-40 minutes after taking the drug. UDCA only dissolves moderate in the upper part of the small intestine but is well absorbed in the nodes and ileum. Achieve peak concentration in plasma after about 1-3 hours.
Distribution
In healthy people, at least 70% of UDCA (unprocessed) fitted plasma proteins. There is no information on UDCA's plasma protein cohesion that has been combined in healthy people as well as patients with primary biliary cirrhosis. UDCA's distribution volume has not been determined but is considered very small because the drug is mostly distributed in loss and small intestine.
Metabolism
After absorption, UDCA undergo first metabolism and gut cycle. UDCA's first liver clearance is about 60% (mainly in the form of glycin). UDCA is quickly excreted into the honey. The UDCA-Glycin combination may be hydrolyzed in the free form. The absorption part will be converted by bacteria in the intestinal tract into lithocholic acid. Another form of metabolism is 7-ketolitholic acid that can be reabsorbed and metabolized in the liver into UDCA and lithocholic acid.
Elimination
UDCA and its metabolites are mainly eliminated in feces. The rate of excretion of urine increases during treatment but still at less than 1% unless the case of severe cholestatic cirrhosis.
Before taking Uroxyl 300mg Davipharm medicine for cirrhosis, melting gallstones (6 blisters x 10 tablets)
How to use
oral drugs. Take medicine with water.
Dosage
Treatment of first bile cirrhosis (PBC)
Adults and the elderly
10 - 15mg/kg/day, divide orally 2 to 4 times.
Children
Should adjust the dose by weight.
melt gallstones
Adults and the elderly
The usual dose is 6 - 12mg/kg/day, drink once in the evening or divide or drink several times. The dose may increase to 15mg/kg/day in obese patients if necessary. The treatment time can be up to 2 years, depending on the size of the gravel, and should continue to treat for another 3 months after the gravel disappears.
Children
Dosage adjustment by weight.
cystic fibrosis with liver disorders in children 6 - 18 years old
20mg/kg/day divided 2-3 times, can be used up to 30mg/kg/day if necessary.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? Overall, other overdose symptoms are not clear due to the reduction of UDCA's absorption when increasing the dose and increased excretion through feces.
No need to use specific treatments, mainly compensation and electrolytes when diarrhea. However, liver function should be monitored. If necessary, ion exchange resin can be used to connect bile acids in the intestine.
Some special subjects
High doses of high doses lasting UDCA (28 - 30mg/kg/day) in patients with Tien Phat biliary fiber (with the designated dose that has not been approved by the FDA) increases the risk of unwanted effects.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.
Side Effects
When using Uroxyl 300 , you may experience unwanted effects (ADR).
Evaluation of unwanted effects based on the following frequency data:
Very common (> 1/10).
Common (1/100 to
rarely (> 1/1,000 to
Rare (> 1/10,000 to
Very rare/unknown (
digestive disorders : In clinical trials, there has been a common report of loose or diarrhea in UDCA treatment. It rarely occurs in the upper right abdominal pain during the treatment of biliary cirrhosis. UDCA can cause nausea and vomiting. The frequency of this influence is not known.
Biliary disorders: During UDCA treatment, the formation of gallstones may occur in a rare case that cannot be dissolved with bile acid therapy and leading to surgery in some patients during the treatment of the progressive phase of Tien Phat bile cirrhosis, very rare cases of loss of cirrhosis, partly recovery after stopping treatment.
Skin and subcutaneous disorders: very rarely occur urticaria. UDCA can cause itching. The frequency of this influence is not known.
The drug can cause other unwanted effects, advising patients to notify unwanted effects when taking the drug.
Instructions on how to handle ADR
When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Urxyl 300 drug contraindicated in the following cases:
Children fail in kasai surgery or do not restore good bile flow in children with bile path.
Precautions when used
The drug is used under the supervision of the treating doctor.
In the first 3 months of treatment, every 4 weeks of doctors should check the ASAT liver function exploration indicators (SGOT), ALAT (SGPT) and Y-AG, then check it once every 3 months. In addition to monitoring to identify signs of response or non -response treatment in patients with primary biliary cirrhosis, this monitor also allows early detection of potential liver damage, especially patients with Tien Phat cirrhosis.
When used to dissolve cholesterol stones
To assess the progression of therapy and promptly detect calcification gallstones, give patients X -rays with contrast and ultrasound drugs in a standing and lying position (ultrasound control) every 6-10 months after starting treatment depending on the size of the stones.
If the gallbladder cannot be seen in X-ray images, or in the case of calcification gallstones, decreased the ability of the gallbladder to contract or frequently suffer from bile cramps, should not use UDCA.
Women use ursodeoxycholic acid to melt gallstones should use hormonal contraception measures due to hormonal contraception may increase the risk of gallstones.
When used in the treatment of Tien Phat biliary cirrhosis, the progressive stage
Very rare for non -reporting cirrhosis, which will be partially reduced after treatment.
Rarely occurs cases of clinical symptoms in patients with primary bile cirrhosis, such as itching. If this condition occurs, reduce the dose to 250mg/day, then gradually increase to the recommended dose.
If diarrhea is required to reduce the dose. Stop treatment in the case of prolonged diarrhea. Avoid a diet rich in calories or cholesterol.
The drug contains lactose, patients with rare genetic diseases galactose, Lapp Lactase deficiency or glucose - galactose absorption disorders should not use this drug.
The drug contains polysorbat 80 can cause allergies and castor oil can cause nausea, vomiting, abdominal pain, diarrhea.
To be out of reach of children.
The ability to drive and operate machinery
Ursodeoxycholic acid has no effect or negligible effect on the ability to drive and operate machinery.
Pregnancy
Animal studies do not see the effects of UDCA on fertility. There is no data on the fertility of UDCA when treated in humans.
Pregnant women: There is no adequate data on UDCA use, especially in the first three months of pregnancy. Animal studies provide evidence of teratogenic effects in the early stages of pregnancy. Ursodeoxycholic acid is not used during pregnancy. Need to stop treating immediately if pregnant and seek medical advice.
Women are likely to get pregnant: Women are likely to be pregnant only to be indicated for treatment when they use reliable contraception. Using non -hormone contraception or taking contraceptives containing low estrogen. However, in patients using ursodeoxycholic acid to dissolve stones, should use non -hormone contraceptive methods because oral hormone contraceptives can increase the risk of gallstones. It is necessary to rule out the possibility of pregnancy before starting treatment.
Breastfeeding period
Do not know if Ursodeoxycholic acid is found in breast milk. Therefore, UDCA should not be taken during breastfeeding. If UDCA is needed, stop breastfeeding.
Drug interaction
UDCA may affect cyclosporin absorption in patients when using these two drugs simultaneously. If used simultaneously, check blood cyclosporin levels for patients and adjust the dosage of cyclosporin if necessary.
Do not use Ursodeoxycholic acid combination with activated carbon, colestyramin, colestipol or aluminum aluminum or aluminum aluminum aluminum because these substances will be attached to UDCA in the intestine to reduce its bioavailability. If it is required to use the above drugs, it is required to take at least 2 hours from Ursodeoxycholic Acid.
Ursodeoxycholic acid affects the secretion of bile acids, so the absorption of oil stems can be affected.
In some cases, UDCA may reduce the absorption of ciprofloxacin.
UDCA reduces the peak and area under the curve (AUC) of the Calcium Nitrendipin channel blocker in healthy volunteers. Interactivity reduces the effectiveness of DASSON treatment also reported. The above interaction, combined with in vitro interactive data, can be explained by the Cytochrome P450 3A. However, in controlled clinical trials indicates that UDCA has an induction effect on the cytochrome P450 3A enzyme. However, no touch was reported when studying interacting with Budesonid, a CYP3A4 CIA
Elkmon is estrogen, contraceptives rich in estrogen and blood cholesterol drugs such as clofibrate, increasing cholesterol secretion from the liver thus promoting the formation of gallstones, antagonism to the effect of UDCA.
Storage
Keep the drug in the original packaging of the manufacturer, covered. Leave the medicine in a dry place, avoid light, the temperature does not exceed 30 ° C, and out of the reach of children.
Expiry date: 36 months from the date of manufacture. Do not use overdue drugs stated on the packaging.
Manufacturer: Dat Vi Pharmaceutical Joint Stock Company.
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