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USE IN SPECIFIC POPULATION:

There are no adequate data from the use in pregnant women. Animal studies do not indicate direct or
indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal
development. Caution should be exercised when prescribing to pregnant women. No experience has been
made so far with the use during lactation. Ketorite has no influence on the ability to drive and use
machines.

ADVERSE REACTIONS:
Adverse effect frequencies are ranked as follows:
Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to <
COMPOSITION: 1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data).
Each film coated tablet contains: Metabolism and nutrition disorders very rare:
alpha-Ketophenylalanine, Calcium salt ............................. 68 mg. Hypercalcaemia.
alpha-Hydroxymethionine, Calcium salt ........................... 59 mg.
alpha-Ketoisoleucine. Calcium salt ................................... 67 mg. If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia,
alpha-Ketoleucine. Calcium salt ...................................... 101 mg. the dose as well as the intake of any other calcium sources has to be reduced.
alpha-Ketovaline, Calcium salt .......................................... 86 mg.
L-Tryptophan ...................................................................... 23 mg. OVER DOSAGE: No case of overdose has been reported.
L-Threonine ........................................................................ 53 mg.
L-Tyrosine ........................................................................... 30 mg. INSTRUCTIONS:
L-Histidine ........................................................................... 38 mg. - Store below 30ºC.
L-Lysine acetate ................................................................ 105 mg. - Protect from heat, sunlight & moisture.
Total nitrogen content per tablet ........................................ 36 mg. - Keep out of the reach of children.
- To be sold on the prescription of a registered medical practitioner only.
Calcium content per tablet ................................................. 50 mg.
PRESENTATION:
Product Specs.: Innovator
Ketorite Tablet : Pack of 10 x 10 tablets.

DESCRIPTION:
Ketosteril tablets are administered for nutrition therapy in chronic kidney disease. Ketorite allows the
intake of essential amino acids while minimising the amino-nitrogen intake.

CLINICAL PHARMACOLOGY:
Mechanism of Action:
Following absorption, the keto- and hydroxy-analogues are transaminated to the corresponding essential
amino acids by taking nitrogen from non-essential amino acids, thereby decreasing the formation of urea
by re-using the amino group. Hence, the accumulation of uraemic toxins is reduced. Keto and hydroxy
acids do not induce hyperfiltration of the residual nephrons. Ketoacid containing supplements exert a
positive effect on renal hyperphosphataemia and secondary hyperparathyroidism.
Moreover, renal osteodystrophy may be improved. The use in combination with a very low protein diet
allows to reduce nitrogen intake while preventing the deleterious consequences of inadequate dietary
protein intake and malnutrition.
Pharmacokinetics:
The plasma kinetics of amino acids and their integration in the metabolic pathways are well established. It
should nevertheless be noted that in uraemic patients, the cause of the changed plasma levels, which
occur frequently in these patients, does not seem to be the absorption of the supplied amino acids, i. e. the
absorption itself is not disturbed.
The changed plasma levels seem to be due to impaired post-absorptive kinetics, which can be detected in
a very early stage of the disease. In healthy individuals, the plasma levels of ketoacids increase within 10
min after oral administration. Increases of up to the 5-fold the baseline levels are achieved. Peak levels
occur within 20-60 min, and after 90 min levels stabilise in the range of the base levels.
Gastrointestinal absorption is thus very rapid. The simultaneous increases in the levels of the ketoacids
and the corresponding amino acids show that the ketoacids are transaminated very rapidly. Due to the
physiological utilisation pathways of ketoacids in the body it is likely that exogenously supplied ketoacids
are very rapidly integrated into the metabolic cycles. Ketoacids follow the same catabolic pathways as
classical amino acids. No specific study on ketoacid excretion has been performed to date.

DRUG INTERACTION STUDIES:

Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium
levels. Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolines such as
ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be
taken at the same time to avoid disturbed absorption of the active substances. An interval of at least two
hours should elapse between the ingestion of these drugs. The susceptibility to cardioactive glycosides,
and hence the risk for arrhythmia will increase, if produces elevated serum calcium levels.
Uraemic symptoms improve under therapy, Thus, in case of aluminium hydroxide administration, the dose
of this drug has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease.

INDICATION AND USAGE:

Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney
disease in connection with a limited dietary protein intake of 40 g/day or less (adult). Usually this applies to
patients whose glomerular filtration rate (GFR) is less than 25 mL/min.

DOSAGE AND ADMINISTRATION:

If not otherwise prescribed the dose for adults (70 kg body weight) is 4 to 8 tablets three times daily during
meals. The tablets must not be chewed. Ingestion during meals facilitates proper absorption and the
metabolisation into the corresponding amino acids. There is no experience in children.

METHOD OF ADMINISTRATION:
For oral use:
Tablets are 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 (adult

CONTRAINDICATIONS:
l Hypersensitivity to the active substances or to any of the excipients.
l Hypercalcaemia.
l Disturbed amino acid metabolism.

WARNINGS & PRECAUTIONS:

The serum calcium level should be monitored regularly. Ensure sufficient calorie intake. No experience has
been gained so far with the administration in paediatric patients. In the presence of hereditary
phenylketonuria, attention should be given to the fact that contains phenylalanine. Monitoring of the
serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide

DRUG INTERACTIONS:
Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium
levels. Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolones such as
ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be
taken at the same time to avoid disturbed absorption of the active substances. An interval of at least two FOR FURTHER INFORMATION PLEASE CONTACT:
hours should elapse between the ingestion of these drugs
The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase if produces
elevated serum calcium levels. Uraemic symptoms improve under therapy. Thus, in case of aluminium Manufactured by :
hydroxide administration, the dose of this drug has to be reduced if necessary. Serum phosphate levels CCL Pharmaceuticals (Pvt.) Ltd. 2801-A
should be monitored for a decrease. 62 Industrial Estate, Kot Lakhpat, Lahore, Pakistan. 25182-0003-002-0000-0000