Ketosteril Ketoanalogues and Amino Acids Tablets 100s

Ketosteril Tablets 100s is a prescription renal nutrition medicine containing ketoanalogues, a hydroxyanalogue and essential amino acids in calcium-salt form.

Ketosteril is used as part of the conservative nutritional management of selected adults with chronic kidney disease who are following a medically supervised protein-restricted diet. It supplies essential amino-acid precursors while limiting additional nitrogen intake.

Ketosteril must be used under the supervision of a doctor, nephrologist, pharmacist or renal dietitian. It should not be used as an unrestricted nutritional supplement or as a replacement for an appropriately planned renal diet.

Ketosteril Tablets 100s Product Information

Composition of Each Ketosteril Tablet

What Is Ketosteril Used For?

Ketosteril is used for nutritional therapy in selected patients with chronic kidney disease. Its approved product information describes its use for preventing and treating complications associated with impaired or deficient protein metabolism while dietary protein intake is restricted.

This treatment approach generally applies to adults with significantly reduced kidney function, including patients whose glomerular filtration rate is below 25mL/min, when dietary protein intake has been restricted to approximately 40g per day or less under professional supervision.

The exact protein allowance must be determined by a nephrologist or renal dietitian. Patients should not independently restrict dietary protein because an inadequately planned diet may cause malnutrition, muscle loss or insufficient calorie intake.

How Ketosteril Works

Ketosteril provides selected essential amino acids together with their nitrogen-free ketoanalogues or hydroxyanalogues.

After absorption, the ketoanalogues can be converted into their corresponding amino acids by incorporating nitrogen from other amino groups in the body. This allows essential amino-acid requirements to be supported while limiting additional dietary nitrogen intake.

This mechanism is intended to complement a professionally planned low-protein or very-low-protein diet. Ketosteril is not effective as a substitute for dietary management and should not be used with an unrestricted high-protein diet unless specifically instructed by the treating healthcare professional.

How to Take Ketosteril

• Take Ketosteril exactly as prescribed by the treating doctor or nephrologist.
• Take the tablets during meals to support proper absorption and conversion into the corresponding amino acids.
• Swallow the tablets whole with water.
• Do not chew or crush the tablets.
• Follow the protein and calorie intake prescribed by the renal dietitian or treating doctor.
• Do not increase, reduce or discontinue treatment without professional advice.
• Attend all scheduled blood tests and nutritional assessments.

The reference product information describes a weight-related adult dosage equivalent to approximately one tablet per 5kg of body weight per day. For an adult weighing approximately 70kg, the referenced dosage is four to eight tablets three times daily during meals.

This reference information must not be used for self-dosing. The prescribed quantity depends on body weight, kidney function, nutritional status, dietary protein intake, calcium levels and the patient’s complete treatment plan.

Dietary Supervision Is Essential

Ketosteril should be used together with a protein-restricted diet planned by an appropriately qualified healthcare professional.

The treatment plan should provide enough calories to avoid the body breaking down its own muscle and protein stores. Patients may require ongoing assessment of:

• Daily protein intake
• Total calorie intake
• Body weight and muscle mass
• Appetite and food intake
• Serum albumin and other nutritional markers
• Kidney function
• Calcium and phosphate levels

Do not begin a severe protein restriction without advice from a nephrologist or renal dietitian.

Monitoring During Treatment

A healthcare professional may monitor:

• Serum calcium levels
• Serum phosphate levels
• Kidney function and glomerular filtration rate
• Urea and other renal biochemical markers
• Nutritional status
• Body weight and muscle condition
• Dietary protein and calorie intake
• Concurrent calcium and vitamin D intake

Regular serum-calcium monitoring is particularly important because every Ketosteril tablet contains calcium and treatment may cause or worsen hypercalcaemia.

Who Should Not Take Ketosteril?

Ketosteril should not be used in patients with:

• Allergy to an active component or another ingredient in the tablet
• Hypercalcaemia or abnormally high blood-calcium levels
• A disorder affecting amino-acid metabolism

Patients with hereditary phenylketonuria must tell their doctor because Ketosteril contains a phenylalanine component.

Hypercalcaemia Warning

Ketosteril contains calcium and may increase blood-calcium levels. Hypercalcaemia may be more likely when Ketosteril is combined with calcium-containing medicines, high-dose calcium products or certain vitamin D treatments.

Possible symptoms of high calcium may include:

• Nausea or vomiting
• Constipation
• Abdominal discomfort
• Excessive thirst
• Frequent urination
• Muscle weakness
• Unusual tiredness
• Confusion
• Irregular heartbeat

Some patients may have no noticeable symptoms. Regular blood tests are therefore required even when the patient feels well.

If hypercalcaemia develops, the treating doctor may review vitamin D intake, other calcium sources and the prescribed Ketosteril dose.

Possible Side Effects

Not everyone experiences side effects. The principal adverse effect identified in the referenced product information is hypercalcaemia.

Contact a doctor or pharmacist if symptoms of high calcium occur or if another persistent or unexpected reaction develops.

Seek urgent medical attention for swelling of the face, lips, tongue or throat, difficulty breathing, a severe skin reaction or another sign of a serious allergic response.

Medicine and Supplement Interactions

Tell the doctor and pharmacist about all prescription medicines, non-prescription products, vitamins, minerals, traditional medicines and supplements being used.

Products requiring particular consideration include:

• Calcium-containing medicines and supplements: combined use may cause or worsen hypercalcaemia.
• Vitamin D products: these may contribute to elevated calcium levels and may require dosage review.
• Tetracycline antibiotics: calcium may reduce their absorption.
• Quinolone antibiotics: medicines such as ciprofloxacin and norfloxacin may form poorly absorbed compounds with calcium.
• Iron preparations: absorption may be reduced when taken at the same time.
• Fluoride preparations: simultaneous administration may affect absorption.
• Estramustine: calcium may interfere with absorption.
• Cardiac glycosides: elevated calcium may increase sensitivity and the risk of abnormal heart rhythms.
• Aluminium hydroxide: the dosage may require review as uraemic symptoms improve, and serum phosphate should be monitored.

The referenced product information recommends an interval of at least two hours between Ketosteril and medicines that form poorly soluble compounds with calcium, including certain antibiotics, iron, fluoride and estramustine.

Patients should follow the exact timing instructions given by their doctor or pharmacist.

Pregnancy and Breastfeeding

There are limited clinical data regarding Ketosteril use during pregnancy and breastfeeding.

Patients who are pregnant, planning a pregnancy or breastfeeding should consult their doctor before treatment. The expected nutritional benefit and potential risks should be individually assessed.

Use in Children

The referenced product information states that adequate experience in paediatric patients is unavailable.

Ketosteril should not be supplied to a child unless specifically prescribed and monitored by an appropriate paediatric kidney specialist.

Storage Instructions

• Store below 25°C unless the Malaysian packaging states otherwise.
• Keep the tablets in their original packaging.
• Keep the blister packaging tightly closed and protect the tablets from moisture.
• Keep out of reach of children.
• Do not use tablets that appear damaged, wet or deteriorated.
• Do not use after the expiry date printed on the supplied packaging.
• Product appearance, packaging, batch number and expiry date may vary between supplied batches.

Frequently Asked Questions

What is Ketosteril?

Ketosteril is a prescription renal nutrition medicine containing ketoanalogues, a hydroxyanalogue and essential amino acids. It is used together with a medically supervised protein-restricted diet in selected adults with chronic kidney disease.

Is Ketosteril a vitamin or ordinary nutritional supplement?

No. Ketosteril is registered in Malaysia as a Prescription-Full medicine. It should only be used according to a doctor’s prescription and a professionally planned renal nutrition programme.

What is Ketosteril used for?

Ketosteril is used for nutritional therapy in selected chronic kidney disease patients whose dietary protein intake has been medically restricted. Its purpose is to supply essential amino-acid precursors while limiting additional nitrogen intake.

Can Ketosteril cure chronic kidney disease?

No. Ketosteril does not cure chronic kidney disease. It forms part of a broader conservative treatment plan that may include dietary management, blood-pressure control, diabetes treatment and other kidney-protective measures.

Can Ketosteril replace dialysis?

No. Ketosteril is used in selected patients as part of pre-dialysis conservative management. It must not be used to replace dialysis when dialysis is medically required.

Can Ketosteril be taken without a low-protein diet?

Ketosteril is intended to complement a medically supervised protein-restricted diet. Using it without the prescribed dietary programme may not provide the intended nutritional strategy.

Should a patient reduce protein intake independently?

No. Excessive or poorly planned protein restriction can result in malnutrition and muscle loss. The appropriate protein and calorie intake should be determined by a nephrologist or renal dietitian.

When should Ketosteril be taken?

Ketosteril should generally be taken during meals to support absorption and conversion into the corresponding amino acids. Follow the dosage and timing printed on the dispensing label.

Can Ketosteril tablets be crushed or chewed?

No. The referenced product information states that the tablets should be swallowed whole and must not be chewed.

Does Ketosteril contain calcium?

Yes. Each tablet contains approximately 50mg of calcium. Regular serum-calcium monitoring may therefore be required.

Can Ketosteril cause high calcium?

Yes. Hypercalcaemia is a recognised adverse effect. The risk may increase when Ketosteril is combined with calcium-containing products or certain vitamin D treatments.

Can Ketosteril be taken with antibiotics?

Calcium in Ketosteril may reduce the absorption of tetracycline and quinolone antibiotics. The referenced product information recommends separating these medicines from Ketosteril by at least two hours, unless a healthcare professional provides different instructions.

Does Ketosteril contain phenylalanine?

Yes. Patients with hereditary phenylketonuria must inform their doctor because Ketosteril contains a phenylalanine ketoanalogue.

Is Ketosteril a prescription medicine in Malaysia?

Yes. Ketosteril is registered as a Prescription-Full medicine under Malaysian registration number MAL15045140ARSZ.

Who manufactures Ketosteril?

The Malaysian registration record lists Fresenius Kabi Malaysia Sdn. Bhd. as the product registration holder and Labesfal Laboratorios Almiro S.A., Portugal, as the manufacturer.

How many tablets are supplied in one pack?

The P-Hub listing contains 100 film-coated tablets.

Can pharmacies request Ketosteril through P-Hub?

Ketosteril Tablets 100s is listed in the P-Hub B2B catalogue for approved pharmacy members. Quotation, ordering eligibility and supply are subject to P-Hub membership requirements, prescription medicine controls and current product availability.

Prescription Medicine Notice

Ketosteril is a prescription medicine in Malaysia. It should only be supplied, dispensed and used according to applicable Malaysian requirements and the instructions of a registered doctor, pharmacist or nephrology healthcare team.

The information on this page is provided for pharmacy catalogue and professional product-reference purposes. It does not replace a kidney assessment, renal nutrition plan, prescription, approved Malaysian package insert or advice from a qualified healthcare professional.

Product appearance, packaging, batch number, availability and expiry date may vary. Verify all information on the physical product packaging and approved insert before dispensing or use.

Product Information Sources

• Fresenius Kabi – Ketosteril Product Information
  
• National Pharmaceutical Regulatory Agency Malaysia – Ketosteril Registration Renewal
  
• Ketosteril Summary of Product Characteristics
  

Product information last reviewed: 11 July 2026.