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 Neoxidil, individual responses cannot be predicted. 

Women aged 18-65: 
Hair and scalp should be thoroughly dry prior to topical application of Neoxidil. A dose of 1 ml Neoxidil 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 Neoxidil are necessary for continued hair growth.
Anecdotal reports indicate that re-grown hair may disappear three to four months after stopping Neoxidil 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 Neoxidil 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. 
Using the Extended spray-tip applicator: 
Uncap the bottle. 
Direct the bottle pump to the center of the area to be treated, pump once and spread the product with the fingertips. 
Repeat 10 times to deliver a dose of 1 ml. Re-cap the bottle after use. 
The hair and scalp should be completed dry when the product is applied, working out from the center of the area to be treated. 
Do not apply the product in other parts of the body. 
It may take up to 4 months before onset of action (i.e. signs of hair growth) exist. 
When treatment with minoxidil is stopped, regrowth cases and a return to the initial condition can be expected within 3 to 4 months. 
Wash the hands thoroughly before and after applying the product. 

Neoxidil is contra-indicated: In users with history of hypersensitivity to the active substance, or to any of the other excipients of the product. 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 Neoxidil, 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 Neoxidil and see a doctor if hypotension is detected or if the patient is experiencing chest pain, palpitations, 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 Neoxidil. 
Some patients have experienced changes in hair color and/or texture with use of Neoxidil. 
Neoxidil 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 Neoxidil. 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 Neoxidil and consult their doctor. 

Users should be aware that, whilst extensive use of Neoxidil 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 or voluntary overdose after external use with the product will make an increase on the intensity of the dermatological adverse reactions. 
Accidental ingestion may cause serious cardiac adverse events. Therefore this product has to be kept out of the reach of children. 
Neoxidil 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. 
Neoxidil 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 Neoxidil. 

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 fetus at exposure levels that are very high compared to those intended for human exposure.
There is potentially a risk of fetal 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. 

This product may cause dizziness or hypotension (see section 4.8). If affected, patients should not 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 Reactions (Preferred Term)
Immune System Disorders	Common	Hypersensitivity reactions (including face oedema, generalised erythema, pruritus generalised, swelling face, and throat tightness)
	Not Known	Angioedema (including lip oedema, lip swelling, oedema mouth, oropharyngeal swelling, pharyngeal oedema, swollen tongue and tongue oedema)
Psychiatric disorders	Not known	Depressed mood
Nervous System Disorders	Very common	Headache
	Uncommon	Dizziness
Eye disorders	Not known	Eye irritation
Cardiac disorders	Common	Chest pain
	Uncommon	Heart rate increased Palpitation
	Not known	Heart rate increased
Vascular disorders	Not known	Hypotension
Respiratory, thoracic and mediastinal disorders	Uncommon	Dyspnea
Gastrointestinal Disorders	Uncommon	Nausea
	Not know	Vomiting
Skin and subcutaneous tissue disorders	Common	Hypertrichosis (unwanted nonscalp hair including facial hair growth in women) Pruritus (including rash pruritic generalized and eye pruritus) Rash (including pustular, papular, generalized, vestibular and macular rash) Dermatitis (including contact, allergic, atopic and seborrheic dermatitis)
	Rare	Changes in hair texture
	Not known	Dry skin, Skin exfoliation (including exfoliative rash and dermatitis exfoliative) Acne (acneiform rash) Temporary hair loss (see section 4.4) Changes in hair color.
General disorders and administration site conditions	Common	Oedema peripheral
	Not known	Application site reactions (These sometimes involve nearby structures like the ears and face and typically consist of pruritus, irritation, pain, rash, oedema, dry skin, erythema and rash erythematous but can sometimes be more severe and include exfoliation, dermatitis, blistering, bleeding and ulceration)
Investigations	Common	Weight increased

Reporting of suspected adverse reactions

* Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2340.
SFDA Call Center: 19999
Email: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

* Other GCC Status:
Please contact the relevant competent authority.
 

Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of Neoxidil are applied to larger surface areas of the body or areas other than the scalp. 
Because of the concentration of minoxidil in Neoxidil, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (5 ml of Neoxidil 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
Individual responses to Neoxidil are variable and unpredictable.

The effect of Neoxidil has been assessed in phase III clinical trials in women conducted over a 48 week treatment period. 
In these studies Neoxidil 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. The mean changes observed in this parameter in these studies were significantly in favour of Neoxidil and were as follows:

Mean change in non-vellus hair count in reference 1 cm2 area of scalp compared with baseline
	Regaine for Women Regular Strength (minoxidil 2%)	Vehicle	Pairwise comparison
Baseline	150.4	138.4
	Mean change from baseline	Mean change from Baseline
16 weeks	+35.9	+20.0	2%>vehicle
32 weeks	+26.7	+15.2	2%>vehicle
48 weeks	+20.7	+9.4	2%>vehicle

Using non-vellus hair count as an efficacy criteria, Neoxidil has also been shown to stabilize 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 Neoxidil usage.

Patient evaluation of visible hair growth
	% of Females reporting regrowth after 8 months Neoxidil usage	% of Females reporting regrowth after 4 months Product vehicle usage
Minimal re-growth	30-40	29-33
Moderate to dense re-growth	20-25	7-12
Total	55-59	40-41

In addition, Neoxidil has been shown to stabilize hair loss (shown as re-growth or no loss) in 4 out of 5 females as calculated from two clinical studies that showed stabilization 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 Neoxidil 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 with reduced conception and implantation rates as well as a reduction in the number of live pups.
 

20 mg/ml cutaneous solution
Propyleneglycol (E1520), ethanol and purified water.
 

Not applicable.
 

36 months

Neoxidil is flammable.
Store below 25ᵒ C.
 

Bottle with spray-pump applicator containing 60ml of solution.
Pack size: 1 x 60 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.
Any unused product or waste material should be disposed of in accordance with local requirements.