Regein - instructions for use, dose, side effects, contraindications

Active substanceMinoxidilMinoxidil

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Regain®

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Regain®

solution externally

Johnson & Johnson, LLC Russia

Dosage form: & nbsp

Solution for external use.

Composition:

1 ml of the preparation contains:

active substance - minoxidil 20 mg / ml, 50 mg / ml;

Excipients: for a concentration of 2%: ethanol - 0.6 ml, propylene glycol - 0.2 ml, purified water - up to 1.0 ml;

for a concentration of 5%: ethanol - 0.3 ml, propylene glycol - 0.5 ml, purified water - up to 1.0 ml.

Description:

Clear colorless or a light yellow solution.

Pharmacotherapeutic group:A treatment for alopecia.

ATX: & nbsp

D.11.A.X.01 Minoxidil

Pharmacodynamics:

With topical application Minoxidil noted its stimulating effect on hair growth in individuals with androgenetic alopecia (hair thinning, baldness). Hair growth occurs after 4 or more months of use. 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 the termination of the use of REGEAN®, the growth of new hair is suspended, and within 3-4 months the restoration of the original appearance is possible. The exact mechanism of action of the REGEAN® preparation in the treatment of androgenetic alopecia is unknown.

Pharmacokinetics:

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

After discontinuation of the drug, approximately 95% Minoxidil, which enters the systemic circulation, is excreted within 4 days. The profile of the metabolic biotransformation of minoxidil after external application of the REGEAN® preparation has not been fully studied to date.

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

Minoxidil and its metabolites are excreted by hemodialysis.Excreted mainly with urine.

Indications:For the treatment of androgenetic alopecia (hair restoration) and stabilization of hair loss in men and women.

Contraindications:

increased sensitivity to minoxidil or other components of the drug;
violation of the integrity of the skin;
dermatosis of the scalp;
age: under 18 years old and over 65 years of age.

Pregnancy and lactation:The effect of REGEAN® on pregnancy is unknown. With systemic absorption minoxidil excreted with human milk.

The drug REGEIN® should not be used during pregnancy and lactation.

Dosing and Administration:

For external use only.

Use REGENN® only as directed. Regardless of the size of the treated area, 1 ml of REGEAN® solution should be applied 2 times a day to the affected areas of the scalp, starting from the center of the affected area. Do not apply REGEIN® to other parts of the body.

The total daily dose should not exceed 2 ml. Patients who do not have cosmetically satisfactory hair growth when applying a 2% solution, and patients who require faster hair growth, can use a 5% solution.

For men, Regain® is most effective in hair loss on the top of the head, for women - with hair loss in the middle part.

Apply REGENH only on the dry skin of the scalp. The method of application depends on the applicator used, as described below. If you applied the drug with your fingertips, after handling the head, your hands should be thoroughly washed.

Recommendations for using attachments:

For the application of REGEAN® to the scalp, one of the following tips can be used:

A. Pulverizer

This nozzle is better suited for applying the drug to large areas of the scalp.

1. Remove the large outer cap and the inner screw cap from the vial.

2. Place the spray nozzle on the bottle and screw it tightly.

3. Remove the transparent cap.

4. Aim the head spray 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 inhaling the aerosol. After use, put on the bottle a transparent cap and a large outer cap.

B. Extended spray nozzle

This nozzle is best suited for applying REGEIN® to small areas of baldness or for treating the skin under the preserved hair.

1. To use an extended nozzle on the bottle should be installed with a spray gun. Perform the operations A.1 and A.3 (see above).

2. Remove the small spray head with spray gun; reinforce the elongated spray nozzle on the spray gun hub. Remove the small cap from the end of the extended nozzle.

3. After directing the nozzle to the center of the area of alopecia, press the spray gun once, 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 inhaling the aerosol. After use, you can put the cap on the end of the extended nozzle.

The clinical experience of using the REGEAN® preparation shows that the appearance of the first signs of stimulation of hair growth is possible after applying the drug 2 times a 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 effects:

Local side effects

Side effects observed in clinical studies of the drug REGEIN®, 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 (hair loss), unwanted hair growth and seborrhea.

In a comparative clinical trial involving the use of a solution of minoxidil 5%, 2% and placebo, 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 diseases	nonspecific allergic reactions (skin rash, urticaria) face edema
Respiratory system	shortness of breath, allergic rhinitis
Nervous system	headache, dizziness, vertigo, neuritis
The cardiovascular system	pain in the chest, fluctuations in blood pressure, palpitations, changes in the rhythm of the heart beat
Miscellaneous	edema

A clear causal relationship between the use of REGEAN® and the occurrence of the side effects listed above has been established only in the case of dermatological reactions.

Overdose:

Accidental ingestion of the drug REGEYN® may cause systemic side effects due to vasodilating properties minoxidil (5 mL 2% REGEYN® solution contain 100 mg of minoxidil - the maximum recommended dose for adults in the treatment of hypertension, 5 ml of 5% REGEYN® solution contain 250 mg of minoxidil , i.e., a dose 2.5 times the maximum recommended daily dose for adults in the treatment of hypertension).

Signs of an overdose are fluid retention, lowering blood pressure, tachycardia. Treatment is symptomatic and supportive.

To eliminate fluid retention if necessary, diuretics can be prescribed; for the treatment of tachycardia - beta-blockers.

To treat hypotension should be administered intravenously 0.9% solution of sodium chloride. Do not prescribe sympathomimetic drugs, for example, norepinephrine and epinephrine, having excessive cardiostimulating activity.

Interaction:

There is a theoretical the possibility of strengthening orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, but not yet receiving clinical confirmation.

It can not be ruled out very much a slight increase in minoxidil in the blood of patients suffering from hypertension and taking minoxidil In the case of concomitant use of REGEAN®, although relevant clinical studies have not been performed.

Determined that minoxidil for external use can interact with some other medicines for external use. Simultaneous use a solution of minoxidil for external use and a cream containing betamethasone (0.05%), leads to a decrease in the systemic absorption of minoxidil.

Simultaneous use cream containing tretinoin (0.05%) leads to an increased absorption of minoxidil.

Simultaneous application to the skin minoxidil and preparations for external use, such as tretinoin and dithranol, which cause changes in the protective functions of the skin, can lead to an increase in absorption minoxidil.

Special instructions:

REGENE® is intended exclusively for external use.

Before starting treatment with REGEAN®, 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 REGEAN® to the skin, minoxidil in small amounts absorbed through the skin, so there is a risk of developing systemic side effects, such as: water and salt retention, generalized and local edema, pericardial effusion, pericarditis, pericardial tamponade, tachycardia, angina pectoris, orthostatic enhancement hypotension caused by some antihypertensive drugs, for example, guanethidine and its derivatives. The appointment of REGEAN® to patients with arterial hypertension receiving treatment with guanethidine or derivatives of guanethidine, or minoxidil, is possible only under medical observation conditions (see section "Interaction with other drugs").

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 REGEAN® can exacerbate these diseases.

When systemic secondary effects or severe skin reactions, patients should abolish REGENN and seek medical attention.

Action of the drug REGEIN® y 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.

Safety and efficiency Regener ® for patients younger than 18 years old and over 65 years of age is not established.

The preparation of REGEAN® is included 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.

After the beginning of the use of the drug REGEIN®, increased hair loss can be noted. This effect is caused by the influence of minoxidil, which 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 two weeks.

Accidental ingestion of the solution inside may lead to serious consequences. The observed symptoms mainly affect the cardiovascular system and include fluid retention, lowering of blood pressure or tachycardia (see Section "Overdose"). Warn your patients about the need to store this medication, as well as other medicines, in a place inaccessible to children.

If the medicine has become unusable or the expiration date has expired, do not throw it into the waste water and throw it out! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

Effect on the ability to drive transp. cf. and fur:

The drug REGEIN® does not affect ability to drive vehicles and to carry out potentially hazardous activities.

Form release / dosage:

Solution for external use 2% and 5%.

Packaging:

For 60 ml of solution in a bottle of high-density polyethylene with an outer cap of polypropylene, a screw cap made of polypropylene and a spacer of low-density polyethylene. For 1 bottle together with the device for dosing application (atomizer, extended spray nozzle) and instructions for use in a cardboard bundle

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:For a concentration of 2%: 5 years,

for a concentration of 5%: 3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:ПN013070 / 01

Date of registration:05.11.2009 / 24.01.2013

The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia

Manufacturer: & nbsp

ASM AEROSOL-SERVICE AG Switzerland

Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia

Information update date: & nbsp20.09.16

Illustrated instructions

Instructions

Regain® (Regaine®)