Revasil (Spray) Instructions for Use

Marketing Authorization Holder

Patent-Pharm, JSC (Russia)

Manufactured By

Altayvitamins, JSC (Russia)

ATC Code

D11AX01 (Minoxidil)

Active Substance

Minoxidil (Rec.INN registered by WHO)

Dosage Form

Revasil

External use spray 2%: 50 or 100 ml bottle with applicator nozzles

Dosage Form, Packaging, and Composition

Spray for external use2%.

50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of alopecia in men and women

Pharmacotherapeutic Group

Other drugs used in dermatology

Pharmacological Action

With topical application, minoxidil has been noted to have a stimulating effect on hair growth in individuals with androgenic alopecia (hair thinning, baldness). It improves microcirculation, stimulates the transition of hair cells into the active growth phase, and alters the effect of androgens on hair follicles.

It reduces the formation of 5-alpha-dihydrotestosterone (possibly mediated), which plays a significant role in the formation of baldness. The best effect is achieved with a short duration of the disease (no more than 10 years), young age of patients, baldness in the crown area of no more than 10 cm, and the presence of more than 100 vellus and terminal hairs in the center of the bald spot.

Signs of hair growth are noted after 4 or more months of using the drug. The onset and degree of severity of the effect may vary among different patients. After discontinuation of Revasil, the growth of new hair stops, and within 3-4 months, the original appearance may be restored. The exact mechanism of action of Revasil in the treatment of androgenic alopecia is unknown.

Minoxidil is not effective in cases of baldness caused by medication intake, improper nutrition (iron (Fe) deficiency, vitamin A), or as a result of styling hair in “tight” hairstyles.

Pharmacokinetics

With external application, minoxidil is poorly absorbed through normal intact skin: on average, 1.5% (0.3-4.5%) of the total applied dose enters the systemic circulation. The influence of concomitant skin diseases on the absorption of minoxidil is unknown.

After discontinuation of the drug, approximately 95% of the minoxidil that entered the systemic circulation is eliminated within 4 days. The profile of metabolic biotransformation of minoxidil after external application of Revasil has not been fully studied to date.

Minoxidil does not bind to plasma proteins and is excreted by the kidneys through glomerular filtration. Minoxidil does not penetrate the blood-brain barrier.

It is excreted primarily in the urine. Minoxidil and its metabolites are eliminated by hemodialysis.

Indications

For the treatment of androgenic alopecia (restoration of hair growth) and stabilization of the hair loss process in men and women.

ICD codes

Dosage Regimen

For external use only. Regardless of the size of the treated area, apply 1 ml of the solution using the dispenser (7 presses) 2 times a day to the affected areas of the scalp, starting from the center of the affected zone. Wash your hands after application. 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 mid-parting area. Apply Revasil only to the dry skin of the scalp. The solution does not require rinsing.

The first signs of hair growth stimulation may appear after using the drug 2 times a day for 4 months or more. The onset and degree of hair growth, as well as hair quality, may vary among different patients.

According to individual reports, within 3-4 months after discontinuation of treatment, restoration of the original appearance can be expected.

The duration of treatment is on average about 1 year.

Adverse Reactions

Local side effects: Side effects observed in clinical studies of Revasil were mostly scalp dermatitis.

More pronounced cases of dermatitis, manifested as redness, scaling, and inflammation, were observed less frequently.

In rare cases, scalp itching, contact dermatitis, folliculitis, hypertrichosis (unwanted hair growth on the body, including facial hair growth in women), seborrhea were noted.

The use of minoxidil can cause increased hair loss during the transition from the resting phase to the growth phase, where old hair falls out and new hair grows in its place. This temporary phenomenon is usually observed 2-6 weeks after the start of treatment and gradually stops within the next two weeks (appearance of the first signs of minoxidil action).

Systemic side effects (in case of accidental ingestion of the drug) Dermatological conditions: nonspecific allergic reactions (skin rash, urticaria), facial edema.

Respiratory system: shortness of breath, allergic rhinitis.

Nervous system: headache, dizziness, vertigo, neuritis.

Cardiovascular system: chest pain, fluctuations in blood pressure, rapid heartbeat, changes in heart rhythm, edema.

Contraindications

• Hypersensitivity to minoxidil or other components of the drug;
• Age under 18 years;
• Impaired skin integrity, dermatoses of the scalp.

With caution. Elderly age – over 65 years.

Use in Pregnancy and Lactation

The drug should not be used during pregnancy and breastfeeding.

Pediatric Use

Contraindicated in children under 18 years of age.

Geriatric Use

With caution: elderly age – over 65 years.

Special Precautions

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

Apply Revasil only to the dry skin of the scalp after bathing or wait about 4 hours after applying the drug before bathing. Do not get your head wet earlier than 4 hours after applying the drug. If you applied the drug using your fingertips, wash your hands thoroughly after treating your head. It is recommended to wash your hair as usual while using Revasil. Hair spray and other hair care products can be used during the period of Revasil application. Before applying hair care products, first apply Revasil and wait until the treated area of skin is completely dry. There is no data indicating that hair dye, perming, or the use of hair softeners can in any way reduce the effectiveness of the drug. However, to prevent possible skin irritation of the scalp, it is necessary to ensure that the drug has been completely washed off the hair and scalp before using these chemical agents.

Before starting treatment with Revasil, patients should undergo a general examination, including collection and study of medical history. The doctor must ensure that the scalp skin 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 irritation of the eyes. If the drug gets on sensitive surfaces (eyes, irritated skin, mucous membranes), rinse the area with plenty of cold water.

Overdose

Accidental ingestion of Revasil can cause systemic side effects due to the vasodilating properties of minoxidil (5 ml of Revasil contains 100 mg of minoxidil, which is the maximum recommended dose for adults when taken orally for the treatment of arterial hypertension).

Signs of overdose fluid retention, decreased blood pressure, tachycardia.

Treatment diuretics may be prescribed if necessary to eliminate fluid retention; beta-blockers for the treatment of tachycardia.

For the treatment of arterial hypotension, 0.9% sodium chloride solution should be administered intravenously. Symptomatic agents, such as norepinephrine and epinephrine, which have excessive cardiotonic activity, should not be prescribed.

Drug Interactions

There is a theoretical possibility of enhanced orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, which, however, has not received clinical confirmation. A very slight increase in the blood content of minoxidil in patients suffering from arterial hypertension and taking Minoxidil orally cannot be excluded in case of simultaneous use of Revasil, although relevant clinical studies have not been conducted.

It has been established that Minoxidil for external use can interact with some other topical medications.

Concomitant use of minoxidil topical solution and cream containing betamethasone (0.05%) leads to a decrease in the systemic absorption of minoxidil. Concomitant use of cream containing tretinoin (0.05%) leads to increased absorption of minoxidil. Simultaneous application of minoxidil and topical preparations such as tretinoin and dithranol, which cause changes in the protective functions of the skin, may lead to increased absorption of minoxidil.

Storage Conditions

At a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life. 4 years. Do not use after the expiration date.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.