503A

Biotin / Finasteride / Minoxidil Capsules

503A

Biotin / Finasteride / Minoxidil Capsules

503A

Biotin / Finasteride / Minoxidil Capsules

5 mg / 2.5 mg / 0.25 mg5 mg / 2.5 mg / 2.5 mg

Biotin / Finasteride / Minoxidil Capsules

$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.

Biotin / Finasteride / Minoxidil Capsule (Each)

5 mg / 2.5 mg / 0.25 mg5 mg / 2.5 mg / 2.5 mg

Biotin, Finasteride, and Minoxidil – A Simple Overview

Biotin, also known as vitamin H or a B vitamin, plays an important role in keeping your body’s metabolism running smoothly. It helps break down carbohydrates, fats, and proteins, turning food into energy. You can find biotin in foods like liver, eggs, fish, seeds, and nuts. Our bodies don’t produce enough of it naturally, so we need to get it through diet or supplements. People sometimes use biotin to support hair and nail health, treat skin issues like cradle cap, or address conditions such as diabetes, high cholesterol, and nerve problems. It’s also important during pregnancy and dialysis treatments because deficiencies can happen in those situations. Interestingly, biotin is even used in some cosmetic products and cancer treatments.

It helps improve urine flow by shrinking the prostate, although not every man experiences noticeable benefits. It also lowers levels of PSA, a marker used to detect prostate cancer, which means doctors need to adjust test results when using this medication. Finasteride is also used to treat male pattern baldness, helping slow hair loss and encouraging new growth on the scalp.

Minoxidil, on the other hand, is a treatment for both high blood pressure and hair loss. The oral form is used for severe hypertension, while the topical version—known widely as Rogaine—is popular for treating hair loss. It works for about 30% of men and up to 60% of women with hereditary baldness. The higher 5% solution promotes faster hair growth compared to the 2% version. Foam formulations have made the treatment easier to apply and more comfortable for some users. Though originally approved in the 1970s for blood pressure, minoxidil’s role in hair regrowth has made it one of the most commonly used solutions for thinning hair.

Understanding Finasteride and Minoxidil

Finasteride and minoxidil are two widely used treatments for common issues like hair loss and high blood pressure. Though they work differently, both have unique ways of helping people feel better and manage their conditions.

Finasteride is a man-made compound that’s similar in structure to testosterone, one of the key male hormones. By doing so, it helps men with an enlarged prostate by improving urine flow and reducing prostate size. It’s also used to treat male pattern baldness, especially in areas where DHT causes hair follicles to shrink. Interestingly, finasteride doesn’t seem to interfere with other hormones like cortisol or thyroid hormones, nor does it affect blood sugar or cholesterol levels.

Minoxidil, on the other hand, works in a completely different way. This widening of blood vessels lowers blood pressure but also triggers a natural response from the body to hold onto more water and sodium, sometimes causing swelling. That’s why doctors often prescribe it with other medications like beta-blockers or diuretics to balance out these side effects.

While it’s not fully understood how it helps hair grow, studies suggest that it shortens the waiting time between hair loss and new hair growth. It also seems to block certain effects of calcium in hair cells that stop growth, encouraging follicles to produce thicker, stronger hair. Importantly, it only works on areas with weakened hair follicles and doesn’t create new ones.

Together, finasteride and minoxidil offer effective solutions for people struggling with prostate issues or hair thinning. While neither is a miracle cure, they target specific causes and can significantly improve quality of life when used under proper medical guidance.

Safety Considerations for Biotin, Finasteride, and Minoxidil

While biotin, finasteride, and minoxidil are commonly used for health benefits like hair growth and managing medical conditions, it’s important to understand how they can affect the body and when caution is needed.

High doses—sometimes taken for hair, skin, or nail health—can cause test results to be falsely high or low, leading to misdiagnoses. For example, tests that measure heart damage markers like troponin could show normal results even if there’s a problem, delaying treatment. Doctors need to ask patients about biotin use before testing and adjust results if necessary. Biotin is generally safe during pregnancy and breastfeeding when taken within recommended amounts, but extra supplementation is not needed unless a deficiency is diagnosed.

Finasteride, used to treat hair loss and prostate enlargement, is not approved for use by women who are pregnant or trying to conceive. It may cause birth defects in male babies, particularly affecting genital development. Women should avoid handling broken tablets, and breastfeeding mothers should also avoid its use since its effects on infants are unknown. In men, finasteride can reduce prostate-specific antigen (PSA) levels, which doctors use to screen for prostate cancer. This can complicate diagnosis, as low PSA levels may mask cancer. There’s also some evidence that while finasteride reduces the overall risk of prostate cancer, it might increase the chances of developing aggressive forms. It can also affect sperm count and semen quality, so fertility concerns should be discussed with a doctor.

Minoxidil, used topically for hair loss and orally for severe hypertension, carries its own risks. It widens blood vessels, lowering blood pressure, but this can trigger side effects like fluid retention, fast heart rate, and in rare cases, heart problems. It’s not recommended for people with heart or kidney diseases unless under strict medical supervision. Systemic use requires other medications to counteract side effects. Topical use is generally safe but should be used cautiously in people with skin injuries or sensitivities, as it can be absorbed more easily.

Understanding the Side Effects of Biotin, Finasteride, and Minoxidil

Biotin, finasteride, and minoxidil are popular supplements and medications used to support hair growth or manage health conditions. While generally considered safe when used properly, they can sometimes cause side effects, especially if not taken as directed.

Biotin is a vitamin that’s important for overall health, and serious side effects are rare—even at higher doses. However, there has been one reported case where an elderly woman developed a life-threatening condition called eosinophilic pleuro-pericardial effusion after taking high doses of biotin along with another vitamin for two months. This suggests that excessive use, especially with other supplements, may have risks in vulnerable individuals.

Finasteride is commonly used to treat hair loss and prostate issues. Most side effects are mild and temporary. Some men experience sexual side effects such as reduced libido, erectile dysfunction, or problems with ejaculation, especially during the first year of treatment. In a few cases, these effects persisted even after stopping the medication. Breast tenderness or enlargement (gynecomastia) has also been reported, sometimes leading to further health concerns. There’s also evidence that finasteride might impact sperm count or semen quality, although these effects are often reversible once treatment is stopped. Importantly, finasteride can cause birth defects if used during pregnancy, so women who are pregnant or trying to conceive should avoid it altogether.

Oral minoxidil can cause fluid retention, leading to swelling and, in rare cases, heart complications like congestive heart failure. It may also cause a fast heartbeat, headaches, or changes in blood tests, though these are usually temporary. Hair growth on unwanted areas of the body can occur, especially with oral minoxidil, but it typically reverses after stopping the drug. Topical minoxidil is less likely to cause serious problems but may irritate the skin where it’s applied. Rare reactions like rashes or more severe skin conditions have been reported.

Biotin
It is advised to take biotin at the suggested acceptable intake (AI) during pregnancy. Usually, no diagnosed deficiency and a balanced diet are eaten; therefore, supplementing outside of dietary intake is usually not required.

Finasteride
Finasteride is not FDAapproved for use in women of childbearing age and is contraindicated during pregnancy. Finasteride might cause fetal harm. By preventing the conversion of testosterone to DHT, finasteride and other 5alphareductase inhibitors have the potential to cause abnormalities in the male fetus’s external genitalia. Women attempting to conceive or those who are pregnant should avoid handling broken or crushed finasteride tablets. Assessed is the dispersion of finasteride into human semen; it seems to be well below the threshold level related with abnormalities in animals.

Minoxidil
Categorization for minoxidil is pregnancy risk C. Animal reproduction studies have revealed negative consequences, including decreased capacity, even if no sufficient human trials have looked at the effects of this medication on the fetus. to create and decreased offspring survival. An infant whose mother had a daily dose of 10 mg of minoxidil during pregnancy showed facial dysmorphic characteristics and hypertrichosis. Consequently, in deciding whether or not to give this medication while pregnant, the possible hazards to the unborn as well as any conceivable difficulty in conceiving have to be considered. against the possible advantages for the mother.

Biotin
Breastfeeding women may intake biotin inside the advised adequate intake (AI) criteria. If a healthy diet is eaten and no deficiencies have been noted, supplementing outside of dietary intake is usually not required.

Finasteride
Finasteride is advised to be avoided during breastfeeding and is not FDA-approved for usage in women of reproductive age. It is not clear whether finasteride passes into human milk. Therefore, the impacts of finasteride on a nursing infant or nursing mother cannot be known.

Minoxidil
Minoxidil should not be given to a nursing mother, the producer states. Though other experts are less at ease with the use of minoxidil, the American Academy of Pediatrics (AAP) views it to be usually compatible with breastfeeding. Strong antihypertensive medication for lactating moms. Minoxidil was quickly expelled into the breast milk in one case study of a woman consuming 5 mg PO twice every day. The nursing infant showed no negative events after two months. It is unclear how long exposure during breastfeeding influences anything.

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. Office of Dietary Supplements. Biotin fact sheet for health professionals. September 2018. Internet version, retrieved June 24, 2019. Available on the World Wide Web at: https://ods.od.nih.gov/factsheets/Biotin-HealthProfessional/– LinkOpens in New Tab
  2. Proscar (finasteride) package insert. Whitehouse Station, NJ: Merck and Co.; 2014 Jan.
  3. Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003:349:213-22.
  4. FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer. Retrieved June 9, 2011.
  5. DeVillez RL. The Therapeutic Use of Topical Minoxidil. Dermatol Clin 1990;8:367-74.
  6. Olsen EA, Dunlap FE, Funicella T, et al. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol 2002;47:377-85.
  7. Olsen EA, Whiting D, Bergfeld W, et al. A multicenter, randomized, placebo-controlled, double-blind clinical trial of a novel formulation of 5% minoxidil topical foam versus placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol 2007;57(5):767-74. Epub 2007 Aug 29
  8. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes-Panel on Folate, Other B Vitamins, and Choline and the Subcommittee on Upper Reference Levels of Nutrients, Food and Nutrition Board, Institute of Medicine (IOM). Dietary Reference Intakes for Thiamine, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline. 1999, 2000. The National Academy of Sciences Press, Washington DC.
  9. Bauer JH, Alpert MA. Rapid reduction of severe hypertension with minoxidil. J Cardiovasc Pharmacol 1980;2 Suppl:S189-99.
  10. Alpert MA, Bauer JH. Rapid control of severe hypertension with minoxidil. Arch Intern Med 1982;142(12):2099-104.
  11. Pogatsa-Murray G, Varga L, Varga A, et al. Changes in left ventricular mass during treatment with minoxidil and cilazapril in hypertension patients with left ventricular hypertrophy. J Hum Hypertens 1997;11(3):149-56.
  12. Buhl AE. Minoxidil’s action in hair follicles. J Invest Dermatol 1991;96:73S-4S.
  13. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol 2004;150:186-194.
  14. Sato T, Tadokoro T, Sonoda T, et al. Minoxidil increases 17b-hydroxysteroid dehydrogenase and 5a-reductase activity of cultured human dermal papilla cells from balding scalp. J Derm Sci 1999;19:123-5.
  15. US Food and Drug Administration (FDA). FDA Safety Communication: Update: The FDA warns that biotin may interfere with lab tests.
  16. Elston MS, Sehgal S, Toit SD, et al. Factitious graves’ disease due to biotin immunoassay interference – a case and review of the literature. J Clin Endocrinol Metab 2016;101(9):3251-3255.
  17. Propecia (finasteride) package insert. Whitehouse Station, NJ: Merck and Co., INC.; 2013 Sept.
  18. Loniten (minoxidil) tablets package insert. Kalamazoo, MI: Pharmacia; 2006 Feb.
  19. Health Care Financing Administration. Interpretive Guidelines for Long-term Care Facilities. Title 42 CFR 483.25(l) F329: Unnecessary Drugs. Revised 2015.
  20. Kaler SG, Patrinos ME, Lambert GH, et al. Hypertrichosis and congenital anomalies associated with maternal use of minoxidil. Pediatrics 1987;79:434-6.
  21. Minoxidil tablets package insert. Corona, CA: Watson Laboratories, Inc; 2009 Jun.
  22. American Academy of Pediatrics (AAP) Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001;108(3):776-789.
  23. Valdivieso A, Valdes G, Spiro TE, et al. Minoxidil in breast milk. Ann Intern Med. 1985;102:135. Letter.
  24. McConnell JD, Bruskewitz R, Walsh P, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N Engl J Med 1998;338:557-63.

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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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