Consumer medicine information

Women's Regaine Extra Strength Foam

Minoxidil

BRAND INFORMATION

Brand name

Regaine

Active ingredient

Minoxidil

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Women's Regaine Extra Strength Foam.

WHAT IS WOMEN'S REGAINE® FOAM?

WOMEN'S REGAINE® Foam is a white foam containing 5% minoxidil for use only on the scalp to help regrow hair in women. It contains the active ingredient Minoxidil in a foam base of alcohol, water, glycerol, cetyl alcohol, citric acid, lactic acid, stearyl alcohol, polysorbate 60, butyl hydroxytoluene and propellant.

What is WOMEN'S REGAINE® Foam used for?

WOMEN'S REGAINE® Foam is used as a long-term treatment for common baldness. It is not a cure for baldness, but in some women it can improve hair regrowth.

WHO MAY USE WOMEN'S REGAINE® FOAM?

WOMEN'S REGAINE® Foam may be appropriate for you if you are an adult who is at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of your scalp. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss.

WOMEN'S REGAINE® Foam is for general thinning of hair on the top of the scalp as shown below. WOMEN'S REGAINE® Foam has been shown to regrow hair in women with the degrees of hair loss shown. If women have more hair loss than shown, WOMEN'S REGAINE® Foam may not work.

Many of those experiencing hair loss have other family members with gradual thinning of hair or hair loss. If there is no family history of gradual thinning or gradual hair loss, or hair loss is patchy, see your doctor.

WILL WOMEN'S REGAINE® FOAM WORK FOR ME?

The amount of hair regrowth is different for each person. Not everyone will respond to WOMEN'S REGAINE® Foam. The response to WOMEN'S REGAINE® Foam cannot be predicted. No one will be able to grow back all their hair.

To see your best results with WOMEN'S REGAINE® Foam, make sure you apply the product directly to the scalp once daily. For some women, WOMEN'S REGAINE® Foam may not work.

WOMEN’S REGAINE® Foam will not prevent or improve hair loss related to pregnancy, the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; excessive vitamin A intake), the recently discontinued use of birth control pills, low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, WOMEN’S REGAINE® Foam will not improve hair loss due to:

  • Damage from the use of hair care products which cause scarring or deep burns of the scalp.
  • Hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp.

HOW SOON CAN I EXPECT RESULTS FROM USING WOMEN'S REGAINE® FOAM?

Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with WOMEN'S REGAINE® Foam also takes time. Generally, new hair growth is slow for a WOMEN'S REGAINE® Foam user. Results may be seen as early as 3 months with once daily use. For some women, it may take at least 6 months for results to be seen. If you do not see any results after 6 months, stop using WOMEN'S REGAINE® Foam and seek the advice of your doctor or pharmacist.

When you first begin using WOMEN'S REGAINE® Foam, an increase in hair loss may occur within the first 2-6 weeks. However, if it continues, see your doctor or pharmacist.

IF WOMEN'S REGAINE® FOAM IS WORKING,WHAT WILL THE HAIR LOOK LIKE?

At first, hair growth may be soft, downy, and colourless hairs. After further use, the new hairs should be the same colour and thickness as the other hairs on your scalp.

HOW LONG DO I NEED TO USE WOMEN'S REGAINE® FOAM?

If you respond to WOMEN'S REGAINE® Foam, you need to use it once daily to keep and continue the hair regrowth. Up to 3 months of usage may be needed to see your best results from WOMEN'S REGAINE® Foam.

WHAT HAPPENS IF I COMPLETELY STOP USING WOMEN'S REGAINE® FOAM? WILL I KEEP THE NEW HAIR?

Continuous use of WOMEN'S REGAINE® Foam is needed to maintain hair regrowth. If you stop using WOMEN'S REGAINE® Foam, the normal hair loss process will start again. You will probably lose your newly regrown hair in three to four months.

HOW DO I USE WOMEN'S REGAINE® FOAM?

For best results, apply half a capful once a day directly to the scalp in the hair loss area. Using more than the recommended amount will not improve results. Each can should last two months, if used as directed. Never take this product by mouth or apply to other parts of the body. Please refer to the "Directions for Use" section of this booklet.

WHEN DO I USE WOMEN'S REGAINE® FOAM?

Apply WOMEN'S REGAINE® Foam once daily. If you apply at night, allow application to dry completely before going to bed.

WHAT IF I FORGET TO USE WOMEN'S REGAINE® FOAM OR MISS A DOSE?

If you miss one daily dose of WOMEN'S REGAINE® Foam, just continue with your next dose. You should not make up for missed doses.

CAN I USE WOMEN'S REGAINE® FOAM MORE THAN ONCE A DAY? WILL IT WORK FASTER, BETTER?

No. WOMEN'S REGAINE® Foam will not work faster or better if used more than once a day. More frequent use or larger doses have not been shown to speed up hair growth and may increase your chances of side effects.

WHAT KIND OF SHAMPOO SHOULD I USE WITH WOMEN'S REGAINE® FOAM?

If you wash your scalp before applying WOMEN'S REGAINE® Foam, use a mild shampoo.

CAN I USE HAIR SPRAYS, MOUSSES, CONDITIONERS, GELS, ETC.?

Yes. There is no reason to change your usual hair care routine when using WOMEN'S REGAINE® Foam. However, you should apply WOMEN'S REGAINE® Foam first and wait for it to dry before applying your styling aids.

CAN I HAVE MY HAIR COLOURED OR PERMED OR USE HAIR RELAXERS WHILE USING WOMEN'S REGAINE® FOAM?

Yes. We have no evidence that colouring, perming, or using relaxers on your hair change the effect of WOMEN'S REGAINE® Foam. However, because the use of a permanent wave and hair colour can cause scalp irritation on certain people, we recommend the following precautions:

  1. To avoid possible scalp irritation, you should make sure all of the WOMEN'S REGAINE® Foam has been washed off the hair and scalp before using colour or perm chemicals.
  2. For best results, do not apply WOMEN'S REGAINE® Foam on the same day that you use a chemical treatment on your hair.
  3. Do not use WOMEN'S REGAINE® Foam for 24 hours after using any chemicals to make sure your scalp has not been irritated by the perm or colour treatment. If no irritation occurs, continue use of WOMEN'S REGAINE® Foam as usual.
  4. Simply restart your normal WOMEN'S REGAINE® Foam routine. There is no need to use more WOMEN'S REGAINE® Foam to make up for missed applications. Missing one day of WOMEN'S REGAINE® Foam will not affect your hair regrowth results.

CAN I APPLY WOMEN'S REGAINE® FOAM AND WASH MY HAIR AN HOUR LATER?

No. For WOMEN'S REGAINE® Foam to work best, you should allow WOMEN'S REGAINE® Foam to remain on the scalp for about 4 hours before washing.

DIRECTIONS FOR USE

  • Please familiarize yourself with the instructions below in order to help make your product application a success.
  • This product should be used ONCE DAILY, EVERY DAY.
  • To be effective, it is important to apply the product DIRECTLY TO YOUR SCALP and NOT TO YOUR HAIR so that it can easily get to your hair follicles to help regrow your hair.
  • There is no need to shampoo your hair before using the product. If you wish to shampoo your hair before applying WOMEN'S REGAINE® Foam, towel dry your hair so that the skin on the scalp is dry.
  • TO OPEN the container: Hold ring (see diagram on page 12). While holding ring, twist cap to line up the arrow on the ring with the arrow on the cap. (Figure 1 below) Tilt cap back and pull off cap.
  • Within your hair thinning areas, make a center part to help maximize scalp exposure. Part your hair at least 2 more times on each side of the center part (Figure 2 below).
  • The foam may begin to melt on contact if your fingers are warm. Rinse your fingers in cold water first before dispensing. Be sure to dry them thoroughly before handling the foam.
  • Hold the can straight upside down, press nozzle to dispense half a capful of the foam onto a non-absorbent surface (Figure 3 below). The total amount of foam applied should not exceed half a capful.
  • Using your fingertips, spread just enough foam over the hair loss areas and gently massage the foam into the scalp starting from the back to front (forehead) direction (Figure 4 below). Use until all the foam is gone.
  • After each use, thoroughly clean and dry the dish or saucer if used.
  • Wash your hands well with soap and water after applying.
  • TO CLOSE the container: place cap on container and snap into place. Be sure arrows do not line up so cap remains child resistant.

ARE THERE ANY SPECIAL WARNINGS ABOUT THE USE OF WOMEN'S REGAINE® FOAM?

For external use only.

Extremely flammable: Avoid fire, flame, or smoking during or immediately following application.

DO NOT USE IF

  • you are pregnant or breastfeeding.
  • you are unsure of the reason for your hair loss.
  • your degree of hair loss is more than that shown on page 2 of this booklet, because this product may not work for you.
  • you have no family history of hair loss.
  • your hair loss is sudden and/or patchy.
  • your hair loss is associated with childbirth.
  • you do not know the reason for you hair loss.
  • you are under 18 or over 65 years of age.
  • your scalp is red, inflamed, infected, irritated, or painful.
  • You have had an allergic reaction to WOMEN’S REGAINE® Foam or any of its ingredients.
  • you use other medicines on the scalp.
  • The expiry date printed on the pack has passed.

Ask your pharmacist or doctor if:

  • You are taking any other medicines, including medicines you have bought without a prescription from a pharmacy or a supermarket.
  • You have any heart problems such as heart failure or disorders of heart rhythm.
  • You have blood pressure problems.
  • You have any skin diseases.
  • You have had a stroke.

Some medicines may affect the way others work. Your pharmacist or doctor will be able to tell you what to do when using WOMEN’S REGAINE® Foam with other medicines.

WHEN USING THIS PRODUCT

  • do not use more than directed.
  • do not apply on other parts of the body.
  • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
  • dizziness or decrease in blood pressure may occur. If affected, do not drive or operate machinery.
  • some people have experienced changes in hair colour and/or texture.
  • it takes time to regrow hair. Results may occur in 3 months with once daily use. For some women you may need to use this product once daily for at least 6 months before you see results.
  • the amount of hair regrowth is different for each person.

This product will not work for everyone.

STOP USE AND CONSULT A DOCTOR IF

  • chest pain, rapid heartbeat, faintness, or dizziness occurs
  • decrease in blood pressure or blood pressure changes are detected
  • sudden, unexplained weight gain occurs
  • your hands or feet swell
  • scalp irritation or redness occurs
  • unwanted facial hair growth occurs
  • you do not see hair regrowth in 6 months

May be harmful if used when pregnant or breast-feeding.

Keep out of reach of children.

Accidental ingestion may cause serious side effects. If swallowed, get medical help or contact a Poisons Information Centre (telephone number AUS: 13 11 26, NZ: 0800 764 766) immediately.

WHAT ARE THE MOST COMMON SIDE EFFECTS WITH WOMEN'S REGAINE® FOAM?

The most common side effects are itching and other skin irritations of the treated area of the scalp. WOMEN'S REGAINE® Foam contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas.

If WOMEN'S REGAINE® Foam accidentally gets into these areas, rinse with large amounts of cool tap water. Stop using WOMEN'S REGAINE® Foam and contact your doctor if irritation persists.

CAN WOMEN'S REGAINE® FOAM PRODUCE UNWANTED HAIR?

Unwanted hair growth has been reported on the face and on other parts of the body with REGAINE® use. Unwanted hair growth may be caused by the transfer of WOMEN'S REGAINE® Foam to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of WOMEN'S REGAINE® Foam.

If you experience unwanted hair, discontinue using WOMEN'S REGAINE® Foam and see your doctor for recommendations about appropriate treatment. After stopping use of WOMEN'S REGAINE® Foam, the unwanted hair, if caused by the use of WOMEN'S REGAINE® Foam, should go away over time. You can take steps to decrease the chances for unwanted hair growth:

  1. Limit the application of WOMEN'S REGAINE® Foam only to the scalp,
  2. If you use the hands to apply WOMEN'S REGAINE® Foam, wash your hands thoroughly afterwards, and
  3. Allow sufficient drying time before going to bed (usually 2 to 4 hours before going to bed after applying WOMEN'S REGAINE® Foam).

CAN I USE WOMEN'S REGAINE® FOAM FOR BALDNESS OR HAIR LOSS IN BABIES AND CHILDREN?

No. WOMEN'S REGAINE® Foam must not be used to treat baldness or hair loss in babies or children.

WHAT FACTORS MAY INCREASE THE RISK OF SERIOUS SIDE EFFECTS WITH WOMEN'S REGAINE® FOAM?

WOMEN'S REGAINE® Foam should be applied only to the scalp. The risk of side effects may be greater when WOMEN'S REGAINE® Foam is applied to other parts of the body.

If you have any other questions, ask your health care professional call our Customer Care Centre 1800 029 979 (Australia) or 0800 446 147 (New Zealand).

Storage condition: Protect from sunlight. Do not expose to temperatures above 50°C. Store below 25°C.

Save this booklet for future reference.

TO OPEN:

  1. Hold RING. (See diagram)
  2. While holding RING twist CAP to line up white arrow on RING with gray arrow on CAP.
  3. Pull off the CAP.

TO CLOSE:

  1. Place CAP on container and snap into place.
  2. Be sure arrows DO NOT line up so CAP remains child resistant.

Published by MIMS January 2019

BRAND INFORMATION

Brand name

Regaine

Active ingredient

Minoxidil

Schedule

S2

 

1 Name of Medicine

Minoxidil.

2 Qualitative and Quantitative Composition

Men's Regaine Extra Strength, Men's Regaine Extra Strength Foam, Women's Regaine.

Active ingredient.

Minoxidil 50 mg/mL (5%).

Excipients with known effect.

Alcohol.

Women's Regaine Regular Strength.

Active ingredient.

Minoxidil 20 mg/mL (2%).

Excipients with known effect.

Alcohol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Men's Regaine Extra Strength, Women's Regaine Regular Strength.

Clear, colourless to light yellow liquid.

Men's Regaine Extra Strength Foam, Women's Regaine.

White to yellowish, creamy foam.

4 Clinical Particulars

4.1 Therapeutic Indications

Regaine Topical Application, Extra Strength Topical Application and Extra Strength Foam are indicated for the treatment of androgenetic alopecia (common baldness) in healthy adult males and females.

4.2 Dose and Method of Administration

For external use only.
Use Regaine Topical Application, Extra Strength Topical Application and Extra Strength Foam only as directed. Do not apply Regaine to any area of the body other than the scalp. Make sure the scalp and hair are thoroughly dry and that the skin is healthy and intact.
Do not use a hairdryer to speed the drying of Regaine, because blowing air on the scalp may decrease the effectiveness of Regaine. Regaine must remain in contact with the scalp for several hours (up to 4 hours).
At least four months of twice daily applications of Regaine (once a day application for Women's Regaine) are generally required before evidence of hair regrowth can be expected. Onset and degree may be variable among patients.

Note.

Following discontinuation of medication, relapse to pretreatment appearance has been reported to occur within 3-4 months.

Dose: topical application (solution).

1 mL Regaine 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. After applying Regaine, wash hands thoroughly.

Directions for use of solution.

Dropper.

This applicator is designed to deliver a measured amount (1 mL or 1 dose) of solution.
1. Remove the large outer cap off the bottle; unscrew the child resistant cap.
2. Hold the bottle upright. Whilst ensuring that the dropper is immersed in the solution, squeeze the bulb to fill the dropper to the black line. The applicator now contains one full dose (1 mL) of Regaine and is ready for use.
3. Aim the dropper to the area of the scalp you wish to treat, lifting any hair out of the way with your fingers or comb. Gently squeeze the dropper bulb and apply the solution dropwise.
4. Massage the solution into the scalp gently with your fingers. Wash your hands after you have finished massaging the solution into your scalp.
5. Replace the child resistant dropper by screwing the dropper firmly onto the bottle. Place the larger outer cap on the bottle when not in use.

Dose: topical foam.

Men's Regaine Extra Strength Topical Foam.

Regaine foam should be applied sparingly twice per day to the scalp, beginning at the centre of the affected area. Up to half a capful may be used, but men with a small area of hair loss may need less. After applying Regaine, wash hands thoroughly.

Women's Regaine Topical Foam.

Regaine foam should be applied sparingly once a day to the scalp, beginning at the centre of the affected area. After applying Regaine, wash hands thoroughly.

Directions for use of foam.

1. To open container: Match arrow on can ring with line on cap. Pull off cap.
2. Within the hair thinning area, part the hair into one or more rows to maximize scalp exposure.
3. The foam may begin to melt right away on contact with your warm skin. If your fingers are warm, rinse them in cold water first. (Be sure to dry them thoroughly before handling the foam).
4. Hold the can upside down and press nozzle to dispense the topical foam product into the palm of your hand. The total amount of foam applied should not exceed half a capful.
5. Using your fingers, spread the foam over the hair loss area and gently massage into scalp and then wash your hands well.
6. After each use, close the container to make child resistant by snapping the cap back on to the can.

4.3 Contraindications

Regaine topical foam and topical solution are contraindicated in patients with a history of hypersensitivity to minoxidil, or ethanol.
Regaine topical solution is also contraindicated in patients with a history of hypersensitivity to propylene glycol.
Regaine is also contraindicated in pregnant or nursing women.

4.4 Special Warnings and Precautions for Use

Keep this and all medications out of the reach of children.
Accidental ingestion of Regaine could lead to serious adverse effects.
Before starting a patient on Regaine, the physician or pharmacist should ascertain that the patient has a healthy, normal scalp. It should not be applied to inflamed, infected, irritated or painful scalp skin.
Although extensive use of topical minoxidil has not revealed evidence that enough 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 a systemic effect, and physicians and patients need to be aware of this.
Regaine is recommended for use only in healthy adults with normal cardiovascular status. The safety of Regaine is unknown in patients with cerebrovascular disease or cardiovascular disease (including ischaemic heart disease, cardiac arrhythmias or congestive heart failure). Patients with a history of underlying heart disease should be aware that adverse effects in them might be especially serious (also see Section 4.8 Adverse Effects (Undesirable Effects)).
The patient should stop using Regaine and see a physician if hypotension is detected or if experiencing chest pain, rapid heart beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp. If affected by dizziness or hypotension do not drive or operate machinery.
In the event of severe dermatological reactions patients should discontinue use of Regaine and contact their physician or pharmacist.
Regaine contains an alcohol base which will cause burning and irritation of the eye on contact. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), the area should be bathed with copious amounts of cool tap water.
The effects of Regaine in patients with concomitant skin diseases, or in those using topical corticosteroids or other dermatological preparations, are unknown. There is a possibility that an increase in bioavailability of topically administered minoxidil may occur in the presence of inflammatory conditions of the scalp and such situations are to be avoided. Topical minoxidil should not be used concurrently with any other medications on the scalp.
If a patient wishes to wear any form of protective headgear, they should be instructed to allow 1 hour to elapse after using Regaine before covering the head. Some patients have experienced changes in hair colour and/or texture with use of Regaine.
Topical minoxidil therapy should be stopped if hair regrowth is not evident after 6 months of treatment.
Topical minoxidil should not be used if hair loss is patchy and/or sudden or if the reason for the hair loss is unknown. Using more than the recommended dose or more often will not improve results. Continued use is necessary to increase and maintain hair re-growth, or hair loss will begin again. A temporary increase in hair shedding may occur within the first 2-6 weeks of treatment. Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.
Products labelled for women: topical minoxidil should not be used if hair loss is due to childbirth.

Use in the elderly.

Safety and efficacy of Regaine in patients over 65 years of age have not been established.

Paediatric use.

Safety and efficacy of Regaine in patients under 18 years of age have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are currently no known drug interactions associated with the use of Regaine. Although it has not been clinically demonstrated, there exists the theoretical possibility of absorbed minoxidil potentiating orthostatic hypotension in patients currently taking peripheral vasodilators. In vitro studies have shown that paracetamol and diethylcarbamazine may inhibit the stimulation of hair growth by minoxidil.
The use of Regaine concurrently with cutaneously used drugs which alter the stratum corneum barrier, e.g. tretinoin and anthralin/dithranol is not recommended due to the possibility of increased absorption of cutaneously used minoxidil and consequently, increased potential for adverse drug reactions.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In fertility studies in rats, minoxidil decreased live litter size at oral doses of 3-10 mg/kg/day and at 80 mg/kg/day SC.
(Category C)
Oral administration of minoxidil has been associated with hypertrichosis in the newborn infant following exposure in utero. The safety of topical minoxidil in pregnancy has not been established, therefore Regaine should not be used by pregnant women.
Subcutaneous administration of minoxidil to pregnant rats during organogenesis caused foetal deaths, decreased foetal weight, and increased incidences of external, visceral and skeletal abnormalities. These effects were observed in two strains of rats at doses of 120 to 160 mg/kg/day, and were associated with mild to moderate maternal toxicity. No development effects were observed at nonmaternotoxic dose levels. No teratogenic effects were observed in rabbits at oral doses up to 10 mg/kg/day or at subcutaneous doses up to 49 mg/kg/day. In a peri/postnatal study in rats, subcutaneous administration of minoxidil at 80 mg/kg/day caused an increase in gestation length, prolonged parturition, an increased incidence of stillbirths and reduced birth weight.
 Systemically absorbed minoxidil is secreted in human milk. Regaine should not be used by nursing women.
Subcutaneous administration of minoxidil at 80 mg/kg/day to lactating rats suppressed postnatal growth and increased postnatal mortality of the offspring. These effects may have been due to interference with nursing behaviour rather than to ingestion of drug related material by the offspring.

4.7 Effects on Ability to Drive and Use Machines

May cause dizziness or hypotension (see Section 4.8 Adverse Effects (Undesirable Effects)). If affected do not drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

The most frequently encountered adverse effect in clinical trials with Regaine was mild dermatitis of the scalp. The dermatological events were of a similar type and severity in the 2% and 5% groups, but the incidence was greater in the 5% group.
Most frequently reported adverse reactions with 2% and 5% topical minoxidil in commercial marketing experience are dermatological reactions and include: local erythema, itching and dry skin/scalp flaking. Increased hair shedding can occur due to minoxidil's action of shifting hairs in the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks (first sign of action of minoxidil).
Other adverse reactions that have been reported very rarely (< 0.01%) include irritant dermatitis (redness/erythema, scaling/rash scaly and burning), non-specific allergic reactions, hives, hypersensitivity, allergic contact dermatitis, allergic rhinitis, facial swelling, folliculitis, alopecia, hypertrichosis, hair abnormalities, seborrhoea, shortness of breath, headache, neuritis, dizziness/lightheadedness, syncope, vertigo, oedema, chest pain, blood pressure changes (decreased and increased blood pressure, hypotension, hypertension), palpitations and pulse rate changes, rapid heart beat/tachycardia.
Rare cases of hypertrichosis (unwanted non-scalp hair including facial hair growth in women) have been reported.

Clinical trial data.

The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled randomized clinical trials in adults evaluating either 2% or 5% minoxidil solution, and two placebo-controlled randomized clinical trials in adults evaluating a 5% foam formulation.
Table 1 includes adverse drug reactions from the 7 solution studies and Table 2 includes adverse events from the 2 foam studies where greater than one event was reported and the event occurred in 1% of patients or more and at a greater incidence than placebo.
Adverse drug reactions identified in clinical trials with topical minoxidil are included in Tables 1 and 2; the frequencies are provided according to the following convention: Very common ≥ 1/10; Common ≥ 1/100 and < 1/10; Uncommon ≥ 1/1,000 and < 1/100; Rare ≥ 1/10,000 and < 1/1,000; Very rare < 1/10,000; Not known (cannot be estimated from the available data).

Post-marketing data.

Additional adverse drug reactions (ADRs) identified during post-marketing experience with minoxidil are included in Table 3. In this table, the frequencies are provided according to the following convention: Very common ≥ 1/10; Common ≥ 1/100 and < 1/10; Uncommon ≥ 1/1,000 and < 1/100; Rare ≥ 1/10,000 and < 1/1,000; Very rare < 1/10,000; Not known (cannot be estimated from the available data).

Reporting suspected adverse events.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at: https://www.tga.gov.au/reporting-problems.

4.9 Overdose

Due to the high concentration of minoxidil in Regaine, accidental ingestion may produce systemic effects related to the vasodilatory action of minoxidil. Signs and symptoms of drug overdosage would most likely be cardiovascular effects associated with fluid retention, tachycardia or lowered blood pressure. Fluid retention can be managed with appropriate diuretic therapy. Tachycardia can be controlled by administration of a beta-adrenergic blocking agent. Symptomatic hypotension should be treated by intravenous administration of normal saline. Sympathomimetic drugs, such as noradrenaline and adrenaline, should be avoided because of their excessive cardiac stimulating activity.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

When applied topically, Regaine has been shown to stimulate hair growth in males and females with alopecia androgenetica; however, the exact mechanism of action of Regaine in the treatment of alopecia androgenetica is not known. The regrowth can be observed after approximately 4 or more months of use and is variable among patients. Upon discontinuation of treatment with Regaine, new hair growth stops and restoration of pretreatment appearance may occur within 3-4 months.
Topical application of Regaine showed no systemic effects related to absorption of minoxidil when tested in controlled clinical trials in both normotensive and untreated hypertensive patients.
Minoxidil administered orally for the treatment of hypertension has a direct peripheral vasodilator effect which reduces elevated systolic and diastolic blood pressure by decreasing peripheral vascular resistance. Reduction of peripheral arteriolar resistance and the associated fall in blood pressure induces sympathetic, vagal inhibitory, and renal homeostatic mechanisms, including an increase in renin secretion, which lead to increased heart rate and cardiac output, and salt and water retention. Minoxidil does not interfere with vasomotor reflexes and therefore does not produce orthostatic hypotension. In experimental animals, the drug does not enter the central nervous system (CNS) in significant amounts.

Clinical trials.

In 2,326 adults with early male pattern baldness who applied 1 mL of 2% TMS (transdermal minoxidil solution) on the scalp twice daily for 12 months, cosmetically acceptable hair growth was observed in only a small % of individuals. Dense hair growth occurred in only 8% of individuals. Moderate hair growth was observed in a further 30% of subjects.
Two studies in healthy males aged 18-50 years with androgenetic alopecia showed statistically significant differences favouring 5% over 2% TMS with regard to nonvellus hair counts. Compared to mean baseline counts of 103-106/cm2, at the end of 32 weeks treatment mean increases in nonvellus hair counts were 39/cm2 in subjects who received 5% TMS (N = 163), 30/cm2 in subjects who received 2% TMS (N = 79), and 5/cm2 in subjects who received placebo (N = 79). In the other study, compared to mean baseline counts of 144-152/cm2, at the end of 48 weeks treatment mean increases in nonvellus hair counts were 19/cm2 in subjects who received 5% TMS (N = 137), 13/cm2 in subjects who received 2% TMS (N = 139), and 4/cm2 in subjects who received placebo (N = 70).
Two studies in healthy females aged 18 to 50 years with androgenetic alopecia showed statistically significant differences favouring 5% over placebo, but not over 2% TMS with regard to nonvellus hair counts. Compared to mean baseline counts of 178-185/cm2, at the end of 36 weeks treatment mean increases in nonvellus hair counts were 18/cm2 in subjects who received 5% TMS (N = 64), 15/cm2 in subjects who received 2% TMS (N = 74) and 3/cm2 in subjects who received placebo (N = 40). In the other study, compared to mean baseline counts of 138-150/cm2, at the end of 48 weeks treatment mean increases in nonvellus hair counts were 25/cm2 in subjects who received 5% TMS (N = 97), 21/cm2 in subjects who received 2% TMS (N = 106) and 9/cm2 in subjects who received placebo (N = 50).
Examination of efficacy data based on hair weight measurements demonstrated an overall clinical benefit of 5% TMS and 2% TMS in stimulating hair growth. Additionally, this study strongly demonstrated the stabilisation of hair loss over the 2 year treatment period.
The efficacy and safety of Regaine Extra Strength Foam was evaluated in a 16-week, double-blind, placebo-controlled study in males with androgenetic alopecia. Increase in mean non vellous hair count after 8, 12 and 16 weeks in the target area were significantly greater (p < 0.0001) for the Regaine Extra Strength Foam treated subjects (n = 180; intent-to-treat population) compared to the placebo foam treated subjects (n = 172; intent-to-treat population). Analysis of subject ratings of treatment after 16 weeks of treatment were also statistically better (p < 0.0001) for the Regaine Extra Strength Foam treated subjects compared to the placebo foam treated subjects. These results were confirmed by subsequent analysis based on the per protocol population.
Overall the study treatments were well tolerated and the incidence of adverse events with 5% minoxidil foam was similar to that with placebo foam.
Two studies were performed to assess the efficacy and safety of MTF (minoxidil topical foam) when applied once a day (OD) in female subjects with female pattern hair loss. In one study 5% MTF OD was compared to a foam vehicle containing no active product. Each was applied once daily, for 24 weeks. After 24 weeks of treatment, the 5% MTF OD group (n = 200) re-grew 13.4 hairs/cm2 and the foam vehicle group (n = 197) re-grew 4.3 hairs/cm2, a treatment difference of 9.1 hairs/cm2 (p < 0.0001). After 24 weeks of treatment, subjects in the 5% MTF OD group observed improved scalp coverage from baseline. The adjusted mean scalp coverage scores were 0.75 versus 0.06 for the 5% MTF OD and the foam vehicle groups, respectively, a significant treatment difference of 0.69 (p < 0.0001). In the other study, the efficacy of 5% MTF OD was compared to 2% TMS BID (twice daily). Compared to mean baseline counts of 169.7/cm2, after 24 weeks treatment mean increases in non-vellus hair counts were 23.9/cm2 in subjects who received 5% MTF OD (n = 161). 5% MTF OD was concluded to be at least as effective as 2% MTS BID. Overall safety analyses have shown 5% MTF OD to be well tolerated in healthy subjects and in women with female pattern hair loss (FPHL). The safety profile of 5% MTF in females was generally similar to that observed in clinical trials of 5% MTF BID in males.

5.2 Pharmacokinetic Properties

Following topical application, minoxidil is poorly absorbed from normal intact skin. Of the total applied dose an average of 1.7% (range 0.3-4.5%) of the topical solution reaches the systemic circulation. The relative absorption of the topical foam is approximately 50% of a similar dose of topical solution. In contrast, minoxidil is almost completely absorbed from the gastrointestinal tract following oral administration of minoxidil tablets. Following cessation of topical dosing of Regaine, approximately 95% of systemically absorbed minoxidil is eliminated within 4 days. The effects of concomitant dermal diseases on absorption are unknown.
The metabolic biotransformation of minoxidil absorbed following topical application has not been fully determined. But the active form of the drug appears to be a sulfated metabolite, minoxidil sulfate. Orally administered minoxidil is metabolised predominantly by conjugation with glucuronic acid at the N-oxide position in the pyrimidine ring but also by conversion to more polar products. Minoxidil does not bind to plasma proteins and its renal clearance corresponds to the glomerular filtration rate. Minoxidil does not cross the blood-brain barrier. Minoxidil and its metabolites are haemodialysable and are excreted principally in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Genetic toxicology studies showed that minoxidil does not cause gene mutation in bacterial cells, but gene mutation studies in mammalian cells have not been reported. Minoxidil had weak clastogenic activity in a cytogenetics assay in Chinese hamster lung cells in vitro, but there was no evidence of similar effects in cultured human lymphocytes, or in an in vivo assay (micronucleus test in mice). Minoxidil did not cause DNA damage in an alkaline elution assay in Chinese hamster fibroblasts or unscheduled DNA synthesis in rat hepatocytes.

Carcinogenicity.

Carcinogenic activity of minoxidil has been investigated following dietary administration to mice at 10-64 mg/kg/day, and following topical administration to mice and rats at 8-80 mg/kg/day. Minoxidil treatment was associated with the development of benign pituitary tumours and malignant mammary tumours in female mice, hepatic adenomas and splenic haemangiosarcomas in male mice, and adrenal medullary and clitoral gland adenomas in female rats. The hepatic tumours were only observed at high dose levels. The development of mammary adenocarcinomas in mice may be related to stimulation of prolactin release.
Tumour development in the pituitary, preputial and clitoral glands may also involve endocrine mechanisms, while the vascular wall tumours in mouse spleen and adrenal medullary tumours in rats may be related to the vasodilator activity of the drug.
In a 12 month photocarcinogenicity study in hairless mice, topical minoxidil did not accelerate the development of dermal tumours initiated by ultraviolet light.

6 Pharmaceutical Particulars

6.1 List of Excipients

Men's Regaine Extra Strength, Women's Regaine Regular Strength.

Excipients: alcohol, propylene glycol and water.

Men's Regaine Extra Strength Foam, Women's Regaine.

Excipients: alcohol, water, glycerol, cetyl alcohol, citric acid, lactic acid, stearyl alcohol, polysorbate 60, butyl hydroxytoluene and propellant.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

36 months.

6.4 Special Precautions for Storage

Topical applications.

Men's Regaine Extra Strength, Women's Regaine Regular Strength: Store below 30°C.

Foams.

Men's Regaine Extra Strength Foam, Women's Regaine: Store below 25°C.

6.5 Nature and Contents of Container

Men's Regaine Extra Strength topical solution is available in a 60 mL and 4 x 60 mL bottle (Aust R 79914).
Women's Regaine Regular Strength topical solution is available in a 60 mL and 3 x 60 mL bottle (Aust R 81852).
Men's Regaine Extra Strength topical foam is available in a 60 g and 2 x 60 g aerosol can (Aust R 277919).
Women's Regaine topical foam is available in a 60 g and 2 x 60 g aerosol can (Aust R 240952).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Minoxidil, a peripheral vasodilator, occurs as a white or off-white, odourless, crystalline solid which is readily soluble in propylene glycol or ethanol, soluble in water to the extent of 2 mg/mL and is almost insoluble in acetone, chloroform or ethyl acetate. The chemical name for minoxidil is 2, 4-diamino-6-piperidino-pyrimidine-3- oxide, (MW = 209.25).

Chemical structure.


CAS number.

38304-91-5.

7 Medicine Schedule (Poisons Standard)

Schedule 2.

Summary Table of Changes