REGAINE FOR WOMEN
Alternate Name:
Minoxidril
Rogaine
Strength: 2%
Pack Quantity: 60ml
Regaine For Women Regular Strength is medically proven to treat thinning hair
Therapeutic indications
Regaine for Women Regular Strength is indicated for the treatment of alopecia androgenetica in women aged between 18 and 65.
Onset and degree of hair regrowth may be variable among users. Although trends in the data suggest that those users who are younger, whose hair has been thinning for a shorter period of time or who have a smaller area of thinning on the vertex are more likely to respond to Regaine for Women Regular Strength, individual responses cannot be predicted
Posology and method of administration
Women aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application of Regaine for Women Regular Strength. A dose of 1 ml Regaine for Women Regular 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 four months or more before evidence of hair growth can be expected.
If hair regrowth occurs, twice daily applications of Regaine for Women Regular Strength are necessary for continued hair growth. Anecdotal reports indicate that regrown hair may disappear three to four months after stopping Regaine for Women Regular 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 Women Regular Strength over the entire bald area until chamber is empty.
Children and the Elderly
Not recommended. The safety and effectiveness of Regaine for Women Regular Strength in users aged under 18 or over 65 has not been established.
Contraindications
Regaine for Women Regular Strength is contra-indicated:
− 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 Women Regular Strength, the user should determine that the scalp is normal and healthy.
The patient should stop using Regaine for Women Regular 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 Women Regular Strength.
Regaine for Women Regular 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 Women Regular Strength 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 Women Regular Strength contains propylene glycol, which may cause skin irritation.
Some patients have experienced changes in hair colour and/or texture with use of Regaine for Women Regular Strength.
Patients should be advised to consult their doctor or pharmacist if they are concerned at any time during treatment with Regaine for Women Regular Strength.
Users should be aware that, whilst extensive use of Regaine for Women Regular 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 (e.g. 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 corticosteroids, tretinoin, dithranol or petrolatum 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 are no adequate data from the use of minoxidil in pregnant women. Studies in animals have shown reproductive toxicity (see Section 5.3). The potential risk for humans is unknown. Regaine should not be used during pregnancy.
In pregnant rats administered a single subcutaneous dose of 0.9 mg/kg minoxidil, the concentrations in foetuses were 19% to 28% of the maternal plasma concentration.
It is recommended that breast-feeding should be discontinued during treatment with Regaine
Undesirable effects
In placebo controlled trials, the overall frequency of medical events in females in all body system categories was approximately five times that of males.
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. Users should stop using Regaine if they experience persistent redness or irritation of the scalp.
Some consumers reported increased hair shedding upon initiation of therapy with Regaine. 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 and consult their doctor.
Particular attention has been 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 if they experience chest-pain, tachycardia, faintness, dizziness, sudden unexplained weight gain, or swollen hands or feet. Rare cases of hypotension have been reported.
