Description
Not applicable.
1. NAME OF THE MEDICINE
ALOPEXY 2 PER CENT, solution for cutaneous application
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil ................................................................................................................................................ 2 g
Per 100 ml of solution for cutaneous application.
Notable excipient: propylene glycol
For a complete list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for dermal application.
4. CLINICAL DATA
4.1 Therapeutic indications
This medicine is indicated in the case of moderate hair loss (androgenetic alopecia) in adult men and women. It promotes hair growth and stabilises hair loss.
4.2. Dosage and method of administration
Dermal route.
RESERVED FOR ADULTS.
Apply twice a day a dose of 1 ml to the scalp, starting from the centre of the area to be treated.
The daily dose should not exceed 2 ml.
Spread the product with the fingertips so as to cover the entire area to be treated.
Before and after applying the solution, wash your hands thoroughly.
Apply to perfectly dry hair and scalp.
Using the pipette
A pipette allows you to take precisely 1 ml of solution to be spread over the whole area to be treated.
Use of the pump with applicator:
Remove the cap of the bottle and unscrew the cap that closes the bottle.
Screw the dosing pump onto the bottle.
To apply: direct the pump towards the centre of the area to be treated, press once and spread the product with the fingertips so as to cover the entire area to be treated.
Repeat 6 times to apply a 1 ml dose.
4.3. Contraindications
Hypersensitivity to minoxidil or to any of the other components of the solution.
4.4. Special warnings and precautions for use
Warnings
Before using topical minoxidil, the subject should ensure that the scalp is normal and healthy.
Increased percutaneous absorption of minoxidil, which may result in systemic effects, may occur in the case of:
- dermatosis or scalp injury,
- concomitant application of retinoic acid, anthralin or any other irritating topical,
- increase in the dose applied and/or increase in the frequency of applications: it is imperative to respect the dosage and the method of administration.
Similarly, although extensive use of minoxidil solution has not revealed any systemic effects, it cannot be excluded that increased absorption due to individual variability or unusual sensitivity may cause systemic effects. Patients should be advised of this.
If systemic effects (e.g., decreased blood pressure, tachycardia, signs of fluid retention, chest pain) or severe dermatologic reactions occur, treatment should be discontinued.
In patients with a history of heart disease, the benefit of treatment should be weighed. They should be particularly warned of potential adverse effects so that treatment can be discontinued at the onset of any of them and a physician notified.
Do not apply minoxidil:
- in cases of sudden hair loss, hair loss due to illness or medication,
- on another part of the body.
Precautions for use
Accidental ingestion may result in severe adverse effects (see section 4.9).
In the event of accidental contact with the eye, injured skin or mucous membranes, the solution (containing ethyl alcohol) may cause a burning sensation and irritation: rinse thoroughly with running water.
Sun exposure is not recommended when applying minoxidil.
This medicine contains propylene glycol and may cause skin irritation.
4.5. Interactions with other medicinal products and other forms of interaction
The data available to date do not suggest the existence of clinically significant interactions.
4.6. Pregnancy and lactation
Pregnancy
Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effects in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have been shown to be teratogenic in animals in well-conducted studies in two species.
Clinically, there are currently no sufficiently relevant data to assess a possible malformative or fetotoxic effect of minoxidil when administered during pregnancy.
Therefore, as a precautionary measure, minoxidil should not be used during pregnancy.
Breastfeeding
When administered systemically, minoxidil passes into breast milk; therefore, the drug should be avoided in nursing mothers.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
- Mostly minor skin reactions: local irritation with, in particular, scaling, erythema, dermatitis, dry skin, hypertrichosis (at a distance), burning and pruritus (particularly due to the presence of alcohol).
- More rarely: allergy (sensitivity, rhinitis, rash, generalized erythema, facial edema), dizziness, tingling, headache, weakness, neuritis, edema, taste alteration, ear infection (especially otitis externa), visual disturbances, eye irritation.
- Alopecia, irregular hair growth, chest pain, changes in blood pressure and pulse rate have been reported.
Liver abnormalities may occur.
- Due to the presence of propylene glycol, contact eczema may occur.
It should be noted, however, that these medical events, especially those that have been reported less frequently, have been reported without it being possible to establish formally the imputability to the treatment.
4.9. Overdose
Accidental ingestion may cause systemic effects due to the vasodilatory action of minoxidil (5 ml of solution contains 100 mg of minoxidil, the maximum dose used for oral administration in adults treated for hypertension). Signs and symptoms of possible overdosage would be cardiovascular, with decreased blood pressure, tachycardia and fluid retention. Fluid retention may be treated with appropriate diuretic therapy, tachycardia and angina with a beta-blocker or other sympathetic nervous system inhibitor. Symptomatic hypotension may be treated by intravenous administration of isotonic sodium chloride solution. The use of sympathomimetics such as norepinephrine and adrenaline should be avoided because of excessive cardiac stimulation.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class:
OTHER DERMATOLOGICAL DRUGS
ATC Code: D11AX01
Efficacy and safety in subjects under 18 and over 65 years of age have not been studied.
Applied topically, minoxidil stimulates keratinocyte growth in vitro and in vivo and hair growth in some subjects with androgenetic alopecia.
The onset of this phenomenon occurs after approximately 4 months (or more) of use and varies from subject to subject.
Upon discontinuation of treatment, regrowth ceases and a return to the initial state can be expected within 3 to 4 months.
The precise mechanism of action is not known. Topical application of minoxidil in controlled clinical trials in normotensive or hypertensive patients has not resulted in the observation of systemic events related to minoxidil absorption.
5.2. Pharmacokinetics
Minoxidil, when applied topically, is only poorly absorbed: an average of 1.4% (ranging from 0.3 to 4.5%) of the applied dose reaches the systemic circulation. Thus, for a dose of 1 ml of 2% solution (i.e. 20 mg minoxidil applied to the skin), the amount of minoxidil absorbed corresponds to approximately 0.28 mg.
In comparison, when given orally (in the treatment of certain hypertensive diseases), minoxidil is almost completely absorbed from the gastrointestinal tract. It has also been shown that the lowest dose of minoxidil administered I.V. that induces clinically significant hemodynamic effects in patients with mild to moderate hypertension is 6.86 mg.
The results of pharmacokinetic studies indicate that the three main factors that increase the absorption of topical minoxidil are
- quantitative increase in the applied dose,
- increased frequency of application,
- decrease in barrier function of the stratum corneum of the epidermis.
This increase is rapidly limited by a saturation effect.
Absorption of minoxidil after topical application is not affected by gender, UV exposure, simultaneous application of a moisturizer, occlusion (hair prosthesis), evaporation of the solvent (hair dryer), or surface area of application.
Serum minoxidil levels following topical administration are dependent on the rate of percutaneous absorption. After discontinuation of topical application, approximately 95% of absorbed minoxidil is eliminated within 4 days.
The biotransformation of absorbed minoxidil after topical application is not fully understood.
5.3. Preclinical safety data
Not known.
6. PHARMACEUTICAL DATA
6.1. List of excipients
γ-Cyclodextrin, 96 percent ethanol, propylene glycol, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
- Packaged in a bottle (brown glass): 3 years
- Bottle pack (PET): 2 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of outer packaging
- Bottle (brown glass) of 15 ml, 30 ml or 60 ml with or without pipette (Polystyrene/polyethylene) graduated to 1 ml. Box of 1 or 3.
- 60 ml bottle (PET) with pipette (Polystyrene/polyethylene) graduated to 1 ml and dosing pump with applicator. Box of 1 or 3.
6.6. Special precautions for disposal and handling
No special requirements.
7. MARKETING AUTHORIZATION HOLDER
PIERRE FABRE DERMATOLOGIE
45, PLACE ABEL GANCE
92100 BOULOGNE
8. MARKETING AUTHORISATION NUMBER(S)
- 330 924-1: 15 ml bottle (brown glass) with pipette (polystyrene/polyethylene).
- 330 228-5: 30 ml in a bottle (brown glass) with pipette (polystyrene/polyethylene).
- 330 925-8: 60 ml in a bottle (brown glass) with pipette (polystyrene/polyethylene).
- 332 175-6: 2 vials (brown glass) of 60 ml + 1 vial (brown glass of 15 ml).
- 335 273-9: 60 ml bottle (brown glass) box of 3.
- 362 991-6: 60 ml bottle (PET) with pipette (Polystyrene/polyethylene) and dosing pump with applicator. Box of 1.
- 364 307-5: 60 ml bottle (PET) with pipette (Polystyrene/polyethylene) and dosing pump with applicator. Box of 3.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
[To be completed by the holder]
10. DATE OF UPDATE OF THE TEXT
[to be completed by the holder]
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
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