Revasil outdoor spray 2%, 50ml

Composition

100 ml of the drug contains: Active ingredient: minoxidil – 2.0 g; excipients: ethanol (ethyl alcohol) 95% – 51.7 g, propylene glycol-20.7 g, purified water-up to 100 ml

Pharmacological action

Pharmacotherapy group: Alopecia treatment tool. ATX: D. 11. A. X. 01 Minoxidil Pharmacodynamics : Being a peripheral vasodilator, minoxidil when applied externally increases microcirculation in the area of hair follicles. Minoxidil stimulates vascular endothelial growth factor (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 (androgenetic alopecia) in the initial stage. The exact mechanism of action of minoxidil for external use in hair loss is not fully understood. Pharmacokinetics: Suction. When applied externally, minoxidil is poorly absorbed through intact skin: on average,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) are approximately 18.71 ng*h/ml and 2.13 ng/ml, respectively. The time to reach the maximum minoxidil concentration (TMAX) is 5.79 hours. The effect of minoxidil on hemodynamics is not expressed until the average serum minoxidil concentration reaches 21.7 ng / ml. Distribution Although it was previously reported that minoxidil does not bind to plasma proteins, later in vitro ultrafiltration demonstrated its reversible binding to human blood proteins in the range of 37-39%. Since only 1-2% of minoxidil is absorbed by external use, 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. Output. The half-life of minoxidil with external use is on average 22 hours. 97% of minoxidil and its metabolites are excreted by the kidneys and 3% – through the intestine. After discontinuation of the drug, approximately 95% of minoxidil applied externally is eliminated within 4 days.

Indications

Treatment of androgenetic alopecia in men and women.

Use during pregnancy and lactation

The drug is contraindicated in women during pregnancy and breastfeeding.

Contraindications

• Hypersensitivity to minoxidil or other components of the drug.
• Under 18 years of age and over 65 years of age.
• Violation of the integrity of the skin, dermatosis of the scalp.
• Simultaneous use of other medications for application to the scalp.
• Pregnancy, breast-feeding period.

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

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO): very common >1/10; often from >>1/100 to >><1/10; infrequently >1/1000 to <1/10; infrequently ><1/100; rarely from >1/10000 to <1/100; rarely from ><1/1000; very rare Nervous system disorders: often-headache; very rarely-dizziness. Skin and subcutaneous tissue disorders: often – pruritus, rash; rarely – dermatitis, which manifests itself in the form of redness, peeling and inflammation; very rarely – temporary hair loss, hair discoloration, hair texture disorders, hypertrichosis (unwanted hair growth outside the application site), reactions at the application site (these reactions can spread to the ears and face, include: itching, irritation, pain, rash, swelling, dry skin, erythema; however, in some cases, reactions can be more severe, including: exfoliation, dermatitis, blistering, bleeding, ulceration)Immune system disorders: very rare – angioedema (manifestations of angioedema may include: lip edema, oral tissue edema, oropharyngeal edema, pharyngeal edema, and tongue edema), hypersensitivity (hypersensitivity may include: generalized erythema, generalized pruritus, facial edema, and tightness in the throat), allergic contact dermatitis. Visual disturbances: very rarely – eye irritation. Cardiac disorders: very rarely – tachycardia, palpitation sensation. Respiratory, thoracic and mediastinal disorders: very rare – shortness of breath. Disorders of the gastrointestinal tract: very rarely-nausea, vomiting. General disorders and disorders at the injection site: very rarely – peripheral edema, chest pain. Vascular disorders: infrequently-decreased blood pressure. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

There is a theoretical possibility of increasing orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, which, however, has not received clinical confirmation. It is impossible to exclude a very slight increase in the content of minoxidil in the blood of patients suffering from arterial hypertension and taking minoxidil orally in the case of simultaneous use of Revasil, although appropriate clinical studies have not been conducted. It has been established that minoxidil may interact with some other drugs for external use when used externally. Concomitant use of a minoxidil solution for external use and a cream containing betamethasone (0.05%) leads to a decrease in the systemic absorption of minoxidil. Concomitant use of a cream containing tretinoin (0.05%) leads to increased absorption of minoxidil. Concomitant application of minoxidil to the skin and topical preparations such as tretinoin and ditranol, which cause changes in the protective functions of the skin, may lead to increased absorption of minoxidil.

How to take, course of use and dosage

For external use only. Regardless of the size, apply 1 ml of the solution using a dispenser (7 taps) 2 times a day to the affected areas of the scalp, starting from the center of the affected area. Wash your hands after use. The total daily dose should not exceed 2 ml (the dose does not depend on the size of the affected area). For men, the drug Revasil is most effective for hair loss on the crown, for women – for hair loss in the middle part. Apply Revasil only on dry scalp skin. The solution does not require rinsing. The appearance of the first signs of suspension of hair loss and restoration of hair growth is possible after using 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. Increasing the dose of the drug or using it more frequently will not improve the results of therapy. If there is no increase in hair growth after using the drug Revasil for 16 weeks, then the use of the drug should be discontinued. After starting the use of the drug Revasil, increased hair loss may occur. This effect is caused by the influence of minoxidil. It is expressed in stimulating the transition of hair from the resting phase (telogen) to the growth phase (anagen). Thus, there is a loss of old hair, in place of which new ones grow. The temporary increase in hair loss usually lasts for 2-6 weeks from the start of treatment, and then decreases within 2 weeks. If the increased hair loss continues, then the use of the drug should be stopped and consult a doctor. For the effectiveness of the drug and its achievement of hair follicles, it is important to apply the drug on the scalp, and not on the hair. Do not apply Revasil to other areas of the body. Special patient groups. There are no recommendations on the dosage of Revasil for use in patients with renal and hepatic insufficiency.

Overdose

If higher than recommended doses are applied to larger areas of the body or other areas of the body other than the scalp, systemic absorption of minoxidil may increase, which may therefore lead to the development of adverse events. Symptoms: fluid retention, low blood pressure, tachycardia, dizziness. Treatment: if necessary, diuretics can be prescribed to eliminate fluid retention; beta – blockers can be used to treat tachycardia. For the treatment of arterial hypotension,0.9% sodium chloride solution should be administered intravenously. Do not prescribe symptomatic medications, such as norepinephrine and epinephrine, which have excessive pacing activity.

Special instructions

Do not apply the product to other areas of the body. Apply Revasil only on dry scalp skin after bathing, or wait about 4 hours after applying the product before bathing. Do not let your head get wet earlier than 4 hours after applying the drug. If you have applied the drug using your fingertips, wash your hands thoroughly after treating the head. Wash your hair when using Revasil is recommended in the usual mode. Hairspray and other hair care products can be used during the use of Revasil.Before applying hair care products, you must first apply Revasil 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 in any way reduce the effectiveness of the drug. However, to prevent possible irritation of the scalp, it is necessary to make sure that the product has been completely washed off the hair and scalp before using these chemicals. Before starting treatment with Revasil, patients should undergo a general examination, including the collection and study of a medical history. The doctor should make sure that the scalp is healthy. If systemic side effects or severe skin reactions occur, patients should discontinue the drug and consult a doctor. The drug Revasil contains ethyl alcohol, which can cause inflammation and irritation of the eyes. If the drug gets on sensitive surfaces (eyes, irritated skin, mucous membranes), it is necessary to rinse the area with plenty of cold water. The drug will not be effective if you use: a hair dryer after applying the drug to the scalp; hair care products that can cause scarring, as well as deep burns to the scalp; hair care methods that require strong pulling of the hair from the scalp (for example, braiding “tight” braids (braiding) or a ponytail hairstyle). Apply the drug Revasil only on a healthy scalp. You can not use it for inflammation, infection, irritation, soreness of the skin, as well as simultaneously with other medications applied to the scalp. Do not use the drug Revasil in cases of sudden hair loss, alopecia areata, when alopecia develops after childbirth, in the case of baldness caused by taking medications, improper nutrition (iron deficiency, vitamin A), as a result of styling hair in “tight” hairstyles, as well as in the case when the cause of hair loss is unknown. Accidental ingestion of the drug can lead to the development of serious adverse events from the heart. Therefore, this product should be stored out of the reach of children.

Form of production

Spray for external use.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 4 years.

Active ingredient

Minoxidil

Dosage form

spray for external use