Composition, form of production and packaging
? Foam for external use 5% of white to yellowish white color, preserving the structure during the observation period of one minute.
1 g
minoxidil 47.5 mg *
[PRING] ethanol anhydrous - 536.3 mg, purified water - 314.1 mg, butylhydroxytoluene - 0.9 mg **, lactic acid - 10 mg, citric acid anhydrous - 1 mg, glycerol - 20 mg, cetyl alcohol - 11 mg, stearyl alcohol - 5 mg, polysorbate 60-4 mg, propellant-propane / n-butane / isobutane (%) (48:30:22) -50.2 mg.
60 g - aluminum cylinders (1) with a valve with a sprayer and a cap with an anti-tamper protection system - polymeric packaging.
60 g - aluminum cylinders (3) with a valve with a sprayer and a cap with an anti-tamper protection system - polymer packing.
* the actual amount of minoxidil, without propellant, is 50 mg / g;
** the actual amount of butylhydroxytoluene, without propellant, is 1 mg / g.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
The drug for the treatment of alopecia. As a peripheral vasodilator, minoxidil, when applied externally, enhances microcirculation in the area of ​​the hair follicles. It stimulates the growth factor of the vascular endothelium, 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 and moderate stages. The exact mechanism of action of minoxidil for external use in hair loss is not fully understood.
PHARMACOKINETICS
Suction
When applied externally on intact skin, approximately 1-2% of the solution of minoxidil undergoes systemic absorption.
In a clinical study, systemic absorption of 5% foam for external use was approximately half the systemic absorption of a 5% solution for external use. The average values ​​of AUC 0-12 h and C max with 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).
T max with a 5% foam is 5.42 hours and is similar to that of 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, later in vitro ultrafiltration has demonstrated its reversible binding to human plasma proteins in the 37-39% range.
Since only 1-2% of the externally minoxidil applied is absorbed, the degree of binding to plasma proteins observed in vivo after external application will be clinically insignificant.
V d of minoxidil after iv introduction at a dose of 4.6 mg and 18.4 mg is 73.1 liters and 69.2 liters, respectively.
Metabolism
Approximately 60% of minoxidil, absorbed after external application, is metabolized with the formation of minoxidil glucuronide, mainly in the liver.
Excretion
T 1/2 of minoxidil for external use on average is 22 hours, compared with 1.49 hours for oral administration. 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
- Androgenic alopecia in men and women.
DOSING MODE
The drug is intended for external use. Before applying Regein В®, the hair and scalp should be thoroughly dried.
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.
To men 1 g (1/2 of a cap) of foam to put or render 2 times / sut (in the morning and in the evening) on ​​the amazed sites of a pilar part of a head. Do not use Regein ®more than once every 12 hours. The total daily dose should not exceed 2 g of the drug (100 mg minoxidil).
To women 1 g (1/2 of a cap) of foam to put or render 1 times / sut on the amazed sites of a pilar part of a head. Do not use Regene В® more often than 1 time / day. The daily dose should not exceed 1 g of the drug (50 mg minoxidil).
Do not apply Regain В® to other areas of the body.
Recommendations for the use of a cylinder
1. Turn the cap so that the arrows on the sprayer and the cap are aligned.
2. Tilt the cap back and remove it.
3. Before extruding the foam, it is recommended first to rinse your fingers with cold water and thoroughly dry, When exposed to warm skin, the foam may dissolve.
4. Turn the balloon upside down, press the sprayer and squeeze the necessary amount of foam on the fingers.
5. Distribute the foam with fingertips over the areas of baldness and rub gently into the skin of the scalp.
6. After using the RegeneВ® drug, put a cap on the balloon. To keep the package protected from accidental opening by children, it is necessary to check that the arrows on the sprayer and the cap are not aligned.
After applying RegeneВ®, you should thoroughly wash your hands.
The appearance of the first signs of suspension of hair loss and restoration of hair growth is possible after the use of the medicine Regein В® 2 times / day in men for 2-4 months and 1 time / day in women for 3-6 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 use of the medicine Regein В® in men for 16 weeks and for women within 24 weeks, hair growth is not increased, then the drug should be discontinued.
After the application of the drug Regein В® , 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.
SIDE EFFECT
The frequency of adverse reactions is given in the form of the following gradation: very often (? 1/10); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1000); Very rarely (<1/10 000), including individual messages of the unspecified frequency (the frequency can not be calculated from the available data).
Adverse events observed during clinical trials
From the nervous system: often - a headache.
From the skin and subcutaneous tissues: often - skin itching, rash; rarely - dermatitis, manifested in the form of redness, peeling and inflammation.
Post-marketing data
Allergic reactions: very rarely - angioedema (edema of the lips, edema of the oral cavity, swelling of the pharynx, swelling of the pharynx and edema of the tongue), hypersensitivity (edema of the face, generalized erythema, generalized skin itching, a feeling of tightness in the throat), allergic contact dermatitis.
From the nervous system: very rarely - dizziness, headache.
From the side of the organ of vision: very rarely - irritation of the eyes.
From the cardiovascular system: very rarely - tachycardia, palpitation; infrequently - a decrease in blood pressure.
From the respiratory system: very rarely - shortness of breath.
From the side of the digestive system: very rarely - nausea, vomiting.
From the skin and subcutaneous tissues: very rarely - reactions at the site of application (these reactions can spread to the ears and face, include: itching, irritation, pain, rash, swelling, dry skin, erythema, but in some cases, there may be more reactions severe, including: exfoliation, dermatitis, blistering, bleeding, ulceration), temporary hair loss, hair color changes, hair texture disorder, hypertrichosis (unwanted hair growth outside the site of application).
Other: very rarely - peripheral edema, pain in the chest.
If any of the side effects indicated in the manual are aggravated or any other side effects not indicated in the instructions are noted, the patient should inform the physician about it.
CONTRAINDICATIONS
- violation of the integrity of the skin of the head;
- dermatosis of the scalp;
- simultaneous use of other medicines on the scalp;
- Pregnancy;
- the period of lactation (breastfeeding);
- age up to 18 years;
- age over 65;
- hypersensitivity to minoxidil or other components of the drug.
With caution should prescribe the drug to patients with cardiovascular diseases, arrhythmia, renal and hepatic insufficiency.
PREGNANCY AND LACTATION
The drug Regene В® in the form of foam is contraindicated in women during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given to patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should prescribe the drug to patients with hepatic insufficiency.
APPLICATION FOR CHILDREN
The drug is contraindicated for use in patients under the age of 18 years.
APPLICATION IN ELDERLY PATIENTS
The drug is contraindicated in patients aged over 65 years.
SPECIAL INSTRUCTIONS
Before starting treatment with Regein В® , a general examination should be carried out, including the collection and study of medical history. The doctor should make sure that the skin of the scalp is healthy.
Apply Regene В® medicine only to the healthy scalp skin. You can not use the drug in case of inflammation, infection, irritation, soreness of the skin, as well as simultaneously with other medicinal products applied to the skin of the scalp.
Do not use Regain В® medicine in cases of sudden hair loss, focal alopecia, when alopecia develops after childbirth, 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.
If the blood pressure drops or if there is chest pain, rapid heartbeat, weakness or dizziness, sudden unexplained weight gain, swelling of the hands or feet, persistent redness or irritation of the scalp, the patient should stop using Regein В® and consult a doctor.
Some components of the drug may cause burning and irritation. In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse affected area with plenty of cool water. The preparation contains butylhydroxytoluene, cetyl and stearyl alcohol, which can cause local skin reactions (eg, contact dermatitis).
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.
The contents of the cylinder are under pressure. Do not pierce or burn the cylinder. The preparation is highly flammable, so do not spray the contents of the container near open flames, polished or painted surfaces. Avoid contact with sources of naked flames when using, storing and disposing of the container. Do not heat the cylinder above 50 В° C. When applying the drug should refrain from smoking.
The patient should be informed that if the medicinal product has become unusable or has expired, it should not be poured into waste water or thrown out into the street. It is necessary to place the drug in a bag and put it in a garbage container. These measures will help protect the environment.
Recommendations for the use of the drug in conjunction with hair care products
The drug will not be effective when used:
- hair dryer after applying foam 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").
There is no need to wash your head to apply the drug. In case of washing the head before applying the drug, it is necessary to dry hair and scalp.
When using hair styling products, first apply the foam and wait until it dries, and then use hair styling products.
Washing of the head is allowed no less than 4 hours after the application of the drug.
Data on the effect of staining, perm, hair straighteners on the effectiveness of the drug there. As perm and coloring can cause irritation of the scalp, the following precautions are recommended:
- before dyeing and / or perm, it is necessary to make sure that the medicine has been washed off from the hair and scalp to avoid possible irritation of the scalp;
- For best results, do not apply the medication on the same day as the chemical treatment of the hair;
- After using any chemicals, do not apply the medication within 24 hours to make sure that the scalp is not irritated after a chemical wave and / or staining.
Impact on the ability to drive vehicles and manage mechanisms
In connection with the possible development of headache, dizziness, eye irritation, care should be taken when driving vehicles and engaging in certain activities that require an increased concentration of attention and speed of psychomotor reactions. When these undesirable phenomena appear, one should refrain from performing these activities.
OVERDOSE
If doses exceeding recommended are applied to large areas of the body or other parts of the body, in addition to the scalp, an increase in the systemic absorption of minoxidil may be possible, which may lead to the development of undesirable phenomena.
Symptoms: undesirable effects from the cardiovascular system associated with sodium and water retention, as well as tachycardia, lowering blood pressure and dizziness.
Treatment: symptomatic and maintenance therapy. For the treatment of tachycardia, beta-blockers can be prescribed, diuretics for the elimination of edema. In the case of a decrease in blood pressure, a 0.9% solution of sodium chloride should be administered. Do not use sympathomimetic drugs, for example, epinephrine and norepinephrine, which have excessive cardiostimulating activity.
DRUG 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.
We can not exclude a very small increase in minoxidil in the blood in patients with hypertension taking minoxidil inwards, in the case of simultaneous use of the drug Regein, although relevant clinical studies have not been conducted.
It has been established that minoxidil for external use can interact with some other drugs for external use.
With external use, minoxidil should not be used concomitantly with any other medicines (GCS, tretinoin, anthralin) applied to the scalp.
The simultaneous use of minoxidil in the form of foam for external use and cream containing betamethasone (0.05%) leads to a decrease in the systemic absorption of minoxidil.
Simultaneous use of cream containing tretinoin (0.05%) leads to an increase in the absorption of minoxidil.
The simultaneous application of minoxidil to the skin and preparations for external use such as tretinoin and dithranol, which cause changes in the protective functions of the skin, may lead to an increase in the absorption of minoxidil.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
