503A

Anti-Aging Siro Gel

503A

Anti-Aging Siro Gel

0.001 / 4%

Anti-Aging Siro Gel

$100.00

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Product Overview

This product is available solely through our 503A Compounding Pharmacy, ensuring personalized care and precision in every order. Please note that a valid prescription is required for purchase. If you do not have an account, please contact us.

Anti-Aging Siro Gel (Niacinamide / Sirolimus [Rapamycin]) (30 g)

0.001 / 4%

acid Kojic
Used in cosmetics and food to retain or alter the colors of materials, it is a moderate inhibitor of pigment development in plant and animal tissues.

Niacinamide
Nicotinic acid is an antilipemic in clinical medicine, but nicotinamide (niacinamide) is not useful for this objective. The first hypolipidemic agent proven to reduce overall mortality in MI patients and lower the incidence of secondary myocardial infarction (MI) was nicotinic acid. No additional advantage, however, of combining extended-release niacin with lovastatin or simvastatin on cardiovascular morbidity and mortality over and above that seen for extended-release Monotherapy with niacin, simvastatin, or lovastatin has been shown to be effective. Moreover, the AIMHIGH study showed that simultaneous ingestion of simvastatin and extended-release niacin (1500–2000 mg/day PO) does not lead to a larger decrease. on cardiovascular event incidence than simvastatin only.

Sirolimus
By suppressing the mTOR route, sirolumus or topical rapamycin, a topical antiaging substance, lowers cellular senescence and opens more room for good Encouraging tissue growth and shielding the skin barrier. It expression of the senescence regulator p16INK4A slows symptoms of photoaging. Furthermore used to avoid organ rejection in transplant patients, rapamycin is a drug used to treat some tumors of the immune system, lymphoproliferative disorders, and malignancies. It acts as an immunosuppressant by blocking the mTOR pathway, which is essential for cell development and proliferation. Other indicators include acne vulgaris, psoriasis, rheumatoid arthritis. Structurally it mimics sirolimus, also known as rapamune.

Acidkojic
Kojic acid’s tyrosinase inhibitory action inhibits the melanocyte’s creation of pigment. This gives off a skinlightening impact.

Nicotinamide
Either nicotinic acid or nicotinamide will satisfy nutritional niacin needs; as vitamins, both have the same biochemical processes. Still, as pharmacologic compounds, they vary drastically. The body does not immediately transform nicotinic acid into nicotinamide; nicotinamide is produced only as a result of coenzyme metabolism. Nicotinic acid is added in erythrocytes and other tissues into nicotinamide adenine dinucleotide (NAD), a coenzyme. NAD is used to create a second coenzyme, nicotinamide adenine dinucleotide phosphate (NADP). In cellular metabolic routes, these two coenzymes work in at least 200 distinct redox processes. Hydrolysis in the liver and intestines causes nicotinamide to be released from NAD and transferred to other tissues; these tissues then use nicotinamide to generate more NAD as necessary.

Apart from acting as a vitamin, niacin (nicotinic acid) possesses several doserelated pharmacological traits. Characteristic “niacinflush” results from this action. Histamine and/or prostacyclin release could explain nicotinic acid-induced vasodilatation. Flushing could produce parallel itching, migraines, or agony. Nicotinic acid’s flushing effects seem to be linked to the 3carboxyl radical on its pyridine ring. In contrast to nicotinic acid, nicotinamide (niacinamide) does not seem to cause flushing and lacks a carboxyl radical in the 3 position on the pyridine ring.

Nicotinic acid can be used as an antilipemic agent; however, nicotinamide shows no hypolipidemic action. And raises HDL cholesterol. Although the mechanism of nicotinic acid’s anti-lipemic action is unknown and unrelated to its physiological function as a vitamin, The main effects of nicotinic acid are lowered hepatic production of VLDL. Many processes have been suggested, including inhibition of free fatty acid release from adipose tissue, reduced triglyceride synthesis, more lipoprotein lipase action

Niacinamide (Niacin)

Allergies: People who are allergic to niacin or any ingredient in the product should avoid taking it.

Gender differences: Women may have slightly higher niacin levels in the blood compared to men and may also respond better to its cholesterol-lowering effects.

Older adults: Overall, niacin seems to work the same in older and younger adults. However, some elderly patients may be more sensitive to its side effects.

Liver health: Niacin should not be used in people with serious liver disease. Those who drink a lot of alcohol or have a history of liver or gallbladder problems need close monitoring. Liver function tests (LFTs) should be checked regularly, as niacin can sometimes cause liver damage—especially with long-acting (extended-release) forms. If liver enzymes rise too high or symptoms of liver trouble appear, niacin should be stopped.

Stomach issues: Niacin can trigger stomach acid production, so people with active ulcers should not take it. Even those with a past history of ulcers should be cautious.

Heart and blood pressure: Because niacin widens blood vessels, it may worsen low blood pressure, heart attack, or unstable angina—especially when taken with other blood pressure–lowering drugs.

Gout and uric acid: High doses may increase uric acid, which can trigger gout attacks. Patients with gout should be monitored closely.

Phosphorus levels: Niacin can cause low phosphorus levels, although this is usually temporary. Doctors may check blood tests if you’re at risk.

Muscle risks with statins: Rarely, niacin combined with statins (cholesterol medicines) has caused serious muscle breakdown (rhabdomyolysis). Any unexplained muscle pain or weakness should be reported right away.

Blood sugar: Niacin can raise blood sugar levels, so people with diabetes should be cautious.

Children: Niacin can be used safely in children for vitamin deficiency, but its use for cholesterol problems in kids is limited and should only be done under a specialist’s care.

Pregnancy & breastfeeding: Normal dietary doses are safe in pregnancy, but high-dose niacin is not recommended because of possible risks. For safety, most manufacturers advise avoiding high doses while nursing.

Kidney disease: People with kidney problems should use caution since niacin is cleared by the kidneys.

Blood and clotting: Niacin can slightly reduce platelets and affect clotting. Surgery patients may need blood tests before and during treatment.

Common side effect: Flushing (warmth, redness, itching) is very common with niacin use.

Sirolimus (Rapamycin)

Allergies: People allergic to sirolimus should not take it.

Infections: Since it weakens the immune system, patients with active infections should not start treatment until the infection is controlled.

Pregnancy: Sirolimus is unsafe in pregnancy—it may harm the unborn baby.

Kidney or liver problems: Dose adjustments may be needed since the drug is cleared through these organs.

Cholesterol and diabetes: Sirolimus may raise cholesterol, triglycerides, or blood sugar.

Wound healing: It can slow wound healing, so patients undergoing surgery should be carefully monitored.

Older adults: Seniors may be more sensitive and might need lower doses.

Drug interactions: Sirolimus can interact with many medications, including antifungals, antibiotics, anticonvulsants, and other immunosuppressants. Close monitoring is required if it’s taken with other drugs.

Niacinamide (Niacin / Nicotinic Acid)

  • At normal daily recommended amounts (RDA), niacin is generally safe.

  • Larger doses (over 1 g/day) can cause more side effects, especially with niacin (nicotinic acid) compared to niacinamide.

Common side effects:

  • Flushing: warmth, redness, tingling, or itching of the face, neck, and chest.

  • Dizziness or low blood pressure: especially when standing up suddenly.

  • Headache or migraine.

  • Skin rash or itching.

  • Stomach upset: nausea, diarrhea, bloating, or abdominal pain (usually improves if taken with food).

Less common but important risks:

  • Liver problems: can raise liver enzymes or, rarely, cause liver failure. Regular blood tests are needed.

  • High blood sugar: may worsen diabetes or cause new-onset high blood sugar.

  • Gout: high doses may raise uric acid and trigger gout attacks.

  • Low phosphorus: in people at risk, blood phosphorus should be checked.

  • Bleeding/clotting problems: high doses can lower platelets or affect clotting times.

  • Muscle problems: rare cases of serious muscle damage (rhabdomyolysis), especially when combined with statins.

  • Eye problems: blurred vision or macular edema in rare cases.

  • Other: trouble sleeping, fatigue, skin darkening, or dry skin.

Tips to reduce flushing:

  • Start with a low dose and increase slowly.

  • Take with meals.

  • Avoid alcohol or hot drinks before dosing.

  • Sometimes an aspirin (325 mg) 30 minutes before niacin may help (doctor’s advice needed).


Sirolimus (Rapamycin)

Common side effects:

  • Swelling in legs, ankles, or feet.

  • High blood pressure.

  • Nausea, vomiting, stomach upset.

  • Headache or difficulty sleeping.

Serious side effects (need medical attention):

  • Infections: higher risk because sirolimus suppresses the immune system.

  • Cancer risk: particularly skin cancer or lymphoma with long-term use.

  • Kidney or liver damage.

  • Lung problems: cough, shortness of breath, or fluid around the lungs.

  • Bleeding issues.

  • High cholesterol or triglycerides.

  • High blood sugar / worsening diabetes.

Patients taking sirolimus should have regular monitoring (blood tests, checkups) and report any unusual symptoms promptly. Dose adjustments may be needed if there are kidney or liver problems.

Acide Kojic
Using kojic acid safely and effectively during pregnancy has not been provenMoreover uncertain is whether it can have an impact on reproductive ability or create fetal damage if applied topically to a pregnant woman. Use during pregnancy might not be advisable.

Niacinamide
Because niacin is a vital nutrient, one would anticipate it to be safe at dosages reaching the suggested daily allowance (RDA) when given to pregnant womenUnder these circumstances, niacin is designated as pregnancy category A. Niacin is designated as pregnancy category C when given parenterally for pellagra treatment or in dosages higher than the RDA for dyslipidemia. Most manufacturers advise against the use of niacin during pregnancy in doses above the RDA. The possible advantages of highdose niacin treatment must be balanced against hazards since no toxicological investigations have been carried out.

Sirolimus
Pregnant women should not take rapamycin because it might harm the fetus.

Acid Kojic
Whether topical kojic acid is absorbed or excreted in human breast milk is unknown; therefore, nursing mothers should use it carefully.

Niacinamide
A niacin (Niaspan) producer believes excretion into human milk is expectedeven if no studies have been done in nursing mothers. Serious negative reactions in nursing infants from lipidaltering doses of nicotinic acid cause the maker to advise the cessation of nursing or the medicineProportionally to the niacinamide in breast milk, niacin is excreted depending on mother consumptionOnly those lactating women who lack enough dietary intake require niacin supplements. The Recommended Daily Allowance (RDA) of the National Academy 20 mg of Science for niacin during breastfeedingConcerning the intake of nicotinic acid doses over the RDA during breastfeeding, there are no safety statisticsWeigh the advantages of nursing, the risk of possible infant drug exposure, and the danger of an uncorrected or insufficiently treated illnessHealthcare professionals are urged to report any negative reaction an breastfeeding baby shows connected to a drug ingested by the mother to the FDA.

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

  1. Niaspan (niacin extended-release) tablet package insert. North Chicago, IL: Abbott Laboratories; 2015 Apr.
  2. Chung, C.L., Lawrence, I., Hoffman, M. et al. Topical rapamycin reduces markers of senescence and aging in human skin: an exploratory, prospective, randomized trial. GeroScience 41, 861–869 (2019). https://doi.org/10.1007/s11357-019-00113-y– LinkOpens in New Tab
  3. Zhang, J., & Chung, T. (2010). Old drug, new use: sirolimus in dermatology. International journal of dermatology, 49(8), 947-953.
  4. Li, Y., Li, J., & Li, S. (2019). Pharmacokinetics and metabolism of sirolimus. Clinical and experimental pharmacology & physiology, 46(2), 96-107.
  5. Pfizer Inc. (2019). Rapamune (sirolimus) prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s046lbl.pdf– LinkOpens in New Tab
  6. Smit, J. W., & Stokkel, M. P. (2012). Radiopharmaceuticals in the era of targeted therapy: a clinical review. EJNMMI research, 2(1), 50.
  7. Bassleer C, Henrotin Y, Franchimont P. In-vitro evaluation of drugs proposed as chondroprotective agents. Int J Tissue React 1992;14:231-41.
  8. Martel, R. R., & Klicius, J. (1993). Mechanism of action of rapamycin. Journal of Antibiotics, 46(5), 10.1038/ja.1993.113.
  9. AbdelFattah W, Hammad T. Chondroitin sulfate and glucosamine: A review of their safety profile. JAMA 2001;3:16-23.
  10. Monauni T, Zenti MG, Cretti A et al. Effects of glucosamine infusion on insulin secretion and insulin action in humans. Diabetes 2000;49:926-35.
  11. Scroggie DA, Albright A, Harris MD. The effect of glucosamine-chondroitin supplementation on glycosylated hemoglobin levels in patients with type 2 diabetes mellitus: a placebo-controlled, double-blinded, randomized clinical trial. Arch Intern Med 2003;163:1587-90.
  12. Colletti RB, Neufeld EJ, Roff NK, et al. Niacin treatment of hypercholesterolemia in children. Pediatrics 1993;92:78-82.
  13. Expert Panel: National Cholesterol Education Program. Report of the expert panel on blood cholesterol levels in children and adolescents. Pediatrics 1992;89(suppl 2):525-84.
  14. Niacinamide. In: Drugs in Pregnancy and Lactation. A Reference Guide to Fetal and Neonatal Risk. Briggs GG, Freeman RK, Yaffe SJ, (eds.) 7th ed., Philadelphia PA: Lippincott Williams and Wilkins; 2005:1140-1
  15. Health Care Financing Administration. Interpretive Guidelines for Long-term Care Facilities. Title 42 CFR 483.25(l) F329: Unnecessary Drugs. Revised 2015.
  16. Pritchard, S., Szydlo, R. M., Apperley, J. F., & Carreras, E. (Eds.). (2012). The EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies. Springer Science & Business Media.
  17. National Institutes of Health. (2022). Sirolimus. Retrieved from https://livertox.nlm.nih.gov/Sirolimus.htm– LinkOpens in New Tab
  18. Davis, M., Williams, G., & Harrison, B. (2014). Sirolimus-associated delayed wound healing: a case report and review of literature. The Annals of pharmacotherapy, 48(3), 393-397.
  19. Drugs and Lactation Database (LactMed) – Sirolimus. U.S. National Library of Medicine. (2022). Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK501447/– LinkOpens in New Tab
  20. Briggs, G. G., Freeman, R. K., & Yaffe, S. J. (Eds.). (2017). Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. Wolters Kluwer. Pfizer Inc. (2019).
  21. Rapamune (sirolimus) prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021083s046lbl.pdf– LinkOpens in New Tab
  22. Hale, T. W., & Rowe, H. E. (2019). Medications and Mothers’ Milk. Springer Publishing Company.
  23. M. Nakagawa, K. Kawai, K. Kawa Contact allergy to kojic acid in skin care products Contact Derm., 32 (1) (1995), pp. 9-13
  24. McKenney JM, et al. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hypercholesterolemic patients. JAMA 1994;271:672-7.
  25. Niacor (Niacin tablets) package insert. Minneapolis, MN: Upsher-Smith Laboratories, Inc.; 2000 Feb.
  26. Micromedex Solutions. (2022). Sirolimus. Retrieved from https://www.micromedexsolutions.com/home/dispatch– LinkOpens in New Tab
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  28. Drugs.com. (2022). Sirolimus Side Effects. Retrieved from https://www.drugs.com/sfx/sirolimus-side-effects.html

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503A vs 503B

  • 503A pharmacies compound products for specific patients whose prescriptions are sent by their healthcare provider.
  • 503B outsourcing facilities compound products on a larger scale (bulk amounts) for healthcare providers to have on hand and administer to patients in their offices.

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