Generic Name: Essential Amino Acids Brand Name: Ketosteril Classifications: Ketoanalogs; Essential amino acids Therapeutic Actions

of Ketosteril Normalizes metabolic process, promotes recycling product exchange. Reduces ion concentration of potassium, magnesium and phosphate. Indications of Ketosteril Protein energy malnutrition Prevention and treatment of conditions caused by modified or insufficient protein metabolism in chronic renal failure Contraindications of Ketosteril Allergy and hypersensitivity to any content of this drug Hypercalcemia Disturbed amino acid metabolism Caution use for patietn with phenylketonuria Dosage of Ketosteril Four to eight tabs TID 1 tab/5kg body weight/day Adverse Reactions of Ketosteril Hypercalcemia may develop Nursing Considerations of Ketosteril Evaluate for any contraindications Take drug as prescribed Warn the patient about possible side effects and how to recognize them Give with food if GI upset occurs Frequently assess for hypercalcemia

Read more at Nurseslabs.com Ketosteril Drug Study http://nurseslabs.com/ketosteril/ Manufacturer Distributor Contents Fresenius Kabi Hong Kong: Zuellig Amino acids.

Indications Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40 g/day (for adults) ie, generally in patients with a glomerular filtration rate (GFR) <25 mL/min. Dosage For oral use. Swallow whole. Adults (70 kg body weight): If not otherwise prescribed take 4-8 tablets 3 times a day during meals. Ketosteril is given as long as the GFR is <25 mL/min and a diet with an intake of maximum 40 g protein/day (for adults) is followed. Administration Should be taken with food. Swallow whole, do not chew/crush. Overdosage No symptoms have been observed to date. Hypercalcaemia, disturbed amino acid metabolism.

Contraindications

In case of hereditary phenylketonuria, it has to be taken into account that Ketosteril contains phenylalanine. Special Precautions Ketosteril should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly. Ensure the sufficient supply with calories. Effects on the Ability to Drive or Operate Machinery: Not applicable. Use in pregnancy & lactation: No experience has been made so far with the application in pregnancy and lactation. Use in children: No experience has been made so far with the application in paediatric. Adverse Drug Reactions Hypercalcaemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcaemia persists, reduce the dosage of Ketosteril as well as any other source of calcium. Click to view ADR Monitoring Form Drug Interactions The simultaneous administration of medicaments containing calcium (eg, acetolyte) may lead to pathological increases of the serum calcium level or intensification. As the uraemic symptoms improve under Ketosteril, a possible administration of aluminium hydroxide should be reduced. Pay attention to a reduction of serum phosphate. In order not to interfere with absorption, do not take drugs together with Ketosteril that form sparingly soluble compounds with calcium (eg, tetracyclines, quinolone eg, ciprofloxacin and norfloxacin, iron-, fluoride- and estramustin-containing drugs). Between the intake of Ketosteril and drugs from the mentioned categories, a period of at least 2 hrs should pass. The susceptibility towards heart/cardiac-active glycosides and hence also the risk of arrhythmia increases with the raise of the blood calcium concentration. Incompatibilities: None. View more drug interactions with Ketosteril Storage Do not store above 25C. Shelf-Life: 3 years. Description Each tablet contains (RS)-3-methyl-2-oxovaleric acid (-ketoanalogue to DL-isoleucine), calcium-salt 67 mg; 4-methyl-2-oxovaleric acid (-ketoanalogue to leucine), calcium-salt 101 mg; 2-oxo3-phenylpropionic acid (-ketoanalogue to phenylalanine), calcium-salt 68 mg; 3-methyl-2-oxobutyric acid (-ketoanalogue to valine), calcium salt 86 mg; (RS)-2-hydroxy-4-methylthio-butyric acid (-

hydroxyanalogue to DL-methionine), calcium salt 59 mg; L-lysine acetate 105 mg; L-threonine 53 mg; Ltryptophan 23 mg; L-histidine 38 mg; L-tyrosine 30 mg. Total nitrogen content per tablet: 36 mg. Calcium content per tablet: 1.25 mmol = 50 mg. Ketosteril also contains the following excipients: Cornstarch, crospovidone, talc, silicone dioxide, magnesium stearate, macrogol 6000, quinoline yellow E104, poly[butylmethacrylate-co-(2dimethylaminoethyl)metha-crylate-co-methylmetha-crylate] 1:2:1 (Eudragit E), triactine, titanium dioxide E171, povidone K-value 29-32. Mechanism of Action Pharmacology: Pharmacodynamics: Ketosteril allows the intake of essential amino acids while minimising the amino-nitrogen intake. Following ingestion, the ketoanalogues are transaminated by taking nitrogen from non-essential amino acids, thereby decreasing the formation of urea by re-using the amino group. The levels of accumulating uremic toxins are decreased. Keto- and/or hydroxy-acids do not elicit hyperfiltration of residual nephrons. Ketoacid-containing supplements have a positive influence on the renal hyperphosphatemia and secondary hyperparathyroidism and can improve renal osteodystrophy. The use of Ketosteril in association with a very low protein diet allows a reduced intake of nitrogen while avoiding the deleterious consequences of inadequate dietary protein intake and malnourishment. Pharmacokinetics: The plasma kinetics of amino acids and their integration in metabolic pathways are well established. It should nevertheless be noted that, in uremic patients, the plasma disturbances do not seem to depend on digested amino acid intake, and that the post-absorptive kinetics seems to be disturbed very early in the development of the disease. In normal individuals, there is an increase in the plasma level of keto-analogues, 10 min after oral ingestion. These levels reach values that are approximately 5 times higher than the initial level. Peak levels are reached within 20-60 min, and normal levels are reached again after 90 min. Gastrointestinal absorption is thus very rapid. In the plasma, a simultaneous increase in levels of the keto-analogue and the corresponding amino acid show that transamination of the keto-analogues is very rapid. Due to the natural pathways of disposal of -ketonic acids in the organism, it is probable that exogenous intakes are very rapidly integrated into metabolic cycles. Ketoacids follow the same catabolic pathways as the classical amino acids. No specific study on ketoacid excretion has been performed to date. Toxicology: Preclinical Safety Data: Preclinical data reveal no special hazard for humans based on conventional studies of acute and repeated dose toxicity, safety pharmacology and genotoxicity. Ketosteril was found to show no teratogenic property. MIMS Class Supplements & Adjuvant Therapy

ATC Classification B05BA01 - amino acids ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions. Poison Schedule NP

Presentation/Packing

Film-coated tab 100's.

KETOSTERIL (Ketosteril) The composition and the form of : Pill-coated. table 1. active ingredients : DL--methyl okso-2- calcium valerinat (? ketoanalog - isoleucine) : 67 mg - methyl okso-2- calcium valerinat (? ketoanalog-leucine) : 101 mg okso-2--phenyl calcium propionat acid (? ketoanalog - phenylalanine) : 68 mg okso-2- calcium-methyl butyrate (? ketoanalog - valine) : 86 mg DL- gidroksi-2- calcium-methylbutyrate (? gidroksianalog-methionine) : 59 mg - L-lysine monoatsetat : 105 mg - L-Threonine : 53 mg - L-Triptaphan : 23 mg - L-Histidine : 38 mg - L-Tyrosine : 30 mg Other ingredients : corn starch, 44 mg; polivinilpirrolidon-6 mg; talc - 19.57 mg; - colloidal silicon dioxide, 4.4 mg; magnesium stearate 15 mg; polyethylene 6000 - 12.8 mg; polivinilpirrolidon soluble - 43 2 mg skin Pill : talc - 9.1 mg; polyethylene 6000-1.48 mg; hinolinovy yellow E104 - 0.72 mg; eudragit E12, 5 - 5.9 mg; triatsetin - 0.43 mg of titanium dioxide, 7.4 mg the content of calcium in pill - 1.25 mmol = 0.05 g 20 pc in blisters. ; in soldered 5 per package; in one stack of cardboard package. Description pharmaceutical form : Prodolgovatye, dvoyakovypuklye tablets, coated yellow. Description : Combined preparation for the full supply of indispensable amino acids, with a minimum nitrogen. The drugs act : Normalizuyuschee metabolic processes.

Ketonovye similar amino acids in the body fermentativno transaminiruyutsya to the L-amino acids, splitting with urea. Nitrogen promotes recycling products exchange, anabolizmu proteins while reducing the urea concentration in serum. Improves nitrogen exchange. Reduces ion concentrations of potassium, magnesium and phosphate. Clinical pharmacology : The systematic use of the drug has seen an improvement of patients with chronic renal insufficiency. In some cases, can delay the initiation of dialysis. Indication : Protein-energy malnutrition, prevention and treatment of conditions caused by modified or insufficient protein metabolism in chronic renal failure in adults and children 3 years. Mainly used in patients with klubochkovoy filtering speeds below 25 ml / min. Contraindications : Giperchuvstvitelnost, giperkaltsiemiya breach of the exchange amino acids. When hereditary phenylketonuria should keep in mind that product contains Phenylalanine. Application of pregnancy and breast-feeding : The experience of pregnancy is missing. Side Effects : In some cases, giperkaltsiemiya may develop allergic reactions (in patients with hypersensitivity to the drug component). Networking : With the simultaneous application of calcium therapy may increase calcium in the blood serum. As uremicheskih reduce symptoms by Ketosterila dose of a designated aluminum hydroxide should be reduced accordingly. Care should be taken in the level of phosphate in the blood serum. In order not to violate the absorption in the gut, not to be taken together with Ketosterilom LS, capable of combining with calcium compounds of poorly (tetracycline, Moldova, iron and fluorinated drugs and estramustin). Between admission Ketosterila and these drugs should be spaced at least 2 hours Dosing and Administration : inside, not liquid, while food. Adults and children from 3 years to 1 table. 5 kg of body weight per day or 0.1 g / kg standard weight per day. Usual adult dose for weight 70 kg-table 4-8. three times a day; for children under 1 table. 5 kg of body weight per day. Ketosteril appointed throughout the period when the speed klubochkovoy filtering below 25 ml / min. In preddializny period recommended protein content in food is not more than 40 grams of protein per day (depending on the degree of chronic renal failure). Recommended protein food for children 3-10 years - 1,4-0,8 g / kg / day, from 10 years and above, 1-0,6 g / kg /

day. For patients in dialysis, protein intake should be in accordance with the recommendations. Precautions : It should regularly monitor the level of calcium in blood serum. Doing giperkaltsiemii to reduce admission of vitamin D. If giperkaltsiemiya remains Ketosterila dose should be reduced, as well as other sources of calcium. Special instructions : Need to ensure adequate calorie foods. Shelf life : 3 years Storage conditions : dry, the dark place at a temperature not exceeding 25 C

Ketosteril is generally known as Compound -Ketoacid Tablets and it is used for preventing and treating renal damages due to protein metabolism disorder in chronic kidney disease and the effects are better with low-protein diets. It is usually applied to those that have glomerular filtration rate (GFR) less than 25ml/min and the standard of low-protein diet is 40g/day or less for adults. There are many treatments for chronic renal failure and in recent years both eastern and western scholars advocate the use of ketosteril to treat chronic kidney disease and help lower creatinine level. Metabolic disorders of protein, amino acid are very common among renal failure patients and they are in a state of negative nitrogen balance. Ketosteril can supply amino acid and reduce the producing of urea and help lower the level of creatinine and urea nitrogen and at the same time improve the nutritional status.

The combination of ketosteril and low-protein diet can achieve the following functions: 1. Alleviate the symptoms of uremia. The symptoms and discomforts of uremia are caused by the excessive accumulation of metabolic wastes of proteins. 2. Protect the remaining renal functions and slow down the progression of illness conditions. 3. Guarantee the patients nutrition even with obvious reduction of protein intake. 4. Improve the metabolic complications due to renal insufficiency. Ketosteril does have certain effects on lowering creatinine, but it still depends on the patients illness and physical conditions and patients should not rely on ketosteril only. The root cause of increased creatinine level is the damage of renal intrinsic cells and tissues and the decreased ability of the glomerular filtration, therefore when the damaged parts are repaired and the glomerular filtration rate is improved the accumulated creatinine and other wastes will be filtered out of the body by the kidneys and the creatinine level will decrease naturally. Micro-Chinese Medicine has the functions of softening and dilating blood vessels, anti-inflammation, anti-coagulation and degradation of extracellular matrix. It can block the process of renal fibrosis, repair damaged renal intrinsic cells and tissues and rebuild

kidney structure and functions so as to lower creatinine naturally and from the root.

Tag: High Creatinine Treatment PreviousHow to Reduce High Creatinine Level Naturally NextFoods to Avoid with High Creatinine Level