KETAG XT

Description

KETAG XT is part of the conservative treatment of patients with Chronic Kidney Disease.

KETAG XT contains amino acids, partly in form of their corresponding-Ketoanalogues, essential for patients with Chronic Kidney Disease. In combination with a protein-restricted diet KETAG XT is an excellent tool to treat Chronic Kidney Disease in the pre-dialysis period with high pill burden.

It offers double strength of Alpha Ketoanalogues ensures the intake of essential amino acids and prevents deleterious consequences of inadequate dietary protein intake by reducing pill burden hence increasing patient compliance and convenience.

Benefits

• Reduction of uremic symptoms, which are largely due to an accumulation of degradation products of the protein metabolism
• Preservation of the residual renal function and therefore slowing down the rate of progression of the chronic kidney disease and delaying the onset of dialysis
• Preservation of the nutritional status, despite the marked reduction of the daily protein intake
• Improvement of metabolic complications due to renal insufficiency (e.g. proteinuria, disturbances in calcium-phosphate, carbohydrate and lipid metabolism)

Composition

One film coated tablet contains:

• Calcium-3-methyl-2-oxovalerate (α-Ketoanalogue to isoleucine, Calcium salt) 134 mg
• Calcium-4-methyl-2-oxovalerate (α-Ketoanalogue to leucine, Calcium-salt) 202 mg
• Calcium-2-oxo-3-phenylpropionate (α-Ketoanalogue to phenylalanine, Calcium-salt) 136 mg
• Calcium-3-methyl-2-oxobutyrate (α-Ketoanalogue of valine, Calcium-salt) 172 mg
• Calcium-DL-2-hydroxy-4-(methylthio)-butyrate α-hydroxyanalogue to methionine, Calcium salt) 118 mg
• L-lysine Acetate U.S.P (Eq. To L Lysine 150 mg) 210 mg
• L-threonine U.S.P 106 mg
• L-tryptophan U.S.P 46 U.S.P mg
• L-histidine U.S.P 76 mg
• L-tyrosine U.S.P 60 mg

Indications

Prevention & therapy of damages due to CKD till GFR is 15 ml/min, i.e. stages II, III & IV of CKD

Mechanism of Action

On absorption alpha Ketoanalogue get converted to their respective amines by taking up the Nitrogen from non essential amino acids, thus reducing the nitrogenous waste load on the kidneys and fulfilling the nutritional requirement.

Contraindications

Hypercalcaemia, disturbed amino acid metabolism. In case of hereditary phenylketonurie it has to be taken into account that this product contains phenylalanine.

Precautions and Warnings

No experience has been made so far with the application in pregnancy and pediatrics. Ketag XT should be taken along with meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly. An adequate supply of calories should be ensured.

Undesirable effects

Hypercalcemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcaemia persists, reduce the dosage of Kestead XT as well as any other source of calcium.

Drug Interactions

Simultaneous administration of medicinal products that contain calcium (e.g. acetolyte) may trigger, or worsen, a pathological increase in the serum calcium level.

As the uraemic symptoms improve under therapy with Ketag XT tablets, the dose of aluminium hydroxide administered should be reduced, as appropriate. The patient should be monitored for reduced levels of serum phosphate.

In order not to interfere with absorption, an appropriate interval should be observed between administration of Ketag XT tablets and medicinal products which form poorly soluble compounds with calcium (e.g. tetracyclines, quinolones such as ciprofloxacin and norfloxacin, preparations that contain iron, fluoride and estramustin). An interval of at least 2 hours should be observed between the intake of Ketag XT tablets and such preparations. If administration of Ketag XT tablets leads to increased blood levels of calcium, the sensitivity to medicinal products which increase heart action (cardiac glycosides) and thus also the risk of cardiac arrhythmia is increased.

Dosage Form

Oral Tablet

Dosage and Administration

1 Tablet/10 kg body weight/day along with meal, divided in 3 equal dosage

Storage

Do not use Ketag XT after expiry date Keep out of the reach of children Do not store above 25°C Protect from moisture

Presentation

10 tablets packed in a strip, 5 such strips packed in a carton