Cosilon, spray 5% 60 ml

Pharmaceutical group: Dermatotropic agents.

Pharmaceutical action:

In external application of minoxidil its stimulating effect on hair growth in persons with androgenic alopecia (hair thinning, alopecia) has been noted. It improves microcirculation, stimulates the transition of hair cells into an active growing phase, changes the effect of androgens on the hair follicles. It reduces the formation of 5-alpha-dehydrotestosterone (probably indirectly), which plays a significant role in the formation of baldness.

The best effect is achieved if the follicle is not more than 10 years old, the patient is young, the baldness in the vertex is not more than 10 cm, the central baldness has more than 100 down and terminal hairs.
The appearance of hair growth is observed after 4 or more months of application of the preparation. The onset and the degree of the effect may vary from patient to patient.

After discontinuation of the use of Cosilon® the growth of new hair is suspended; within 3-4 months it is possible to restore the initial appearance. The exact mechanism of action of Cosilon® in the treatment of androgenetic alopecia is unknown. Minoxidil is ineffective in cases of alopecia caused by taking the drug, improper nutrition (iron (Fe) deficiency, vitamin A deficiency), as a result of hair styling in “tight” hairstyles.

Pharmacokinetics:

When applied externally, minoxidil is poorly absorbed through normal intact skin: on average, 1.5% (0.3-4.5%) of the total dose applied enters the systemic bloodstream. The effect of concomitant skin diseases on the absorption of minoxidil is unknown.
After discontinuation of the drug approximately 95% of minoxidil that entered the systemic bloodstream is eliminated within 4 days. The metabolic biotransformation profile of minoxidil after external use of Cosilon® has not yet been fully understood.

Minoxidil does not bind to plasma proteins and is excreted by the kidneys via glomerular filtration. Minoxidil does not penetrate the blood-brain barrier.

It is excreted mainly with the urine. Minoxidil and its metabolites are excreted by hemodialysis.

Indications

Androgenic alopecia in men and women (in order to restore hair or stabilize hair loss).

Active ingredient

Composition

1 ml of the solution contains:

The active ingredient is minoxidil 50.00 mg;

Supplementary substances: propylene glycol – 700.00 mg, ethanol 96% – 200.00 mg, water to 1.00 ml.

How to take, the dosage

To dry scalp, apply 1 ml of Cosilon solution twice daily and gently rub in, starting from the center of the affected area.

Interaction

There is a theoretical possibility of increased orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, but this possibility has not been clinically confirmed.

The very slight elevated blood levels of minoxidil in patients with arterial hypertension receiving oral minoxidil cannot be excluded when Cosilon® is used concomitantly, although appropriate clinical studies have not been performed.

Minoxidil has been found to interact with some other topical medications when used externally.

The simultaneous use of minoxidil solution for external use and cream containing betamethasone (0.05%) leads to decreased systemic absorption of minoxidil. Simultaneous application to the skin of minoxidil and topical preparations such as tretinoin and ditranol, which cause changes in skin protective functions, may result in increased absorption of minoxidil.

Special Instructions

Cosilon® is applied only to dry scalp after bathing or at least 4 hours before bathing. Hands should be washed thoroughly after application to the scalp.

Wash hair as usual when using Cosilon®. Hairspray and other hair care products can be used while using Cosilon®. Before applying hair care products, first apply Cosilon® and wait until the treated skin area is completely dry.

There is no evidence that hair coloring, perming or the use of hair softeners will impair the effectiveness of the product in any way. However, to prevent potential scalp irritation, be sure to wash the product completely off the hair and scalp before applying these chemicals.

Before treatment with Cosilon® patients should undergo a general evaluation including collection and review of medical history. The physician must ensure that the scalp is healthy.

If patients experience systemic side effects or severe skin reactions, they should discontinue the drug and see their physician.

Cosilon® contains ethyl alcohol. In case of contact of the drug with sensitive surfaces (eyes, irritated skin, mucous membranes) the area should be rinsed with plenty of cold water.

The effect of the drug on the ability to drive vehicles and work on machines:

Influence of the drug on psychomotor functions has not been noted. The drug does not affect the ability to operate vehicles.

Contraindications

Hypersensitivity, pregnancy, breastfeeding; skin integrity disorders, dermatosis of the scalp.

Side effects

Skin disorders: hypertrichosis, thinning and increase pigmentation of body hair; when used topically – dry and flaky scalp, dermatitis (itching, rash), eczema, increased alopecia, scalp burning sensation, folliculitis (sensitivity or painfulness at hair roots), erythema.

Allergic reactions: rash, facial edema, rhinitis, urticaria.

Others: sodium and water retention in the body, edema, shortness of breath, syncope, decreased libido.

Overdose

Accidental oral administration of Cosilon® may cause systemic side effects due to the vasodilator properties of minoxidil (5 ml of Cosilon® contains 250 mg of minoxidil, 2.5 times the maximum recommended dose for adults when taken orally for the treatment of arterial hypertension).

The signs of overdose are fluid retention, decreased blood pressure, and tachycardia.

Treatment: Diuretics may be prescribed to eliminate fluid retention if necessary; beta-adrenoblockers may be prescribed to treat tachycardia.

In order to treat arterial hypotension, intravenous 0.9% sodium chloride solution should be administered. Symptomatic agents such as norepinephrine and epinephrine with excessive cardiac stimulatory activity should not be administered.

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