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Anhui Medipharm Co.,Ltd.
ANHUI MEDIPHARM CO.,LTD.
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Compound α-Ketoacid Tablets, Compound, GMP Medicine with BP/CP/USP Standard

Anhui Medipharm Co.,Ltd.
Anhui Medipharm Co.,Ltd.
City: Hefei
Province/State: Anhui
Country/Region: China
Tel: 86-0551-63840330
Contact Person:
Mrs Jeny

Compound α-Ketoacid Tablets, Compound, GMP Medicine with BP/CP/USP Standard

Brand Name : Medipharm/Shinepharm
Model Number : AMC12064
Certification : GMP, ISO
Place of Origin : CHINA
MOQ : 2000box
Payment Terms : T/T, Western Union, MoneyGram
Supply Ability : 1500 boxes per month
Delivery Time : 45 days after confirm artworks
Packaging Details : depends client request
Specification : Compound
Shelf life : 3 YEARS
Registration dossiers : Yes
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COMPOSITION
Each tablet contains:

D,L-a-Ketoisoleucine Calcium…………………………………………………67mg

a- Ketoleucine Calcium…………………………….………………………… 101mg

a-Ketophenylalanine Calcium………………………………………..…………68mg

a-Ketovaline Calcium……………………………………………………...……86mg

D.L-α-Hydroxymethionine Calcium……………………………………………59mg

L-Lysine Acetate……………………………………………………………….105mg

L-Threonine………………………………………………………………..……53mg

L-Tryptophan……………………………………………………………………23mg

L-Histidine………………………………………………………………………38mg

L-Threonine……………………………………………………………………...30mg

DESCRIPTION
This compound tablets contain 4 kinds of Calcium Amino Acid, 1 kind of Calcium Hydroxyl-amino Acid and 5 kinds of Amino Acids.
CHARACTERS

Compound α-Ketoacid Tablets are yellow film coated. The tablet color is white after film removed. For each tablet, the total nitrogen content is 36mg and the total calcium content reaches 1.25mmol which equals approximately to 50mg.

PHARMACOLOGY AND TOXICOLOGY

Compound α-Ketoacid Tablets can supply the essential amino acids and reduce the intake of ammonia nitrogen. Ketone or hydroxyamino acid does not contain amidogen, which can help them utilize the nitrogen from non-essential amino acids to transfer into amino acids. This can reduce the synthesis of urea as well as the accumulation of the uremic toxic products. Ketone or hydroxyamino does not cause the ultrafiltration of remnant nephron, alleviate the renal hyperphosphatemia and secondary hyperparathyroidism and improve the status of renal osteodystrophy. With the low-protein diet together, Compound α-Ketoacid Tablets can reduce the intake of nitrogen and at the same time avoid the adverse consequences caused by insufficient protein intake and malnutrition.The results of toxicology researches indicate that Compound α-Ketoacid Tablets has low toxicity. Chronic toxicology researches show that minimum toxicity dose of dog is 1200 mg/day and rat 2700 mg/day. After conversion, the dosage for the human body (70 kg) is 84 g/day according to dog dosage and 189 g/day according to rat dosage.

This product has no embryo toxicity.


PHARMACOKINETICS

For the normal individuals, the plasma level will rise 10 minutes after taking ketone or hydroxyamino acid, at this time the plasma concentration is up to five times the initial level which will reach the peak after 20-60 minutes and decrease to the normal level after 90 minutes. The ketone or hydroxyamino acid in the plasma and corresponding amino acid concentration increase at the same time, which shows the fast transamination of ketone or hydroxyamino. As the ketone or hydroxyamino acid in human body has its own distribution pathway, the intake from external can enter metabolic cycle fast, and their catabolism pathway is the same with amino acids.

USAGE

With the low-protein diet together, Compound α-Ketoacid Tablets can be taken as prevention and treatment of damage caused by protein metabolic as chronic renal insufficiency, usually for patients with glomerular filtration rate lower than for 25ml per minutes. Low protein diet requires adult daily requirement protein intake of 40g or less than 40g.

DOSAGE

By oral administration. 3 times a day, 4 to 8 tablets every time. Swallow whole tablets during meals. If necessary, be directed by doctor. This dosage is calculated according to 70kg adult weight.For patients with glomerular filtration rate lower than for 25ml per minutes, this product can be used long time with with no more than 40 grams daily (adult) of low protein diet.

ADVERSE EFFECTS

Hypercalcemia may occur. When hypercalcemia occurs, the patients shall reduce the intake of Vitamin D. When hypercalcemia continues, the patients shall reduce the intake dosage of this product and the intake of other calcium substances.

TABOOS
Metabolism disorders of hypercalcemia and amino acid.Hereditary phenylacetone urine patients shall pay attention to the containing of phenylalanine.
PRECAUTIONS

The medicine is suggested to be taken during the meal so as to make full absorbed and transfer into corresponding amino acid. The calcium level in serum shall be monitored regularly and adequate intake of calorie shall be ensured.

Keep out of the reach of children.

Do not take the products out of expiration time.

INDICATION FOR PREGNANT AND NURSING MOTHER

None experience for usage of pregnant and nursing mother.

DRUG INTERACTIONS

This product can lead the rising of calcium level in serum while taken with other calcium medicines at same time.

For uremic patients taking this product, if they take aluminum hydroxide drugs at thesame time, the dosage of aluminum hydroxide drugs shall be reduced. Pay attention to the decrease of phosphorus level in serum.In order not to affect the absorption of drugs, other drugs which can form slightly solubility compounds combined with calcium shall not be taken with this products at the same time, including tetracycline, quinolone like ciprofloxacin and norfloxacin, iron, fluoride and drugs containing estramustine, etc. The interval between taking of this product and these referred drugs above shall not be less than 2 hours.The rise of calcium level in serum can increase the sensitivity of cardiac glycoside drug and therefore increase the risk of arrhythmia.


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