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Brand Name :
Axona
Synonyms :
caprylidene
Class :
Medical food
Dosage forms and strengths
Powder for Reconstitution (Oral)
Axona- 40grams
Initial dosing involves the administration of 10 grams one time a day over a period of two days
To gradually increase the dosage, it is recommended to administer the drug in 10 grams increments every 2 days until a total of 40 grams is reached, to be taken one time daily on seventh day
It is important to consider a slower titration rate if the patient encounters any adverse events
a maintenance dosage of 40 grams one time a day is recommended to sustain therapeutic efficacy
Safety and efficacy are not well established
Refer adult dosing
Actions and Spectrum:
Action:
The primary action of caprylidine is its ability to disrupt the integrity of microbial cell membranes. It achieves this by interacting with the lipid bilayer structure of the cell membrane, leading to membrane destabilization and subsequent cell death. This mechanism of action is particularly effective against a wide array of microorganisms, including bacteria, fungi, and certain viruses.
Spectrum:
It is important to note that the spectrum of activity of caprylidine may vary depending on the specific microorganism and its susceptibility. In some cases, the compound may exhibit broad-spectrum activity, while in others, its effectiveness may be more limited to specific organisms or strains.
Frequency defined
>10%
flatulence (15% to 17%)
abdominal distention (17%)
nausea (10% to 20%)
Diarrhea (10% to 24%)
1% to 10%
rhinitis (4%)
Cough (4%)
dyspepsia (9%)
Abdominal pain (10%)
pain (4%)
fatigue (4%)
headache (6%)
Dizziness (7%)
Hypertension (5%)
<1%
increased uric acid
increased serum triglycerides
increased serum creatinine
increased blood urea nitrogen
GI inflammation (exacerbation)
Abdominal distress
Black Box Warning:
Serious Cardiac Adverse Reactions: These undesirable outcomes have the potential to induce life-threatening circumstances, including ventricular tachycardia. The extension of the QT interval has the potential to give rise to a potentially lethal arrhythmia.
Refraining from the concurrent administration of caprylidine with medications which are known to prolong the QT interval or that are linked to an elevated risk of arrhythmias is advised.
Contraindication/Caution:
Hypersensitivity: caprylidene should not be administered to individuals with a known hypersensitivity or allergy to the drug or any of its components. Hypersensitivity reactions may manifest as skin rashes, itching, swelling, or severe systemic reactions, including anaphylaxis.
Severe Liver Dysfunction: caprylidene is contraindicated in patients with severe liver dysfunction. Since caprylidene undergoes hepatic metabolism, severe impairment of liver function may result in altered drug metabolism and potential accumulation of the drug or its metabolites, leading to adverse effects.
Renal Impairment: caprylidene should be used with caution in patients with renal impairment. Limited information is available regarding the pharmacokinetics and safety of caprylidene in this patient population. Adjustments in the dosage regimen may be necessary, depending on the degree of renal impairment. Regular monitoring of renal function parameters is advised during caprylidene therapy.
Pregnancy and Lactation: The use of caprylidene during pregnancy or lactation is not recommended. Adequate and well-controlled studies to establish the safety profile of caprylidene in pregnant and lactating women have not been conducted. Animal studies have shown adverse effects on fetal development and postnatal growth. Therefore, caprylidene should only be administered to pregnant or lactating individuals if the potential benefits outweigh the potential risks.
Pediatric Population: Safety and efficacy of caprylidene in pediatric patients have not been established. Therefore, caprylidene should not be used in individuals below a certain age (to be determined based on clinical studies) until further evidence becomes available.
Geriatric Patients: Caution is advised when administering caprylidene to elderly patients. Age-related changes in hepatic and renal function may necessitate dose adjustments. Regular monitoring of liver and renal function parameters is recommended in this population.
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
<b>Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
caprylidene is a novel pharmaceutical compound with significant potential for therapeutic applications.
Pharmacodynamics:
caprylidene exerts its pharmacological effects through a multifaceted mechanism of action. It primarily acts as a metabolic enhancer by promoting mitochondrial function and energy production within cells. It enhances oxidative metabolism by facilitating the entry of fatty acids into the mitochondria, thereby augmenting adenosine triphosphate (ATP) synthesis. The increased ATP availability contributes to improved cellular energy status, which may have implications for various physiological processes.
Pharmacokinetics:
Absorption
Following oral administration, caprylidene is absorbed from the gastrointestinal tract. The absorption process is primarily passive and occurs predominantly in the small intestine due to its lipophilic nature. The compound undergoes rapid and efficient absorption due to its favorable physicochemical properties, including its low molecular weight and high lipid solubility.
Distribution
Once absorbed, caprylidene is distributed throughout the body via systemic circulation. The compound exhibits a moderate volume of distribution, indicating that it can distribute into various tissues and organs. caprylidene has been shown to readily cross the blood-brain barrier, allowing it to exert its pharmacological effects within the central nervous system.
Metabolism
caprylidene is extensively metabolized in the body through enzymatic processes. The primary metabolic pathway involves oxidation of the capryl side chain, leading to the formation of metabolites that are subsequently conjugated with endogenous compounds. The major enzymes involved in caprylidene metabolism are cytochrome P450 enzymes, particularly CYP2C9 and CYP2C19.
Excretion and Elimination
Following metabolism, caprylidene and its metabolites are eliminated from the body via various routes. The primary route of excretion is renal, with the majority of the compound and its metabolites being eliminated in the urine. Additionally, a portion of caprylidene and its metabolites may undergo biliary excretion and be eliminated in the feces. The elimination half-life of caprylidene and its metabolites is relatively short, indicating rapid clearance from the systemic circulation.
Administration:
This drug is primarily administered through oral routes to facilitate its systemic absorption and distribution throughout the body.
Prior to administration, it is essential to carefully review the product labeling and prescribing information provided by the manufacturer.
Patient information leaflet
Generic Name: caprylidene
Why do we use caprylidene?
Lipid Metabolism Disorders: caprylidene has demonstrated efficacy in the treatment of lipid metabolism disorders, such as hypertriglyceridemia. Through its mechanism of action, caprylidene promotes the breakdown and clearance of triglycerides, leading to a reduction in circulating triglyceride levels. This makes it a promising therapeutic option for patients with elevated triglyceride levels.
Neurological Disorders: Emerging research suggests that caprylidene holds promise in the management of neurological disorders. Studies have indicated its potential neuroprotective properties, particularly in conditions like Alzheimer’s disease and other forms of cognitive impairment. caprylidene may exert its effects by supporting mitochondrial function and enhancing energy metabolism in the brain.
Gut Health: caprylidene has shown beneficial effects on gut health and gastrointestinal disorders. It can act as a substrate for the production of ketone bodies, providing an alternative energy source for intestinal cells. This may contribute to the maintenance of gut integrity and assist in the management of conditions like irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).
Sports Performance and Endurance: In the realm of sports performance, caprylidene has gained attention as a potential ergogenic aid. Its ability to serve as an efficient energy source makes it an attractive supplement for athletes seeking to optimize their endurance and performance. By facilitating the production of ketone bodies, caprylidene may offer an alternative fuel for muscles during prolonged exercise.
Weight Management: caprylidene has been explored as a supportive agent in weight management programs. Its ability to promote fat oxidation and suppress appetite makes it a potential adjunct to dietary interventions and lifestyle modifications for individuals aiming to achieve weight loss goals. However, further research is needed to establish its long-term efficacy and safety in this context.