Aplazar Alpha Ketoanalogue Tablet, Packaging Size: 1*10 Tablets

Description:

APLAZAR contains all amino acids essential for uremic patients, five out of them are keto or hydroxyanalogue in the form of calcium salts. Therefore it allows reduction in the nitrogen supply and provides calcium. It is a medication for the treatment of chronic kidney disease patients on Conservative management therapy (CKD stage I, II, III). In combination with very low protein diet / low protein diet, it helps in delaying the progression of kidney disease in the Predialysis period.

Composition

One film-coated tablet contains:

Calcium-3-methyl-2-oxovalerate (α-ketoanalogue of isoleucine,Calcium salt)67 mg

Calcium-4-methyl-2-oxovalerate (α-ketoanalogue of leucine,Calcium-salt)101 mg

101 mg Calcium-2-oxo-3-phenylpropionate (α-ketoanalogue of phenylalanine,Calcium-salt) 68 mg

Calcium-3-methyl-2-oxobutyrate (α-ketoanalogue of valine,Calcium-salt) 86 mg

Calcium-DL-2-hydroxy-4-(methylthio)-butyrate α-hydro xyanalogue of methionine,Calcium salt)59mg

L-lysine 75 mg

L-threonine 53 mg

L-tryptophan 23 mg

L-histidine 38 mg

L-tyrosine 30 mg

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 per day (for adults) and less; i.e. generally in patients with a glomerular filtration rate (GFR) below 25 ml/min.

Contraindications:

Hypercalcemia, 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. APLAZAR should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly.

Undesirable effects:

Hypercalcemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcaemia persists, reduce the dosage of APLAZAR 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 uremic symptoms improve under therapy with APLAZAR tablets, the dose of aluminum hydroxide administered should be reduced.

Dosage and Administration:

In general, unless prescribed otherwise, four to eight tablets are swallowed whole three times daily during meals. This dosage applies to adults (70 kg bodyweight) (1 tablet/5 kg body weight/day).

Storage

Do not use APLAZAR after expiry date

Keep out of the reach of children

Do not store above 25°C

Protect from moisture

Presentation:

APLAZAR is available as tablets in a blister of 10 tablets and 10 such blisters in a box