Minoxidil (Rogaine)

1. Health Canada Product Monograph — Minoxidil

• Topical minoxidil 2% solution and 5% foam are used to treat male pattern hair loss (androgenetic alopecia) on the top of the scalp in men.
• Topical minoxidil 5% foam is used to treat female pattern hair loss on the top of the scalp in women.
• It is effective only for hair loss caused by hereditary male or female pattern baldness, not for other causes of hair loss, receding hairlines, or hair loss that is sudden or patchy in pattern.

Contraindicated in pregnancy. Confirm pregnancy status and discuss alternative therapy with the prescriber before dispensing.

• Topical minoxidil is contraindicated in pregnancy, since there are no adequate studies in pregnant women.

• Topical minoxidil is contraindicated during breastfeeding, since absorbed minoxidil is known to pass into human breast milk.

• Safety and efficacy of the men's 2% solution and 5% foam have not been established in men over 65 and should not be used in this age group.
• The women's 5% foam has been shown to be safe and effective in women up to 87 years of age.

• Safety and efficacy have not been established in anyone under 18, and Health Canada has not authorized a pediatric indication.
• Accidental skin contact with a treated scalp has caused reversible excess hair growth (hypertrichosis) in infants and children, so contact between children and treated areas should be avoided.

• Men's 2% solution: 1 mL is applied to the affected scalp area twice daily, regardless of the size of the area, up to a maximum of 2 mL per day; apply only to a dry scalp and wash hands thoroughly afterward.
• Men's 5% foam: half a capful, about 1 gram, is applied to the affected scalp area twice daily, up to a maximum of 2 grams per day.
• Women's 5% foam: half a capful, about 1 gram, is applied once daily to the thinning areas of the scalp and left on for at least 4 hours for best results.
• Visible hair regrowth typically takes 2 months or more of consistent twice-daily use to appear, and continued use is needed to maintain any regrowth.
• Treatment should be stopped if there is no improvement after one year of consistent use.
• If a men's dose is missed, apply as soon as remembered if within a few hours of the usual time; otherwise skip it and resume the regular schedule without doubling the next dose.
• If a women's foam application is missed, skip the missed dose and resume the normal schedule; do not use twice as much or twice as often.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Minoxidil is for external scalp use only and must not be swallowed; accidental ingestion can cause serious heart-related effects, including lowered blood pressure, fast heart rate, and fluid retention.
• Reported cases of accidental or intentional ingestion have caused rapid heartbeat, low blood pressure, fainting, heart attack, and acute kidney failure.
• Fluid retention from an overdose can be managed with an appropriate diuretic, and a fast heart rate can be controlled with a beta-blocker.
• Minoxidil and its breakdown products can be removed by dialysis, though this does not quickly reverse its effects.
• Severe low blood pressure from an overdose is treated with intravenous normal saline; epinephrine and norepinephrine should be avoided because they can excessively stimulate the heart.

• Scalp itching may occur.
• Scalp irritation, dryness, or scaling may occur.
• Skin rash may occur.
• Acne at the application site may occur.
• Redness (erythema) of the scalp may occur.
• Headache may occur.
• Increased shedding of hair may occur in the first two to six weeks of treatment as hair growth cycles shift; this typically resolves and is not a reason to stop unless it persists beyond two weeks.
• Changes in hair colour or texture have been reported.
• Cold or respiratory infection symptoms, such as a runny nose, sinus congestion, or cough, have been reported.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Excess, unwanted hair growth (hypertrichosis) can occur on the face or other skin areas that come into contact with the product.
• Allergic reactions, including swelling of the lips, mouth, or throat (angioedema) and generalized hives or itching, have been reported.
• Contact dermatitis (allergic skin reaction) can occur.
• Chest pain, a rapid or irregular heartbeat, fainting, or dizziness can signal that minoxidil has been absorbed into the bloodstream in amounts sufficient to affect the heart or blood pressure, and treatment should be stopped and a doctor consulted.
• Sudden unexplained weight gain or swelling of the hands or feet can indicate fluid retention from systemic absorption.
• Seek urgent medical attention for chest pain, a fast or irregular heartbeat, fainting, severe dizziness, or swelling of the face or throat.

• Use with caution in patients with known cardiovascular disease or a history of cardiac arrhythmia; consult a physician before starting treatment.
• Use with caution in patients with a scalp abnormality, including psoriasis or sunburn, or with a shaved, broken, inflamed, infected, or severely sunburned scalp, since these increase absorption and irritation risk.
• Do not use together with occlusive dressings or other topical medications on the scalp, since these can increase absorption of minoxidil.
• Avoid inhaling the spray or foam, and avoid contact with the eyes; if accidental contact occurs, rinse thoroughly with cool water.
• The solution and foam contain alcohol-based and other ingredients, including butylated hydroxytoluene, cetyl alcohol, and stearyl alcohol, that can cause local skin reactions in sensitive individuals.
• Do not use if hair loss is sudden, patchy, or not clearly related to hereditary pattern baldness, since minoxidil is not effective for these causes and an underlying condition may need evaluation.
• Certain medications, treatments such as chemotherapy, and conditions such as thyroid disorders, iron deficiency, or secondary syphilis can cause temporary hair loss that should not be treated with minoxidil.

• Contraindicated in women who are pregnant, breastfeeding, or have hair loss related to childbirth.
• Contraindicated in patients with known hypersensitivity to minoxidil or to any ingredient in the formulation.
• Contraindicated in patients with treated or untreated high blood pressure.
• Contraindicated in patients whose hair loss is not due to hereditary pattern baldness.

• Other topical medications that alter the skin's outer barrier, such as tretinoin or anthralin, may increase absorption of minoxidil if used on the scalp at the same time.
• Topical corticosteroids such as betamethasone can change how much minoxidil is absorbed into the skin versus the bloodstream.
• There is a theoretical risk that absorbed minoxidil could add to the blood-pressure-lowering effect of other vasodilator medications, such as hydralazine.

• Minoxidil is applied to the scalp and is not taken by mouth, so food timing does not apply.

• Men's solution and foam are applied twice daily, and women's foam is applied once daily, to a clean, dry scalp; the exact time of day does not matter as long as the schedule is kept consistent.

• Store the topical solution and foam at controlled room temperature, between 15°C and 30°C.
• Keep the foam canister upright, avoid puncturing or incinerating it, and do not expose it to heat above 50°C.

• Minoxidil (Rogaine) is a topical treatment applied directly to the scalp to help regrow hair lost to hereditary pattern baldness in men and women.
• It must be applied consistently, exactly as directed, for at least 2 months before any regrowth is likely to be seen, and ongoing use is needed to maintain results.
• Minoxidil is for external use on the scalp only; accidental swallowing can cause serious heart-related effects and needs urgent medical attention.
• Stop using minoxidil and see a doctor for chest pain, rapid heartbeat, fainting, or swelling of the hands, feet, or face.