Description
Release form
Spray for external use.
Packing
50 ml – bottles (1) – packs of cardboard.
Pharmacological action
Pharmacotherapeutic group: Alopecia is a remedy.
ATX:
D.11.AX01 Minoxidil
Pharmacodynamics: As a peripheral vasodilator, minoxidil, when applied topically, enhances microcirculation in the hair follicles. Minoxidil stimulates vascular endothelial growth factor (VEGF), which is believed 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: Absorption.
When applied topically, minoxidil is poorly absorbed through intact skin: on average, 1.5% (1-2%) of the total applied dose enters the systemic circulation. The average values of the 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 concentration of minoxidil (TCmax) is 5.79 hours. The effect of minoxidil on hemodynamics is not expressed until until the average serum concentration of minoxidil reaches 21.7 ng / ml.
Distribution of
Although it was previously reported that minoxidil does not bind to plasma proteins, its reversible binding to human blood proteins was later demonstrated by in vitro ultrafiltration in the range of 37-39%. Since only 1-2% of minoxidil is absorbed when applied topically, the degree of its binding to plasma proteins is clinically insignificant.
Metabolism.
Approximately 60% of minoxidil is metabolized to form minoxidil glucuronide, primarily in the liver.
Withdrawal.
The half-life of minoxidil for external use averages 22 hours. 97% of minoxidil and its metabolites are excreted by the kidneys and 3% through the intestines. After discontinuation of the drug, approximately 95% minoxidil, applied externally, excreted within 4 days.
Indications
Treatment of androgenetic alopecia in men and women.
Contraindications
Hypersensitivity to minoxidil or other components of the drug.
Age under 18 and over 65.
Violation of the integrity of the skin, dermatosis of the scalp.
The simultaneous use of other drugs for application to the scalp.
Pregnancy, the period of breastfeeding.
Caution: Patients with cardiovascular disease and arrhythmias, patients with renal and hepatic insufficiency should consult a doctor before starting treatment with the drug.
Use during pregnancy and lactation
The drug is contraindicated in women during pregnancy during breastfeeding.
Special instructions
Do not apply to other parts of the body.
Apply Revasil only on 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 applying the drug. If you applied the drug with your fingertips, wash your hands thoroughly after treating the head. It is recommended to wash hair when using Revasil in the usual way. Hairspray and other hair care products can be used during the period of use of the drug Revasil. Before applying hair care products, first apply Revasil and wait until the treated area of ² ¹ ² ¹the skin has completely dried. There is no evidence that hair coloring, perm, or the use of hair softeners can in any way reduce the effectiveness of the drug. However, to prevent possible irritation of the skin of the scalp, you must make sure that the drug was completely washed off the hair and skin of the 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 must 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.
Revasil contains 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 used: a hair dryer after applying the product to the scalp hair care products that can cause scarring, as well as deep scalp burns of hair care methods that require strong pulling of hair from the scalp (for example, weaving tight braids (brading) or ponytail hairstyle).
Apply Revasil only on healthy scalp. You can not use it with inflammation, infection, irritation, soreness of the skin, as well as simultaneously with other drugs applied to the skin of the scalp.
Do not use the drug Revasil in cases of sudden hair loss, focal alopecia, when alopecia develops after childbirth, in case of baldness caused by taking medications, malnutrition (iron, vitamin A deficiency), as a result of hair styling in tight hairstyles, and also 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 drug should be stored in places inaccessible to children.
Composition of
100 ml of the preparation contains: active substance: minoxidil – 2.0 g
excipients: ethanol (ethanol) 95% – 51.7 g, propylene glycol – 20.7 g, purified water – up to 100 ml.
Dosage and administration
For external use only.
Regardless of the size, apply 1 ml of the solution with a dispenser (7 presses) 2 times a day to the affected areas of the scalp, starting from the center of the affected area. Wash 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, Revasil is most effective for hair loss on the crown, for women – for hair loss in the middle parting.
Apply Revasil only on dry skin of the scalp. The solution does not require rinsing.
The appearance of the first signs of a suspension of hair loss and restoration of hair growth is possible after the use of the drug Revasil 2 times a day for 2-4 months.
To achieve and maintain the achieved effect of hair growth restoration, 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 use of the medicinal product Revasil for 16 weeks there has been no increase in hair growth, then the use of the drug should be discontinued.
Enhanced hair loss may occur after the start of the use of the drug Revasil. 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 the place of which new ones grow. Temporary increase in hair loss usually lasts for 2-6 weeks from the start of treatment, and then decreases for 2 weeks. If increased hair loss continues, then the use of the drug should be discontinued and consult a doctor.
For the effectiveness of the drug and its achievement of the hair follicles, it is important to apply the drug to the skin of the scalp, and not to the hair.
Do not apply Revasil to other parts of the body.
Special patient groups.
There are no recommendations for dosage of the drug 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 frequency unknown - according to available data, it is not possible to establish the frequency of occurrence. Disorders of the nervous system: often – headache very rarely – dizziness. Disorders of the skin and subcutaneous tissues: often – itching, rash rarely – dermatitis, manifested in the form of redness, peeling and inflammation very rarely – temporary hair loss, hair color change, violation of hair texture, hypertrichosis (undesirable hair growth outside the place of use ), reactions at the site of application (these reactions can extend 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 rarely – angioedema (manifestations of angioedema can be: swelling of the lips, swelling of the tissues of the oral cavity , oropharyngeal edema, pharyngeal edema and swelling of the tongue), hypersensitivity (manifestations of hypersensitivity can be: generalized erythema, generalized skin itching, facial swelling and a feeling of tightness in the throat), allergic th contact dermatitis. Disorders of the organ of vision: very rarely – eye irritation. Disorders from the heart: very rarely – tachycardia, palpitations. Disorders of the respiratory system, chest and mediastinal organs: very rarely – shortness of breath. Disorders of the gastrointestinal tract: very rarely – nausea, vomiting. General disorders and disorders at the injection site: very rarely – peripheral edema, pain in the chest. Vascular disorders: infrequently – lowering blood pressure. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor. Drug Interactions There is a theoretical possibility of enhancing orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators means, not received, however, 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 case of simultaneous use of the drug Revasil, although relevant clinical studies have not been conducted. It has been established that minoxidil, when applied topically, can interact with some other drugs 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 the systemic absorption of minoxidil. The simultaneous use of a cream containing tretinoin (0.05%) leads to increased absorption of minoxidil. The simultaneous application of minoxidil and topical preparations, such as tretinoin and dithranol, to the skin, which cause changes in the protective functions of the skin, can lead to increased absorption of minoxidil. Overdose If doses in excess of the recommended dose are applied to larger areas of the body or other parts of the body, in addition to the scalp, an increase in systemic absorption of minoxidil may result, which may therefore lead to the development of undesirable effects. Symptoms: fluid retention, decreased blood pressure, tachycardia, dizziness. Treatment: Diuretics for the treatment of tachycardia – beta blockers can be prescribed to eliminate fluid retention if necessary. 0.9% sodium chloride solution should be administered intravenously to treat arterial hypotension. Symptomatic agents such as norepinephrine and epinephrine with excessive cardio-stimulating activity should not be prescribed. Storage Conditions At a temperature not exceeding 25 ° C. Keep out of the reach and sight of children. Shelf life 4 years. Deystvuyushtee substance Minoxidil Prescription conditions from pharmacies Without prescription dosage form spray for topical use Possible product names Revasil spray for external use 2% 50 ml
