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

Being a peripheral vasodilator, minoxidil at external application strengthens microcirculation in the field 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 stage. The exact mechanism of action of minoxidil for external use in hair loss is not fully understood.

Pharmacokinetics:

Suction.

With external application minoxidil poorly absorbed through intact skin: an average of 1.5% (1-2%) of the total applied dose enters the systemic circulation. The average area under the concentration-time curve (AUC) and maximum concentration (Cmax) is approximately 18.71 ng / hr and 2.13 ng / ml, respectively. The time to reach the maximum concentration of minoxidil (TCmax) is 5.79 hours. The effect 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 blood proteins in the range of 37-39%. Since only 1-2% of minoxidil is absorbed when applied externally, the degree of its binding to plasma proteins is clinically insignificant.

Metabolism.

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

Excretion.

The half-life of minoxidil for external application averages 22 hours. 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 androgenetic alopecia in men and women.

Contraindications:

Hypersensitivity to minoxidil or other components of the drug.
The age is under 18 years old and over 65 years of age.
Violation of the integrity of the skin, dermatosis of the scalp.
Simultaneous use of other drugs for application to the scalp.
Pregnancy, the period of breastfeeding.

Carefully:Patients with cardiovascular diseases and arrhythmia, patients with renal and hepatic insufficiency, before starting treatment with the drug should consult with a doctor.

Pregnancy and lactation:

The drug is contraindicated in women during pregnancy during breastfeeding.

Dosing and Administration:

For external use only.

Regardless of the size, apply 1 ml of solution with a dosage unit (7 strokes) 2 times a day to the affected areas of the scalp, starting from the center of the affected area. After application, wash hands.

The total daily dose should not exceed 2 ml (the dose does not depend on the size of the affected area).

For men, Revasil is most effective in hair loss on the vertex, for women - with hair loss in the middle part.

Apply Revasil only on the dry skin of the scalp. The solution does not require flushing.

The appearance of the first signs of suspension of hair loss and restoration of hair growth is possible after applying the drug Revasil 2 times a day for 2-4 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 the application of the drug Revasil for 16 weeks, hair growth does not increase, then the drug should be discontinued.

After the introduction of the drug Revasil, 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 2 weeks. If increased hair loss continues, then the drug should be used. discontinue and consult with your doctor.

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.

Do not apply Revasil to other parts of the body.

Special groups of patients.

There are no recommendations for dosing Revasil for use in patients with renal and hepatic insufficiency.

Side effects:

Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO): very often> 1/10; often from> 1/100 to <1/10; infrequently> 1/1000 to <1/100; rarely from> 1/10000 to <1/1000; very rarely <1/10000,including individual messages; the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

Impaired nervous system: often - headache; very rarely - dizziness.

Disturbances from the skin and subcutaneous tissues: often - itchy skin, rash; rarely - dermatitis, manifested in the form of redness, flaking and inflammation; very rarely - temporary hair loss, hair color change, hair texture disorder, hypertrichosis (unwanted hair growth outside the site of application), reactions at the site of application (these reactions can spread to 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)

Immune system disorders: 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 (manifestations of hypersensitivity can be: generalized erythema, generalized skin itching, face swelling and feeling restrained in throat), allergic contact dermatitis.

Disorders from the side of the organ of vision: very rarely - eye irritation.

Heart Disease: very rarely - tachycardia, palpitation.

Disturbances from the respiratory system, chest and mediastinal organs: very rarely - dyspnea.

Disturbances 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.

Vascular disorders: infrequently - lowering blood pressure.

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

Overdose:

If doses in excess of those recommended are applied to larger areas of the body or other areas of the body other than the scalp, an increase in the systemic absorption of minoxidil may be possible, which can lead to the development of undesirable phenomena.

Symptoms: fluid retention, lowering blood pressure, tachycardia, dizziness.

Treatment: To eliminate fluid retention if necessary, diuretics can be prescribed; for the treatment of tachycardia - beta-blockers.

For the treatment of arterial hypotension, a 0.9% solution of sodium chloride should be administered intravenously. Do not prescribe symptomatic remedies, for example, norepinephrine and epinephrine, 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 simultaneous application of the drug Revasil, although relevant clinical studies have not been conducted.

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

The simultaneous use of a solution of minoxidil for external use and a cream containing betamethasone (0.05%) leads to a decrease in systemic absorption of minoxidil. Simultaneous application 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 absorption

minoxidil.

Special instructions:

Do not apply the drug to other parts of the body.

Apply Revasil only on the dry skin of the scalp after bathing or wait about 4 hours after applying the drug before bathing. Do not let your head get wet earlier than 4 hours after application. If you applied the drug with your fingertips, after handling the head, your hands should be thoroughly washed. Wash hair with Revasil is recommended in the usual mode. Hairspray and other hair care products can be used during the period of application of Revasil. Before applying hair care products, first apply the Revasil preparation and wait until the treated area of the skin is completely dry. There is no evidence that hair coloring, perming, or the use of hair softeners can somehow reduce the effectiveness of the drug.However, to prevent possible irritation of the skin of the scalp, you need to make sure that the drug has been completely washed off the hair and skin of the scalp before applying these chemicals.

Before starting treatment with Revasil, 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.

When systemic side effects or severe skin reactions occur, patients should cancel the drug and consult a doctor.

The composition of the drug Revasil includes ethyl alcohol, which can cause inflammation and eye irritation. In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse the area with plenty of cold water.

The drug will not be effective when using: a hair dryer after applying the product to 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").

To apply a medicine Revasil follows only on a healthy skin of a pilar part of a head. You can not use it for inflammation, infection, irritation, soreness of the skin, and also at the same time as other medicinal products applied to the scalp.

Do not use Revasil 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. 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.

Form release / dosage:Spray for external use 2%.

Packaging:50 ml or 100 ml in a glass bottle, screwed with a spray head (pump) with a plastic lid. Each vial with instructions for the use of the drug in a pack of cardboard.

Storage conditions:At a temperature not exceeding 25 °FROM.

Keep out of the reach of children.

Shelf life:4 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000232

Date of registration:16.02.2011 / 09.06.2016

The owner of the registration certificate:PATENT-FARM, CJSC PATENT-FARM, CJSC Russia

Manufacturer: & nbsp

ALTAYVITAMINS, CJSC Russia

Information update date: & nbsp20.09.16

Illustrated instructions

Instructions

Revasil (Revasil)