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Ketosolv

Ketosolv

Manufacturer:

Globela Pharma

Distributor:

Solvang

Marketer:

AMB HK
Full Prescribing Info
Contents
Ketoanalogues, essential amino acids.
Action
Pharmacotherapeutic Group: Renal nutrition therapy.
Pharmacology: Mechanism of Action: In normal individuals, there is an increase in the plasma level of ketoanalogues, 10 minutes after oral ingestion. These levels reach values that are approximately 5 times higher than the initial level. Peak levels are reached within 20-80 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 ketoanalogues and the corresponding amino acid show that transamination of the ketoanalogues is very rapid. Due to the natural pathways of disposal of α-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.
Indications/Uses
For prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with a limited protein in food of 40 g/day (for adult) and less, i.e. generally in patients with glomerular filtration rate (GFR) below 25 mL/min.
Dosage/Direction for Use
For oral use.
Four to eight tablets, three times a day.
1 tablet/5 kg body weight/day.
Should be taken with food (swallow whole, do not chew/crush) or as prescribed by the physician.
Duration of Treatment: The product is administered as long as the glomerular filtration rate (GFR) is below 25 mL/min, and concomitantly, dietary protein is restricted to 40 g/day or less (adults).
Overdosage
No symptoms have been observed to date.
Contraindications
Allergy and hypersensitivity to any content of this drug; Hypercalcemia; Disturbed amino acids metabolism; Caution with use for patients with phenylketonuria.
Special Precautions
Ketoanalogues + Essential amino acids contains phenylalanine. It should be used with caution in phenylketonuria patients.
Ketoanalogues + Essential amino acids 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 sufficient supply of calories.
Use In Pregnancy & Lactation
No experience has been made so far with the administration of Ketoanalogues + Essential amino acids during pregnancy and lactation.
Adverse Reactions
Hypercalcemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcemia persists, reduce the dosage of Ketoanalogues + Essential amino acids as well as any source of calcium.
Drug Interactions
The simultaneous administration of medicaments containing calcium (e.g., acetolyte) may lead to pathological increase of the serum calcium level or intensification. As the uraemic symptoms improve under Ketoanalogues + Essential amino acids, a possible administration of aluminum hydroxide should be reduced. Pay attention to a reduction of serum phosphate. In order not to interfere with absorption, do not take Ketoanalogues + Essential amino acids together with drugs that form sparingly soluble compounds with calcium [e.g., tetracyclines, quinolone (e.g., ciprofloxacin, norfloxacin), iron, fluoride, and estramustine-containing drugs]. Between the intake of Ketoanalogues + Essential amino acids and drugs from the mentioned categories, a period of at least 2 hours should pass. The susceptibility towards heart/cardiac-active glycosides and hence also the risk of arrhythmia increase with the rise of the blood calcium concentration.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
MIMS Class
Other Drugs Acting on the Genito-Urinary System
ATC Classification
A16AA - Amino acids and derivatives ; Used in treatment of alimentary tract and metabolism problems.
Presentation/Packing
Form
Ketosolv FC tab
Packing/Price
100's
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