Topical Finasteride 2.5% & Minoxidil 5% Gel Safety Information

What is Topical Finasteride & Minoxidil Gel?

Topical finasteride & minoxidil gel is a prescription medication used for the treatment of male pattern hair loss (androgenetic alopecia). It is a treatment alternative to oral finasteride that has been shown in research studies to be safe and effective.

Unlike oral finasteride, topical finasteride & minoxidil gel is a compounded product and has not been authorized by Health Canada. It is only available if prescribed after an online consultation with a medical provider through Essential Clinic.

The use of topical finasteride to treat hair loss has not been as comprehensively studied as oral finasteride. While research has shown that serum DHT levels decrease while using topical finasteride, the systemic side effects (e.g., sexual dysfunction) typically associated with oral finasteride were not reported in the studies of topical finasteride.

Topical finasteride 2.5% & minoxidil 5% gel should not be used at the same time as any other topical minoxidil product or oral finasteride or dutasteride product.

Do not allow individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, or children handle this medication. Do not allow any of these individuals to come into contact with the treatment site (your scalp) after the medication has been applied. If they do, they should immediately clean the site of contact on their skin with soap and water.

If hair growth is going to occur with the use of topical finasteride & minoxidil, it usually occurs after the medicine has been used for several months and lasts only as long as the medicine continues to be used. Hair loss will begin again within a few months after treatment is stopped.

This product is available in the following dosage forms:

• Gel
• Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your clinician will make. For this medicine, the following should be considered:

Allergies

Tell your clinician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric, Pregnancy, & Breastfeeding

This medicine should not be used by women or children. Do not allow individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, or children handle this medication. Do not allow any of these individuals to come into contact with the treatment site (your scalp) after the medication has been applied. If they do, they should immediately clean the site of contact on their skin with soap and water.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Do not use this medicine if you are taking oral finasteride or dutasteride for hair loss or for treatment of an enlarged prostate (Propecia, Proscar, Avodart - any 5-alpha reductase inhibitor). Oral finasteride / dutasteride and topical finasteride & minoxidil cannot be used at the same time.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your clinician if you have any other medical problems, especially:

• Chronic liver disease
• History of breast cancer
• History of prostate cancer
• Any skin problems, an irritation, or a sunburn on the scalp— these conditions may cause too much topical minoxidil or finasteride to be absorbed into the body and may increase the chance of side effects.

Proper Use

This medicine usually comes with patient instructions. It is important that you read the instructions carefully.

It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your clinician ordered. To do so may increase the chance of it being absorbed through the skin. For the same reason, do not apply topical finasteride & minoxidil to other parts of your body. Absorption into the body may affect the heart and blood vessels and cause unwanted effects.

Do not use any other skin products on the same skin area on which you use topical finasteride and minoxidil. Hair coloring, hair permanents, and hair relaxers may be used during therapy as long as the scalp is washed just before applying the hair coloring, permanent, or relaxer. Topical finasteride & minoxidil should not be used 24 hours before and after the hair treatment procedure. Be sure to not double your doses of topical finasteride & minoxidil to make up for any missed doses.

• Use this medication exactly as your healthcare provider tells you to use it.
• Do not use this medication more than twice a day as it will not improve results and can increase the risk of side effects.
• Wash your hands with soap immediately after applying this medication to your scalp.

If your scalp becomes abraded, irritated, or sunburned, check with your clinician before applying minoxidil.

Topical finasteride & minoxidil gel is for use on the scalp only. Keep this medicine away from the eyes, nose, and mouth. If you should accidentally get some in your eyes, nose, or mouth, flush the area thoroughly with cool tap water.

Dosing

The dose of this medicine will be different for different patients. Follow your clinician’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your clinician tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For hair growth:
  • Apply 2 Pumps (1ml) to the scalp once a day.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Individuals who are pregnant or breastfeeding, individuals who have the potential to become pregnant, or individuals under the age of 18 should not handle this medication.

Do not keep outdated medicine or medicine no longer needed.

Precautions

It is important that your clinician check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Tell your clinician if you notice continued itching, redness, or burning of your scalp after you apply topical finasteride & minoxidil. If the itching, redness, or burning is severe, wash the medicine off and check with your clinician before using it again.

Hair loss may continue for 2-8 weeks after you start using topical finasteride & minoxidil gel. Tell your clinician if your hair loss continues after 8 weeks. Also, tell your clinician if your hair growth does not increase after using topical finasteride & minoxidil gel for 4 months.

Do not use this medication for a condition for which it was not prescribed. Do not give this medication to other people, even if they have the same symptoms you have. It may harm them. Minoxidil is suspected to be toxic to cats and dogs. Please do not allow cats, dogs, or other pets to ingest this medication or to come into contact with the treatment site after the medication has been applied. If these occur, consult your pet's veterinarian.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

The most common side effects of topical finasteride + minoxidil gel typically occur at the site of medication application (scalp). These side effects include:

• Itching
• Redness
• Irritation
• Burning sensation
• Contact dermatitis
• Dry, & flaky scalp

If you develop any of the following side effects, stop using this topical medication and contact your clinician as soon as possible:

• Chest pain
• Rapid heart beat
• Faintness or dizziness
• Sudden & unexplained weight gain
• Swelling of hands or feet
• Breast tenderness/enlargement
• Unwanted facial hair growth
• Sexual dysfunction (e.g., low libido, erectile dysfunction, decreased volume of ejaculate)
• Symptoms of depression
• No scalp hair regrowth after 6 months of use
• Severe scalp irritation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Contact your clinician for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.