Hair Loss Treatment Plan 

It is best to take it each day at the same time. If you miss a dose, skip the missed dose and continue on your regimen the next day. Of course, if you are off by just a few hours, take your medication and get back onto your daily rhythm. It is important to take your medication without days of interruption, so be sure to pack enough when traveling, on vacation, etc. Oral minoxidil can be taken with or without food.

The pills should be kept dry and at room temperature between 68°F to 77°F (20°C to 25°C). The bathroom is a moist environment, so choose another place. They must be stored away from children and pets.

Oral minoxidil was originally studied for blood pressure, and the hair growth effects were unintentional. In clinical trials for oral minoxidil for blood pressure, patients who experienced hypertrichosis, or “elongation, thickening, and enhanced pigmentation of body hair” noticed it three to six weeks after beginning treatment. The hair growth was usually first noticed on the temples, between the eyebrows, between the hairline and the eyebrows, or in the sideburn area of the upper lateral cheek, later extending to the back, arms, legs, and scalp. Upon discontinuation of the oral minoxidil, new hair growth stops. After one to six months, hair may return to pre-treatment appearance.

You might have heard about topical minoxidil for androgenic alopecia, or male pattern baldness, which is applied on the skin as a scalp foam or solution. Oral minoxidil is minoxidil in tablet form that is taken by mouth.

High-dose oral minoxidil is used to treat high blood pressure, and it’s FDA approved for that purpose. So why did healthcare providers start using minoxidil for hair loss? It’s because about 80% of patients in clinical trials were noted to experience hypertrichosis, or “elongation, thickening, and enhanced pigmentation (darkening) of body hair.”

Oral minoxidil for hair loss is an off-label use for the medication, meaning that it’s not explicitly approved by the FDA for the treatment of hair loss, though healthcare providers can use their medical judgment to prescribe it if they think it’s the right treatment.

The exact mechanism of action of oral minoxidil is not completely understood. It increases the length of the growth phase of hair follicles (a process called “anagen”) and increases the size of hair follicles, which dictates the thickness/diameter of the hair that comes out of the follicle, which is thought to lead to promoting hair regrowth.

Minoxidil is also thought to relax smooth muscle in blood vessel walls, causing them to widen and increasing blood flow. This may be one of the ways that minoxidil works to stop or slow hair loss and, in some cases, regrow hair.

No. Male pattern baldness is unlike many other conditions that lead to baldness (e.g., autoimmune diseases, vitamin deficiency, protein deficiency) in that once it has progressed to the point where the scalp is bald, regrowth is virtually impossible.

Please read the full PDR for a full, detailed overview of minoxidil.

Oral minoxidil is used at lower dosages for androgenic alopecia. At higher doses, it is typically used as a treatment for high blood pressure. Side effects of oral minoxidil are typically minimal at lower dosages. Some side effects can include initial hair loss or shedding, unwanted hair growth (hypertrichosis), low blood pressure (hypotension), and swelling in the legs (edema), among others.

Initial hair loss or shedding: Because of how minoxidil works, many people report experiencing increased hair loss during the first six weeks of use before seeing improved hair growth. This is true for both oral and topical treatment. While this can be concerning for someone already worried about their hair thinning, it’s a well-known phenomenon and typically resolves after a month as the new hair grows in.

Excessive hair growth (hypertrichosis): Because oral minoxidil reaches the whole body, as opposed to topical minoxidil that you apply just on the scalp, the most common side effect is unwanted hair growth in areas other than the scalp. The complaint is more common among women than men but may affect as many as one in four people. It’s also more common at higher doses over 5 mg per day than at the doses usually used to treat hair loss.

Headaches: Approximately one in 10 people experience headaches that typically improve over time.

Dizziness and low blood pressure: Oral minoxidil, at higher doses (10–40 mg per day), is typically used as a treatment for high blood pressure (hypertension). While the low doses usually prescribed for hair loss aren’t supposed to affect a person’s blood pressure, symptoms of low blood pressure are possible. These symptoms include lightheadedness or dizziness, especially when sitting up or standing up quickly. Let your healthcare provider know if you are taking any other medications, particularly those used to treat high blood pressure (like diuretics (water pills) or other treatments for hypertension).

Insomnia and lower leg swelling can also occur in some people taking minoxidil by mouth. If you experience swelling, stop taking minoxidil and tell your provider. There are additional, less common side effects of taking minoxidil by mouth. Tell your healthcare provider or pharmacist about all the medications and supplements you are taking, any health conditions you have or have had in the past, and any side effects you notice from taking the medication.

Children: Caution and careful attention to dosing is required for the use of oral minoxidil in children. Minoxidil is not prescribed on the Ro platform to children.

Women: Oral minoxidil is considered pregnancy category C, which means animal reproduction studies have shown adverse effects, and there are no adequate and well-controlled studies in humans. Potential benefits may warrant use of the drug in pregnant women despite potential risks. Of note, the animal studies evaluating minoxidil evaluated it administered at relatively high doses, with some studies evaluating minoxidil at five times the maximum recommended oral antihypertensive human dose, which is larger than the dose typically used for hair loss. Of note, there has been a report of minoxidil excretion in the breast milk of a woman treated with 5 mg oral minoxidil twice daily for hypertension. Because of the potential for adverse effects in nursing infants from minoxidil absorption, oral minoxidil is generally not administered to nursing women.

Elderly: Studies of people taking oral minoxidil did not sufficiently evaluate people aged 65 and older to determine whether they respond differently from younger subjects. The PDR suggests that systemic dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

Liver impairment: Since minoxidil is metabolized in the liver, those with liver impairment may not be able to clear it from the body as easily as those with healthy livers.

Kidney impairment: Currently, we do not recommend LDOM for use in patients with moderate to severe kidney disease because it can cause an increase in pulmonary artery pressure.

Pulmonary arterial hypertension: We do not recommend patients with pulmonary arterial hypertension take LDOM.

There are additional warnings and precautions that should be taken into consideration before using minoxidil.

Those with a history of minoxidil hypersensitivity should not use minoxidil.

Minoxidil is relatively contraindicated in patients with cardiac disease (e.g., angina, coronary artery disease, recent or acute myocardial infarction) or cerebrovascular disease, because a reflex increase in heart rate and decrease in blood pressure can make these conditions worse.

Minoxidil is relatively contraindicated in patients with kidney disease, pre-existing pulmonary hypertension, or chronic congestive heart failure not secondary to hypertension.

Minoxidil is contraindicated in patients with pheochromocytoma because the blood pressure-lowering effects of the drug can stimulate catecholamine (epinephrine and norepinephrine) secretion.

Anyone with a history of any of these conditions should inform their provider.

Because minoxidil can lower blood pressure, it is critically important to only take minoxidil at the dose recommended by your provider, as blood pressure that is too low can be dangerous. Please contact poison control immediately if you take more than 40 mg (sixteen 2.5 mg tablets or eight 5 mg tablets) of minoxidil.

Are there any drug interactions? Because minoxidil can lower blood pressure, there are a lot of potential drug interactions. A list of potential drug interactions can be found on the PDR. Of note, you should be especially careful if you already take any medication also known to lower blood pressure. This is why it’s important to tell your provider about all of the medications you are taking and keep your provider informed if you start taking any new medications.

The FDA requires that drugs go through a clinical testing process to establish that they’re safe and effective to treat a particular condition. Healthcare providers may prescribe a drug for an unapproved use if they judge that it is medically appropriate for their patient. This type of prescribing is called “off-label” prescribing. Off-label prescribing practices are sometimes validated by clinical experience and research and may be a widely recognized clinical practice. Healthcare providers have the discretion to prescribe drugs off label based on a patient’s unique medical history, symptoms, and preferences. Talk to your Ro-affiliated provider if you have any concerns or questions about using oral minoxidil off label. You can always message your healthcare provider through your Ro account.

It is best to take it each day at the same time. If you miss a dose, skip the missed dose and continue on your regimen the next day. Of course, if you are off by just a few hours, take your medication and get back onto your daily rhythm. It is important to take your medication without days of interruption, so be sure to pack enough when traveling, on vacation, etc. Finasteride can be taken with or without food.

The pills should be kept dry and at room temperature between 68˚F to 77˚F (20˚C to 25˚C). The bathroom is a moist environment, so choose another place. They must be stored away from children and pets. Also, broken pills can expose the skin to finasteride. This is category X, meaning that it can cause birth defects. Though they are coated and generally considered safe when unbroken, women should never touch these pills.

Finasteride takes 3 to 4 months to show any benefit. It can take up to a year to see the maximum results. Moreover, as finasteride enters the system, it may even cause more shedding of fine hairs. Do not be concerned – this is expected. Also, some men do not respond to the medication; this can be as high as 1 out of every 10 men. As long as you do not experience side effects, it is best to continue medication for one full year before deciding whether the medication is doing all it can for you.

Finasteride blocks the conversion of testosterone to dihydrotestosterone (DHT). Male pattern baldness (MPB) or androgenic alopecia, is caused not by testosterone, but by DHT. It is DHT that causes hair follicles to shrink and lose the ability to create new hairs. This is called “miniaturization.” Testosterone is changed into DHT by an enzyme called 5 alpha-reductase. That enzyme comes in different forms and one form of the enzyme converts testosterone into DHT in the prostate and on the scalp. Researchers first tried treating enlarged prostates with finasteride. Finasteride is called a 5 alpha-reductase inhibitor, meaning it stops the enzyme from changing testosterone into DHT. They ended up finding that the medication stopped hair loss in the study patients and even regrew hair for some. It is unknown why the hair follicles of some men are more predisposed to DHT – causing follicles to shrink – but genetics is a big part of it. No one knows precisely how a man’s genes cause hair loss, but there are over 250 genes that can come from either parent. It is a man’s genes that determine if he will lose his hair or not. The genes could code for more receptors (places for DHT to “land”) on a hair follicle, or make them more sensitive to DHT. That being said, we do know that blocking DHT can slow or even reverse hair loss. In one European study (Euro J of Dermatol 2008; 18: 400–6), men treated with 1 mg finasteride over a five year period “led to a 93% decrease relative to placebo in the 5-year likelihood of developing further hair loss.” That is excellent and has been reproduced in other studies—but does it regrow hair? In one analysis, “Three double-blind, randomized, placebo-controlled Phase III studies of finasteride were conducted in 1879 men ages 18–41 years with mild to moderate AGA (this stands for Androgenic Alopecia, which is male pattern baldness).” “Two of the studies enrolled men with predominantly vertex hair loss …and one study enrolled men with predominantly frontal (anterior mid-scalp) hair loss.” The results were quite strong in several regards. Hair growth and cessation of hair loss were noted in significant numbers of patients and to a significant degree. In the vertex group, after two years “66% of men were rated as having improved hair growth…compared with 7% of men receiving placebo.” In terms of stopping hair loss, “Only 17% of men receiving finasteride lost hair based on hair count during the two-year studies, compared with 72% of the men receiving placebo.” Men with frontal hair loss experienced a benefit, but it was not as robust as it was for the men in the vertex group. The conclusion stated, “Based on hair counts, no further hair loss was observed in 83% of finasteride-treated men with vertex hair loss after 2 years and in 70% of finasteride-treated men with frontal hair loss after 1 year. Based on standardized clinical photography, the chances of mild to moderate visible regrowth are 61% on the vertex (with an additional 5% achieving great visible regrowth) after 2 years and 37% on the frontal area after 1 year.” It is important to understand that androgenic alopecia is different from many other causes of baldness. Some people can lose all their hair from an autoimmune problem, severe weight loss and dietary deficiencies, cancer treatments, or infections, and regrow hair completely. With MPB, once a section of the scalp is completely bald, regrowing hair is almost impossible. It seems that MPB causes a very specific change during miniaturization and regrowth cannot occur once baldness has occurred. This is discussed below, but this explains why attempts to regrow hair should happen before baldness occurs and why starting early is helpful in preserving hair. For a detailed explanation, read the educational sections below. Side effects in men using finasteride are generally minimal; nonetheless, some patients develop a decrease in semen production, a decrease in libido (which resolved with cessation of the medication), or erectile dysfunction. (More about this below) These generally resolve either while taking the medication or when the medication is stopped. However, there is the possibility that permanent changes can occur in some patients. If sexual side effects occur, such as decreased sexual desire or difficulty gaining or maintaining erections, we recommend stopping the medication immediately. Finasteride should never be considered for pregnant women, and there are no benefits in that population that outweigh the risk. The FDA has listed it in pregnancy category X. Finasteride also reduces the androgenic effect of DHT in the prostate, which is why finasteride is used to treat enlarged prostates. In fact, finasteride was first used in the higher 5 mg dose to treat enlarged prostates. There is a great deal more information concerning finasteride that must be reviewed to help you best understand your hair loss. This information can be found below.

Please read the full PDR for a full, detailed overview of finasteride.

Finasteride (1 mg) treats male pattern hair loss (MPB or androgenic alopecia) in men only. It has a proven effect on the crown. Its effectiveness in bitemporal recession has not been established. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months. Finasteride (5 mg) is used to treat men with symptoms of enlarged prostate to improve symptoms like difficulty urinating, to reduce the risk of getting urinary retention (urine trapped in the bladder), and to reduce the number of men who need surgery of the prostate. Finasteride at any dose is not approved for the prevention of prostate cancer.

There is a very powerful warning about finasteride and the risk it poses for women who become pregnant or who breastfeed. The following warning about women and finasteride cannot be overstated.

PREGNANCY: The PDR states, “Finasteride use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5 α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus.”

The PDR also states, “Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed."

For this reason women should never use finasteride.

The medication has not been approved for use in children.

Children should not use finasteride and it should be kept far from their access (as should all medications).

Also, it should never be used in those allergic to any component of the finasteride tablet or medications in the same class of drug (e.g., dutasteride).

Sexual side effects

Sexual side effects can include a decrease in sexual desire (libido), a decrease in semen volume, or erectile dysfunction (ED). These side effects were noted in 3.8% of men taking finasteride and in 2.1% of men taking a placebo (“sugar pill”). Breaking it down by each side effect, a decreased libido occurred in 1.8% of men (1.3% who took placebo), erectile dysfunction in 1.3% (.7% on placebo), and decreased semen volume in .8% (.4% who took placebo). A very small number of men experience other ejaculation disorders.

The PDR states, “Resolution occurred in men who discontinued therapy with finasteride tablets due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to <0.3% by the fifth year of treatment with finasteride tablets.”

This all sounds easy and straightforward – the sexual side effects are transient and manageable – but that is not the point. The point is that these side effects can happen. If you are one of the people that notices a change, the statistics about side effects occurring for a small number of patients won’t matter. Whether to continue the medication or not is an intensely personal choice. That is why it is so important to think about what it would mean if you were one of those few men who has an issue. A tiny decrease in semen volume may be trivial, but erectile dysfunction may not be, even if it goes away with time.

Lastly, there is the possibility a side effect can persist after the drug is stopped. It is rare, but possible. And again, “rare” is meaningless if it happens to you. The studies quoted had very few men discontinue medication due to “drug-related sexual adverse experiences,” which was only 1.2% of men compared to .9% of men who took the sugar pill.

Breast changes

There have been rare reports of breast cancer in men. Some studies have shown breast cancer in men taking finasteride (about 1 in a thousand).

The PDR states that in a 7-year study of 18,882 men “there was 1 case of breast cancer in men treated with finasteride tablets, and 1 case of breast cancer in men treated with placebo.”

They noted, “The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.”

Have any side effects been reported since finasteride was first approved?

These are called post marketing reports. Patients have the ability to report possible side effects voluntarily so a relationship to finasteride may not be established.

Some men have reported breast tenderness and enlargement.

There have been reports of “hypersensitivity reactions such as rash, pruritus (itching), urticaria (hives), and angioedema” (including swelling of the lips, tongue, throat, and face).

Sexual dysfunction that continued after discontinuation of treatment has also been noted. Reports include erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders.

The PDR notes that testicular pain was reported.

The PDR states, “Treatment with PROSCAR for 24 weeks to evaluate semen parameters in healthy male volunteers revealed no clinically meaningful effects on sperm concentration, mobility, morphology, or pH. A 0.6 mL (22.1%) median decrease in ejaculate volume with a concomitant reduction in total sperm per ejaculate was observed. These parameters remained within the normal range and were reversible upon discontinuation of therapy with an average time to return to baseline of 84 weeks.

The PDR, in referring to post marketing reports, also states, “male infertility and/or poor seminal quality were reported rarely in men taking PROSCAR for the treatment of BPH. Normalization or improvement of poor seminal quality has been reported after discontinuation of finasteride. The independent role of PROSCAR in these events is unknown.”

Yes.

Children: Finasteride cannot be used in children.

Women: Finasteride is category X for a reason. It can lead to birth defects. Finasteride cannot be used in pregnant, possibly pregnant, or nursing women and should not be used in women at all. If a woman who is pregnant, is breastfeeding, or could possibly be pregnant, touches a tablet, she must wash her hands immediately with soap and water and contact her physician.

Elderly: Men aged 65 and over weren’t included in the early FDA studies on baldness, which used the low 1 mg dose of Finasteride. However, the PDR states, “Based on the pharmacokinetics (the way a drug behaves in the body) of finasteride 5 mg, no dosage adjustment is necessary in the elderly.”

Liver impairment: Since finasteride is metabolized in the liver, men with liver impairment may not be able to clear finasteride from the body as easily as men with normal livers.

Kidney impairment: No dosage adjustment is necessary.

Blood donation

Men using finasteride should not donate blood while on the medication or for one month afterward.

Prostate specific antigen

Prostate specific antigen is a blood test used to screen men for prostate cancer. The problem with finasteride is that it can make the PSA level very low in the men who take finasteride—even men with prostate cancer. This fact makes interpreting levels more difficult. A man with a normal level while on finasteride may still have prostate cancer. Interpreting levels must always be done with this knowledge. Every physician involved in your care must know you are on finasteride.

Also, any increases of PSA while on finasteride must be evaluated. The PDR states, “Any confirmed increase from the lowest PSA value while on finasteride tablets may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5 α-reductase inhibitor (e.g., finasteride).”

Increased risk of high-grade prostate cancer with finasteride and similar drugs

There is the possibility that finasteride may increase the number of men who eventually get high grade prostate cancer. In one study, men aged 55 and over with a normal digital rectal examination and normal PSA “taking finasteride 5 mg/day (5 times the dose of finasteride tablets used for hair loss)…had an increased risk” of higher grade prostate cancer. Some feel that the finasteride makes it easier to detect these higher grade cancers, but it is a risk that should be acknowledged.

The PDR does state, “Whether the effect of 5α-reductase inhibitors (like finasteride) to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.”

In clinical studies, single doses of finasteride up to 400x the dose given for hair loss and multiple doses of finasteride up to 80 g/day given for three months did not result in adverse reactions. At the moment, the PDR does not recommend any specific treatment for an overdose, though extremely high doses can kill rats.

The PDR states, “No drug interactions of clinical importance have been identified.” Compounds that have been tested include antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found. Also, finasteride (1 mg or more), was used in studies with “acetaminophen, acetylsalicylic acid, α-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.” This lack of effect on other medications and inability of other medications to affect a drug (finasteride) is exceedingly uncommon. Still, interactions that have yet to be identified are possible. Therefore, if any should occur report them to the FDA at 1–800–FDA–1088 or http://www.fda.gov/Safety/MedWatch/default.htm.

For best results, follow these four simple steps when applying Roman Hair Solution Rx. Remember to use it only once daily, as directed by your healthcare provider. Using it more often, or using more than the recommended amount, can increase the risk of side effects.

Step 1: Spray it Use the spray to cover the areas on your scalp that experience hair loss, which may include the crown of the head and/or each side of a receding hairline. Do not exceed 4 sprays total. When you spray, make sure you press the sprayer firmly, all the way down.

__Step 2: Massage it __ Once you’ve sprayed on the solution, massage it into the balding areas of the scalp. Tip your head back slightly to prevent any solution from running down your forehead.

Step 3: Remove any excess medication and wash your hands Wipe away any excess medication that may have run onto your face or down your neck, and wash your hands well after you finish.

Step 4: Let it dry Let the solution dry so it can absorb properly into the scalp. If you apply the solution in the morning, try not to get your hair wet before the end of the day. If you apply at night, you can wash your hair the next morning.

Avoid getting the medication in your eyes. If this occurs, rinse your eyes with large amounts of cool water. You may apply the solution to wet or dry hair, but allow it to dry completely before applying other products.

Store your Hair Solution Rx in a cool, dark place, away from direct sunlight. When traveling, try to avoid exposure to excessive heat. If unused, discard after the date listed on your bottle.

If you miss an application for one or more days, don’t double up as a way to “catch up.” Instead, continue applying once per day.

Patients can generally expect to see improvement in hair growth after three months of consistent use, although this time period can vary from person to person. Individual responses can depend on several factors including consistency of use, severity of hair loss, genetics, age, and overall health. Generally, we recommend consistent use for six months before fully evaluating effectiveness. Hair growth is a gradual process and it’s important to have realistic expectations. Roman Hair Solution Rx may not work for everyone. If you’re concerned about the progress of your treatment, please consult with your healthcare provider.

No. Male pattern baldness is unlike many other conditions that lead to baldness (e.g., autoimmune diseases, vitamin deficiency, protein deficiency) in that once it has progressed to the point where the scalp is bald, regrowth is far less likely.

Topical minoxidil is a medication that is commonly used to treat male pattern hair loss. It’s currently available commercially and over the counter as a solution or foam. Note that the concentration of minoxidil in Roman Hair Solution Rx is 6%, which is stronger than the commercially available concentrations of 2% and 5%.

Minoxidil was originally developed and FDA-approved in the oral form to treat hypertension. One of the common side effects noted in 80% of the patients in the clinical trials for minoxidil for blood pressure was hypertrichosis, or “elongation, thickening, and enhanced pigmentation of body hair.” Thus, the idea for a novel, topical treatment for male pattern hair loss was born. Since then, topical minoxidil has been formulated and FDA-approved for androgenic alopecia for both men and women. Oral minoxidil in low doses is also used off-label for the treatment of androgenic alopecia.

The exact mechanism of action of oral minoxidil is not completely understood. It increases the length of the growth phase of hair follicles (a process called “anagen”) and increases the size of hair follicles, which determines the thickness/diameter of the hair that comes out of the follicle, which is thought to lead to promoting hair regrowth.

Minoxidil is also thought to relax smooth muscle in blood vessel walls, causing them to widen and increase blood flow. This may be one of the ways that minoxidil works to stop or slow hair loss and, in some cases, regrow hair.

Topical minoxidil is typically well-tolerated and most people use this treatment with minimal side effects. Common side effects of topical minoxidil include irritation at the site of application, unwanted hair growth, and a temporary shedding of hair.

Other rare but serious side effects of topical minoxidil include:

• Facial swelling or swelling of the face, hands, feet, or lower legs

• Blurred vision or other changes in vision

• Chest pain

• Dizziness

• Fainting

• Fast or irregular heartbeat

• Headache

• Lightheadedness

• Numbness or tingling of hands, feet, or face

• Weight gain

You should stop treatment and contact your provider immediately if you experience any of these serious side effects.

You should inform your provider if you have any of the following conditions:

• Heart disease, congestive heart failure, angina/chest pain

• Pulmonary hypertension

• Hypertension or high blood pressure or if you’re taking medications to control blood pressure

• If you’re already using over the counter treatment for hair loss (Rogaine)

Please read the full PDR for a complete, detailed overview of minoxidil.

Finasteride blocks the conversion of testosterone to dihydrotestosterone (DHT) by inhibiting an enzyme called 5 alpha-reductase. DHT causes androgenic alopecia by a process called “miniaturization,” during which hair follicles shrink and lose the ability to create new hairs. A person’s genetics determines their susceptibility to this type of hair loss. By blocking 5 alpha-reductase, finasteride stops the conversion of testosterone to DHT and therefore, stops or reduces the effect of DHT on the hair follicle. In clinical trials, oral finasteride stopped hair loss and even regrew hair for some. This effect is more significant in the scalp vertex than in the frontal scalp.

Finasteride was originally tested and approved to treat benign prostatic hyperplasia, or enlarged prostate, in a 5 mg oral dose. Later, it was approved and marketed for androgenic alopecia under the trade name Propecia, as a 1 mg dose.

Side effects in men using oral finasteride are generally minimal; nonetheless, some patients experience a decrease in semen production, decreased libido, or erectile dysfunction. These generally resolve either while taking the medication or when the medication is stopped. However, there is the rare possibility that permanent changes can occur in some patients.

Additional rare side effects that have been reported in patients taking oral finasteride include depression, thoughts of suicide or suicidal behavior, breast tenderness, and an association with male breast cancer.

Topical finasteride is an off-label treatment for male-pattern hair loss. The benefit of using topical finasteride is that it is applied directly to the scalp, exhibiting its effects locally with the aim to reduce systemic side effects. Nevertheless, absorption of finasteride into the bloodstream is possible and therefore, the risk of systemic side effects is possible.

Studies of topical finasteride are limited as compared to the extensive research of the oral alternative, but one clinical trial comparing a compounded topical finasteride concentration of 0.25% to oral finasteride and placebo showed a 34.6% reduction in blood DHT levels in those receiving the topical treatment. The study also showed that, despite the reduced DHT in the blood, the patients who used the topical finasteride were less likely to experience sexual side effects than those receiving oral finasteride. It’s important to note that the strength of finasteride in Roman Hair Solution Rx is 0.3%, which is higher than the one used in the cited study. Additionally, Roman Hair Solution Rx is a compounded spray, which also includes minoxidil and tretinoin, so it is possible that the systemic absorption could theoretically reach levels similar to that of oral finasteride.

Finasteride should never be considered for pregnant women, and there are no benefits in that population that outweigh the risk. The FDA has listed it as dangerous in pregnancy, also known as “category X.”

Children should not use finasteride and it should be kept far out of their reach (as should all medications).

If you have a history of hypersensitivity or allergy to finasteride you should avoid using this medication.

Men using finasteride should not donate blood while on the medication or for one month afterward.

Prostate-specific antigen (PSA) is a blood test used to screen men for prostate cancer. Finasteride can make the PSA level very low in men—even those with prostate cancer. A man with a normal PSA level while on finasteride may still have prostate cancer. Interpreting levels must always be done with this knowledge. Every physician involved in your care needs to know if you are on finasteride.

Finasteride may possibly increase the number of men who eventually get high-grade prostate cancer. In one study, men aged 55 and over with a normal digital rectal examination and normal PSA “taking finasteride 5 mg/day (5 times the dose of finasteride tablets used for hair loss)…had an increased risk” of higher-grade prostate cancer. Some feel that the finasteride makes it easier to detect these higher-grade cancers, but it is a risk that should be acknowledged.

Please read the full PDR for a full, detailed overview of finasteride.

While tretinoin alone is not a sufficient treatment for hair loss, it’s sometimes included with other hair loss treatments to increase their efficacy.

A healthy scalp is crucial for supporting hair growth, and tretinoin can improve the overall health and condition of the scalp. Tretinoin's exfoliating properties can help remove dead skin cells, reduce scalp inflammation, and promote a healthier environment for hair follicles.

When applied topically, tretinoin can improve the absorption of minoxidil. By increasing the penetration of minoxidil into the scalp, tretinoin may enhance its effectiveness in promoting hair growth.

Tretinoin may stimulate hair follicles in some cases. While the exact mechanisms are not fully understood, tretinoin is believed to increase the size and activity of hair follicles, potentially leading to improved hair growth in individuals with certain types of hair loss.

Common side effects of tretinoin include:

• Skin irritation, dryness, peeling

• Burning, stinging, or itching

• Increased sensitivity to sunlight

• Skin discoloration

• Exacerbation of acne

• Skin sensitivity

• Allergic reactions

If you experience severe or persistent side effects with tretinoin, or if you have concerns about its use, please let us know.

The following groups should avoid using tretinoin:

• Individuals with a known allergy or hypersensitivity to tretinoin

• Individuals with certain skin conditions, such as eczema, rosacea, or open wounds, should avoid using tretinoin in those areas, unless directed by a healthcare provider

• Women who are pregnant or breastfeeding. Tretinoin is known to have the potential to harm a developing fetus when used during pregnancy. It should not be used by pregnant women, women who are planning to become pregnant, or those who are breastfeeding.

Please read the full PDR for a complete, detailed overview of tretinoin.

Androgenic alopecia (AGA), or male pattern baldness (MPB) affects 98.6% of men. Hair loss is not just a condition of the elderly. From adolescence on, those who are genetically inclined to going bald start losing hair. In fact, over 60% of men have experienced significant hair loss by 35. 20% of men are losing their hair in two places in their early twenties: the hairline and the crown. Those two areas of hair loss ultimately blend into the fully bald top of the head with which we are all too familiar. The remaining “horseshoe” pattern of hair often is all that remains.

As you will read below, even before baldness begins to appear, the process of shrinkage or “miniaturization” of hair follicles begins, and once it has progressed too far, it is irreversible—or nearly so.

For as many as 20% of men, hair loss can begin before their 21st birthday. What is it that makes men so susceptible to male pattern baldness (androgenic alopecia)? Hair loss is due to dihydrotestosterone (DHT). DHT makes the hair follicles vacate a man’s scalp by slowly destroying clusters of hair follicles. DHT causes the hair follicles to miniaturize over many years. The process may begin slowly but the progression is relentless.

At first, only thinning of hair is noticed, not clear baldness. Some men embrace the process, shaving their heads in response, but many regret the appearance of aging while they still feel young and vital. Fortunately, we have an understanding of how DHT undermines hair growth and therapies that exist to interrupt or slow the process.

First, it’s important to know that we’re born with all the hair cells we will ever have: about 5 million of them. The scalp will have the densest concentration of these hair cells and the average head will hold about 100,000 hairs, though it varies by hair color. Blondes average 150,000, brown-haired people have 110,000, and redheads have about 90,000 scalp hairs. There will never be more. The good thing is that hair can regenerate, and every time a hair falls from your head or is found in a brush, another hair stands ready to take its place. Nevertheless, once a hair follicle becomes too shrunken (miniaturized) by the effects of DHT, it becomes exceedingly unlikely that the hair-producing follicle will return to normal function. Totally bald spots will most often remain so. That’s why more and more young men are starting treatment sooner than later.

Hair increases in length by about half an inch every month or six inches each year. There are 100,000 hairs on the scalp and they are never all in the same phase at the same time—otherwise, we would shed all our hair at once and go through cycles of full heads of hair and complete baldness.

There are many causes of hair loss. While this list is not comprehensive, it gives you a sense of how vulnerable hair growth is and how more than one factor is often responsible.

Genetics Genes will determine whether you will preserve hair into your 60s or start losing it in your 20s. A recent study found that there are over 250 genetic areas that influence male pattern baldness (MPB) and they can be inherited from either parent. I may be possible in the future, by analyzing genetic patterns, to predict who is more likely to develop MPB and even at what stage of life. Moreover, knowing the various genes involved may lead to novel hair regrowth treatments.

Poor health Anemia, especially iron deficiency anemia, is a well-known cause of hair loss. Men are susceptible to iron deficiency when eating a diet low in iron. Hair cells divide more rapidly than any others and a balanced diet is essential to healthy hair and nails. One of the problems with identifying hair loss related to diet, stress, or even illness, is that the hair loss can occur months after the triggering event.

It isn’t just poor health due to iron deficiency or anemia that can be a problem. Vitamin B deficiency, protein deficiency, and even Vitamin A excess can all cause hair loss and be rectified with a well-balanced diet, though the short-term use of vitamins to treat deficiencies may be needed.

Chronic illness The physical and emotional stress of any chronic illness can start a cascade of hair loss. Not only the stress but chronic illnesses itself (e.g., cancer, cancer treatment, autoimmune disease) can result in hair loss. Inadequate calorie consumption can cause hair loss. It’s often seen in anorexia nervosa and eating disorders. Thyroid conditions can alter hair growth dramatically. Uncontrolled diabetes is also a cause. Realistically, while some conditions are more frequently associated with shedding hair, any illness can cause hair loss, even something as common as the flu.

Autoimmune disease Autoimmune diseases like lupus are notorious for causing hair loss, occasionally damaging skin so deeply that baldness results. Alopecia areata is an autoimmune disease (sometimes brought on by stress) that can cause areas of complete baldness. Seborrhea and psoriasis are two skin conditions that can occur in multiple locations on the body and can cause hair loss when they affect the scalp.

Scarring from acute injury or chronic inflammation Damage to the skin from any chronic inflammation or from a deep injury like a burn or a deep widespread injury can damage hair follicles. Some autoimmune diseases can cause “scarring alopecia” and hair regrowth will not occur. Unlike almost all the other conditions described, hair will not usually regrow over a deep scar.

Infections Tinea Capitis, a commonly known fungal infection caused by ringworm, is usually seen in children and presents as single or multiple round patches of baldness with broken hairs. Sometimes these patches can be difficult to distinguish from seborrhea or psoriasis. Less familiar are the two types of Piedra (Translation—Stone), which is caused by a fungus and can lead to hard nodules on the scalp.

Hormones Hair growth cycles are very sensitive to hormone levels. Men who use testosterone to bolster their athletic performance (unprescribed) can see male pattern baldness develop rapidly in the same way.

Medications Medications like chemotherapy that affect rapidly dividing cells (like hair cells) will cause anagen effluvium and the sudden loss of hair. Other medications cause hair to go into the resting phase and result in telogen effluvium.

Ultimately, the names of the hair growth phases may not matter, but the list of medications below and the hair loss they may cause matter a great deal. Note if you’re taking any and if they might be playing a role. Other medications may cause hair loss other than those on the list below. If you noticed hair loss after starting a medication, even months later, it’s worth considering whether that medication could potentially be responsible.

Anticoagulants (blood thinners): Hair loss typically begins about 3 months after starting the medication. Drugs include warfarin (Panwarfarin, Sofarin, Coumadin) and heparin injections.

Gout medications: Allopurinol (Lopurin and Zyloprim)

Beta blockers: Beta blockers include Atenolol (Tenormin), Metoprolol (Lopressor), Nadolol (Corgard), Propranolol (Inderal, Inderal LA), Timolol (Blocadren) Nonsteroidal anti-inflammatories: Ibuprofen (Advil, Motrin)

Angiotensin-converting enzyme inhibitors: These are most often used to control blood pressure. Examples include Captopril (Capoten), Enalapril (Vasotec), Lisinopril (Zestril, Prinivil).

Acne medication: Vitamin A can lead to hair loss and Accutane is made from Vitamin A

Antidepressants: Amitriptyline (Elavil, Endep), Amoxapine (Asendin), Clomipramine (Anafranil) Desipramine (Norpramin, Pertofrane), Doxepin (Adapin, Sinequan), Fluoxetine (Prozac), Haloperidol (Haldol), Imipramine (Janimine, Tofranil, Tofranil PM), Nortriptyline, (Pamelor, Aventyl), Paroxetine (Paxil), Protriptyline (Vivactil), Sertraline (Zoloft), Trimipramine (Surmontil)

Anti-seizure medications: trimethadione (Tridione) and valproic acid (Depakote).

Stress-related hair loss Stressful life events (e.g., death of a loved one, illness, or divorce) can lead to hair loss, resolving completely when the stress is relieved.

Lastly, an inability to control the urge to pull repeatedly on hair can lead to hair loss. This is an impulse control disorder called trichotillomania.

Inappropriate grooming Even a good thing can be overdone. Excessive pressure placed on hair follicles by pulling hairs too tightly, as with ponytails or cornrowing, can cause hair loss.