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WOMEN'S ROGAINE is a brand name for Minoxidil, supplied as a aerosol, foam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Men’s ROGAINE (Minoxidil Topical 2% Solution) and Men’s ROGAINE FOAM 5% (Minoxidil Foam 5% w/w) are indicated for: • the treatment of male androgenetic alopecia (male pattern hair loss) on the top of the scalp (vertex). Women’s ROGAINE FOAM 5% (Minoxidil Foam 5%w/w) is indicated for: • the treatment of female…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • FOR EXTERNAL USE ONLY. Do not ingest. Use Women’s Rogaine Foam 5% (minoxidil topical foam), Men’s ROGAINE (minoxidil topical solution) or Men’s ROGAINE FOAM 5% (minoxidil topical foam) only as directed. Apply Women’s Rogaine Foam 5%, Men’s ROGAINE or Men’s ROGAINE FOAM 5% when the hair and scalp are thoroughly dry.
The safety and efficacy of Men’s ROGAINE or Men’s ROGAINE FOAM 5% in users aged under 18 or in men over 65 years of age have not been established. Women’s Rogaine Foam 5% has been found to be safe and effective in women from 18 up to 87 years of age.
2 Recommended Dose and Dosage Adjustment Men’s ROGAINE A total dose of 1 mL Men’s ROGAINE (20 mg minoxidil) should be applied twice per day to the scalp, beginning at the centre of the affected area. This dose should be used regardless of the size of the affected area.
The total daily dose should not exceed 2 mL (40 mg minoxidil). After applying Men’s ROGAINE, wash hands thoroughly. Do not apply Men’s ROGAINE to any other area of the body. Men’s ROGAINE FOAM 5% A dose of half (½) capful (equal to 1 gram of foam or 50 mg minoxidil), Men’s ROGAINE FOAM 5% should be applied to the total affected hair loss areas of the scalp (not on the hair) twice daily.
The total daily dosage should not exceed 2 grams of foam (100 mg minoxidil) in men. It may take twice-daily applications for 2 months or more before evidence of hair growth can be expected. If hair regrowth occurs, twice daily applications of Men’s ROGAINE FOAM 5% are necessary for continued hair growth.
Regrown hair may disappear three to four months after stopping Men’s ROGAINE FOAM 5% application and the balding process will continue. Treatment should be discontinued if there is no improvement after one year. Men’s ROGAINE® Minoxidil Topical 2% Solution Men’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Women’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Page 6 of 67 Women’s ROGAINE FOAM 5% Apply half (½) capful foam (50 mg minoxidil) on a clean non-absorbent surface such as a dish.
Make a centre part within the hair thinning areas to help maximize scalp exposure. Part the hair at least 2 more times on each side of the centre part around the thinning area. Spread the foam with the fingertips over the hair loss scalp areas and gently massage foam into the scalp starting from the back to front (forehead) direction.
09%). 43%). 7% for Placebo Foam group) were not considered drug related, and no serious event resulted in discontinuing study participation. 7% in the Rogaine Foam 5% group, 7% in the Placebo Foam group) reflected mild to moderate pain or skin irritation.
2% in the Placebo Foam group) were headache, alopecia, and rash (one case each) in the Rogaine Foam 5% group, and tachycardia, nausea, and hyperventilation (one case each) in the Placebo Foam group. 2% for Placebo Foam). 0% for Placebo Foam).
2% for Placebo Foam). 0% for Placebo Foam). 0% for Placebo Foam). For the long-term treatment with Men’s ROGAINE FOAM 5% BID (an open-label safety extension phase of Study 006), 114 subjects out of 143 subjects completed one year of treatment.
1% of the subjects reported adverse events. 3%). 0 %) but were not considered to be drug related. All other adverse events were considered mild or moderate in nature. 2% of the subjects reporting adverse events. 8% overall). Women’s ROGAINE FOAM 5% The clinical trial safety database comprises a total of 942 subjects, of whom 576 were treated with one or more formulations of 5% Minoxidil Topical Foam (MTF).
In the placebo-controlled phase 3 study of efficacy and safety (MINALO3005), patterns of adverse events indicated that both 5% MTF once daily and foam vehicle were well tolerated by the subjects. No difference in the overall incidence of adverse events between treatment groups (approximately 50% of subjects in each group) was observed.
The incidence of specific adverse events was generally similar between the treatment groups. 5%, respectively). In the active-controlled phase 3 study of efficacy and safety (MINALO3004), patterns of adverse events indicated that both 5% MTF once daily and 2% Minoxidil Topical Solution (MTS) applied twice daily were well tolerated by the subjects.
General • Men’s ROGAINE, Men’s ROGAINE FOAM 5% and Women’s ROGAINE FOAM 5% are for external use only. Apply only to scalp. Do not ingest. • Before applying Men’s ROGAINE, Men’s ROGAINE FOAM 5%, or Women’s ROGAINE FOAM 5%, the user should determine that the scalp is normal and healthy.
• Hands should be washed thoroughly after use. • Inhalation of the spray should be avoided. • Men’s ROGAINE, Men’s ROGAINE FOAM 5% and Women’s ROGAINE FOAM 5% contain ethanol (alcohol) which will cause burning and irritation of the eye.
In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), the area should be bathed with large amounts of cool tap water. • Men’s ROGAINE FOAM 5% and Women’s ROGAINE FOAM 5% also contain butylated hydroxytoluene, cetyl alcohol, and stearyl alcohol.
, contact dermatitis), or irritation to the eyes or mucous membranes. , contact dermatitis). Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Topical Solution / 20 mg/mL (2%) minoxidil Alcohol 60% v/v, Propylene Glycol, Purified Water.
Topical Foam / 50 mg/g (5%) minoxidil Butylhydroxytoluene (BHT), Cetyl Alcohol, Citric Acid Anhydrous, Glycerol Anhydrous, Lactic Acid, Polysorbate 60, Propellant Aeropin 70 (Propane, Butane, Isobutane), Purified Water, SD Alcohol 40-B, Stearyl Alcohol.
Men’s ROGAINE® Minoxidil Topical 2% Solution Men’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Women’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Page 9 of 67 • Some patients have experienced changes in hair colour and/or texture with Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5% use.
• Shedding of hair may occur within two to six weeks after initiating therapy, likely due to minoxidil’s action on shifting hairs from the resting telogen phase to the growing anagen phase. If shedding persists for more than two weeks, users should stop applying Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5% and consult their doctor.
Men’s ROGAINE, Men’s ROGAINE FOAM 5% and Women’s ROGAINE FOAM 5% are contraindicated: • in Women who are pregnant or breastfeeding or have hair loss associated with childbirth. • in individuals with a history of hypersensitivity to minoxidil or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • in individuals with treated or untreated hypertension. • in individuals whose baldness is not due to hereditary factors. Men’s ROGAINE and Men’s ROGAINE FOAM 5% are only effective for the treatment of male vertex alopecia androgenetica.
Women’s ROGAINE FOAM 5% is only effective for the treatment of hair loss on the top of the scalp (female pattern hair loss). Men’s ROGAINE® Minoxidil Topical 2% Solution Men’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Women’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Page 5 of 67 • in individuals with any scalp abnormality (including psoriasis and sunburn).
• in individuals with a shaved scalp or whose scalp’s skin is broken, inflamed, irritated, infected, or severely sunburned. • if occlusive dressings or other topical therapeutic medications for treating disorders of the skin of the scalp are being used.
, cornrowing, tight ponytails), may also cause temporary hair loss which should not be treated with Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5%.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Massage until all the foam dose is gone. After each use, thoroughly clean and dry the non-absorbent surface to which the foam was placed before applying to the scalp. The hands should be washed well with soap and water after the application.
Allow Women’s ROGAINE FOAM 5% to remain on scalp for at least 4 hours for best results. Health Canada has not authorized an indication for pediatric use. 4 Administration Men’s ROGAINE Child-Resistant Dropper Works best for applying Men’s ROGAINE to small areas of the scalp or under hair.
1) Remove cap by pushing down while turning the cap counter clockwise. 2) Squeeze the rubber bulb and insert the dropper into the bottle. 3) Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL level, squeeze the extra amount back into the bottle.
4) Place the tip near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a time. 5) Replace the dropper in the bottle and screw on tightly.
6) For future use, the dropper can be removed by pushing down while turning the dropper cap counterclockwise.
Men’s ROGAINE FOAM 5% and Women’s ROGAINE FOAM 5% 1) To open container:
Match arrow on can ring with arrow on cap. Pull off cap. 2) Hold the can upside down and press nozzle to dispense the foam. The total amount of foam applied should not exceed half (½) capful (equivalent to one gram of foam) 3) The foam may begin to melt on contact with warm skin.
If your fingers are warm, rinse them in cold water first. Be sure to dry them thoroughly before handling the foam. 4) The foam should be massaged lightly into the affected areas of the scalp. 5 Missed Dose Men’s ROGAINE If a dose is missed, Men’s ROGAINE should be applied as soon as remembered, if within a few hours of the time usually applied.
Do not apply if it is almost time for the next dose. If a dose is missed, the amount used in the next regular dose should not be doubled. Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5% Men’s ROGAINE® Minoxidil Topical 2% Solution Men’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Women’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Page 7 of 67 If one or two applications are missed, the missed application(s) should be skipped, and treatment should be resumed with the next scheduled application/dose.
Do not use twice as much, or twice as often, the prescribed dose.
3% in 2% MTS twice daily). 0%). 0%). In MINOB-9140-004, because subjects received all study medications simultaneously via skin patches, no comparison of adverse event incidences between treatments is possible. In MINOB-9140-001, the Men’s ROGAINE® Minoxidil Topical 2% Solution Men’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Women’s ROGAINE® FOAM 5% Minoxidil Foam 5% w/w Page 12 of 67 numbers of subjects receiving 2% MTS or 5% MTS were too small to allow meaningful comparison of adverse event rates between treatments.
In addition, in the phase 3 studies, serum minoxidil concentrations were to be determined at the […]
• Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5% should not be used when there is no family history of hair loss, hair loss is sudden and/or patchy, or the reason for hair loss is unknown. • Cases of hypertrichosis have been reported in infants following skin contact with minoxidil application site of patients (caregivers) using topical minoxidil.
Hypertrichosis was reversible, within months, when infants were no longer exposed to minoxidil. Contact between children and minoxidil application sites should be avoided. Cardiovascular • Accidental ingestion may cause serious cardiac adverse events.
• Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5%. • Although the following systemic effects have not been associated with the topical use of Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5%, there is some absorption of minoxidil from the skin and the potential exists for systemic effects such as salt and water retention, hypertension, tachycardia, angina, and edema.
• The patient should stop using Men’s ROGAINE, Men’s ROGAINE FOAM or Women’s ROGAINE FOAM 5% and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet, or persistent redness.
Monitoring and Laboratory Tests Patients should be monitored for signs of systemic effects of minoxidil such as hypotension, chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet, persistent redness or irritation of the scalp.
The use of Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5% should be discontinued in the event of systemic effects and/or severe dermatologic reactions. 1 Pregnant Women There are no adequate and well-controlled studies in pregnant women using Men’s ROGAINE, Men’s ROGAINE FOAM 5% or Women’s ROGAINE FOAM 5%.
These products should not be used in pregnant women. 2 Breast-feeding There are no adequate and well controlled studies in breastfeeding women. Systemically absorbed minoxidil is secreted in human milk. Men’s ROGAINE, Men’s ROGAINE FOAM 5% and Women’s ROGAINE FOAM 5% should not be used in nursing women.
3 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Men’s ROGAINE, Men’s ROGAINE FOAM or Women’s ROGAINE FOAM 5% in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
1 Pediatrics. Accidental ingestion may cause serious cardiac adverse events. Therefore, this product has to be kept out of the reach of children. See 7 Warnings and Precautions, Cardiovascular. 4 Geriatrics Geriatrics (> 65 years of age): The efficacy and safety of Men’s ROGAINE or Men’s ROGAINE FOAM 5% in men over 65 years of age have not been established.
Men’s ROGAINE and Men’s ROGAINE FOAM 5% should not be used in the male geriatric population.