REGAINE EXTRA STRENGTH
Regaine Extra Strength for Men is medically proven to treat thinning hair
Regaine for Men Extra Strength is indicated for the treatment of alopecia androgenetica in men.
Onset and degree of hair regrowth may be variable among users. Although trends in the data suggest that those users who are younger, who have been balding for a shorter period of time or who have a smaller area of baldness on the vertex are more likely to respond to Regaine for Men Extra Strength, individual responses cannot be predicted
Posology and method of administration
Men aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application of Regaine for Men Extra Strength. A dose of 1 ml Regaine for Men Extra Strength cutaneous solution should be applied to the total affected areas of the scalp twice daily. The total dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards.
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 Regaine for Men Extra Strength are necessary for continued hair growth. Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Regaine for Men Extra Strength application and the balding process will continue.
Users should discontinue treatment if there is no improvement after one year.
The method of application varies according to the disposable applicator used:
Pump spray applicator: this is useful for large areas. Aim the pump at the centre of the bald area, press once and spread with fingertips over the entire bald area. Repeat for a total of 6 times to apply a dose of 1 ml. Avoid breathing spray mist.
Extended spray-tip applicator: this is useful for small areas, or under hair. The pump spray applicator must be in place in order to use this additional applicator. Use in the same way as the pump spray.
Rub-on applicator: squeeze the upright bottle once to fill the 1 ml chamber to the black line. Invert bottle, dab on scalp, and spread Regaine for Men Extra Strength over the entire bald area until chamber is empty.
Children and the Elderly
Not recommended. The safety and effectiveness of Regaine for Men Extra Strength in users aged under 18 or over 65 has not been established.
Regaine for Men Extra Strength is contraindicated:
− in women
− in users with a history of sensitivity to minoxidil, ethanol, or propylene glycol
− in users with treated or untreated hypertension
− in users with any scalp abnormality (including psoriasis and sunburn)
− in users with a shaved scalp
− if occlusive dressings or other topical medical preparations are being used
Special warnings and precautions for use
Before using Regaine for Men Extra Strength, the user should determine that the scalp is normal and healthy.
The patient should stop using Regaine for Men Extra Strength and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heart beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness.
Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine for Men Extra Strength.
Regaine for Men Extra Strength is for external use only. Do not apply to areas of the body other than the scalp
Hands should be washed thoroughly after applying the solution. Inhalation of the spray mist should be avoided.
Regaine for Men Extra Strength cutaneous solution contains alcohol, which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water.
Regaine for Men Extra Strength contains propylene glycol, which may cause skin irritation.
Some patients have experienced changes in hair colour and/or texture with Regaine for Men Extra Strength use.
Users should be aware that, whilst extensive use of Regaine for Men Extra Strength has not revealed evidence that sufficient minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (eg. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects
Interaction with other medicinal products and other forms of interaction
Topical drugs, such as tretinoin or dithranol, which alter the stratum corneum barrier, could result in increased absorption of minoxidil if applied concurrently. Although it has not been demonstrated clinically, there exists the theoretical possibility of absorbed minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators
Pregnancy and lactation
There is no evidence as to drug safety in human pregnancy nor is there evidence from animal work that it is free from hazard. Regaine for Men Extra Strength should not be used during pregnancy or lactation
Several thousand patients have used topical minoxidil in clinical trials where a comparison with an inactive solution was made. Dermatological reactions (e.g. irritation, itching) occurred in patients using both solutions. This has been explained by the presence of propylene glycol in both the active and inactive solution.
Reactions reported in commercial marketing experience include: hypertrichosis (unwanted non-scalp hair including facial hair growth in women), local erythema, itching, dry skin/scalp flaking, and exacerbation of hair loss.
Some consumers reported increased hair shedding upon initiation of therapy with Regaine for Men Extra Strength. This is most likely due to minoxidil's action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (>2 weeks), users should stop using Regaine for Men Extra Strength and consult their doctor.
Particular attention was paid to body systems, such as cardiovascular and metabolic, which might have some relevance based on the pharmacology of minoxidil. There was no increased risk to users due to drug related medical reactions in these, or other, body system categories.
Users should stop using Regaine for Men Extra Strength if they experience chest-pain, tachycardia, faintness, dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp. Rare cases of hypotension have been reported.
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