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Ketosteril (ketoanalogue, essential amino acids)

Ketostreril is the brand name for a drug that contains amino acids and ketoanalogues. It is intended for use with a protein-restricted diet.

ketosteril

Uses

What is Ketosteril used for?

It treats patients with chronic kidney disease (CKD), especially stages II, III, and IV.

How should I take Ketosteril?

Read the directions on the packaging for complete information. Check the label and expiration date.

Swallow each tablet whole without crushing or chewing it. Take it with meals.

How do I store Ketosteril?

This product is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store it in the bathroom or the freezer. 

There may be different brands of this drug that may have different storage needs. So, it is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush this product down the toilet or pour them into a drain unless instructed to do so. Additionally, it is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & Warnings

What should I know before using Ketosteril?

Before using this drug, tell your doctor if you are/have:

  • Pregnant or breastfeeding.
  • Taking any other medicines. This includes any prescription, OTC, and herbal remedies.
  • An allergy to any of the ingredients of this product.
  • Any other illnesses, disorders, or medical conditions, especially:
    • Phenylketonuria
    • Hypercalcemia

Is it safe during pregnancy or breastfeeding?

Unfortunately, there isn’t enough information about the safety of using this drug during pregnancy and breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking any medication.

Side Effects

What side effects can occur from Ketosteril?

Like all drugs, this product may have side effects. If they occur, side effects are generally mild and resolve once treatment is finished or the dose is lowered. Some reported side effects include:

  • Allergic reaction
  • Constipation
  • Nausea
  • Headache
  • Muscle weakness

However, not everyone experiences these side effects. In addition, some people may experience other side effects. So, if you have any concerns about a side effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Ketosteril?

This medication may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. 

To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. 

Drugs with known interactions:

  • Calcium supplements
  • Calcium-containing drugs
  • Vitamin D
  • Fluoride
  • Iron supplements
  • Tetracyclines
  • Quinolones
  • Cardiac glycosides

If you experience an adverse drug interaction, stop taking this drug and continue taking your other medication. Inform your doctor immediately to reevaluate your treatment plan. Approaches include dose adjustment, drug substitution, or ending therapy.

Does food or alcohol interact with Ketosteril?

This drug may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Ketosteril?

This drug may interact with underlying conditions. This interaction may worsen your health condition or alter the way the drug works. Therefore, it is important to always let your doctor and pharmacist know all the health conditions you currently have, especially:

Dosage

The information provided is not a substitute for any medical advice. Therefore, you should always consult with your doctor or pharmacist before using any medication.

What is the dose for an adult?

The normal dose for the average adult (weighing 70kg) is 4 to 8 tablets given three times a day, if their GFR falls below 25 mL/min.

Because this medication contains amino acids, doses are calculated based on body weight, renal function, and the amount of protein obtained through the diet. Your doctor will be able to establish the correct dose and regimen for you. 

What is the dose for a child?

There is no established pediatric dose. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Ketosteril available?

Ketosteril is available in the following dosage forms and strengths:

  • Ketosteril film-coated tablets: 600 mg 

Each tablet contains:

Calcium 3-methyl-2-oxovaleric acid (a-ketoanalogue of isoleucine, Ca-salt) 67 mg

Calcium-methyl-2-oxovaleric acid (a-ketoanalogue of leucine, Ca-salt) 101 mg

Calcium-2-oxo-3-phenylpropionic acid (a-ketoanalogue of phenylalanine, Ca-salt) 86 mg

Calcium-3-methyl-2-oxobutyric acid (a-ketoanalogue of valine, Ca-salt) 68 mg

Calcium-DL-2-hydroxy-4-(methylthio)-butyric acid (a-hydroxyanalogue ofmethionine) 59mg, Ca-salt 105 mg

L-lysine acetate (= L-lysine 75 mg) 53 mg

L-threonine 23 mg

L-tryptophan 38 mg

L-histidine 30 mg

L-tyrosine

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to the nearest emergency room.

What should I do if I miss a dose?

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

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Disclaimer

Hello Health Group does not provide medical advice, diagnosis or treatment.

Ketosteril https://www.mims.com/philippines/drug/info/ketosteril Accessed June 22, 2021

Ketosteril® https://www.fresenius-kabi.com/in/products/ketosteril Accessed June 22, 2021

Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet https://clinicaltrials.gov/ct2/show/NCT02649205 Accessed June 22, 2021

Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients (CKD) https://clinicaltrials.gov/ct2/show/NCT03077048 Accessed June 22, 2021

Ketosteril (SG). Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Accessed June 22, 2021. http://online.lexi.com

Current Version

06/22/2021

Written by Stephanie Nera, RPh, PharmD

Updated by: Stephanie Nera, RPh, PharmD


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