Regein - instructions for use, dose, side effects, contraindications

Excipients: Ethanol anhydrous - 536.30 mg, purified water - 314.10 mg, butyl hydroxytoluene - 0.90 mg **, lactic acid - 10.00 mg, citric acid anhydrous - 1.00 mg, glycerol - 20.00 mg, cetyl alcohol - 11.00 mg, stearic alcohol - 5.00 mg, polysorbate 60-4.00 mg; Propellant-propane / n-butane / isobutane (%) (48: 30: 22) -50.20 mg.

* The actual amount of minoxidil, without propellant, is 50.00 mg / g;

** The actual amount of butylhydroxytoluene, without propellant, is 1.00 mg / g.

Description:

Foam is white to yellowish white, preserving the structure during the observation period of one minute.

Pharmacotherapeutic group:A treatment for alopecia

ATX: & nbsp

D.11.A.X.01 Minoxidil

Pharmacodynamics:

Being a peripheral vasodilator, minoxidil with external application increases microcirculation in the area of hair follicles. Minoxidil stimulates the growth factor of the vascular endothelium (VEGF), which is supposed to be responsible for increasing capillary permeability, which indicates a high metabolic activity observed in the anagen phase.

Minoxidil stimulates hair growth in patients with hereditary hair loss (androgenic alopecia) in the initial and moderate stages. The exact mechanism of action of minoxidil for external use in hair loss is not fully understood.

Pharmacokinetics:

Suction

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

In a clinical study, systemic absorption of 5% aerosol for external use was approximately half the systemic absorption of a 5% solution for external use. The average values of the area under the curve "concentration-time" AUC (0-12 h) and maximum concentration (C max) with the application of 5% aerosol were 8.81 ng^xh / ml and 1.11 ng / ml, respectively, which corresponds to approximately 50% of similar parameters when using a 5% solution (18.71 ng^xh/ ml and 2.13 ng / ml, respectively).

The time to reach the maximum concentration of minoxidil (TCmax) with a 5% aerosol is 5.42 hours and is similar to that of a 5% solution (5.79 hours). Influence of minoxidil on hemodynamics is not expressed until the average 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 ultrafiltration in vitro it was demonstrated its reversible binding to human plasma proteins in the range of 37-39%.

Since only 1-2% of the externally minoxidil applied is absorbed, the degree of its binding to plasma proteins in vivo after external application, will be clinically insignificant.

The volume of distribution of minoxidil after intravenous administration at a dose of 4.6 mg and 18.4 mg is 73.1 liters, 69.2 liters, respectively.

Metabolism

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

Excretion

The half-life of minoxidil for external application averages 22 hours, compared with 1.49 hours for oral administration. 97% of minoxidil and its metabolites are excreted by the kidneys and 3% by the intestine.

After discontinuation of the drug, approximately 95% of the minoxidil applied externally is excreted within 4 days.

Indications:Treatment of androgenic alopecia in men and women.

Contraindications:

increased sensitivity to minoxidil or other components of the drug;
violation of the integrity of the skin;
dermatosis of the scalp;
simultaneous use of other drugs on the scalp;
pregnancy;
the period of breastfeeding;
age: under 18 years old and over 65 years of age.

Carefully:

Patients with cardiovascular disease and arrhythmia, renal and hepatic insufficiency should be consulted before starting treatment with Regein®.

Pregnancy and lactation:

The drug Regene® in the form of an aerosol is contraindicated in women during pregnancy and during breastfeeding.

Dosing and Administration:

Outwardly. Before applying the Regain® drug, the hair and skin of the scalp should be thoroughly dried. For the effectiveness of the drug and its achievement of hair follicles, it is important to apply the drug to the scalp, not to the hair.

Dose for men: 1 g (half a cap) of aerosol applied 2 times a day (morning and evening) to the affected areas of the scalp.

Do not use Regene® more than once every 12 hours. The total daily dose should not exceed 2 g of the drug (100 mg minoxidil).

Dose for women: 1 g (half a cap) of aerosol applied once a day to the affected areas of the scalp. Do not use Regene® more often than once a day. The daily dose should not exceed 1 g of the drug (50 mg minoxidil).

Do not apply Regain® to other areas of the body.

Recommendations for the use of an aerosol can:

1. Turn the cap so that the arrows on the sprayer and the cap are facing each other (Fig. 1).

2. Tilting the cap back, remove it.

3. Before squeezing the aerosol, it is recommended first to rinse your fingers with cold water and thoroughly dry, as in contact with warm skin aerosol can dissolve.

4. Turn the aerosol can upside down, press on the nebulizer and squeeze the necessary amount of aerosol onto the fingers (Fig. 2).

5. Spray the aerosol with your fingertips over the areas of baldness and rub gently into the scalp (Figures 3 and 4).

6. After using Regene®, place the cap on the aerosol can. To keep the package protected from accidental opening by children, check that the arrows on the sprayer and the cap are not aligned.

After applying the drug, you should wash your hands thoroughly.

Suspending the first signs of hair loss and regrowth of hair possible after applying the drug Regeyn® 2 times a day in men for 2-4 months, and 1 time per day in women for 3-6 months.

To achieve and maintain the achieved effect of restoring hair growth, the patient should not interrupt the use of the drug, otherwise hair loss will resume.

An increase in the dose of the drug or its more frequent use will not lead to an improvement in the results of therapy.

If after applying the drug Regeyn® men for 16 weeks and women for 24 weeks, increased hair growth is not observed, then the use of the drug should be discontinued.

After the application of the drug Regein®, increased hair loss can occur. This effect is caused by the influence of minoxidil.It is expressed in stimulating the hair transition from the resting phase (telogen) to the growth phase (anagen). Thus, there is a loss of old hair, on the site of which grow new. Temporary increase in hair loss usually lasts for 2-6 weeks from the start of treatment, and then decreases within two weeks.

Side effects:

The frequency of adverse reactions is given in the form of the following gradation: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), including separate messages of the unspecified frequency (the frequency can not be calculated from the available data).

The adverse events that were observed in patients during clinical trials:

Violations from the nervous system.

Often: headache.

Disturbances from the skin and subcutaneous tissues.

Often: itching, rash.

Rarely: dermatitis, manifested in the form of redness, peeling and inflammation.

Postmarketing data:

Impaired immune system.

Very rarely: angioedema (manifestations of angioedema may be: swelling of the lips, edema of the oral cavity, swelling of the oropharynx, swelling of the pharynx and swelling of the tongue), hypersensitivity (hypersensitivity may include: edema of the face, generalized erythema,generalized skin itch, face swelling and a feeling of tightness in the throat), allergic contact dermatitis.

Violations from the nervous system.

Very rarely: dizziness, headache.

Disorders from the side of the organ of sight.

Very rarely: eye irritation.

Violations from the heart.

Very rarely: tachycardia, palpitations.

Disturbances from the respiratory system, chest and mediastinum.

Very rarely: dyspnea.

Disorders from the gastrointestinal tract.

Very rarely: nausea, vomiting.

General disorders and disorders at the site of administration.

Very rarely: peripheral edema, pain in the chest.

Disturbances from the skin and subcutaneous tissues.

Very rarely: reactions at the site of application (these reactions can spread on the ears and face, include: itching, irritation, pain, rash, swelling, dry skin, erythema. However, in some cases, the reactions may be more severe, including: exfoliation, dermatitis, blistering, bleeding, ulceration), temporary hair loss, hair color changes, hair texture disorder, hypertrichosis (unwanted hair growth outside the site of application).

Violations from the vessels.

Infrequent: lowering blood pressure.

If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose:

If doses exceeding the recommended levels are applied to larger areas of the body or other parts of the body other than the scalp, an increase in the systemic absorption of minoxidil may be possible, which may lead to the development of undesirable events. Signs and symptoms of an overdose can be undesirable effects of the cardiovascular system associated with sodium and water retention, as well as tachycardia, lowering blood pressure and dizziness.

Treatment is symptomatic and supportive.

For the treatment of tachycardia, beta-blockers can be prescribed, diuretics for the elimination of edema.

In case of a decrease in blood pressure, a 0.9% solution of sodium chloride should be administered intravenously. Do not use sympathomimetic drugs, for example, epinephrine and norepinephrine, having excessive cardiostimulating activity.

Interaction:

There is a theoretical possibility of strengthening orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, which, however, did not receive clinical confirmation.

It can not be ruled out that there is a very slight increase in minoxidil in the blood of patients suffering from hypertension and taking minoxidil In the case of concomitant use of the drug Regein®, although relevant clinical studies have not been conducted.

Determined that minoxidil for external use can interact with some other medicines for external use.

With external application minoxidil should not be used simultaneously with any other drugs (glucocorticosteroids, tretinoin, anthralin) applied to the scalp. The simultaneous use of an aerosol minoxidil for external use and a cream containing betamethasone (0.05%), leads to a decrease in the systemic absorption of minoxidil. Simultaneous use of cream containing tretinoin (0.05%) leads to an increased absorption of minoxidil.Simultaneous application to the skin minoxidil and preparations for external use, such as tretinoin and dithranol, which cause changes in the protective functions of the skin, can lead to an increase in the absorption of minoxidil.

Special instructions:

Recommendations for the use of the drug in conjunction with hair care products:

The drug will not be effective when used:
- hair dryer after spraying on the scalp;
- hair care products that can cause scarring, as well as deep scalp burns;
- Methods of hair care, requiring a strong pulling of hair from the scalp (for example, braiding "tight" braid (brading) or haircut "ponytail").
There is no need to wash your head to apply the drug. In case of washing the head before applying the drug, it is necessary to dry hair and scalp.
When using hair styling products, you must first spray and wait until it dries, and then use hair styling products.
Washing of the head is allowed no less than 4 hours after the application of the medicinal product.
Data on the effect of staining, perm, hair straighteners on the effectiveness of the drug there. As perm and coloring can cause irritation of the scalp, the following precautions are recommended:
- Before dying and / or perm permitting, it is necessary to make sure that the medicine has been washed off from the hair and scalp to avoid possible irritation of the scalp.
- For best results, do not apply the medication on the same day as the chemical treatment of the hair.
- After using any chemicals, do not apply the medication within 24 hours to ensure that the scalp is not irritated after perm and / or staining.

Before starting treatment with Regein®, patients should undergo a general examination, including the collection and study of medical history.

The physician should make sure that the scalp skin is healthy.

Apply Regene® medication only on the healthy scalp skin. Do not use it for inflammation, infection, irritation, soreness of the skin,as well as simultaneously with other medicinal products applied to the scalp.

Do not use Regain® medicine in cases of sudden hair loss, focal alopecia, when alopecia develops after birth, in case of baldness caused by medication, malnutrition (iron deficiency, vitamin A), as a result of hair styling in "tight" hairstyles , and also in the case when the cause of hair loss is unknown.

Whenever there is a drop in blood pressure or chest pain, rapid heartbeat, weakness or dizziness, sudden unexplained weight gain, swelling of the hands or feet, persistent redness or irritation of the scalp, discontinue use of Regein® and consult a doctor.

Some components of the drug may cause burning and irritation. In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse affected area with plenty of cool water. The preparation contains butylhydroxytoluene, cetyl and stearyl alcohol, which can cause local skin reactions (eg, contact dermatitis).Accidental ingestion of the drug inside can lead to the development of serious adverse events from the heart. Therefore, this product should be stored in places inaccessible to children.

The contents of the aerosol can is under pressure. Do not puncture or incinerate the aerosol can. The drug is highly inflammable, so do not spray the contents of the aerosol can near an open flame, polished or colored surfaces. Avoid contact of the aerosol can with open flame sources during use, storage and disposal. Do not heat the cylinder above 50 ° C. When applying the drug should refrain from smoking.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and throw it out! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

Effect on the ability to drive transp. cf. and fur:

In connection with the possible development of headache, dizziness, eye irritation, care should be taken when driving vehicles and engaging in certain activities that require increased concentration of attention and rapid motor reaction.When these undesirable phenomena appear, one should refrain from performing these activities.

Form release / dosage:

Aerosol for external use 5%.

Packaging:

For 60 g of the drug in an aluminum aerosol can. The aerosol can is equipped with a valve with a nebulizer and a cap with an anti-tamper system.

For 1 or 3 aerosol cans, together with instructions for use in a polymer package with an anti-tamper protection system.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002707

Date of registration:13.11.2014

Expiration Date:13.11.2019

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

ASM AEROSOL-SERVICE AG Switzerland

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp11.09.16

Illustrated instructions

Instructions

Regain® (Regaine®)