Regain, foam 5% 60 ml

Alopecia (baldness)Treatment of androgenic alopecia in men and women.

Indications

Treatment of androgenetic alopecia in men and women.

Special instructions

Recommendations for the use of the drug together with hair care products:

• The drug will not be effective if used:

– a hairdryer after applying foam to the scalp;
– hair care products that can cause scarring and deep burns to the scalp;
– hair care methods that require strong pulling of hair from the scalp (for example, braiding “tight” braids (braiding) or a ponytail).

• There is no need to wash your hair to apply the medication. If you wash your hair before using the drug, you must dry your hair and scalp.

• When using hair styling products, you must first apply the foam and wait until it dries before using hair styling products.

• Hair washing is allowed no less than 4 hours after applying the drug.

• There is no data on the effect of coloring, perm, or hair straighteners on the effectiveness of the drug. Since perming and coloring can cause irritation to the scalp, the following precautions are recommended:

– Before coloring and/or perming, ensure that the medication has been rinsed from the hair and scalp to avoid possible scalp irritation.

– For best results, do not apply the medication on the same day as a chemical hair treatment.

After using any chemicals, do not apply the medication for 24 hours to ensure that the scalp is not irritated by perming and/or coloring.

Before starting treatment with Rogaine®, 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. Rogaine® should only be applied to healthy scalp. It should not be used for inflammation, infection, irritation, soreness of the skin, or simultaneously with other medications applied to the scalp.

Do not use Rogaine® in cases of sudden hair loss, alopecia areata, when alopecia develops after childbirth, in case of baldness caused by taking medications, poor diet (iron deficiency, vitamin A), as a result of styling hair in “tight” hairstyles, and also in cases where the cause of hair loss is unknown.

If you experience a decrease 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, you should stop using Rogaine® and consult a doctor. Some components of the drug may cause burning and irritation.

If the drug gets on sensitive surfaces (eyes, irritated skin, mucous membranes), it is necessary to rinse the affected area with plenty of cool water.

The drug contains butylated hydroxytoluene, cetyl and stearyl alcohol, which may cause local skin reactions (for example, contact dermatitis).

Accidental ingestion of the drug may result in serious adverse cardiac events. Therefore, this drug should be stored out of the reach of children.

The contents of the cylinder are under pressure. Do not puncture or burn the container.

The drug is highly flammable, so do not spray the contents of the container near open flames, polished or painted surfaces.

Contact of the cylinder with open flame sources should be avoided during use, storage and disposal. Do not heat the cylinder above 50 °C. When applying the drug, you should refrain from smoking.

If the medicine has become unusable or has expired, do not pour it into wastewater or throw it outside! Place the medication in a bag and place it in the trash. These measures will help protect the environment!

Active ingredient

Minoxidil

Composition

1 g of the drug contains:

active substance:

minoxidil – 47.50 mg*,

excipients:

anhydrous ethanol – 536.30 mg,

purified water – 314.10 mg,

butylated hydroxytoluene – 0.90 mg**,

lactic acid – 10.00 mg,

anhydrous citric acid – 1.00 mg,

glycerol – 20.00 mg,

cetyl alcohol – 11.00 mg,

stearyl 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;

** Actual amount of butylated hydroxytoluene, without propellant, is 1.00 mg/g.

Pregnancy

Rogaine® foam is contraindicated in women during pregnancy and breastfeeding.

Contraindications

Hypersensitivity to Minoxidil or other components of the drug;
violation of the integrity of the skin;
dermatoses of the scalp;
simultaneous use of other medications on the scalp;
pregnancy;
breastfeeding period;
Age: under 18 years old and over 65 years old.

Side Effects

The frequency of adverse reactions is given in the following gradation: very often (>1/10); often (21/100, 1/1000, <1/100); rare (21/10000, <1/1000); very rare (< 1/10000), including isolated reports of unspecified frequency (frequency cannot be calculated from available data).Adverse events observed in patients during clinical trials:Nervous system disorders.Common: Headache. Disorders of the skin and subcutaneous tissues. Common: skin itching, rash. Rare: dermatitis, manifested by redness, peeling and inflammation.Post-marketing data:Immune system disorders. Very rare: angioedema (manifestations of angioedema can be: swelling of the lips, swelling of the tissues of the oral cavity, swelling of the oropharynx, swelling of the trays and swelling of the tongue), Hypersensitivity (manifestations of hypersensitivity can be: swelling of the face, generalized erythema, generalized skin itching, swelling of the face and a feeling of tightness in the throat), allergic contact dermatitis.Nervous system disorders. Very rare: Dizziness, Headache. Violations of the organ of vision. Very rare: eye irritation.Cardiac disorders. Very rare: tachycardia, palpitations.Disorders of the respiratory system, chest and mediastinal organs. Very rare: shortness of breath.Gastrointestinal disorders. Very rare: nausea, vomiting. General disorders and disorders at the injection site. Very rare: peripheral edema, chest pain.Disorders of the skin and subcutaneous tissues. Very rare: reactions with application (these reactions may extend to the ears and face and include: skin itching, irritation, pain, rash, swelling, dry skin, erythema. However, in some cases, reactions may be more severe, including: exfoliation, dermatitis, blistering, bleeding, ulceration), temporary hair loss, changes in hair color, abnormal hair texture, hypertrichosis (unwanted hair growth outside the site of application).Vascular disorders. Uncommon: Decreased blood pressure. If any of the side effects indicated 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 increased orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, which, however, has not received clinical confirmation.

A very slight increase in the level of minoxidil in the blood of patients suffering from arterial hypertension and taking minoxidil by mouth cannot be excluded in the case of simultaneous use of the drug RegayN®, although corresponding clinical studies have not been conducted.

It has been established that topical minoxidil may interact with some other topical medications.

For external use, minoxidil should not be used simultaneously with any other medications (glucocorticosteroids, tretinoin, anthralin) applied to the scalp.

The simultaneous use of minoxidil foam 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.

Simultaneous application of minoxidil to the skin and drugs for external use, such as tretinoin and Dithranol, which CAUSE changes in the protective functions of the skin, can lead to increased absorption of minoxidil.

Overdose

If doses higher than recommended are applied to larger areas of the body or to areas of the body other than the scalp, systemic absorption of minoxidil may be increased, which may result in adverse effects.

Signs and symptoms of overdose may include adverse cardiovascular effects associated with sodium and water retention, as well as tachycardia, decreased blood pressure, and dizziness.

Treatment is symptomatic and supportive. Beta-blockers can be prescribed to treat tachycardia, and diuretics to eliminate edema.

If blood pressure decreases, 0.9% sodium chloride solution should be administered intravenously. Sympathomimetic agents, such as epinephrine and norepinephrine, which have excessive cardiac stimulating activity, should not be used.

Clinical pharmacology

Pharmacodynamics:

Being a peripheral vasodilator, minoxidil, when applied externally, enhances microcirculation in the area of ​​hair follicles.

Minoxidil stimulates vascular endothelial growth factor (VEGF), which is believed to be responsible for increasing capillary permeability, indicating the high metabolic activity observed in the anagen phase.

Minoxidil stimulates hair growth in patients with early to moderate hereditary hair loss (androgenetic alopecia). The exact mechanism of action of topical minoxidil for hair loss is not fully understood.

Pharmacokinetics:

Suction.

When applied topically to intact skin, approximately 1-2% of the Minoxidil solution is subject to systemic absorption.
In clinical studies, systemic absorption of 5% topical foam was approximately half that of a 5% topical solution.

The average area under the concentration-time curve AUC (0-12 hours) and maximum concentration (Cmax) when using 5% foam were 8.81 ng×h/ml and 1.11 ng/ml, respectively, which corresponds to approximately 50% of the same values ​​when using a 5% solution (18.71 ng×h/ml and 2.13 ng/ml, respectively).

The time to reach the maximum concentration of minoxidil (TCmax) when using 5% foam is 5.42 hours, similar to that when using a 5% solution (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, it was later demonstrated by in vitro ultrafiltration to be reversibly bound to human plasma proteins in the range of 37-39%.

Since only 1-2% of topically applied Minoxidil is absorbed, the degree of its binding to plasma proteins observed 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 or 69.2 l, respectively.

Metabolism.

Approximately 60% of minoxidil absorbed after topical application is metabolized to minoxidil lucuronide, primarily in the liver.

Removal.

The half-life of topical minoxidil averages 22 hours, compared to 1.49 hours for oral use. 97% of minoxidil and its metabolites are excreted by the kidneys and 3% through the intestines.

After stopping use of the drug, approximately 95% of minoxidil applied externally is eliminated within 4 days.

Short product description

Stimulates hair growth in patients with hereditary hair loss in the initial and moderate stages, increasing microcirculation in the area of ​​the hair follicles.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

2 years

Manufacturer

Aerosol-Service AG, Switzerland