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Препарат Косилон® 5%. Bosnalijek (Босналек) Республика Босния-Герцеговина


Producer: Bosnalijek (Bosnalek) Republic Bosnia-Herzegovina

Code of automatic telephone exchange: D11AX01

Release form: Liquid dosage forms. Solution for external use.

Indications to use: Androgenetichesky alopecia.


General characteristics. Structure:

1 ml of solution contains
Active ingredient – minoksidit 50 mg/ml;
Auxiliary вещества:пропиленгликоль – 700 mg, ethanol of 96% – 200,00 mg, water to 1,00 ml.

Description. Transparent solution from light yellow till orange color solution.




Pharmacological properties:

Pharmacodynamics. At external use of a minoksidil its stimulating influence on growth of hair at persons with an androgenic alopecia (a poredeniye of hair, baldness) is noted. Improves microcirculation, stimulates transition of hair cells to the active growing phase, changes impact of androgens on hair sacks. Reduces education 5 - alpha дегидротестостерона it (is possible, mediated) which plays an essential role in formation of baldness. The best effect renders at small prescription of a disease (no more than 10 years), young age of patients, a bald head in the field of a darkness no more than 10 cm, existence in the center of a bald head more than 100 vellus and terminal hair.
Emergence of signs of growth of hair is noted in 4 and more months of use of drug. The beginning and degree of manifestation of effect can fluctuate at different patients.
After drug Kosilon® phase-out growth of new hair stops, within 3-4 months recovery of initial outward is possible. The exact mechanism of effect of the drug Kosilon® at treatment of an androgenetichesky alopecia is unknown. Minoksidil is inefficient in case of the baldness caused by medicine reception, improper feeding (deficit of iron (Fe), vitamin A) as a result of hair dressing in "hard" hairstyles.

Pharmacokinetics. At external use minoksidit badly it is soaked up through the normal unimpaired skin: on average 1,5% (0,3-4,5%) of the general put dose come to a system blood stream. Influence of the accompanying skin diseases on absorption of a minoksidil is unknown.
After phase-out of drug about 95% of the minoksidil which got to a system blood stream it is removed within 4 days. The profile of metabolic biotransformation of a minoksidil after external use of the drug Kosilon® is completely not studied so far.
Minoksidil does not contact proteins of plasma and is brought by kidneys by means of glomerular filtering. Minoksidil does not get through a blood-brain barrier.
It is excreted preferential with urine. Minoksidil and his metabolites are removed by means of a hemodialysis.


Indications to use:

For treatment of an androgenic alopecia (recovery of indumentum) and stabilization of process of a hair loss at men and women.


Route of administration and doses:

Only for external use. Косилон® it is applied only on skin of a pilar part of the head. Not to apply Kosilon® on other body parts.
Before the first use of the sprayer it is necessary to spray solution 2-3 times, uniform spraying will not be reached yet. Next time the sprayer can be used at once.
Irrespective of the size of the processed site it is necessary to apply 1 ml of solution by means of the doser (8 pressing) 2 times a day on affected areas of a pilar part of the head, since the center of the struck zone. After use it is necessary to wash up hands.
The total daily dose should not exceed 2 ml.
For men of Kosilon® it is most effective at a hair loss on the top, for women – at a hair loss in the field of a median hair parting.
You apply the drug Kosilon® only on dry skin of a pilar part of the head. Solution does not demand washing off.
Emergence of the first signs of stimulation of growth of hair perhaps after drug use 2 times a day within 4 months or more. The beginning and degree of manifestation of growth of hair, and also quality of hair can fluctuate at various patients.
According to single messages within 3-4 months after the termination of treatment it is possible to expect recovery of initial outward.
Treatment duration on average about 1 year.
After clinical improvement the dose decreases to 1 ml solution 1-2 times a week. If in 4 months the satisfactory result is not achieved, it is necessary to consult with the dermatologist who can make the decision on treatment extension.


Features of use:

The drug Kosilon® is applied only on dry skin of a pilar part of the head after bathing or not less than in 4 hours before bathing. After putting drug on head skin of a hand it is necessary to wash up carefully. It is recommended to wash hair at drug Kosilon® use in the usual mode. Hairspray and other conditioning agents behind hair can be used during drug Kosilon® use. Before drawing means for care of hair it is necessary to apply at first the drug Kosilon® and to wait until the processed site of skin completely dries up. There are no data that hair-dyeing, performance of a chemical wave or use of softeners for hair can reduce efficiency of drug somehow. However for prevention of possible irritation of a pilar part of the head it is necessary to be convinced that drug was washed completely away from hair and skin of a pilar part of the head before use of these chemical means.
Before beginning treatment with the drug Kosilon®, patients have to undergo the general inspection including collecting and studying of the medical anamnesis. The doctor has to be convinced that skin of a pilar part of the head is healthy.
At emergence of system side effects or heavy skin reactions patients should cancel drug and to see a doctor.
Alcohol is a part of the drug Kosilon®. In case of hit of drug on sensitive surfaces (eyes, the angry skin, mucous membranes) it is necessary to wash out the site a large amount of cold water.

Influence on ability to manage transport and to work at machines
Influence of drug on psychomotor functions is noted. Drug does not influence ability to manage transport.


Side effects:

Use of a minoksidil can cause strengthening of a hair loss upon transition from a resting phase to a growth phase, at the same time old hair drop out, and on their place new grow. This temporary phenomenon is usually observed 2-6 weeks later after an initiation of treatment and gradually stops within two next weeks (emergence of the first signs of action of a minoksidil).
Side effects at external use can be shown in the form of a skin itch in a site of application, contact dermatitis, a folliculitis, a hypertrichosis (undesirable growth of hair on a body, including growth of hair in the person at women), seborrheas.

At an accidental proglatyvaniye of drug the following symptoms can appear:
From integuments: nonspecific allergic reactions (skin rash, small tortoiseshell).
From respiratory system: short wind, allergic rhinitis.
From a nervous system: headache, dizziness, вертиго, neuritis.
From cardiovascular system: thorax pain, fluctuations of arterial pressure, cardiopalmus, change of a rhythm of cordial reductions, hypostases.


Interaction with other medicines:

There is a theoretical possibility of strengthening of orthostatic hypotension at the patients receiving the accompanying treatment by peripheral vasodilators which did not receive, however, clinical confirmation.
It is impossible to exclude very insignificant increased maintenance of a minoksidil in blood of the patients having arterial hypertension and accepting minoksidit inside in case of simultaneous use of the drug Kosilon® though the corresponding clinical trials were not conducted.
It is established that minoksidit at external use can interact with some other medicines for external use.
Simultaneous use of solution of a minoksidil for the external use and cream containing betamethasone (0,05%) leads to decrease in system absorption of a minoksidil. Simultaneous drawing on skin of a minoksidil and drugs for external use, such as третиноин and дитранол which cause changes of protective functions of skin can lead to increase in absorption of a minoksidil.


Contraindications:

Hypersensitivity to a minoksidil or other components of drug.
The age is younger than 18 years. Advanced age – is more senior than 65 years.
Disturbance of integrity of integuments, dermatosis of a pilar part of the head.

Use at pregnancy and feeding by a breast.
At pregnancy and feeding by a breast drug should not be used.


Overdose:

Accidental intake of the drug Kosilon® can cause the system side effects caused by vasodilating properties of a minoksidil (5 ml of the drug Kosilon® contain 250 mg of a minoksidil that is 2,5 times more than most recommended dose for adults at intake at treatment of arterial hypertension).
Overdose signs: liquid delay, lowering of arterial pressure, tachycardia.
Treatment: for elimination of a delay of liquid if necessary diuretics can be appointed; for treatment of tachycardia – beta adrenoblockers.
For treatment of arterial hypotension it is necessary to enter intravenously 0,9% chloride sodium solution. It is not necessary to appoint symptomatic means, for example, Norepinephrinum and Epinephrinum having the excessive cardiostimulating activity.


Storage conditions:

At a temperature not above 30 °C. To store in the place, unavailable to children! Period of validity: 2 years. Not to use after a period of validity.


Issue conditions:

Without recipe


Packaging:

Solution for external use of [spirit] 5%.
On 60 ml in a polymeric bottle of white color with the sprayer. Each bottle with the application instruction is placed in a cardboard pack.



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