Maxxhepa Urso 150 Ampharco treatments for cirrhosis caused by raw bile, dissolving cholesterol gallbladder stones (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Ursodeoxycholic Acid
Ingredient
| Composition information | Content |
| Ursodeoxycholic Acid | 150mg |
Uses
indications
Maxxhepa Urso 150 drug is indicated in the following cases:
In addition to replacing/transferring toxic bile acids, other UDCA mechanisms include protecting the damaged bile epithelial cells from the toxic effects of bile acid, inhibiting the death of the program (APOTOSIS) of liver cells, the impact of immunosuppressure, and stimulating bile excretion by liver cells and bile bile cells.
Lithocholic acid when used for long -term animals, causing cholest liver damage can lead to death from liver failure in some species that cannot produce sulfate combinations. UDCA is 7 - dehydroxylation slower than Chenodiol. For UDCA and chenodiol dosage, lithocholic acid concentration in a stable state in bile acid in the bile duct when using UDCA is lower than that of Chenodiol. Humans and chimpanzees can create sulfate combinations of lithocholic acid. Although liver damage is not related to UDCA therapy, in some individuals may reduce sulfate tolerance.
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.
Distribution
In healthy people, at least 70% of UDCA (non -uncompleted) is attached to plasma proteins. There is no information on the cohesion of UDCA associated with plasma proteins in healthy people or patients with primary biliary cirrhosis. However, because the effectiveness of UDCA is more 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 the bile and small intestine. In honey, the peak concentration of UDCA is achieved in 1-3 hours.
Metabolism
Immediately after being absorbed, about 70% of UDCA is secreted when there is no liver disease. This leads to low circulatory blood levels. As the liver disease gets worse, the level of liver secretes decreases. In the liver, UDCA is associated with glycin or taurin, then excreted into the bile. These complexes of UDCA are absorbed in the small intestine according to passive and proactive mechanisms.
These complexes can also be separated in the ileum by intestinal enzymes, leading to free UDCA formation, which can be reabsorbed and combined in the liver. UDCA does not absorb into the colon, where almost reduced 7 - OH into lithocholic acid. A part of UDCA is converted into the isomers of Chenodiol/Acid Chenodexolic (CDCA) through intermediaries 7 - Oxo.
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.
Excretion
UDCA is excreted mainly through feces. When treated, the excretion through the urine increases, but still less than 1%, except in serious cholestatic liver disease.
Before taking Maxxhepa Urso 150 Ampharco treatments for cirrhosis caused by raw bile, dissolving cholesterol gallbladder stones (3 blisters x 10 tablets)
How to use
should swallow whole with water.
Dosage
Cirrhosis due to primary bile (PBC)
Adults: UDCA recommended dose is 14 ± 2 mg/kg/day. In the first 3 months of treatment, Maxxhepa Urso 150 should be divided into 2-4 times a day. Along with the improvement of the liver values can be used once in the evening.
Children:
weight (kg)
The dose range (mg)
Number of capsules x number/day
10 - 20
120 - 320
1 x 2
20 - 30
240 - 480
1 x 2 - 3
30 - 40
360 - 640
1 x 3 - 4
40 - 50
480 - 800
1 x 4
50 - 60
600 - 960
-
60 - 70
720 - 1120
-
70
1120
-
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 until 2 consecutive cholecyst scenes with contrast and/or ultrasound 4 - 12 weeks apart, the gallbladder stones are not identified. This is because these techniques are not reliable to see the stones with a diameter of less than 2 mm.
The possibility of gallbladder recurrence after the treatment of gallbladder stones with bile acid has been estimated up to 50% after 5 years. The effectiveness of Maxxhepa Urso 150 in the treatment of gallbladder gallbladder stones or partial contrast 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 cirrhosis due to primary bile are very rare in children, but when detected the disease, the dose 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 adults but need to be cautious when used for older patients.
Dosage of UDCA in the treatment of gallbladder stones (8 - 12 mg/kg/day).
weight (kg)
The dose range (mg)
Number of capsules x number/day
10 - 20
80 - 240
1
20 - 30
160 - 360
1 x 1 - 2
30 - 40
240 - 480
1 x 2 - 3
40 - 50
320 - 600
1 x 2 - 4
50 - 60
400 - 720
1 x 3 - 5
60 - 70
480 - 840
2 x 2 - 3
70
840
-
UDCA recommended dose is 20 mg/kg/day divided into 2-3 doses, when necessary can increase to 30 mg/kg per day.
weight (kg)
The dose range (mg)
Number of capsules x number/day
10 - 20
200 - 400
1 x 2
20 - 30
400 - 600
1 x 3 - 4
30 - 40
600 - 800
2 x 2 - 3
40 - 50
800 - 1000
2 x 3
50 - 60
1000 - 1200
2 x 4
60 - 70
1200 - 1400
3 x 3
70
1400
-
Specific measures are unnecessary and the consequences of diarrhea should be treated with symptoms with water and electrolyte recovery.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Maxxhepa Urso 150 you can experience unwanted effects (ADR).
Common, ADR> 1/100
Very rare, ADR
Liver disorders: Calcification of gallbladder stones, loss of cirrhosis. Skin and subcutaneous tissue disorders: urticaria, itching, skin rash. 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
Maxxhepa Urso 150 drug is contraindicated in the following cases:
Cholecystitis or acute biliary tract.
The conditions of the liver and intestines hinder the return of the liver - intestines of bile acids: bile stasis outside the liver, bile stasis in the liver, remove ileum, open intestinal - ileum, localized intestinal inflammation, acute or chronic liver disease, suffer from duodenal ulcer, suffering from stomach ulcers. Pregnant women, nursing women, or pregnant women. 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 (YGT) should be monitored by a 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 for cirrhosis due to primary bile, this monitor will also facilitate early detection of hidden liver failure, especially in patients with raw bile cirrhosis. When used to treat cirrhosis due to progression of primary bile (PBC) Unscreted cirrhosis is noticeable in very rare cases, this condition is partially reduced after treatment. In patients with cirrhosis due to primary bile, very rare cases of clinical symptoms can 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 diarrhea, 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. UDCA does not have or negligible effect on the ability to drive and operate machinery. without or less 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. is still unknown whether UDCA is excreted through breast milk or not. Therefore, UDCA should not be used for breastfeeding women. If you need to treat UDCA, you must stop breastfeeding. 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 not well known. Closely monitor the results of simultaneous use of nirendipine 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. Caution when using
The ability to drive and operate machinery
Pregnancy
The period of breastfeeding
Drug interaction
Storage
Store at temperatures below 30 ° C. Avoid direct light and wet place.
Other drugs
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