Composition, form of production and packaging
? The solution for external use is 2% clear, colorless or light yellow in color.
1 ml
minoxidil 20 mg
[PRING] ethanol, propylene glycol, purified water.
60 ml - bottles of high-density polyethylene (1) complete with three nozzles: spray gun, nozzle for rubbing and an extended spray nozzle - pallets (1) - cardboard packs.
? The solution for external use is 5% transparent, colorless or light yellow in color.
1 ml
minoxidil 50 mg
[PRING] ethanol, propylene glycol, purified water.
60 ml - bottles of high-density polyethylene (1) complete with three nozzles: a spray gun, a nozzle for rubbing and an extended spray nozzle - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The drug for the treatment of alopecia (baldness). It has a stimulating effect on hair growth in people with androgenic alopecia. The appearance of signs of hair growth is observed after 4 months or more of the drug. The onset and severity of the effect may vary in different patients. A 5% solution of the drug stimulates hair growth more strongly than a 2% solution, which has been shown to increase the growth of fleece hair.
After drug cancellation, the growth of new hair is suspended, and within 3-4 months it is possible to restore the original appearance.
The precise mechanism of action of the drug Regein В® in the treatment of androgenetic alopecia is unknown.
PHARMACOKINETICS
Suction
With external application, minoxidil is poorly absorbed through normal intact skin: on average, less than 1.5% (0.3-4.5%) of the total applied dose enters the systemic circulation. The effect of concomitant skin diseases on the absorption of minoxidil is unknown.
Distribution and Metabolism
The profile of metabolic biotransformation of minoxidil after external application of the preparation of Regein В® has not been fully studied to the present.
Minoxidil does not bind to blood plasma proteins, does not penetrate the GEB.
Excretion
After discontinuation of the drug, approximately 95% of minoxidil, which enters the systemic circulation, is excreted within 4 days.
Excreted mainly with urine by glomerular filtration.
Minoxidil and its metabolites are excreted by hemodialysis.
INDICATIONS
- Androgenic alopecia in men and women (to restore hair and stabilize the process of hair loss).
DOSING MODE
The drug is intended for external use only on the scalp. Do not apply Regain В® to other areas of the body.
Regain В® is applied to the affected areas of the scalp at a dose of 1 ml 2 times / day, starting from the center of the affected area. The drug is used in this dose, regardless of the size of the treated areas of the scalp. The total daily dose should not exceed 2 ml.
Patients who do not have cosmetically satisfactory hair growth when using a 2% solution, and patients who require faster hair growth, a 5% solution can be used.
For men, Regein В® is most effective at loss of hair on the crown, for women - with hair loss in the middle part.
Terms of use
Regain В® is applied only to the dry skin of the scalp. The method of application depends on the applicator used, as described below. If the drug is applied with the fingertips, after handling the head, hands should be thoroughly washed.
A. Pulverizer
This nozzle is suitable for applying the drug to large areas of the scalp.
1. Remove the large outer cap and inner screw cap from the vial.
2. Place the spray gun on the bottle and screw it tightly.
3. Remove the transparent cap.
4. Direct the head of the atomizer to the center of the affected area, press the valve and distribute the drug throughout the site of baldness with your fingertips. To apply a dose of a solution of 1 ml repeat this operation only 6 times.
5. Avoid inhalation of aerosol. After use, put on the bottle a transparent cap and a large outer cap.
B. Extended spray nozzle
This nozzle is suitable for applying the drug to small areas of baldness or to treat the skin under the preserved hair.
1. To use the extended nozzle on the bottle, a spray gun must be installed. Perform points A 1 and A 3 (see above).
2. Remove the small spray head from the spray gun, strengthen the extended spray nozzle onto the spray gun sleeve. Remove the small cap from the end of the extended nozzle.
3. Using the nozzle in the center of the area of ​​alopecia, press the spray gun 1 time, then distribute the drug with your fingertips over the entire area, lightly rubbing into the skin. To apply a dose of a solution of 1 ml repeat this operation only 6 times.
4. Avoid inhalation of aerosol. After use, you can put the cap on the end of the extended nozzle.
C. Nozzle for rubbing
This nozzle is suitable for applying the drug to small areas of alopecia.
1. Remove the large outer cap and inner screw cap from the vial.
2. Install the nozzle for rubbing on the bottle and screw it tightly.
3. Holding the bottle upright, squeeze the bottle in such a way as to fill the upper chamber to the black line. The chamber holds one full dose (1 ml of solution).
4. Turn over the vial, massage the scalp with the scalp so as to process the entire area of ​​alopecia, until the chamber is emptied. After use, put on a large outer cap on the bottle.
Clinical experience of the drug shows that the appearance of the first signs of stimulation of hair growth is possible after applying the drug 2 times / day for 4 months or more. The onset and severity of hair growth, as well as the quality of the hair, can fluctuate in different patients.
According to individual reports, recovery of the initial appearance can be expected within 3-4 months after discontinuation of treatment.
SIDE EFFECT
Local side effects
Side effects observed in clinical studies of the drug Regein В® , in most cases were dermatitis of the scalp. Less frequent cases of more severe cases of dermatitis, manifested in the form of redness, flaking and inflammation.
In rare cases, itchy scalp, allergic contact dermatitis, folliculitis, alopecia, unwanted hair growth and seborrhea were noted.
In a comparative clinical study examining the use of a 5%, 2%, and placebo minoxidil solution, dermatological reactions were most often observed in the group receiving minoxidil 5%. The nature and severity of side effects in the groups receiving minoxidil 5% and 2% were comparable; the incidence of side effects was higher in the 5% treatment group with minoxidil.
Systemic side effects
Less common side effects are grouped by organ systems.
Dermatological reactions: nonspecific allergic reactions (skin rash, urticaria), edema of the face.
On the part of the respiratory system: dyspnea, allergic rhinitis.
From the side of the central nervous system: headache, dizziness, vertigo, neuritis.
From the cardiovascular system: pain in the chest, fluctuations in blood pressure, palpitations, changes in the rhythm of the heart, swelling.
A clear causal relationship between the use of the drug Regein В® and the occurrence of the above side effects is established only in the case of dermatological reactions.
CONTRAINDICATIONS
- children and adolescence under 18;
- age over 65;
- violation of the integrity of the skin of the head;
- dermatosis of the scalp;
- hypersensitivity to minoxidil and other components of the drug.
PREGNANCY AND LACTATION
The effect of the drug Regene В® on pregnancy is unknown. With systemic absorption, minoxidil is excreted in breast milk.
Regein В® should not be used during pregnancy and lactation.
SPECIAL INSTRUCTIONS
Before starting treatment with Regein В® , patients should undergo a general examination, including the collection and study of medical history. The physician should make sure that the scalp skin is healthy.
Although the following effects were not observed when applying RegeneВ® to the skin, minoxidil is absorbed in small amounts through the skin in small amounts, and there is a risk of systemic side effects such as water and salt retention, generalized and local edema, pericardial effusion, pericarditis, pericardial tamponade, tachycardia, angina pectoris, increased orthostatic hypotension caused by some antihypertensive agents, for example, guanethidine and its derivatives. The appointment of the drug Regein В® to patients with hypertension receiving treatment with guanethidine or derivatives of guanethidine, or minoxidil, is possible only under conditions of medical observation.
Patients should undergo periodic examinations to identify possible signs of systemic side effects of minoxidil. When systemic side effects occur, treatment should be discontinued. To treat edema and fluid retention in the body, if necessary, diuretics can be prescribed. To eliminate tachycardia and angina, beta-blockers can be prescribed. Patients with a history of cardiovascular disease should be warned that treatment with RegeneВ® can exacerbate these diseases.
When systemic side effects or severe skin reactions occur, patients should cancel the drug and consult a doctor.
The effect of the drug Regein В® in patients with a violation of the integrity of the skin and with dermatosis of the scalp at the place of application of the drug is unknown.
The safety and efficacy of Regein В® for patients younger than 18 years and over 65 years of age have not been established.
The composition of the drug Regein В® includes ethyl alcohol, which can cause inflammation and eye irritation. In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse affected area with plenty of cold water.
Accidental ingestion of the solution inside may lead to serious consequences. The observed symptoms mainly affect the cardiovascular system and include fluid retention, lowering blood pressure or tachycardia. Patients should be warned about the need to store Regein В® (as well as other medicines) in a place inaccessible to children. If the drug has become unusable or has expired, then you can not pour it into the waste water or throw it into the street; place the drug in a bag and put it in a trash can. These measures will help protect the environment.
OVERDOSE
Accidental ingestion of Regein В® can cause systemic side effects due to the vasodilating properties of minoxidil (5 ml of a 2% solution contains 100 mg of minoxidil, the maximum recommended dose for adults in the treatment of hypertension, 5 ml of a 5% solution contains 250 mg of minoxidil, ie dose of 2.5 times the maximum recommended daily intake for adults in the treatment of hypertension).
Symptoms: fluid retention, decreased blood pressure, tachycardia.
Treatment: diuretics may be prescribed to eliminate fluid retention if necessary; for the treatment of tachycardia - beta-blockers. For the treatment of hypotension, a 0.9% solution of sodium chloride must be administered. Do not prescribe sympathomimetic drugs, for example, norepinephrine and epinephrine, 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 rule out a very slight increase in minoxidil in blood in patients with arterial hypertension and 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.
The simultaneous use of a solution of minoxidil 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 increased 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 2% solution - 5 years, 5% solution - 3 years.
