of Алопекси® 2%
of Алопекси® 5%
the International unlicensed
name Minoksidil Lekarstvennaya the form
Solution for external use, 60 ml
of 100 ml of drug contains
active agent – minoksidit 2.0 g,
excipients: a γ-cyclodextrin, propylene glycol, alcohol of 96%, the water purified.
Active agent contains 100 ml of drug – minoksidit 5.0 g
excipients: propylene glycol, alcohol of 96%, water purified.
Transparent colourless or slightly yellowish color liquid.
Other drugs for treatment of diseases of skin. Minoksidil.
The ATX D11AX01 code
Pharmacokinetics of Topical Administration properties results insignificant absorption of a minoksidil: on average 1.4% (from 0.3 to 4.5%) of the applied dose get to the general system of blood circulation. So, after use of a dose in 1 ml of 2% solutions (on skin 20 mg of a minoksidil get), the quantity of the absorbed minoksidil is about 0:28 mg.
For comparison, at oral administration of a minoksidil (for treatment of a hypertensia form), it is almost completely soaked up in digestive tract. Also it was proved that the minimum dose minoksidit intravenously, causing clinically significant hemodynamic effect in patients with hypertensia easy and moderate severity, makes 6.86 mg.
Results of pharmacokinetic researches indicate existence of the following three major factors promoting the increased absorption at topical administration of a minoksidil:
– quantitative increase in the used dose,
– increase in frequency of use of drug,
– decrease in protective function of a corneal layer of epidermis.
Increase in absorption is quickly limited as a result of effect of saturation.
Absorption of a minoksidil after topical administration is not influenced by a floor, influence of UV rays, simultaneous use of the moistening means, occlusion (carrying a wig), effect of evaporation of solvent (use of the hair dryer), a drug use zone.
Levels of a minoksidil in serum after topical administration depend on intensity of transdermalny absorption. After the termination of external use, about 95% of the absorbed minoksidil are removed within 4 days.
At topical administration of a minoksidil its stimulating influence on growth of hair at persons with an androgenetichesky alopecia (poredeniye of hair, baldness) is noted. At topical administration, minoksidit stimulates growth of keratinotsit of in vitro and in vivo and also growth of hair at some patients with an androgenic alopecia.
This growth is observed approximately through 4 (or more) month of use of drug and shown differently at various people.
After the therapy termination, repeated growth stops, and there is a return to an initial state within 3-4 months.
The exact mechanism of effect of drug is not known. Topical administration of a minoksidil with the normal and increased arterial blood pressure during controlled clinical trials did not cause the system manifestations connected with absorption of a minoksidil in patients.
– for treatment of an androgenetichesky alopecia (recovery of indumentum) and stabilization of process of a hair loss at men and women
the Route of administration and doses
Is intended for external use.
ONLY FOR ADULTS.
You apply 1 ml of drug to head skin two times a day and rub, beginning from the center of the struck area.
The general day dose should not exceed 2 ml.
Distribute solution by means of finger-tips on all area of the struck area.
Carefully wash out hands before putting drug.
Before use be convinced that hair and head skin are dried carefully up.
Use of the graduated pipette:
The graduated pipette
the Graduated pipette allows to measure precisely 1 ml of solution for drawing it on all surface of the struck area.
Use of the pompovy portioning device
This device is convenient for drawing means on the small areas or sites of skin under hair.
1. Attach the applicator to the pompovy device: strong hold the pompovy device, pressing on an upper part of the applicator.
2. Turn off and remove a bottle cover: the white ring with indication of opening has to remain on a bottle.
3. Insert a spray with the applicator attached to it into a bottle and reliably twirl.
4. Fill a pomp: the system of delivery of drug is ready to use.
5. For use: direct a spray to the center of the struck area or under hair, press once and distribute drug finger-tips.
Repeat operation of 6 times to put means in number of 1 ml.
Wash the applicator with warm water after each use.
– local irritation, including peeling, erubescence, dermatitis, xeroderma, a hypertrichosis (in the remote sites), the burning sensation and an itching (in particular because of presence of alcohol in drug)
is not frequent
– an allergy (reactions of sensitivity, rhinitis, rash, a generalized erythema, a face edema
– dizziness, pricking, a headache, weakness, neuritis, hypostases, disturbance of flavoring perception, ear infections (in particular, otitis of an external ear), disorders of vision, irritation of an eye
Was reported about exceptional cases of arterial hypotension and hypertrichosis (undesirable growth of hair on a body, including growth of hair in the person at women) after the beginning of use of the drug Alopeksi. Emergence of atypical results of analyses of function of a liver is possible.
– hypersensitivity to a minoksidil or any other ingredient of solution
– pregnancy and the period of a lactation
– children’s age up to 18 years
Simultaneous drawing on skin of a minoksidil and drugs for external use, such as tretinoin and antralin/ditranol which cause changes of protective functions of skin can lead to increase in absorption of a minoksidil.
Before topical administration of a minoksidil, be convinced that head skin is healthy and is in the normal state.
The increased absorption minoksidit through skin which is capable to cause system influences, can happen in a case:
– a dermatosis or damage of head skin,
– combined use of retinoic acid, an antralin or other irritating medicine of topical administration,
– increase in the used dose and/or frequency of dosing: it is necessary to follow the recommended dosing mode.
Similarly, in spite of the fact that systematic use of solution of a minoksidil did not reveal any system effects, it is impossible to exclude a possibility that the increased absorption caused by individual variability or atypical sensitivity can cause these system influences. It is necessary to inform patients on similar risk.
In case of systemic action of drug (the lowered blood pressure, tachycardia, signs of deduction of water and salt, a stethalgia) or emergence of serious skin reactions, treatment it is necessary to interrupt.
The possibility of use of drug by patients with heart troubles in the anamnesis has to be analyzed regarding a ratio of advantage of treatment and potential risks. Such patients need to be informed especially accurately regarding possible undesirable reactions that in case of their emergence, they could interrupt immediately use of drug and see the attending physician.
It is impossible to apply minoksidit in the following cases:
– if the sudden hair loss (full baldness) after a disease or therapy by any drug took place,
– in relation to any other part of the body.
The accidental ingestion can cause serious undesirable reactions.
In case of accidental hit of drug in eyes, affected areas of skin, a mucous membrane, the solution containing alcohol can cause irritation and burning sensations: it is necessary to wash an affected area with water carefully.
During a usage time of a minoksidil it is not recommended to be affected by sunlight.
Medicine contains propylene glycol and can cause irritation of skin.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose does not influence
Accidental hit of solution in an organism can cause system influences, considering vasodilating effect of a minoksidil (in 5 ml of solution 100 mg of a minoksidil – the maximum oral dose for adults contain at treatment of arterial hypertension).
Symptoms: lowering of arterial pressure, tachycardia, delay of sodium and water.
A form of release and packing
On 60 ml of drug in bottles (polyethylene) with the dosing pipette (polystyrene/polyethylene) graduated with value in 1 ml and the measuring pompovy portioning device for putting solution.
On 1 or 3 bottles together with the instruction for medical use in the state and Russian languages put in a cardboard pack.
To Store storage conditions at a temperature not above 30 °C.
To store out of children’s reach!
A period of storage
2 years for Alopeksi of 2%
3 years for Alopeksi of 5%
the use Period after packing opening 1 month.
Not to apply after the termination of the expiration date specified on packing.
of Proizvoditel Pierre Fabr Medikament Production