Minoxidil Topical

Hair stimulant; a piperidinopyrimidine-derivative vasodilator.5 19 20 37 43 44 73 4 9 14 15 20 40 43 56

Absorption

Bioavailability

Minimally absorbed following topical application to intact scalp;1 15 16 43 61 1.4% of a 2% topical solution may be absorbed.70

Onset

Onset of hair regrowth is variable; however, 2 or ≥4 months usually required before evidence of regrowth is observed following topical administration with 2 or 5% topical solutions, respectively.1 23 25 27 30 34 36 59 101 116 117 121 122 123 126

Distribution

Extent

Not fully determined following topical administration;100 101 however, intact stratum corneum may serve as a barrier that inhibits substantial diffusion of topically applied minoxidil into systemic circulation.68 71 101

Not known whether topical minoxidil crosses the placenta or is distributed into milk.1 72 e

Elimination

Metabolism

Not fully determined following topical administration;1 however, appears to be converted in the hair follicle to an active metabolite, minoxidil sulfate, by minoxidil sulfotransferase.17

Elimination Route

Excreted principally in urine.61

• Product is flammable; importance of keeping product and area of application away from open flame and heat.a b c d

• Importance of using only as directed, only for the indicated types of hair loss, and for at least 2–4 months in order to see results; continuous use required to maintain hair regrowth.a b c d (See Topical Administration under Dosage and Administration.)

• Importance of applying only to healthy, normal scalp and not using topical minoxidil if scalp is inflamed, erythematous, infected, irritated, or painful.116 117 121 122 123 Importance of avoiding contact with the eyes.a b c d

• Importance of washing hands after application.a b c d

• Importance of women using only 2% solution; 5% solution and 5% foam should not be used in women.a b c d

• Importance of reporting any local or systemic adverse reactions, especially chest pain, tachycardia, dizziness, unexplained weight gain, or peripheral edema, to a clinician.a b c d

• Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a b c d

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b c d

• Importance of informing patients of other important precautionary information.a b c d (See Cautions.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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

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

Hair loss may continue for 2 weeks after you start using minoxidil. Tell your doctor if your hair loss continues after 2 weeks. Also, tell your doctor if your hair growth does not increase after using minoxidil for 4 months.

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.

Check with your doctor as soon as possible if any of the following side effects occur:

• Itching or skin rash (continued)

• Acne at site of application
• burning of scalp
• facial hair growth
• increased hair loss
• inflammation or soreness at root of hair
• reddened skin
• swelling of face

• Blurred vision or other changes in vision
• chest pain
• dizziness
• fainting
• fast or irregular heartbeat
• flushing
• headache
• lightheadedness
• numbness or tingling of hands, feet, or face
• swelling of face, hands, feet, or lower legs
• weight gain (rapid)

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

There are no dosage adjustments provided in the manufacturer’s labeling

Foam: Store at 20°C to 25°C (68°F to 77°F). Do not puncture or incinerate container. Do not expose to heat or store at temperatures >49°C (120°F).

Solution: Store at 20°C to 25°C (68°F to 77°F).

CycloSPORINE (Systemic): May enhance the adverse/toxic effect of Minoxidil (Topical). Specifically, hypertrichosis risk may be increased. Monitor therapy

Do not use minoxidil topical if the skin on your scalp is red, swollen, irritated, or infected. This may allow more of the medication to be absorbed by your body, which could be dangerous.

Check the medicine label carefully to make sure minoxidil topical will treat your specific type of hair loss.

Use only the minoxidil topical formula that is made for your gender. Women should not use minoxidil topical products that are made specifically for men.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• heart disease.

FDA pregnancy category C. It is not known whether minoxidil topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether minoxidil topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not use this medicine on anyone under 18 years old without medical advice.

Burning, stinging, or redness at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, this medication can be absorbed through the skin and cause side effects. Stop using this medication and tell your doctor right away if you have any serious side effects, including: unwanted facial/body hair, dizziness, fast/irregular heartbeat, fainting, chest pain, swelling of hands/feet, unusual weight gain, tiredness, difficulty breathing especially when lying down.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

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

Before using minoxidil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: diseases of the scalp (e.g., eczema, infection, cuts), heart problems (e.g., chest pain, heart attack, heart failure), kidney disease, liver disease.

During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.