Ketoalfa 600 mg (Tablet)

Indications

• Prevention & treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease
• Limited dietary protein intake of 40 gm/day or less (adult)
• Patients with glomerular filtration rate (GFR) less than 25 ml/min

Composition

• Calcium-3-methyl-2-oxo-valerate (α-ketoanalogue of isoleucine, calcium-salt)
• L-lysine acetate USP (eqv. to Lysine 75mg)
• L-threonine USP
• L-tryptophan USP
• L-histidine USP as Histidine Hydrochloride Monohydrate
• L-tyrosine USP

Pharmacology

• Contains amino acids, partly in form of corresponding ketoanalogues
• Improves metabolism of protein in the body
• Allows intake of essential amino acids while minimizing amino-nitrogen intake

Dosage & Administration

• Take 4-8 tablets 3 times a day during meals (adults with 70 kg body weight)
• Swallow whole, do not chew
• Food should contain 40 g/day protein or less (adults)
• Ingestion during meals facilitates proper absorption
• Given as long as GFR is between 5 and about 25mL/minute

Interaction

• Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels
• Dose of Ketoalfa may need to be reduced with aluminum hydroxide administration
• Drugs forming hardly soluble compounds with calcium should not be taken at the same time with Ketoalfa acid keto analogue
• Increased susceptibility to cardioactive glycosides
• Monitoring of serum phosphate levels may be needed with concomitant administration of aluminum hydroxide

Contraindications

• Hypersensitivity to the active substances or excipients
• Hypercalcemia
• Disturbed amino acid metabolism

Side Effects

• Hypercalcaemia (Very Rare)
• Intake of vitamin D should be reduced if hypercalcaemia occurs
• Dose of Ketoalfa Acid Keto Analogues and intake of any other calcium sources to be reduced with persisting hypercalcaemia

Pregnancy & Lactation

• No adequate data in pregnant women
• Animal studies do not indicate direct or indirect harmful effects
• Caution should be exercised when prescribing to pregnant women
• No experience with use during lactation

Precautions & Warnings

• Regular monitoring of serum calcium level
• Ensure sufficient calorie intake
• Attention to the fact that Ketoalfa Acid Keto Analogues contains phenylalanine in the presence of hereditary phenylketonuria
• Monitoring of serum phosphate levels with concomitant administration of aluminum hydroxide

Therapeutic Class

• Other genito-urinary preparations

Storage Conditions

• Store at a temperature not exceeding 30°C in a dry place
• Protect from light & moisture

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