Finasteride & Minoxidil Plus+

Why is this medication prescribed?

• Finasteride (Topical). Finasteride is used to treat male pattern hair loss: the gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head in men. Finasteride has not been shown to treat thinning hair at the temples and is not used to treat hair loss in women or children. Unlike oral finasteride, topical finasteride is not used to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland). Finasteride treats male pattern hair loss by blocking a male hormone in the scalp that stops hair growth, with less systemic absorption than the oral version.

  
  

• Minoxidil (Topical). Minoxidil is used to treat hair loss in men and women. It is thought to work by dilating the blood vessels and supplying nutrient-rich blood to the hair follicles. Exactly how this process works is not well-understood.

  
  

• Fluocinolone (Topical). Fluocinolone is used to treat itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin disorders and conditions. Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

  
  

• Retinoic Acid (Topical). Retinoic Acid (aka Tretinoin) is used to treat acne, reduce fine wrinkles, and improve spotty discoloration and rough-feeling skin. It is in a class of medications called retinoids. It works by increasing skin cell turnover, promoting peeling of affected skin areas and unclogging pores.

  
  

How should this medicine be used?

Finasteride & Minoxidil Plus+ (“Plus+”) comes as a spray that should be applied to the affected area once per day, preferably at around the same time every day.

1. Wash your hands and hair/scalp with water and mild, bland, neutral soap or shampoo. Avoid soaps/shampoos that contain:

   • Conditioners, moisturizers, or skin protectants (could reduce Plus+ Spray effectiveness);

     
     

   • Medications or abrasives (such as anti-dandruff or clarifying products);

     
     

   • Ingredients that are drying or formulated for oily hair/skin.

     
     
   
   

2. Apply Plus+ spray to a completely dry scalp. If you do not blow dry, wait at least 20-30 minutes before applying Plus+ Spray. Longer hair = longer wait time.

   
   

3. Spray the required amount into your palm or directly onto the affected area (i.e., where hair is thinning and surrounding areas).

   
   

4. Use clean fingertips to massage the medication thoroughly into the affected area.

   
   

5. Use enough medication to cover the affected area with a thin layer.

   
   

6. Wash your hands thoroughly after applying the medication.

   
   

7. Do not wrap or bandage, and avoid tight-fitting headgear (such beanies).

   
   

Apply the medication to the affected skin area only. Do not let the medication get into your mucous membranes, such as eyes, ears, mouth, corners along your nose, and rectal/genital areas. Do not apply on areas of sunburn.

Follow the directions on your prescription label carefully. Ask your doctor or pharmacist to explain any part you do not understand. Use exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.Using more medication or using it more often will not improve results.

Hair loss and growth happen slowly over time, so it will take at least 3 months of consistent, daily use for most people to see improvement to their hair. Maximum results (the most improvement you can expect from using the medication) are typically achieved after 12 months of as-directed use. If you do not see improvement during the first 12 months of treatment, talk to your doctor about whether you should continue.

The medication only works for as long as you keep using it.So, don’t stop without talking to your doctor - even if you have already noticed improvement. If you do stop, you will probably lose any hair that grew back while you were using the medication. Depending on how long you used the medication, this could mean that you wind up with significantly less hair than when you started. In other words, your hair will probably (and quickly) go back to what it would have been like if you had never used the medication in the first place.

Other uses for this medicine

The ingredients in this medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using Finasteride & Minoxidil Plus+,

• If you are already taking finasteride (oral) or if you have ever been diagnosed with BPH, talk to your doctor before using this medication. Studies have shown that topical use of finasteride (like in the Plus+ Spray) can result in systemic absorption. Continue to take your finasteride (oral) even if you feel well, and do not stop without talking to your doctor

  
  

• Use only nonmedicated shampoos and cosmetics on treated areas. Avoid skin or hair products with a lot of alcohol, menthol, spices, or citrus (e.g., shaving lotions, astringents, and perfumes), as they can sting your skin, especially when you first use the product

  
  

• Do not use any other topical medications on the affected area, such as benzoyl peroxide, hair removers, and dandruff shampoos (especially if they contain salicylic acid, sulfur or resorcinol) unless your doctor directs you to do so. If you have used any of these topical medications recently, ask your doctor if you should wait before using Plus+ Spray

  
  

• Tell your doctor if you have a skin infection or any other skin problems or have ever had diabetes or Cushing's syndrome (an abnormal condition that is caused by excess hormones [corticosteroids])

  
  

• Tell your doctor if you are taking guanethidine (Ismelin) or other medications for high blood pressure

  
  

• Tell your doctor if you have or have ever had heart, kidney, liver, or scalp disease

  
  

• Avoid unnecessary or prolonged exposure to sunlight, and wear protective clothing and sunscreen. The ingredients in Plus+ Spray (especially Minoxidil and Retinoic Acid) may make your skin more sensitive to sunlight.Do not apply on areas of sunburn

  
  

• Tell your doctor and pharmacist if you are allergic to finasteride, minoxidil, fluocinolone, retinoic acid (tretinoin), any other medications, or any of the ingredients in the Plus+ Spray. Ask your pharmacist or check the patient information for a list of the ingredients

  
  

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects

  
  

• Tell your doctor if you have or have ever had liver disease or prostate cancer

  
  

• You should know that Finasteride is only for use in men. Women, especially those who are or may become pregnant, should not use Plus+ Spray - or be exposed to it. Finasteride can be absorbed through the skin, and even very small amounts can harm the fetus. Wash your hands immediately after using this product. If a woman who is pregnant or who could become pregnant comes into contact with Plus+ Spray, she should wash the area with soap and water immediately and call her doctor

  
  
• Keep this medication (and all others) out of the reach and sight of children.,
  

What should I do if I forget a treatment?

Skip the missed treatment and continue your regular schedule. Do not treat twice (or increase the amount) to make up for a missed treatment.

What side effects can this medication cause?

May cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Inability to have or maintain an erection

• Decreased sexual desire

• Problems with ejaculation (including decreased volume of ejaculate)

• Pain in the testicles

• Depression

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• Changes in the breasts such as increased size, lumps, pain, or nipple discharge

• Rash

• Itching

• Hives

• Swelling of the lips and face

• Difficulty breathing or swallowing

Finasteride may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Finasteride may increase the risk that you will develop high-grade prostate cancer (a type of prostate cancer that spreads and grows more quickly than other types of prostate cancer). Talk to your doctor about the risks of taking finasteride.

May cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Red, scaling, or peeling skin at the treatment site (may present as dandruff), usually disappearing after 2-3 weeks.

• Warmth or slight stinging of the skin at the treatment site

• Lightening or darkening of the skin at the treatment site

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• Itching

• Hives

• Swelling of the lips and face

• Difficulty breathing or swallowing

• Pain or discomfort (other than slight, temporary stinging) at the treatment area

May cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Burning, itching, irritation, redness, or drying of the skin at the treatment site

• Acne at the treatment site

• Change in skin color at the treatment site

• Bruising or shiny skin at the treatment site

• Tiny red bumps or rash around the mouth

• Small white or red bumps on the skin

If you experience any of the following symptoms, call your doctor immediately:

• Severe skin rash

• Hives

• Difficulty breathing or swallowing

• Wheezing

• Swelling of the lips and face

• Signs of skin infection, such as fever or (at the treatment site) heat, swelling, or significant pain or redness

May cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Scalp itching, dryness, scaling, flaking, irritation, or burning

If you experience any of the following symptoms, call your doctor immediately:

• Weight gain

• Swelling of the face, ankles, hands, or stomach

• Difficulty breathing (especially when lying down)

• Rapid heartbeat

• Chest pain

• Lightheadedness

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online http://www.fda.gov/Safety/MedWatchor by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill organizers and those for Minoxidil & Finasteride Plus+ Spray, but also eye drops, creams, patches, and inhalers) are not child-resistant; and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

This product contains medications deemed hazardous by the National Institute for Occupational Safety & Health (NIOSH) and require special precaution when disposing. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them, preferably in a sealed container. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking finasteride.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.