Hair Restore Extreme Scalp Solution

Minoxidil

When used topically, minoxidil may help stimulate hair growth. Minoxidil may help with various forms of hair loss, including male pattern baldness or hereditary hair loss.^[1]

Dutasteride

Traditionally, dutasteride may assist with benign prostatic hyperplasia. However, it may also assist with male pattern hair loss.^[2]

Finasteride

As an oral tablet, finasteride may assist with benign prostate hyperplasia and male pattern hair loss.^[3] However, as a topical solution, finasteride may help with male pattern hair loss with potentially less systemic exposure than an oral formulation.^[4]

Tretinoin

Commonly, topical tretinoin may be associated with the potential to help acne or aging skin.^[5] When combined with minoxidil, studies have suggested tretinoin may also help stimulate hair growth.^[6]

Ketoconazole

Most commonly, ketoconazole is considered for the potential to assist with fungal infections.^[7] However, some studies have suggested that topical ketoconazole may also assist with male pattern hair loss.^[8]

Minoxidil

The exact mechanism through which minoxidil may help stimulate hair growth is not well understood. Minoxidil may act on certain stages of the hair follicle cell cycle, specifically shortening the telogen (rest) phase and lengthening the anagen (growth) phase. This may help increase hair length and thickness in the applied areas.^{[1] [9]} Minoxidil may also act through other mechanisms to assist with hair growth such as vasodilation. Minoxidil may help increase vasodilation around the hair follicles, which may help improve circulation and thus support hair growth.^[1]

Dutasteride

Dutasteride may help male pattern hair loss by inhibiting the 5a-reductase enzyme. In the body, this 5a-reductase enzyme converts testosterone to dihydrotestosterone (DHT).^[2] DHT is more potent than other androgenic hormones because of its high affinity to the androgen receptor.^[10] DHT is involved in many areas of sexual development, including maturation of male sexual organs, facial hair, and body and pubic hair. In adulthood, DHT may cause enlargement of the prostate and hair loss in men.^[10] By blocking the 5a-reductase enzyme, dutasteride may help reduce hair loss caused by DHT.^{[2] [10]}

Finasteride

Finasteride may help male pattern hair loss by inhibiting the type II and III isoenzymes of the 5a-reductase enzyme. In the body, this 5a-reductase enzyme converts testosterone to dihydrotestosterone (DHT). The type II isoenzyme is present in the outer root sheath of hair follicles, the prostate, and other sites in the male reproductive tract.^[3] DHT is more potent than other androgenic hormones because of its high affinity to the androgen receptor.^[10] DHT is involved in many areas of sexual development, including maturation of male sexual organs, facial hair, and body and pubic hair. In adulthood, DHT may cause enlargement of the prostate and hair loss in men.^[10] By blocking the 5a-reductase enzyme, finasteride may help reduce hair loss caused by DHT.^{[3] [10]}

Tretinoin

When used in combination with minoxidil, an in vitro study suggested tretinoin may help activate certain kinase pathways associated with cell growth and survival.^[6] Additionally, a study in patients with androgenic alopecia suggested tretinoin may help increase response to topical minoxidil in this patient population. Sharma et al. proposed that topical tretinoin may increase follicular sulfotransferase enzymes in patients with low initial expression. This may help improve response to topical minoxidil in patients with androgenic alopecia who do not respond to minoxidil initially.^[11]

Ketoconazole

Ketoconazole may help increase hair thickness by increasing hair shaft diameter in patients with male pattern baldness. In male pattern baldness, hair follicles are miniaturized which leads to a decrease in thick coarse hair (terminal hair) and an increase in fine, light hairs (vellus hair).^{[8] [12]} The potential increase in hair shaft diameter may help hair appear fuller.^[8]

Ketoconazole may assist with male pattern baldness through inhibition of the enzymes 17-alpha-hydroxylase and 17,20-lyase. These enzymes are needed for steroid synthesis in the brain. Inhibition of these enzymes may help decrease testosterone levels in the body.^[7]

Minoxidil

Precautions for minoxidil may include heart disease or high blood pressure.^[13] Minoxidil may cause adverse cardiac effects if used for extended periods of time or over a large area of skin.^[13] Additionally, skin conditions such as irritation or sunburn on the area of application may increase the chance of side effects.^[13] After application, ensure product is dry prior to initiating contact with others, as excessive hair growth has been reported in babies after skin contact with treated areas.^[1]

Dutasteride

Dutasteride is contraindicated for use in pregnant women, women who may become pregnant, and children. Dutasteride should not be handled by pregnant women or women of childbearing potential due to risk of fetal harm. Patients receiving dutasteride therapy should avoid donating blood during therapy and for 6 months following stopping dutasteride to avoid risk of dutasteride exposure to a pregnant transfusion recipient.^[2]
Dutasteride concentrations may be higher in patients with liver disease due to reduced liver metabolism of the drug. This may lead to increased risk of side effects. Patients with severe liver disease should not use dutasteride due to this risk.^[2]

Finasteride

Finasteride is contraindicated for use in pregnant women, women who may become pregnant, and children. Finasteride should not be handled by pregnant women or women of childbearing potential due to risk of fetal harm. Patients receiving finasteride therapy should not donate blood during therapy and for 6 months following stopping dutasteride to avoid risk of finasteride exposure to a pregnant transfusion recipient.^[3]
In patients with liver disease, finasteride concentrations may be higher due to reduced liver metabolism of the drug.^[3]

Tretinoin

Tretinoin may cause increased sensitivity to the sun. Patients using tretinoin should take precautions and wear sunscreen or cover skin with clothing to protect from sun damage. Avoid use of tretinoin if a sunburn or eczema is present to avoid increased risk of irritation. Tretinoin is contraindicated for use during pregnancy.^[5]

Ketoconazole

Ketoconazole should not be used on burned or damaged skin.^[14] Ketoconazole is contraindicated for use in patients with liver disease. As high doses of ketoconazole may inhibit adrenocortical function, ketoconazole should be avoided in patients with adrenal insufficiency.^[7]

Disclaimer: Do not take this medication if you are allergic to any components of this product. Stop taking your medicine and seek immediate medical attention if you have any signs of a severe allergic reaction such as but not limited to rash or hives spreading across your body, any swelling of the face, tongue, or throat, or any signs of trouble breathing.

Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also, tell them if you smoke, drink alcohol, or use other drugs. Some items may interact with your medicine. This is not a complete list of key warnings, contraindications and precautions. Reach out to your healthcare provider with any questions.

Minoxidil

Potential interactions for topical minoxidil may include cyclosporine and aspirin. Cyclosporine may make certain hair growth in unwanted areas worse when used in combination with minoxidil. Low-dose aspirin may reduce the potential effects on hair growth of minoxidil.^[1]

Dutasteride

Potential drug interactions for dutasteride may include certain cancer medications such as ceritinib, antifungal medications like itraconazole or ketoconazole, antivirals such as ritonavir, certain antibiotics like ciprofloxacin, or blood pressure medications such as diltiazem or verapamil.^[15]

Finasteride

Finasteride may cause orthostatic hypotension, especially if combined with alpha blockers, a class of drug used for high blood pressure.^[3]

Tretinoin

Topical products that may cause skin dryness and irritation should be avoided in combination with tretinoin. Examples of these may include harsh soaps or shampoos, chemicals to color hair, or other topical products that contain alcohol, astringents, or other ingredients that may irritate the skin.^[5]

Ketoconazole

Ketoconazole may interact with other topical products.^[14] Ketoconazole may increase concentrations of benzodiazepines which may lead to increased risk of sedation. Ketoconazole may cause QT prolongation and should not be administered to patients taking antiarrhythmic medications such as cisapride or quinidine. In the liver, ketoconazole is metabolized by the CYP3A4 enzyme. Caution should be taken in patients taking other medications that inhibit or are metabolized by this enzyme.^[7]

Disclaimer: This is not a complete list of potential interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also, tell them if you smoke, drink alcohol, or use other drugs. Some items may interact with your medicine. Reach out to your healthcare provider with any questions.

Minoxidil

Potential side effects that may occur with topical minoxidil include hair shedding, skin irritation, itching, or excessive hair growth known as hypertrichosis. Although minoxidil may help stimulate hair growth, its potential effects on the cell cycle may result in hair shedding in some patients. Topical application may cause skin irritation or discomfort that may include redness or a burning sensation on the applied area. Excessive hair growth is also possible with minoxidil.^[1]

Dutasteride

Dutasteride may affect sexual function, which may include decreased sexual desire or erectile dysfunction.^[2] Dutasteride may also affect sperm count and semen volume.^{[2] [16]}
Due to dutasteride’s potential to inhibit the 5-alpha reductase enzyme, testosterone may be eliminated through other pathways. This may lead to increased estrogen levels which may cause other adverse effects such as gynecomastia.^[2]

Finasteride

Finasteride may affect sexual function, which may include decreased sexual desire or erectile dysfunction. Finasteride may also affect sperm count and semen volume, which may lead to infertility.^[3]
Due to finasteride’s potential to inhibit the 5-alpha reductase enzyme, testosterone may be eliminated through other pathways. This may lead to increased estrogen levels which may cause other adverse effects such as gynecomastia.^{[3] [10]}

Tretinoin

When applied topically, tretinoin may cause itching, skin irritation, redness, or skin pain. Tretinoin may also increase sensitivity to the sun. Take care and wear sunscreen or protective clothing if sun exposure cannot be avoided while using tretinoin.^[5]

Ketoconazole

As a topical formulation, ketoconazole may cause skin reactions including itching or dryness. On the scalp, ketoconazole may cause dry or oily hair.^[7]

Disclaimer: This is not a complete list of side effects. Please call your healthcare provider if you experience any unusual side effects or have any questions

Minoxidil

Minoxidil is not recommended for use in patients who are pregnant or breastfeeding. Minoxidil may cause birth defects in unborn infants if administered to a pregnant woman.^[1] Minoxidil may be excreted into breast milk.^[17]

Dutasteride

Dutasteride is contraindicated in pregnant women as it may cause harm to the unborn child. Pregnant women or women who may be pregnant should not handle dutasteride formulations due to risk for potential skin absorption. It is unknown if dutasteride passes into breast milk.^[2]

Finasteride

Finasteride is contraindicated in pregnant women as it may cause harm to the unborn child. Pregnant women or women who may be pregnant should not handle finasteride formulations due to risk for potential skin absorption. It is unknown if finasteride passes into breast milk and should not be used during breastfeeding.^[3]

Tretinoin

Tretinoin is contraindicated for use during pregnancy. There is a high risk of pregnancy loss and birth defects if tretinoin is administered during pregnancy. It is unknown if tretinoin passes into breast milk, but due to potentially serious risk tretinoin should not be used in breast-feeding women. Tell your healthcare provider if you are pregnant, planning to become pregnant, or are breast-feeding before taking this medication.^[5]

Ketoconazole

There is a lack of information on ketoconazole use in pregnancy, so caution is advised in this patient population. Animal studies of topical ketoconazole in pregnancy demonstrated adverse effects on the fetus. Ketoconazole should only be used in pregnancy if potential benefit exceeds the risk.^[18]

Ketoconazole may pass into breast milk. For this reason, ketoconazole should not be used in breast-feeding.^[7]

Disclaimer: Tell your healthcare provider if you are pregnant, planning to become pregnant, or are breast-feeding prior to taking this formulation.

Store between 68°F to 77°F (20°C – 25°C). Properly discard any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain. Keep all medicine out of the reach of children and pets.

1. Patel P, Nessel TA, Kumar D D. Minoxidil. [Updated 2023 Feb 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482378/
2. Al-Horani RA, Patel P. Dutasteride. [Updated 2024 Mar 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK603726/
3. Zito PM, Bistas KG, Patel P, et al. Finasteride. [Updated 2024 Feb 28]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK513329/
4. Piraccini BM, Blume-Peytavi U, Scarci F, Jansat JM, Falqués M, Otero R, Tamarit ML, Galván J, Tebbs V, Massana E; Topical Finasteride Study Group. Efficacy and safety of topical finasteride spray solution for male androgenetic alopecia: a phase III, randomized, controlled clinical trial. J Eur Acad Dermatol Venereol. 2022 Feb;36(2):286-294. doi: 10.1111/jdv.17738. Epub 2021 Oct 25. Erratum in: J Eur Acad Dermatol Venereol. 2023 Feb;37(2):452. doi: 10.1111/jdv.18750. PMID: 34634163; PMCID: PMC9297965.
5. Yoham AL, Casadesus D. Tretinoin. [Updated 2023 Mar 27]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557478/
6. Kwon OS, Pyo HK, Oh YJ, Han JH, Lee SR, Chung JH, Eun HC, Kim KH. Promotive effect of minoxidil combined with all-trans retinoic acid (tretinoin) on human hair growth in vitro. J Korean Med Sci. 2007 Apr;22(2):283-9. doi: 10.3346/jkms.2007.22.2.283. PMID: 17449938; PMCID: PMC2693596.
7. Sinawe H, Casadesus D. Ketoconazole. [Updated 2023 Jun 26]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559221/
8. Fields JR, Vonu PM, Monir RL, Schoch JJ. Topical ketoconazole for the treatment of androgenetic alopecia: A systematic review. Dermatol Ther. 2020 Jan;33(1):e13202. doi: 10.1111/dth.13202. Epub 2020 Jan 2. PMID: 31858672.
9. Hoover E, Alhajj M, Flores JL. Physiology, Hair. [Updated 2023 Jul 30]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK499948/
10. Kinter KJ, Amraei R, Anekar AA. Biochemistry, Dihydrotestosterone. [Updated 2023 Jul 30]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557634/
11. Sharma A, Goren A, Dhurat R, Agrawal S, Sinclair R, Trüeb RM, Vañó-Galván S, Chen G, Tan Y, Kovacevic M, Situm M, McCoy J. Tretinoin enhances minoxidil response in androgenetic alopecia patients by upregulating follicular sulfotransferase enzymes. Dermatol Ther. 2019 May;32(3):e12915. doi: 10.1111/dth.12915. Epub 2019 Apr 23. PMID: 30974011.
12. Grymowicz M, Rudnicka E, Podfigurna A, Napierala P, Smolarczyk R, Smolarczyk K, Meczekalski B. Hormonal Effects on Hair Follicles. Int J Mol Sci. 2020 Jul 28;21(15):5342. doi: 10.3390/ijms21155342. PMID: 32731328; PMCID: PMC7432488.
13. “Minoxidil (Topical Route).” Mayo Clinic, Mayo Foundation for Medical Education and Research, www.mayoclinic.org/drugs-supplements/minoxidil-topical-route/description/drg-20068750#drug-precautions Accessed 21 Nov. 2024.
14. “Ketoconazole Shampoo.” Cleveland Clinic, Cleveland Clinic, 27 June 2024, my.clevelandclinic.org/health/drugs/20386-ketoconazole-shampoo
15. “Dutasteride (Oral Route).” Mayo Clinic, Mayo Foundation for Medical Education and Research, www.mayoclinic.org/drugs-supplements/dutasteride-oral-route/description/drg-20063575 Accessed 21 Nov. 2024.
16. Amory JK, Wang C, Swerdloff RS, Anawalt BD, Matsumoto AM, Bremner WJ, Walker SE, Haberer LJ, Clark RV. The effect of 5alpha-reductase inhibition with dutasteride and finasteride on semen parameters and serum hormones in healthy men. J Clin Endocrinol Metab. 2007 May;92(5):1659-65. doi: 10.1210/jc.2006-2203. Epub 2007 Feb 13. Erratum in: J Clin Endocrinol Metab. 2007 Nov;92(11):4379. PMID: 17299062.
17. Valdivieso A, Valdés G, Spiro TE, Westerman RL. Minoxidil in breast milk. Ann Intern Med. 1985 Jan;102(1):135. doi: 10.7326/0003-4819-102-1-135_1. PMID: 3966734.
18. “Ketoconazole Topical Pregnancy and Breastfeeding Warnings.” Drugs.Com, Drugs.com, 3 Aug. 2023, www.drugs.com/pregnancy/ketoconazole-topical.html