Product image of Ketosteril (L-Lysine Acetate, L-Tryptophan, L-Histidine, L-Threonine, L-Tyrosine, Keto-Isoleucine Calcium, Keto-) supplied by GNH India

Ketosteril

Active Ingredient:
L-Lysine Acetate, L-Tryptophan, L-Histidine, L-Threonine, L-Tyrosine, Keto-Isoleucine Calcium, Keto-
Origin:
EU

Ketosteril (L-Lysine Acetate, L-Tryptophan, L-Histidine, L-Threonine, L-Tyrosine, Keto-Isoleucine Calcium, Keto-)

Ketosteril, the active ingredient in Ketosteril, is an amino acid supplement presented as an oral formulation for oral use. It supports protein metabolism and reduces nitrogen waste in patients with chronic kidney disease, renal failure on protein‑restricted diets, and those receiving dialysis. It is indicated for adult patients with chronic kidney disease stages 3–5, including those undergoing hemodialysis or peritoneal dialysis, to help maintain nutritional balance.

GNH India supplies Ketosteril as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, renal clinics, dialysis units and pharmacies worldwide, ensuring consistent quality and regulatory compliance.

Manufacturer / TM Owner

Fresenius Kabi Norge As

1
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Indications & Clinical Uses

Ketosteril is used in renal nutrition to support protein metabolism and reduce nitrogen accumulation in chronic kidney disease.

  • Chronic kidney disease: helps reduce nitrogen waste and supports protein balance.
  • Renal failure with dietary protein restriction: assists in maintaining nutritional status while limiting protein intake.
  • Dialysis patients: provides essential keto‑analogues to support amino acid balance during hemodialysis or peritoneal dialysis.

How It Works

  • Ketosteril supplies keto‑analogues of essential amino acids that lack an amino group. After oral absorption they are transaminated in peripheral tissues, converting into the corresponding amino acids. This process supplies the necessary building blocks for protein synthesis while limiting nitrogen production, thereby decreasing uremic toxin accumulation and supporting overall protein metabolism in patients with impaired renal function.

Side Effects

Ketosteril may be associated with several adverse reactions, which are categorized by frequency.

Common Side Effects

  • Nausea
  • Vomiting
  • Loss of appetite
  • Abdominal discomfort
  • Mild headache
  • Dizziness

Serious or Rare Side Effects

  • Hyperkalemia
  • Metabolic acidosis
  • Severe allergic reaction (anaphylaxis)
  • Hepatic dysfunction
  • Severe gastrointestinal bleeding
  • Electrolyte disturbances

Precautions & Warnings

When prescribing Ketosteril, clinicians should consider several precautionary measures to ensure patient safety.

  • Renal function monitoring: assess serum creatinine and eGFR regularly.
  • Electrolyte balance monitoring: check potassium and bicarbonate levels.
  • Nutritional status assessment: evaluate protein intake and albumin.
  • Use in pregnancy: only if clearly needed after risk‑benefit analysis.
  • Concomitant high‑protein diet: avoid as it may diminish nitrogen‑sparing effect.
  • Dose adjustment in dialysis: modify dose based on dialysis schedule and clearance.
  • Store at room temperature: keep in original packaging, protect from moisture and light.

Avoid Interactions

Ketosteril can interact with other medicines or dietary components, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • High protein diet: reduces efficacy of nitrogen‑sparing effect.
  • ACE inhibitors: may increase risk of hyperkalemia.
  • Potassium supplements: additive risk of hyperkalemia.
  • Sodium bicarbonate: may alter acid‑base balance when combined.
  • Immunosuppressants: potential unknown interaction affecting metabolism.

Moderate Interactions (Monitor Closely)

  • Diuretics: may cause electrolyte shifts.
  • Phosphate binders: can affect absorption of keto‑analogues.
  • Antacids: may alter gastric pH and drug uptake.
  • Oral iron supplements: may reduce bioavailability of keto‑analogues.
  • Vitamin D analogues: monitor calcium and phosphate levels.

Frequently Asked Questions

Ketosteril is a renal nutrition supplement containing keto‑analogues of essential amino acids. It is prescribed for patients with chronic kidney disease, especially those on low‑protein diets or receiving dialysis, to help maintain protein balance and reduce nitrogen waste. It supports overall nutritional status in renal failure.

The keto‑analogues in Ketosteril are structurally similar to essential amino acids but lack the amino group. After oral administration they are transaminated in the body, converting into the corresponding amino acids. This supplies needed building blocks while limiting nitrogen production, assisting protein metabolism and reducing uremic toxin accumulation in kidney disease.

The dosage of Ketosteril is individualized by the prescribing clinician based on the patient’s renal function, dietary protein allowance, and dialysis schedule. The prescriber determines the appropriate amount and frequency, and adjustments are made according to clinical response and laboratory monitoring. No standard dose can be provided without a medical prescription.

Safety data for Ketosteril in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and this decision must be made by a qualified healthcare professional. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their physician.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity of Ketosteril. GNH India works with hospitals, pharmacies, and procurement teams worldwide, and will request verification of trade or institutional credentials. After confirmation, the sales team provides pricing, availability, shipping details, and any necessary import documentation.

Ketosteril’s unique composition of keto‑analogues distinguishes it from standard amino‑acid supplements, which contain fully formed amino acids. By providing precursors that are converted in the body, Ketosteril reduces nitrogen load more effectively, making it especially suitable for patients on strict protein restriction or undergoing dialysis. Other products may lack this nitrogen‑sparing benefit.

Ketosteril should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the container tightly closed and avoid exposure to high humidity or extreme temperatures. No refrigeration is required for this oral formulation.

Ketosteril is taken orally, usually with meals to improve absorption. The tablets (or powder, depending on the supplied form) are swallowed whole with water. Patients should follow the dosing schedule prescribed by their healthcare provider and should not split or crush tablets unless specifically instructed.

Although generally well tolerated, Ketosteril can cause serious adverse reactions such as hyperkalemia, metabolic acidosis, severe allergic responses including anaphylaxis, and significant hepatic dysfunction. Patients should be monitored regularly for electrolyte disturbances, liver function, and any signs of severe hypersensitivity, and treatment should be discontinued if these events occur.

Ketosteril is contraindicated in patients with known hypersensitivity to any of its components. It should be used with caution, or avoided, in individuals with uncontrolled hyperkalemia, severe liver disease, or those receiving high‑protein diets that negate its nitrogen‑sparing effect. Pregnant or breastfeeding women should only use it under strict medical supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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