Avogain solution 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 Avogain solution, individual responses cannot be predicted.

Women aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application of Avogain solution. A dose
of 1 ml Avogain solution 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 re-growth occurs, twice daily applications of Avogain solution are necessary for continued hair
growth. Anecdotal reports indicate that re-grown hair may disappear three to four months after
stopping Avogain solution application and the balding process will continue.
Users should discontinue treatment if there is no improvement after one year.
Special Populations
There are no specific recommendations for use in patients with renal or hepatic impairment

Paediatric and Elderly Populations
Not recommended. The safety and effectiveness of Avogain solution in children and adolescents
below the age of 18 years or adults over the age of 65 years has not been established.
Method of administration
For topical use only.
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.

 

Avogain solution 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.

Before using Avogain solution, the user should determine that the scalp is normal and healthy.
Topical minoxidil should not be applied to inflamed, infected, irritated or painful scalp skin (see
section 4.3).
Topical minoxidil is only indicated for the treatment of alopecia androgenetica and should not be
used in other types of hair loss for example when there is no family history of hair loss, hair loss is
sudden and/or patchy, hair loss is due to childbirth or the reason for hair loss is unknown.
The patient should stop using Avogain solution 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 or irritation of the scalp or other unexpected
new symptoms occur (see section 4.8).
Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before
using Avogain solution.
Some patients have experienced changes in hair colour and/or texture with use of Avogain solution.
Avogain solution is for external use only. Do not apply to areas of the body other than the scalp.
Using more than the recommended dose or more often will not improve results.
Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.
Hands should be washed thoroughly after applying the solution. Inhalation of the spray mist should
be avoided.

Some consumers reported increased hair shedding upon initiation of therapy with Avogain solution.
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 Avogain solution and
consult their doctor.
Users should be aware that, whilst extensive use of Avogain solution 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.
Accidental ingestion may cause serious cardiac adverse events. Therefore this product has to be kept
out of the reach of children.
Avogain solution contains ethanol (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.
Avogain solution contains propylene glycol, which may cause skin irritation.
Patients should be advised to consult their doctor or pharmacist if they are concerned at any time
during treatment with Avogain solution.

 

This product should not be used concomitantly with other medications applied topically on the scalp
(see section 4.3).
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.
Guanethidine has been reported to interact with oral formulations of minoxidil resulting in rapid and
pronounced lowering of blood pressure.
There is a theoretical possibility that topical minoxidil may also interact with guanethidine.

This product should not be used during pregnancy or lactation.

Pregnancy
There are no adequate and well controlled studies in pregnant women. Studies in animals have
shown a risk to the foetus at exposure levels that are very high compared to those intended for
human exposure. There is potentially a risk of foetal harm in humans (see section 5.3).
Lactation
Systemically absorbed minoxidil is secreted in human milk. The effect of minoxidil on
newborns/infants is unknown.

Based on the pharmacodynamic and overall safety profile of minoxidil, it is not expected that Avogain
solution would interfere with the ability to drive or operate machinery.

The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled
randomised clinical trials in adults evaluating either 2% or 5% minoxidil solution, and two placebocontrolled
randomised clinical trials in adults evaluating a 5% foam formulation.
Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with
minoxidil are included in the table below by System Organ Class (SOC).

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, including isolated reports
Not known (cannot be estimated from the available data)

ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials
or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category
is listed as 'Not known'.

 

Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses
of Avogain solution are applied to larger surface areas of the body or areas other than the scalp.
Because of the concentration of minoxidil in Avogain solution, accidental ingestion has the potential
of producing systemic effects related to the pharmacological action of the drug (5 ml of Avogain
solution contains 100 mg minoxidil; the maximum recommended adult dose for oral minoxidil
administration in the treatment of hypertension). Signs and symptoms of minoxidil overdosage
would primarily be cardiovascular effects associated with sodium and water retention. Tachycardia,
hypotension, dizziness and lethargy can also occur.

Treatment
Treatment of minoxidil over dosage should be symptomatic and supportive.
Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia
can be controlled by administration of a beta-adrenergic blocking agent.

Pharmacotherapeutic group: other dermatologicals, ATC code: D11AX
Individual responses to Avogain solution are variable and unpredictable.
The effect of Avogain solution has been assessed in phase III clinical trials in women conducted over a
48 week treatment period.
In these studies Avogain solution was compared to the product vehicle without the minoxidil active
ingredient. The primary efficacy criterion was non-vellus hair count in a 1.0 cm2 reference area of
affected scalp. 

Using non-vellus hair count as an efficacy criteria, Avogain solution has also been shown to stabilise
hair loss (defined as re-growth or no loss) in 88% of patients compared with 69% of patients who
received vehicle in one trial following 48 weeks treatment and in 87% of patients compared with 73%
of patients who received vehicle in a further trial following 32 weeks treatment.
Female patients' own evaluations in clinical studies have shown that hair growth was reported by
approximately 60% of females after 8 months of Avogain solution usage.

In addition, Avogain solution has been shown to stabilise hair loss (shown as re-growth or no loss) in
4 out of 5 females as calculated from two clinical studies that showed stabilisation with 88 and 87%
respectively while corresponding figures for vehicle were 69 and 74%.
The mechanism by which minoxidil stimulates hair growth is not fully understood, but minoxidil can
reverse the hair loss process of androgenetic alopecia by the following means:
- increase the diameter of the hair shaft
- stimulate anagen growth
- prolong the anagen phase
- stimulate anagen recovery from the telogen phase
As a peripheral vasodilator minoxidil enhances microcirculation to hair follicles. The Vascular
Endothelial Growth Factor (VEGF) is stimulated by minoxidil and VEGF is presumably responsible for
the increased capillary fenestration, indicative of a high metabolic activity, observed during the
anagen phase.

The failure to detect evidence of systemic effects during treatment with Avogain solution reflects the
poor absorption of topically applied minoxidil from normal intact skin. Systemic absorption of
minoxidil from topically applied solution ranges between 1% and 2% of the total applied dose.
In a study in males, the minoxidil serum concentration time curve (AUC) for the 2% solution averaged
7.54 ng·h/ml compared to a mean AUC of 35.1 ng·h/ml for the 2.5 mg oral formulation. The mean
peak plasma concentration (Cmax) for the topical solution was 1.25 ng/ml, compared to 18.5 ng/ml
following the 2.5 mg oral dose.
There is some evidence from in vitro studies that minoxidil reversibly binds to human plasma
proteins. However, since only 1 – 2% of topically applied minoxidil is absorbed, the extent of plasma
protein binding occurring in vivo after topical application would be clinically insignificant. The volume
of distribution of minoxidil after intravenous administration has been estimated at 70 litres.
Approximately 60% minoxidil absorbed after topical application is metabolised to minoxidil
glucuronide, primarily in the liver. Minoxidil and its metabolites are excreted almost entirely in the
urine, with a very minor degree of elimination via the faeces. Following cessation of dosing,
approximately 95% of topically applied minoxidil will be eliminated within four days.

Preclinical data reveal no special hazards for humans based on conventional studies of safety
pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.
Cardiac effects of minoxidil in dogs are species-specific in terms of the low doses that cause profound
haemodynamic effects and associated changes in the heart. Available data indicate that similar
cardiac effects do not occur in humans treated topically or orally with minoxidil.

Mutagenicity
Minoxidil showed no evidence of mutagenic/genotoxic potential in a number of in vitro and in vivo
assays.
Teratogenicity
Animal reproduction toxicity studies in rats and rabbits have shown signs of maternal toxicity and a
risk to the foetus at exposure levels that are very high compared to those intended for human
exposure (from 19 to 570-fold human exposure). A low, albeit remote, risk of foetal harm is possible
in humans.
Fertility
Preclinical fertility studies in rats have shown minoxidil doses equal to or greater than 3 mg/kg/day
(at least 21-fold human exposure) when administered orally and greater than 9 mg/kg/day (at least
64-fold human exposure) when administered subcutaneously were associated

Excipients Name:
Propylene Glycol
Ethanol 99.9%
Purified Water

Not Applicable

After first opening is 30 days

Store below 30°C, don’t freeze.

HDPE bottle with dispenser.
Pack size: 1 x 50 ml

The solution is flammable. Do not use while smoking, or near any naked flame or strong
heat source. Avoid exposure of the container and contents to naked flames during use,
storage and disposal. Any unused product or waste material should be disposed of in
accordance with local requirements