For the use of a Registered Medical Practitioner, Hospital or Laboratory only.
1. Description
Awaytox 45 is a synbiotic combination of Pre & Probiotics: Lactobacillus acidophilus, Streptococcus thermophilus, Bifidobacterium longum and Fructooligosaccharide. It is used as an adjunct in chronic kidney disease to help reduce gut-derived uraemic toxins.¹⁻⁵
2. Composition
Each cellulose capsule contains:
- Streptococcus thermophilus – 15 billion spores
- Lactobacillus acidophilus – 15 billion spores
- Bifidobacterium longum – 15 billion spores
- Fructo-oligosaccharides – 100 mg
- Excipients – q.s.
Colour: approved colour used in empty vegetarian cellulose capsule shell. Appropriate overages added to compensate loss on storage.
3. Dosage Form
Capsule (vegetarian cellulose capsule)
4. Pharmacology
Pharmacodynamics
Awaytox 45 acts primarily within the gastrointestinal tract.
Mechanism of Action
The probiotic strains (Bifidobacterium longum, Lactobacillus acidophilus, and Streptococcus thermophilus) colonise the intestine and help restore a healthy gut microbial balance.
These beneficial bacteria suppress the growth of pathogenic microorganisms by competing for nutrients and attachment sites and by producing antimicrobial substances such as lactic acid.
The probiotics ferment dietary carbohydrates and FOS, producing short-chain fatty acids such as acetate, and lactic acid. These metabolites:
Lower intestinal pH.
Improve intestinal barrier integrity.
Reduce gut inflammation.
In CKD, probiotics reduce intestinal production of uraemic toxins by decreasing the activity of proteolytic bacteria that generate compounds such as:
Indoxyl sulfate
p-Cresyl sulfate
Ammonia
FOS selectively stimulates the growth and activity of beneficial bacteria, enhancing the effectiveness of the probiotic strains.
Collectively, these actions help reduce the intestinal toxin burden and may improve gastrointestinal health in CKD patients.
Pharmacokinetics
Classical pharmacokinetic parameters are not fully applicable because Awaytox contains live microorganisms rather than conventional drug molecules.
Absorption
The probiotic bacteria are not systemically absorbed.
They survive passage through the stomach and small intestine and reach the colon, where they exert their effects locally.
FOS is not digested or absorbed in the upper gastrointestinal tract.
Distribution
The probiotics remain within the gastrointestinal lumen and transiently colonise the intestine.
There is no clinically significant systemic distribution.
Metabolism
FOS is fermented by probiotic bacteria into short-chain fatty acids such as acetate, and lactic acid, with small amounts of other organic acids.
The probiotic bacteria metabolise dietary substrates and contribute to reduced production of gut-derived nitrogenous and uraemic toxins.
Elimination
Probiotic organisms are gradually eliminated in the faeces.
FOS that is not fermented is excreted unchanged in the faeces.
Continued administration is generally required to maintain the beneficial microbial population.
5. Indications
As an adjunct in chronic kidney disease (CKD), including patients on dialysis, to help reduce gut-derived uraemic toxins.¹⁻⁵
6. Contraindications
Awaytox 45 is contraindicated in patients with:
Known hypersensitivity or allergy to any of the probiotic strains, fructo-oligosaccharides (FOS), or any excipients in the formulation.
Patients with severe immunocompromised states (e.g., profound neutropenia, advanced immunodeficiency) unless prescribed and closely monitored by a physician, as rare cases of probiotic-associated infections have been reported.
Patients with central venous catheters or critical illness should use probiotics only under medical supervision.
7. Precautions
Use under medical supervision in immunocompromised, critically ill, or hospitalised patients.
Caution is advised in patients with severe acute pancreatitis.
Temporary gastrointestinal symptoms such as bloating, flatulence, or abdominal discomfort may occur, particularly during the initial days of therapy.
Maintain adequate hydration during treatment.
If persistent diarrhoea, fever, or signs of systemic infection occur, discontinue use and seek medical evaluation.
To minimise loss of probiotic viability, administer the capsule at least 2–3 hours apart from antibiotics, unless otherwise directed by the physician.
Store the product as recommended by the manufacturer to maintain probiotic potency.
8. Drug Interactions
- Antibiotics may reduce the viability of the probiotic organisms; administer Awaytox 45 at least 2–3 hours apart from antibiotics.
- Immunosuppressants: use under medical supervision.
- No other clinically significant drug interactions are known.
9. Adverse Effects
Awaytox 45 is generally well tolerated. Mild, transient flatulence, bloating, abdominal discomfort or change in stool consistency may occur during the initial days of therapy. Hypersensitivity reactions are rare. Isolated cases of probiotic-associated infection have been reported in severely immunocompromised patients.
10. Dosage & Administration
The dose and duration of Awaytox 45 should be followed as advised by the healthcare professional.
Capsules should be swallowed whole and not opened, chewed or crushed.
11. Overdosage
No specific cases of overdose have been reported with Awaytox 45.
Excessive intake may increase the likelihood of mild gastrointestinal effects such as bloating, flatulence, abdominal discomfort, or diarrhoea due to fermentation of FOS.
Treatment is symptomatic and supportive.
If a large overdose is ingested or significant symptoms develop, medical advice should be sought.
12. Storage
- Store in a dry place at a temperature not exceeding 30°C. Protect from light.
- Keep the container tightly closed. Replace the cap tightly after every use to avoid capsule degradation.
- Keep the medicine out of reach of children.
Additional Information
Key Benefits
- Probiotics in Awaytox 45 are live micro-organisms that confer good health to human beings when consumed in adequate quantities and also prevent the colonisation of pathogenic bacteria
- Fructo-oligosaccharide in Awaytox 45 acts as a prebiotic that supports the growth of beneficial gut bacteria
Safety Information
- Read the label carefully before use
- Do not exceed the recommended dosage
- Keep it away from the reach of children
Evidence summary
Evidence summary: In a 6-month randomised, placebo-controlled crossover pilot study in CKD stage 3–4 using the same three strains (S. thermophilus KB19, L. acidophilus KB27, B. longum KB31), blood urea nitrogen fell in 63% of patients.¹ A 2-month trial in haemodialysis patients showed no statistically significant change in uraemic toxins.² A systematic review found limited but supportive evidence that pre- and probiotics lower p-cresyl sulfate and indoxyl sulfate in CKD.³ The prebiotic oligofructose-enriched inulin reduced serum p-cresyl sulfate by about 20% in haemodialysis patients,⁴ and a synbiotic reduced p-cresyl sulfate in predialysis CKD.⁵
13. Presentation
10 capsules in a container, 6 containers in a box.
References
1. Ranganathan N, Ranganathan P, Friedman EA, et al. Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease. Adv Ther. 2010;27(9):634–647. doi:10.1007/s12325-010-0059-9
2. Natarajan R, Pechenyak B, Vyas U, et al. Randomized controlled trial of strain-specific probiotic formulation (Renadyl) in dialysis patients. Biomed Res Int. 2014;2014:568571. doi:10.1155/2014/568571
3. Rossi M, Klein K, Johnson DW, Campbell KL. Pre-, pro-, and synbiotics: do they have a role in reducing uremic toxins? A systematic review and meta-analysis. Int J Nephrol. 2012;2012:673631. doi:10.1155/2012/673631
4. Meijers BK, De Preter V, Verbeke K, Vanrenterghem Y, Evenepoel P. p-Cresyl sulfate serum concentrations in haemodialysis patients are reduced by the prebiotic oligofructose-enriched inulin. Nephrol Dial Transplant. 2010;25(1):219–224. doi:10.1093/ndt/gfp414
5. Rossi M, Johnson DW, Morrison M, et al. Synbiotics Easing Renal Failure by Improving Gut Microbiology (SYNERGY): a randomized trial. Clin J Am Soc Nephrol. 2016;11(2):223–231.