Ketosteril

🌿 Chronic Kidney Disease (CKD) Management
Indicated for the dietary management of patients with chronic kidney disease, particularly in combination with a low-protein diet, to reduce the accumulation of nitrogenous waste and support metabolic balance.
Useful in:
📌 Stages 3–5 CKD (non-dialysis)
📌 Patients on protein-restricted diets
📌 Early intervention to slow CKD progression

🌿 Prevention & Management of Protein-Energy Malnutrition
Supplies essential amino acids and ketoanalogues to maintain a positive nitrogen balance and prevent muscle wasting without increasing uremic toxins.
Useful in:
📌 Malnourished or at-risk CKD patients
📌 Elderly with renal impairment
📌 Individuals with reduced dietary protein intake

🌿 Delay of Dialysis Initiation
In conjunction with a restricted-protein diet, Ketosteril may help delay the progression to end-stage renal disease and the need for dialysis.
Useful in:
📌 Non-dialysis CKD patients
📌 Conservative management of CKD under medical supervision

🌿 Correction of Amino Acid Imbalance & Metabolic Disturbances
Improves amino acid profile and helps manage metabolic complications in renal impairment without contributing to nitrogen burden.
Useful in:
📌 Patients with altered protein metabolism
📌 Uremic symptoms with dietary protein restriction
📌 Long-term nutritional support in CKD

🧪 Composition of One Film-Coated Ketosteril Tablet

Ketoanalogues (Calcium Salts)

• Calcium 3-methyl-2-oxovaleric acid (α-ketoanalogue of isoleucine): 67 mg
• Calcium 4-methyl-2-oxovaleric acid (α-ketoanalogue of leucine): 101 mg
• Calcium 2-oxo-3-phenylpropionic acid (α-ketoanalogue of phenylalanine): 86 mg
• Calcium 3-methyl-2-oxobutyric acid (α-ketoanalogue of valine): 68 mg
• Calcium DL-2-hydroxy-4-(methylthio)-butyric acid (α-hydroxyanalogue of methionine): 59 mg​

Essential Amino Acids

• L-lysine acetate (equivalent to 75 mg L-lysine): 105 mg
• L-threonine: 53 mg
• L-tryptophan: 23 mg
• L-histidine: 38 mg
• L-tyrosine: 30 mg​

Additional Components

• Total nitrogen content per tablet: 36 mg
• Calcium content per tablet: 50 mg (1.25 mmol)

🌿 Standard Adult Dosage
Dosage: 1 tablet per 5 kg of body weight per day.
Typical adult dose: 6–8 tablets three times daily.
📌 Example: For a 60 kg patient → 12 tablets/day (e.g., 4 tablets per meal)

(Ketosteril is not approved for use in children and adolescents under 18 years of age due to a lack of sufficient safety and efficacy data in this population. The manufacturer explicitly states that there is no clinical experience with its use in pediatric patients.)

🌿 Method of Administration
📌 Oral use only.
📌 Tablets should be swallowed whole with meals to optimize absorption and conversion of ketoanalogues into amino acids.
📌 Do not crush or chew the tablets.

🌿 Duration of Therapy
📌 Long-term use under medical supervision is recommended, particularly in CKD stages 3–5.
📌 To be used in conjunction with a low-protein diet (typically 0.6 g/kg/day or as directed).

Ketosteril contains ketoanalogues of essential amino acids, which are converted in the body into amino acids without producing nitrogenous waste. This helps reduce the uremic toxin load in patients with chronic kidney disease (CKD).

The ketoanalogues use nitrogen already present in the body, helping maintain protein nutrition while minimizing strain on the kidneys. Some are in calcium salt form, which also supports bone health in CKD.

• Pregnancy: Not FDA-classified. Use only if clearly needed and under strict medical supervision. Limited data in humans; animal studies show no harm.
• Lactation: Unknown if excreted in breast milk. Use with caution; monitor mother and infant closely.

Renal-specific amino acid & ketoanalogue supplement used in chronic kidney disease to support low-protein diets.

Should not be used in the following situations:

• Hypercalcemia (high blood calcium levels) – because the formulation contains calcium salts, which can worsen this condition.
• Disorders of amino acid metabolism, such as inherited metabolic conditions where the body can't properly process amino acids.
• Known allergy or hypersensitivity to any of the ingredients in Ketosteril.
• Children and adolescents under 18 years – it's not approved for use in this age group due to insufficient safety data.
• Severe liver disease – use is not recommended unless under close medical supervision.

• Hypercalcemia (most common)
• Mild GI symptoms (nausea, bloating)
• Allergic reactions (rare)
• Possible electrolyte imbalance if not monitored

• Calcium-containing drugs: May increase risk of hypercalcemia.
• Aluminum phosphate binders: May increase aluminum absorption.
• Antibiotics (tetracyclines, quinolones): Calcium may reduce absorption.
• Iron supplements: Separate dosing by 2 hours.

• Store at room temperature (15°C to 25°C).
• Keep in a dry place, away from moisture and heat.
• Keep out of reach of children.
• Do not use after the expiration date on the packaging.