Maxxhepa Urso 300 capsules medicine for cirrhosis is caused by raw bile (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Ursodeoxycholic acid

Ingredient

Composition informationContent
Ursodeoxycholic acid300mg

Uses

indications

Maxxhepa®urso medicine used in the following cases:

  • Treatment of primary bile cirrhosis (PBC). A05AA02

    Ursodeoxycholic acid (UDCA, Ursodiol) is a natural water stem acid, derived from cholesterol, accounting for a small part of the total amount of bile acid in humans.

    Ursodeoxycholic acid uses oral to increase the amount of this bile acid related to the dose, to become the main bile acid, replace/transform the toxic concentration of hydrophobic cavalry acids (bile acid tends to accumulate in biliary liver disease).

    Ursodeoxycholic acid protects the liver, bile gums, dissolves gallstones, reduces blood lipids, reduces blood cholesterol and some immune -regulating effects:

    Protects damaged bile epithelium cells against the toxic effects of bile acids.

    Inhibit death according to the program of liver cells.

    Reducing cholesterol secretion, reducing cholesterol absorption in the intestine and stimulating the release of new cholesterol stones in bile.

    Stimulates liver cells and bile secretion cells.

    Reducing stones, increasing the concentration of bile acids, increasing the activity of lipase enzymes, improving digestive function.

    The immunosuppressive effect: Reducing the pathological manifestation of antigen in accordance with HLA I genuine tissue on liver cells and HLA II on biliary tube epithelial cells, inhibiting Interleukin-2, reducing the number of eosinophilia.

    pharmacokinetics

    absorption:

    Normal UDCA accounts for a small part of the total amount of bile acid in humans (about 5%). After drinking, most UDCA is absorbed by passive diffusion and this absorption is incomplete.

    Metabolism:

    Immediately after being absorbed, about 70% of ursodeoxycholic acid is secreted when not liver disease. This leads to low circulatory blood levels. As the liver disease gets worse, the level of liver secretes decreases.

    In the liver, ursodeoxycholic acid is associated with glycin or taurin, then excreted into the bile. These complexes of ursodeoxycholic acid are absorbed in the small intestine according to passive and active mechanisms. These complexes can also be separated in the ileum by intestinal enzymes, leading to the formation of free ursodeoxycholic acid, which can be reabsorbed and combined in the liver. Ursodeoxycholic acid does not absorb into the colon, where almost 7-oh is lithocholic acid. A part of Ursodeoxycholic acid is converted into Chenodiol/ Chenodioxycholic (CDCA) isomer. Chenodiol is also reduced 7-oh into lithocholic acid.

    These metabolites are less soluble and excreted in stool. A small part of lithocholic acid is reabsorbed, combined with glycin or taurin in the liver and is mounted at the 3rd sulfate.

    Distribution:

    In healthy people, at least 70% of ursodeoxycholic acid (non -conjugate) is attached to plasma proteins. There is no information on the cohesion of ursodexolic acid associated with plasma proteins in healthy people or patients with primary bile cirrhosis. However, because of the effect of ursodeoxycholic acid related to its concentration in bile rather than in plasma, serum concentration is not a factor that indicates clinical bioactivity.

    its distribution volume has not been determined, but is thought to be low because the drug is distributed mainly in bile and small intestine. In honey, the peak concentration of Ursodeoxycholic acid is achieved in 1-3 hours.

    Era:

    Ursodeoxycholic acid eliminates mainly in feces. When treated, the excretion through the urine increases, but still less than 1%, except in serious cholestatic liver disease.

  • Before taking Maxxhepa Urso 300 capsules medicine for cirrhosis is caused by raw bile (3 blisters x 10 tablets)

    How to use

    Maxxhepa®urso drug used orally, should swallow whole tablet with water.

    Note to take the medication regularly.

    Dosage

    There is no limitation of age when taking Maxxhepa®uro in the treatment of first bile cirrhosis (PBC) and dissolving gallbladder stones.

    First biliary cirrhosis (PBC)

    Adults: UDCA recommended dose is 14 ± 2 mg/kg/day. In the first 3 months of treatment, using Maxxhepa®urso should be divided into 2-4 times a day. Along with the improvement of the liver values ​​can be used once in the evening.

    Taxing Maxxhepa®urso in the treatment of first bile cirrhosis (PBC) can continue indefinitely.

    Children: Dosage calculated by body weight.

    Table 1: Dosage of UDCA in the treatment of first bile cirrhosis (12 - 16 mg/kg/day).

    weight (kg) The dose (mg) Maxxhepa®urso dose 10 - 20 120 - 320 -

    20 - 30 - 30 480 - 60 600 - 960 1 capsule x 2 - 3 times/day Time/day

    Adults: UDCA's common dose is 8 - 12 mg/kg/day used in the evening or divided into several doses. When necessary, the dose can be increased to 15 mg/kg daily for obese patients. The time needed to melt stones can be from 6 to 24 months, depending on the size and composition of the stones.

    Monitoring via gallbladder or ultrasound every 6 months can be helpful until the stones are gone.

    Continuous treatment for 2 consecutive cholecyst scenes with contrast and/or ultrasound 4 - 12 weeks apart from gallbladder stones. This is because these techniques are not reliable to see the stones with a diameter of less than 2 mm. The possibility of a gallbladder recurrence after the treatment of gallbladder stones with bile acid has been estimated up to 50% after 5 years. The effectiveness of maxxhepa®uro in the treatment of contrast or partial contrast gallbladder stones has not been tested, but these stones are generally thought to be less soluble than contrast stones. The non -cholesterol stones account for 10-15% of the stones without contrast and may not be dissolved by bile acid.

    Children: Cholesterol -rich gallbladder stones and primary bile cirrhosis are very rare in children, but when detected, the dosage should be calculated by body weight. There is no adequate data on efficiency and safety for children.

    Elderly: There is no evidence that suggests to change the dose for the elderly but need to be cautious when used for older patients.

    Table 2: UDCA's dose in the treatment of gallbladder stones (8 - 12 mg/kg/day)

    weight (kg) the dose (mg) Maxxhepa®urso dose 80 - 240 - 20 - 30 160 - 360 1 capsules x 1 time/day 40 240 - 480 1 capsules x 1 time/day Time/day 840 1 capsule x 2 - 3 times/day Liver is related to cystic fibrosis in children 6 - 18 years old

    UDCA recommended dose is 20 mg/kg/day divided into 2-3 doses, when necessary can increase to 30 mg/kg per day.

    Table 3: UDCA dose in the treatment of liver disorders related to cystic fibrosis in children 6 - 18 years old (20 mg/kg/day)

    weight (kg) the dose (mg) Maxxhepa®urso dose 200-400 - 20-30 400-600 1 capsule x 2 times/day 40 600-800 1 capsule x 2 - 3 times/day Time/day 50 - 60 1000-1200 2 capsules x 2 times/day width = "175"> 2 capsules x 2 times/day 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 symptoms of overdose are rarely occurring because the absorption of UDCA decreases when increasing the dose and therefore more part will be excreted in the feces.

    Specific measures are unnecessary and the consequences of diarrhea should be treated with symptoms with water and electrolyte recovery.

    In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

    What to do when forgetting 1 dose? If this dose is close to the time of the next dose, skip the missed dose and use the next dose regularly according to the schedule. Do not use double dose.

    Side Effects

    In the recommended dose, UDCA is well tolerated and unwanted effects.

    Common (ADR ≥ 1/100)

  • Gastrointestinal disorders: Fertilizer or diarrhea, nausea, vomiting.
  • Very rare (ADR Gastrointestinal disorders: Severe upper abdominal pain, constipation.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    contraindicated

    Maxxhepa®urso drugs contraindicated in the following cases:

  • Hypersensitivity to UDCA or any ingredients of the drug. energy. pregnancy.

    Caution when using

    Monitoring patients:

    Should use UDCA under medical supervision.

    During the first 3 months of treatment, liver function parameters such as Aspartate Transaminase (AST/SGOT), Alanine Transaminase (ALT/SGPT) and gamma-glutamyl transferase (γGT) should be monitored by the doctor every 4 weeks, then every 3 months. In addition to allowing the identification of those who respond and do not respond among patients who are being treated with biliary cirrhosis, this monitor will also facilitate early detection of hidden liver failure, especially in patients with Tien Phat biliary cirrhosis.

    When used to treat first -biliary cirrhosis (PBC):

    Understanding cirrhosis is very rare in the case, this condition is partially reduced after treatment.

    In patients with primary biliary cirrhosis, very rare cases of clinical symptoms may deteriorate at the beginning of treatment, for example, itching may increase. In this case, the dose should be reduced to 250 mg of UDCA per day and then gradually increases to the recommended dose.

    If diarrhea, dose reduction and in case of prolonged diarrhea, treatment should be discontinued.

    When used to dissolve gallbladder cholesterol stones:

    Should visit gallbladder (photometric gallbladder photography) with general images and clogged images in a standing and lying position (checking via ultrasound) 6 - 10 months after starting treatment to evaluate the progression of treatment therapy and timely detection of any gallbladder calcification, depending on the size of the gravel.

    If you can't see the gallbladder on X -rays, or in the case of calculating gallbladder stones, decline in gallbladder or frequent bile cramps, UDCA should not be used.

    excipients:

    The drug contains lactose. Therefore, patients with rare genetic diseases are galactose intolerance, lactase deficiency or Glucose-Galactose should not use this drug.

    Special subjects

    Women are likely to be pregnant: It should only be used for women who are likely to get pregnant if they use reliable methods of contraception: non -hormone contraception measures or low -dose anti -oral contraceptives are recommended. However, in female patients using UDCA tablets to melt gallbladder stones, they should use non -hormone contraception, because oral contraceptives can increase gallstones. The possibility of pregnancy must be excluded before starting treatment.

    Children: The safety and effectiveness of UDCA in children has not been confirmed.

    Older patients: Studies suitable for UDCA have not been conducted in older patients. However, separate problems in the elderly will limit the use or benefits of UDCA in the elderly is possible.

    Liver/bile/pancreatic: Patients with hemorrhage due to varicose veins, hepatitis, ascites, or emergency liver transplant, should be treated with appropriate specific treatment. Caution should be used when using UDCA in the case of biliary obstruction partially due to external causes.

    The effect of drugs on driving and operating machinery

    UDCA does not have or negligible effect on the ability to drive and operate machinery.

    Using drugs for women during pregnancy and lactation

    Using drugs for pregnant women:

    There are no or few data on UDCA use in special pregnant women in the first 3 months of pregnancy. Animal studies show that toxicity that causes teratogenicity in the early stages of pregnancy. Do not use UDCA during pregnancy. Stop treatment and visit a doctor as soon as you find pregnancy.

    Use medicine for breastfeeding women:

    It is still not known whether UDCA will be excreted through breast milk. Therefore, UDCA should not be used for breastfeeding women. If you need to treat UDCA, you must stop breastfeeding.

    Drug interaction

    should not use UDCA along with activated carbon, Colestyramin, Colestipol or antacids containing aluminum hydroxid and/or smectite (aluminum oxid), because these drugs attach UDCA to the small intestine, thus hinder its absorption and effectiveness. If it is necessary to use the drug contains one of these substances, it must be taken at least 2 hours before or after using UDCA.

    UDCA may affect the absorption of ciclosporin from the small intestine. In patients who are taking ciclosporin, the doctor should check the concentration of ciclosporin in the blood and adjust the dose of ciclosporin if necessary.

    In some special cases, UDCA can reduce the absorption of ciprofloxacin.

    In a clinical study in healthy volunteers using UDCA (500 mg/day) and Rosuvastatin (20 mg/day), gently increases the concentration of rosuvastatin in plasma. The clinical involvement of this drug interaction with other statin drugs is unknown.

    UDCA has shown that it can reduce the peak of plasma (CMAX) and the area under the curve (AUC) of the Calcium Nitrendipine drug in healthy volunteers. Closely monitor the results of simultaneous use of nitrendipine and UDCA have been recommended. Nitrendipine dose may be increased. Drug interaction reduces the effectiveness of Dapson's treatment.

    Hormones that create estrogen and some blood cholesterol medications such as clofibrate increases cholesterol secretion in the liver and therefore can promote gallstones, which counter -effects use UDCA to melt gallbladder stones.

  • Storage

    Leave a cool place, avoid light, temperature below 30⁰C.

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