Regaine foam for outside. apply. 5% balloon 60 g # 3

Product form, composition and packaging Foam for external use 5% from white to yellowish-white color, retaining the structure during the observation period of one minute.

1 g

minoxidil

47.5 mg *

anhydrous ethanol - 536.3 mg, purified water - 314.1 mg, butylhydroxytoluene - 0.9 mg **, lactic acid - 10 mg, anhydrous citric acid - 1 mg, glycerol - 20 mg, cetyl alcohol - 11 mg, stearyl alcohol - 5 mg, polysorbate 60 - 4 mg, propellant - propane / n-butane / isobutane (%) (48:30:22) - 50.2 mg.

60 g - aluminum cylinders (1) with a valve with a spray and a cap with a child-proof system - polymer packaging. 60 g - aluminum cylinders (3) with a valve with a spray and a cap with a child-proof system - polymer packaging.

* the actual amount of minoxidil, without the propellant, is 50 mg / g ** the actual amount of butylhydroxytoluene, without the propellant, is 1 mg / g Pharmacological action As a peripheral vasodilator, when applied externally, minoxidil enhances microcirculation in the area of ��hair follicles.

Stimulates vascular endothelial growth factor, which is believed to be responsible for increasing capillary permeability, which indicates the high metabolic activity observed in the anagen phase.

Minoxidil stimulates hair growth in patients with hereditary hair loss (androgenetic alopecia) in the initial to moderate stages.

The exact mechanism of action of topical minoxidil for hair loss is not fully understood.

When applied topically to intact skin, approximately 1-2% minoxidil solution undergoes systemic absorption.

In a clinical study, the systemic absorption of the 5% topical foam was approximately half of the systemic absorption of the 5% topical solution.

The average values ��of AUC0-12 h and Cmax when using 5% foam were 8.81 ng x h / ml and 1.11 ng / ml, respectively, which corresponds to approximately 50% of the same indicators when using a 5% solution (18.71 ng x h / ml and 2.13 ng / ml respectively).

Tmax when using 5% foam is 5.42 hours and is similar to that when using a 5% solution (5.79 hours).

The effect of minoxidil on hemodynamics is not pronounced until the mean serum concentration of minoxidil reaches 21.7 ng / ml.

Distribution

Although it was previously reported that minoxidil does not bind to plasma proteins, later, by in vitro ultrafiltration, its reversible binding to human plasma proteins in the range of 37�39% was demonstrated.

Since only 1�2% of topically applied minoxidil is absorbed, the degree of plasma protein binding observed in vivo after topical application will be clinically insignificant.

The Vd of minoxidil after intravenous administration at a dose of 4.6 mg and 18.4 mg is 73.1 L and 69.2 L, respectively.

Metabolism

Approximately 60% of minoxidil absorbed after external use is metabolized to minoxidil glucuronide, mainly in the liver.

Withdrawal

T1 / 2 of minoxidil for external use averages 22 hours, compared to 1.49 hours for oral administration.

97% of minoxidil and its metabolites are excreted by the kidneys and 3% through the intestines.

After stopping the use of the drug, approximately 95% of minoxidil applied externally is excreted within 4 days. Indications for use - androgenic alopecia in men and women. Contraindications for use - violation of the integrity of the scalp

- dermatoses of the scalp

- the simultaneous use of other drugs on the scalp

- pregnancy

- lactation period (breastfeeding)

- age under 18

- age over 65

- hypersensitivity to minoxidil or other components of the drug.

The drug should be prescribed with caution to patients with cardiovascular diseases,

Name ENG

REGAINE

ATX code

Minoxidil

Dosage

5% x 60g

Structure

1 ml of solution contains minoxidil 50 mg.

Indications

Androgenetic alopecia in men and women (in order to restore the hairline or stabilize the hair loss process).

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Contraindications

Children and adolescents up to 18 years old

hypersensitivity to minoxidil and other components of the drug.

The drug should not be applied in case of redness, inflammation, infection, soreness of the scalp (including sunburn).

INN / Active ingredient

minoxidil

Specifications

Category

Baldness

Scope of the medicinal product

Leather

Release form

Spray

Manufacturer country

Switzerland

Package quantity, pcs

3

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Regaine

The amount of the dosage form in the primary package

60 g

Primary packaging type

Balloon

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Alopecia Remedy

Anatomical and therapeutic characteristics

D11AX01 Minoxidil [Topical]

Dosage form

Foam for outdoor use

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

50 mg

Package weight, g

200

Mode of application

:

The drug is intended for external use. Dry the hair and scalp thoroughly before using Regaine. For the drug to be effective and to reach the hair follicles, it is important to apply the drug to the scalp and not to the hair. For men, apply 1 g (1/2 cap) of foam 2 times / day (morning and evening) to the affected areas of the scalp. Do not use Regaine more often than 1 time in 12 hours. The total daily dose should not exceed 2 g of the drug (100 mg of minoxidil). For women, apply 1 g (1/2 cap) of foam once a day to the affected areas of the scalp. You should not use Regaine more than 1 time / day. The daily dose should not exceed 1 g of the drug (50 mg of minoxidil). Do not apply Regaine to other areas of the body.

Information on technical characteristics, delivery set, country of manufacture