Avogain 5% solution 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 Avogain 5% solution, individual
responses cannot be predicted.

Men aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application Avogain 5% solution.
A dose of 1 ml Avogain 5% 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 Avogain 5% solution are necessary for continued
hair growth. Anecdotal reports indicate that regrown hair may disappear three to four months after
stopping Avogain 5% 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 5% solution in children and adolescents
below the age of 18 years or adults over 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 5% solution 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.

Before using Avogain 5% 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 5% 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 5% solution.
Some patients have experienced changes in hair colour and/or texture with use of Avogain 5%
solution .
Avogain 5% 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 5%
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 5%
solution and consult their doctor.

Users should be aware that, whilst extensive use of Avogain 5% 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 5% 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 5% solution contains propylene glycol, which may cause skin irritation.

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 are unknown.

Based on the pharmacodynamic and overall safety profile of minoxidil, it is not expected that Avogain
5% 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'.

Body System (SOC) Frequency Adverse Drug Reaction (Preferred
Term)
Immune System Disorders Common Hypersensitivity reactions (including
face oedema, generalised erythema,
pruritus generalised, swelling face, and
throat tightness)
Uncommon Angioedema (including lip oedema, lip
swelling, oedema mouth,
oropharyngeal swelling, pharyngeal
oedema, swollen tongue and tongue
oedema)
Nervous System Disorders Very common Headache
Uncommon Dizziness
Eye disorders Uncommon Eye irritation
Cardiac disorders Common Chest pain
Uncommon Heart rate increased
Palpitations
Vascular disorders Uncommon Hypotension
Respiratory, thoracic and mediastinal
disorders
Uncommon Dyspnoea

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 on below contact.
Reporting of suspected adverse reaction(s)
The National Pharmacovigilance and Drug Safety Centre (NPC)
o Fax: +966-11-205-7662
o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
o Toll free phone: 8002490000
o E-mail: npc.drug@sfda.gov.sa
o Website: www.sfda.gov.sa/npc
Other GCC States: - Please contact the relevant competent authority

4.9 Overdose
Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses
of Avogain 5% solution are applied to larger surface areas of the body or areas other than the scalp.
Because of the concentration of minoxidil in Avogain 5% solution, accidental ingestion has the
potential of producing systemic effects related to the pharmacological action of the drug (2 ml of
Avogain 5% 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 overdosage 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
The effect of Avogain 5% solution has been assessed in a phase III clinical trial conducted over a 48
week treatment period.
In this study Avogain 5% solution was compared to the product vehicle without the minoxidil active
ingredient and also to 2% minoxidil cutaneous solution.
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Avogain 5% Solution 50ml
1.3. Product Information
1.3.1 Summary of Product Characteristics (SPC)
The primary efficacy criterion was non-vellus hair count in a 1.0cm2 reference area of affected scalp.
The mean changes observed in this parameter in these studies were significantly in favour of active
treatment. A significant dose effect was also demonstrated. The results are summarized in the
following table:
Mean change in non-vellus hair count in reference 1cm2 area of scalp compared with baseline

Efficacy was further assessed by comparing photographs taken at various time-points with baseline.
Assessment was undertaken by patients using a 100mm visual analogue scale and assessing scalp
coverage where point 0 represented much less scalp coverage, 50mm no difference and 100mm
much more scalp coverage. In addition, an assessment was undertaken by 2 blinded reviewers who
compared photographs taken at baseline and after 48 weeks. Differences were assessed using a 7
point categorical scale viz:
Dense growth
Moderate growth
Minimal growth
No change
Minimal loss
Moderate loss
Dense loss

Based upon these photographic data, around 60% of the patients experienced an increased scalp
coverage after 48 weeks treatment with as defined by re-growth of hair; compared with around 23%
at an average for those who received vehicle alone. Of these, around 35% treated with Avogain 5%
solution experienced dense or moderate regrowth compared with around 7% who received vehicle
alone. In addition 30% of patients who received Avogain 5% solution were adjudged to have no
change between the photographic assessments of hair growth compared with 60% who received
vehicle alone. Stabilisation of hair loss (expressed both as regrowth of hair and no continuation of
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Avogain 5% Solution 50ml
hair loss) can therefore be expected in about 4 out of 5 of patients using Avogain 5% solution
compared with 3 out of 4 patients using vehicle alone.
Avogain 5% solution may therefore be considered by men who wish to achieve a faster onset and
greater degree of hair regrowth than would be expected through the use of Avogain regular strength.
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:
− increasing the diameter of the hair shaft
− stimulating anagen growth
− prolonging the anagen phase
− stimulating anagen recovery from the telegon 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.
The systemic absorption of minoxidil from a 5% solution formulation has been estimated in a
pharmacokinetic study in subjects with androgenetic alopecia, which included 5% topical foam as a
comparator. This demonstrated that in men, the systemic absorption of minoxidil from twice daily
application of 5% minoxidil solution was about twice that, as observed with 5% minoxidil foam. The
mean steady state AUC (0-12 hr) and Cmax for 5% minoxidil foam, 8.81 ng·hr/mL and 1.11 ng/mL,
respectively, were both approximately 50 % of AUC (0-12 hr) and Cmax of the 5% solution, 18.71
ng·hr/mL and 2.13 ng/mL, respectively. The time to maximum minoxidil concentration (Tmax) for the
5% solution, 5.79 hr, was similar to Tmax for the 5% foam, 5.42 hr.
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.
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Avogain 5% Solution 50ml
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. 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 8-fold human exposure) when administered orally and greater than 9 mg/kg/day (at least
25-fold human exposure) when administered subcutaneously were associated with reduced
conception and implantation rates as well as a reduction in the number of live pups.

Propylene glycol
Ethanol
Water

Not applicable

After first opening is 30 days

Store below 30°C, don’t freeze.

HDPE bottle with dispenser.
Pack Size 50ml

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