The use of roaccutane for the treatment of acne in cosmetology

Instructions for use ROACCUTAN

Roaccutane should only be prescribed by physicians, preferably dermatologists, who are experienced in the use of systemic retinoids and are aware of the drug's teratogenic risks. Both female and male patients should be given a copy of the Patient Information Leaflet.

To avoid accidental exposure of the drug to the body of other people, donated blood should not be collected from patients who are receiving or have recently (1 month) received Roaccutane.

It is recommended to monitor liver function before treatment, 1 month after treatment, and then every 3 months or as indicated.

A transient and reversible increase in liver transaminases was noted, in most cases within normal values. If the level of liver transaminases exceeds the norm, it is necessary to reduce the dose of the drug or discontinue it.

Fasting serum lipid levels should also be determined before treatment, 1 month after the start of treatment, then every 3 months or as indicated. Typically, lipid concentrations normalize after dose reduction or discontinuation of the drug, as well as with diet. It is necessary to monitor a clinically significant increase in triglyceride levels, since their rise above 800 mg/dL can be accompanied by the development of acute pancreatitis, possibly with a fatal outcome. In case of persistent hypertriglyceridemia or symptoms of pancreatitis, Roaccutane should be discontinued.

In rare cases, depression, psychotic symptoms and suicidal attempts have been described in patients treated with Roaccutane. Although their causal relationship with the use of the drug has not been established, special caution should be exercised in patients with a history of depression and all patients should be monitored for the occurrence of depression during treatment with the drug, if necessary, using consultations with appropriate specialists.

In rare cases, at the beginning of therapy, an exacerbation of acne is observed, which resolves within 7-10 days without adjusting the dose of the drug.

Several years after the use of Roaccutane in large doses for the treatment of dyskeratosis, bone changes developed, incl. premature closure of the epiphyseal growth zones, therefore, when prescribing the drug to any patient, the ratio of possible benefits and risks should first be carefully assessed.

Patients receiving Roaccutane are recommended to use moisturizing ointment or body cream, lip balm to reduce dry skin and mucous membranes at the beginning of therapy.

Patients receiving Roaccutane require careful monitoring to identify severe skin reactions and, if necessary, consider discontinuing the drug.

While taking Roaccutane, pain in muscles and joints and an increase in CPK activity are possible, which may be accompanied by a decrease in tolerance to intense physical activity.

Deep chemical dermoabrasion and laser treatment should be avoided in patients undergoing treatment with Roaccutane, as well as for 5-6 months after the end of treatment due to the possibility of increased scarring in atypical places. During treatment with Roaccutane and for 6 months after it, hair removal using wax applications cannot be performed due to the risk of epidermal detachment, scar development and dermatitis.

During the period of taking Roaccutane, you need to carefully monitor your visual acuity. Dryness of the conjunctiva of the eyes, clouding of the cornea, deterioration of night vision and keratitis usually disappear after discontinuation of the drug. If the mucous membrane of the eyes is dry, you can use applications of a moisturizing eye ointment or an artificial tear preparation. Patients with dry conjunctiva should be monitored for possible development of keratitis. Patients with vision complaints require an examination by an ophthalmologist, after which it is necessary to consider the advisability of discontinuing Roaccutane. If you are intolerant to contact lenses, you should use glasses during therapy.

Exposure to sunlight and UV rays should be limited. If necessary, use sunscreen with a high protection factor of at least 15 SPF.

Rare cases of the development of benign intracranial hypertension (“pseudotumor cerebri”) have been described, incl. when used in combination with tetracyclines. In such patients, Roaccutane should be discontinued immediately.

During therapy with Roaccutane, inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, Roaccutane should be immediately discontinued.

Rare cases of anaphylactic reactions that occurred only after previous external use of retinoids have been described. Severe allergic reactions dictate the need to discontinue the drug and carefully monitor the patient.

Patients at high risk (with diabetes, obesity, chronic alcoholism or lipid metabolism disorders) may require more frequent laboratory monitoring of glucose and lipid levels when treated with Roaccutane. If you have diabetes or suspect it, more frequent determination of glycemia is recommended.

Impact on the ability to drive vehicles and operate machinery

Since some patients may experience a decrease in night vision acuity, which sometimes persists even after the end of therapy, patients should be advised to exercise caution when driving at night.

Roaccutane®

Pregnancy is an absolute contraindication for therapy with Roaccutane®. If pregnancy occurs, despite warnings, during treatment or within a month after the end of therapy, there is a very high risk of giving birth to a child with severe malformations.

Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs during a period when a woman takes isotretinoin orally (at any dose and even for a short time), there is a very high risk of giving birth to a child with developmental defects.

Roaccutane® is contraindicated in women of childbearing potential unless the woman's condition meets all of the following criteria:

- she must have severe acne that is resistant to conventional treatments;

- she must accurately understand and follow the doctor’s instructions;

- she must be informed by the doctor about the danger of pregnancy during treatment with Roaccutane® within one month after it and urgent consultation if pregnancy is suspected;

- she should be warned about the possible ineffectiveness of contraceptives;

— she must confirm that she understands the essence of the precautionary measures;

- she must understand the need and continuously use effective methods of contraception for one month before treatment with Roaccutane®, during treatment and for a month after its completion (see section “Interaction with other drugs”); it is advisable to use 2 different methods of contraception at the same time, including barrier;

- she must have received a negative result from a reliable pregnancy test within 11 days before starting the drug; A pregnancy test is strongly recommended monthly during treatment and 5 weeks after the end of therapy;

- she should start treatment with Roaccutane® only on the 2-3 day of the next normal menstrual cycle;

- she must understand the need for mandatory visits to the doctor every month;

- when being treated for a relapse of the disease, she must constantly use the same effective methods of contraception for one month before starting treatment with Roaccutane®, during treatment and for a month after its completion, as well as undergo the same reliable pregnancy test;

- She must fully understand the need for precautions and confirm her understanding and desire to use reliable methods of contraception as explained to her by the doctor.

Use of contraception as directed above during treatment with isotretinoin should be recommended even in women who do not routinely use contraception due to infertility (except in patients who have had a hysterectomy), amenorrhea, or who report not being sexually active.

The doctor must be sure that:

— the patient has a severe form of acne (nodulocystic, conglobate acne or acne with a risk of scarring); acne that does not respond to other types of therapy;

- a negative result from a reliable pregnancy test was obtained before starting the drug, during therapy and 5 weeks after the end of therapy; the dates and results of the pregnancy test must be documented;

- the patient uses at least 1, preferably 2 effective methods of contraception, including a barrier method, for one month before starting treatment with Roaccutane®, during treatment and for a month after its completion;

— the patient is able to understand and fulfill all of the above requirements for pregnancy protection;

— the patient meets all of the above conditions.

Pregnancy test

According to current practice, a pregnancy test with a minimum sensitivity of 25 mIU/ml should be performed in the first 3 days of the menstrual cycle:

Before starting therapy:

— To exclude possible pregnancy, before starting contraception, the result and date of the initial pregnancy test must be recorded by a doctor. In patients with irregular menstruation, the timing of a pregnancy test depends on sexual activity and should be performed 3 weeks after unprotected intercourse. The doctor should inform the patient about contraceptive methods.

— A pregnancy test is carried out on the day of prescription of the drug Roaccutane® or 3 days before the patient’s visit to the doctor. The specialist should record the test results. The drug can only be prescribed to patients receiving effective contraception for at least 1 month before starting therapy with Roaccutane®.

During therapy:

— The patient must visit the doctor every 28 days. The need for monthly pregnancy testing is determined in accordance with local practice and taking into account sexual activity and previous menstrual irregularities. If indicated, a pregnancy test is performed on the day of the visit or three days before the visit to the doctor, the test results must be recorded.

End of therapy:

- 5 weeks after the end of therapy, a test is performed to exclude pregnancy.

A prescription for Roaccutane® for a woman capable of childbearing can be issued only for 30 days of treatment; continuation of therapy requires a new prescription of the drug by a doctor. It is recommended that a pregnancy test, writing a prescription and receiving the drug be carried out on the same day.

The drug Roaccutane® should be dispensed at the pharmacy only within 7 days from the date of issuing the prescription.

To help physicians, pharmacists and patients avoid the risk of fetal exposure to Roaccutane®, the company aims to warn about the drug's teratogenicity and emphasize the absolute mandatory use of reliable contraceptive measures for women of childbearing age. The program contains the following materials:

for doctors:

— a doctor’s guide to prescribing Roaccutane® to women

— informed consent form for the patient

— form for recording the prescription of the drug to women for the patient:

— patient information brochure

- what you need to know about contraception

— for the pharmacist:

— a guide for the pharmacist on the dispensing of the drug Roaccutane®.

Full information about teratogenic risk and strict adherence to measures to prevent pregnancy should be provided to both men and women.

For male patients

Existing data indicate that in women, exposure to the drug from the semen and seminal fluid of men taking Roaccutane® is not sufficient to cause the teratogenic effects of Roaccutane®.

Men should exclude the possibility of other persons, especially women, taking the drug.

If, despite the precautions taken, pregnancy does occur during treatment with Roaccutane® or within a month after its end, there is a high risk of very severe fetal malformations (in particular, from the central nervous system, heart and large blood vessels) . In addition, the risk of spontaneous miscarriage increases.

If pregnancy occurs, therapy with Roaccutane® is discontinued. The advisability of maintaining it should be discussed with a doctor specializing in teratology. Severe congenital malformations of the fetus in humans associated with the use of Roaccutane® have been documented, including hydrocephalus, microcephaly, cerebellar malformations, anomalies of the external ear (microtia, narrowing or absence of the external auditory canal), microphthalmia, cardiovascular anomalies (tetrad Fallot, transposition of the great vessels, septal defects), malformations of the face (cleft palate), thymus gland, pathology of the parathyroid glands. Because isotretinoin is highly lipophilic, it is very likely that it passes into breast milk. Due to possible side effects, Roaccutane® should not be prescribed to nursing mothers.

The use of roaccutane for the treatment of acne in cosmetology

Korchevaya T.A.

Acne is a disease of the hair follicles and sebaceous glands. In the pathogenesis of acne, four interrelated factors are important: pathological follicular hyperkeratosis, excessive secretion of the sebaceous glands, proliferation of Propionibactertum acnes (P. acnes) and inflammation. In addition, the nature and volume of secretion of the sebaceous glands is influenced by androgens, which can also play an important role in the pathogenesis of acne.

Excess sebum production plays an additional role in the pathogenesis of acne. In patients suffering from acne, sebum production increases significantly, which usually correlates with the severity of the disease. The secretion of the sebaceous glands is a substrate for the proliferation of P. acnes. In this case, lipolysis of sebum occurs by bacterial lipases to free fatty acids, which in turn contribute to inflammation and the formation of comedones.

In patients with acne, P. acnes multiplies and plays a key role in the inflammatory phase of the disease. When the contents of the follicle enter the skin itself, aseptic inflammation occurs. Depending on the location and extent of inflammation, papules, pustules and cysts are formed.

In connection with the above, for rational treatment of acne, it is important for us to solve the following main tasks:

• reduce the effect of androgens on the sebaceous glands,
• reduce sebum formation,
• reduce inflammation,
• reduce the number of P. acnes,
• normalize the mitotic activity of the skin.

Rational treatment is based on correct clinical assessment. The duration of acne, the maximum severity and location of the lesion should be determined.

Topical treatment alone may be indicated for mild to moderate noninflammatory acne, mild superficial inflammatory acne without scarring, and as an adjunct to oral therapy for moderate to severe acne.

Systemic therapy is necessarily combined with local therapy and is indicated for the treatment of patients with moderate to severe acne, especially in cases of scarring or a tendency to psychosocial disorders.

Currently, Roaccutane is the most effective drug for the treatment of severe forms of acne. Clinical experience shows that it can cause long-term remissions or cures in most patients. Roaccutane reduces sebum production by 80%. There is a significant reduction in comedogenesis and P. acnes counts within 4 to 8 weeks after initiation of treatment.

Roaccutane is teratogenic. When prescribing it to women of childbearing age, it is necessary to exclude pregnancy two weeks before treatment. But the drug does not stay in the tissues for a long time and therefore, 1-2 months after treatment with Roaccutane, pregnancy is not prohibited. The opinion of some gynecologists and a number of other specialists who do not recommend getting pregnant for the entire first year after treatment with Roaccutane is erroneous: the level of the drug in the blood returns to the physiological norm within two weeks after discontinuation of the drug. And for men, in terms of childbearing, it has no contraindications, since it has no effect on sperm.

Economic efficiency. The cost of a course of treatment with Roaccutane is not always clearly perceived not only by the patient, but even by the doctor. But we must remember the high effectiveness of the drug, its surprisingly lasting effect on severe cystic, atheromatous acne, which, unfortunately, has always been considered a chronic recurrent skin disease. And here the doctor is faced with a choice: either he offers the patient treatment for a long time followed by numerous cosmetic procedures to prevent relapse; carry out repeated courses of treatment in case of relapse of inflammation, which, especially in cystic forms, is almost inevitable. With this tactic for treating acne, the total costs of treatment extended over time without the use of Roaccutane will undoubtedly be higher. Doctors are attracted to treatment with Roaccutane, of course, by the result itself: “I receive deep satisfaction from the results of treatment with this drug, as the patient’s skin improves and evens out almost without much effort on the part of the doctor.” Indeed, often even with the most complex cosmetic procedures we cannot achieve the same cosmetic effect on the skin that Roaccutane treatment provides. And most importantly, clinical cure is observed in the vast majority of patients. We understand that investing money in a temporary effect such as we often see from antibiotics for acne would, of course, be inappropriate. Therefore, the patient asks about guarantees. According to various authors, the percentage of effectiveness is very high: from 80% to 95%.

We have noticed that treating foci of chronic infection increases the effectiveness of treatment and reduces the percentage of relapses.

We begin to prepare the patient for taking Roaccutane already at the stage of a standard examination for the drug:

1. Sanitation of foci of chronic infection (gastrointestinal tract, ENT organs, etc.), 2. Sanitation of the skin with concomitant demodicosis: - Delex-acne gel (contains sulfur), - Metrogyl jelly (contains metronidazole).

We believe that it is not always advisable to carry out monotherapy with Roaccutane. To improve skin smoothing, enhance the anti-inflammatory effect, accelerate healing, eliminate post-acne defects in the early stages, when they are more susceptible to influence, we recommend combining Roaccutane at different stages of treatment with a number of medications and cosmetic procedures:

• vitamin E (taken orally in a prophylactic dosage),
• homeopathy and antihomotoxicology,
• Skinoren,
• oxygen ozone therapy,
• mesotherapy,
• myostimulation,
• enzymatic peeling (to remove possible peeling of facial skin),
• diathermocoagulation of abscesses,
• massotherapy.

Among antihomotoxic drugs, I would like to especially highlight the use of Traumeel in complex therapy with Roaccutane.

The use of Traumeel S and Roaccutane in the treatment of severe forms of acne (240 patients)

The table shows that when Roaccutane is combined with the antihomotoxic drug Traumeel, the effect of treatment occurs much earlier and the smoothing of scars is more pronounced.

Unfortunately, Roaccutane does not combine well with liquid nitrogen, cosmetic cleansing, dermabrasion, chemical and acid peels. After completion of treatment with this drug for different periods of 3 months. up to 6 months if necessary, chemical and acid peeling and dermabrasion can be performed. Cosmetic cleansing - earlier: after 1-2 weeks, and with small dosages - at the end of the Roaccutane course.

Conclusion.

Roaccutane acts on the most important mechanism of acne - increased sebum secretion. Gradually, the sebaceous glands decrease in size, sebaceous cysts disappear, and therefore, inflammation in the area of ​​these glands decreases. It is with the restructuring of the sebaceous glands that a lasting effect or clinical recovery is associated with treatment with Roaccutane.

It is possible to combine Roaccutane at different stages of treatment with anti-scarring and anti-inflammatory homeopathy, as well as with a number of cosmetic procedures.

Roaccutane caps 10mg N30 (Hoffman-La Roche)

Roaccutane should only be prescribed by physicians, preferably dermatologists, who are experienced in the use of systemic retinoids and are aware of the drug's teratogenicity risk. Both female and male patients should be given a copy of the Patient Information Leaflet. To avoid accidental exposure of the drug to the body of other people, donated blood should not be taken from patients who are receiving or have recently (1 month) received Roaccutane. It is recommended to monitor liver function and liver enzymes before treatment, 1 month after treatment, and then every 3 months or as indicated. A transient and reversible increase in liver transaminases was noted, in most cases within normal values. If the level of liver transaminases exceeds the norm, it is necessary to reduce the dose of the drug or discontinue it. Fasting serum lipid levels should also be determined before treatment, 1 month after initiation, and then every 3 months or as indicated. Typically, lipid concentrations normalize after dose reduction or discontinuation of the drug, as well as with diet. It is necessary to monitor a clinically significant increase in triglyceride levels, since their rise above 800 mg/dL or 9 mmol/L can be accompanied by the development of acute pancreatitis, possibly fatal. In case of persistent hypertriglyceridemia or symptoms of pancreatitis, Roaccutane should be discontinued. In rare cases, depression, psychotic symptoms, and very rarely, suicide attempts have been described in patients treated with Roaccutane. Although their causal relationship with the use of the drug has not been established, special caution should be exercised in patients with a history of depression and all patients should be monitored for the occurrence of depression during treatment with the drug, if necessary, referring them to an appropriate specialist. However, discontinuation of Roaccutane may not lead to the disappearance of symptoms and further observation and treatment by a specialist may be required. In rare cases, at the beginning of therapy, an exacerbation of acne is observed, which resolves within 7-10 days without adjusting the dose of the drug. Several years after the use of Roaccutane for the treatment of dyskeratosis, at a total course dose and duration of therapy higher than those recommended for the treatment of acne, bone changes developed, including premature closure of the epiphyseal growth plates, hyperostosis, calcification of ligaments and tendons. Therefore, when prescribing the drug to any patient, the ratio of possible benefits and risks should first be carefully assessed. Patients receiving Roaccutane are recommended to use moisturizing ointment or body cream, lip balm to reduce dry skin and mucous membranes at the beginning of therapy. During post-marketing surveillance with the use of the drug Roaccutane, cases of severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been described. These events can be serious and can lead to disability, life-threatening conditions, hospitalization or death. Patients receiving Roaccutane require careful monitoring to identify severe skin reactions and, if necessary, consider discontinuing the drug. While taking Roaccutane, pain in muscles and joints and an increase in serum creatinine phosphokinase are possible, which may be accompanied by a decrease in tolerance to intense physical activity. Deep chemical dermoabrasion and laser treatment should be avoided in patients receiving Roaccutane, as well as for 5-6 months after the end of treatment due to the possibility of increased scarring in atypical places and the occurrence of hyper- and hypopigmentation. During treatment with Roaccutane and for 6 months after it, hair removal using wax applications cannot be performed due to the risk of epidermal detachment, scar development and dermatitis. Since some patients may experience a decrease in night vision acuity, which sometimes persists even after the end of therapy, patients should be informed about the possibility of this condition, advising them to exercise caution when driving at night. Visual acuity must be carefully monitored. Dryness of the conjunctiva of the eyes, corneal opacities, deterioration of night vision and keratitis usually disappear after discontinuation of the drug. If the mucous membrane of the eyes is dry, you can use applications of a moisturizing eye ointment or an artificial tear preparation. Patients with dry conjunctiva should be monitored for possible development of keratitis. Patients with vision complaints should be referred to an ophthalmologist and consider the advisability of discontinuing Roaccutane. If you are intolerant to contact lenses, you should use glasses during therapy. Exposure to sunlight and UV rays should be limited. If necessary, use sunscreen with a high protection factor of at least 15 SPF. Rare cases of the development of benign intracranial hypertension (“pseudotumor cerebri”) have been described, incl. when used in combination with tetracyclines. In such patients, Roaccutane should be discontinued immediately. During therapy with Roaccutane, inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, Roaccutane should be immediately discontinued. Rare cases of anaphylactic reactions that occurred only after previous external use of retinoids have been described. Severe allergic reactions dictate the need to discontinue the drug and carefully monitor the patient. Patients at high risk (with diabetes, obesity, chronic alcoholism or lipid metabolism disorders) may require more frequent laboratory monitoring of glucose and lipid levels when treated with Roaccutane. If diabetes is present or suspected, more frequent monitoring of glycemia is recommended.

Roaccutane capsules 20 mg No. 10x3

Name

Roaccutane caps. 20 mg in blister pack No. 10x3

Description

The capsules are one half brownish-red in color, the other half white, opaque, oval, with the inscription “ROA 20” on the surface in black ink; the contents of the capsules are a homogeneous suspension from yellow to dark yellow.

Main active ingredient

Isotretinoin

Release form

The capsules are one half brownish-red in color, the other half white, opaque, oval, with the inscription “ROA 20” on the surface in black ink; the contents of the capsules are a homogeneous suspension from yellow to dark yellow. 1 caps. isotretinoin 20 mg Excipients: soybean oil - 215.84 mg, yellow beeswax - 15.36 mg, hydrogenated soybean oil - 15.36 mg, partially hydrogenated soybean oil - 61.44 mg. Composition of the capsule shell: glycerol 85% - 49.835 mg, gelatin - 120.66 mg, Karion 83 (hydrolyzed potato starch, mannitol, sorbitol) - 12.86 mg, red iron oxide dye (E172) - 0.145 mg, titanium dioxide (E171) - 1.97 mg . Ink composition: shellac, black iron oxide dye (E172); Ready-made ink Opacode Black S-1-27794 can be used. 10 pieces. - blisters (3) - cardboard packs. 10 pieces. - blisters (10) - cardboard packs.

Dosage

20 mg in blister pack No. 10x3

special instructions

Roaccutane should only be prescribed by physicians, preferably dermatologists, who are experienced in the use of systemic retinoids and are aware of the drug's teratogenicity risk. Both female and male patients should be given a copy of the Patient Information Leaflet. To avoid accidental exposure of the drug to the body of other people, donated blood should not be taken from patients who are receiving or have recently (1 month) received Roaccutane. It is recommended to monitor liver function and liver enzymes before treatment, 1 month after treatment, and then every 3 months or as indicated. A transient and reversible increase in liver transaminases was noted, in most cases within normal values. If the level of liver transaminases exceeds the norm, it is necessary to reduce the dose of the drug or discontinue it. Fasting serum lipid levels should also be determined before treatment, 1 month after initiation, and then every 3 months or as indicated. Typically, lipid concentrations normalize after dose reduction or discontinuation of the drug, as well as with diet. It is necessary to monitor a clinically significant increase in triglyceride levels, since their rise above 800 mg/dL or 9 mmol/L can be accompanied by the development of acute pancreatitis, possibly fatal. In case of persistent hypertriglyceridemia or symptoms of pancreatitis, Roaccutane should be discontinued. In rare cases, depression, psychotic symptoms, and very rarely, suicide attempts have been described in patients treated with Roaccutane. Although their causal relationship with the use of the drug has not been established, special caution should be exercised in patients with a history of depression and all patients should be monitored for the occurrence of depression during treatment with the drug, if necessary, referring them to an appropriate specialist. However, discontinuation of Roaccutane may not lead to the disappearance of symptoms and further observation and treatment by a specialist may be required. In rare cases, at the beginning of therapy, an exacerbation of acne is observed, which resolves within 7-10 days without adjusting the dose of the drug. Several years after the use of Roaccutane for the treatment of dyskeratosis, at a total course dose and duration of therapy higher than those recommended for the treatment of acne, bone changes developed, including premature closure of the epiphyseal growth plates, hyperostosis, calcification of ligaments and tendons. Therefore, when prescribing the drug to any patient, the ratio of possible benefits and risks should first be carefully assessed. Patients receiving Roaccutane are recommended to use moisturizing ointment or body cream, lip balm to reduce dry skin and mucous membranes at the beginning of therapy. During post-marketing surveillance with the use of the drug Roaccutane, cases of severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been described. These events can be serious and can lead to disability, life-threatening conditions, hospitalization or death. Patients receiving Roaccutane require careful monitoring to identify severe skin reactions and, if necessary, consider discontinuing the drug. While taking Roaccutane, pain in muscles and joints and an increase in serum creatinine phosphokinase are possible, which may be accompanied by a decrease in tolerance to intense physical activity. Deep chemical dermoabrasion and laser treatment should be avoided in patients receiving Roaccutane, as well as for 5-6 months after the end of treatment due to the possibility of increased scarring in atypical places and the occurrence of hyper- and hypopigmentation. During treatment with Roaccutane and for 6 months after it, hair removal using wax applications cannot be performed due to the risk of epidermal detachment, scar development and dermatitis. Since some patients may experience a decrease in night vision acuity, which sometimes persists even after the end of therapy, patients should be informed about the possibility of this condition, advising them to exercise caution when driving at night. Visual acuity must be carefully monitored. Dryness of the conjunctiva of the eyes, corneal opacities, deterioration of night vision and keratitis usually disappear after discontinuation of the drug. If the mucous membrane of the eyes is dry, you can use applications of a moisturizing eye ointment or an artificial tear preparation. Patients with dry conjunctiva should be monitored for possible development of keratitis. Patients with vision complaints should be referred to an ophthalmologist and consider the advisability of discontinuing Roaccutane. If you are intolerant to contact lenses, you should use glasses during therapy. Exposure to sunlight and UV rays should be limited. If necessary, use sunscreen with a high protection factor of at least 15 SPF. Rare cases of the development of benign intracranial hypertension (“pseudotumor cerebri”) have been described, incl. when used in combination with tetracyclines. In such patients, Roaccutane should be discontinued immediately. During therapy with Roaccutane, inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, Roaccutane should be immediately discontinued. Rare cases of anaphylactic reactions that occurred only after previous external use of retinoids have been described. Severe allergic reactions dictate the need to discontinue the drug and carefully monitor the patient. Patients at high risk (with diabetes, obesity, chronic alcoholism or lipid metabolism disorders) may require more frequent laboratory monitoring of glucose and lipid levels when treated with Roaccutane. If diabetes is present or suspected, more frequent monitoring of glycemia is recommended.

pharmachologic effect

Retinoid for systemic treatment of acne. Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of Roaccutane has not yet been clarified, but it has been established that the improvement in the clinical picture of severe forms of acne is associated with suppression of the activity of the sebaceous glands and a histologically confirmed reduction in their size. In addition, isotretinoin has been shown to have anti-inflammatory effects on the skin. Hyperkeratosis of epithelial cells of the hair follicle and sebaceous gland leads to desquamation of corneocytes into the gland duct and to blockage of the latter with keratin and excess sebaceous secretion. This is followed by the formation of a comedone and, in some cases, the addition of an inflammatory process. Roaccutane inhibits the proliferation of sebocytes and acts on acne, restoring the normal process of cell differentiation. Sebum is the main substrate for the growth of Propionibacterium acnes, so reducing sebum production inhibits bacterial colonization of the duct.

Pharmacokinetics

Since the kinetics of isotretinoin and its metabolites is linear, its plasma concentrations during therapy can be predicted based on data obtained after a single dose. This property of the drug also suggests that it does not affect the activity of liver enzymes involved in the metabolism of drugs. Absorption Absorption of isotretinoin from the gastrointestinal tract varies. The absolute bioavailability of isotretinoin was not determined, since there is no release form of the drug for intravenous use in humans. However, extrapolation of data obtained in an experiment in dogs suggests a rather low and variable systemic bioavailability. In patients with acne, maximum plasma concentrations (Cmax) at steady state after administration of 80 mg isotretinoin on an empty stomach were 310 ng/ml (range 188-473 ng/ml) and were achieved after 2-4 hours. Plasma concentrations of isotretinoin are approximately 1.7 times higher than blood concentrations due to poor penetration of isotretinoin into red blood cells. Taking isotretinoin with food increases bioavailability by 2 times compared to taking it on an empty stomach. Distribution Isotretinoin binds to a high degree (99.9%) with plasma proteins, mainly with albumin, therefore, over a wide range of therapeutic concentrations, the content of the free (pharmacologically active) fraction of the drug is less than 0.1% of its total amount. The volume of distribution of isotretinoin in humans has not been determined because there is no dosage form available for intravenous administration. Equilibrium concentrations of isotretinoin in the blood (C ss min) in patients with severe acne who took 40 mg of the drug 2 times a day ranged from 120 to 200 ng/ml. The concentrations of 4-oxo-isotretinoin in these patients were 2.5 times higher than those of isotretinoin. There is insufficient data on the penetration of isotretinoin into tissues in humans. Concentrations of isotretinoin in the epidermis are two times lower than in serum. Metabolism After oral administration, three main metabolites are found in plasma: 4-oxo-isotretinoin, tretinoin (all-trans retinoic acid) and 4-oxo-retinoin. The main metabolite is 4-oxo-isotretinoin, whose plasma concentrations at steady state are 2.5 times higher than the concentrations of the parent drug. Less significant metabolites have also been discovered, including glucuronides, but the structure of not all metabolites has been established. Isotretinoin metabolites have biological activity confirmed in several laboratory tests. Thus, the clinical effects of the drug in patients may be the result of the pharmacological activity of isotretinoin and its metabolites. Because isotretinoin and tretinoin (all-trans retinoic acid) are reversibly converted into each other in vivo, the metabolism of tretinoin is related to the metabolism of isotretinoin. 20-30% of the isotretinoin dose is metabolized by isomerization. Enterohepatic circulation may play a significant role in the pharmacokinetics of isotretinoin in humans. In vitro metabolism studies have shown that several CYP enzymes are involved in the conversion of isotretinoin to 4-oxo-isotretinoin and tretinoin. Apparently, none of the isoforms plays a dominant role in this case. Roaccutane and its metabolites do not have a significant effect on the activity of enzymes of the CYP system. Excretion Following oral administration of radiolabeled isotretinoin, approximately equal amounts are found in urine and feces. The terminal phase half-life for unchanged drug in patients with acne averages 19 hours. The terminal phase half-life for 4-oxo-isotretinoin appears to be longer, averaging 29 hours. Isotretinoin is a natural (physiological) retinoid. Endogenous concentrations of retinoids are restored approximately 2 weeks after the end of taking Roaccutane. Pharmacokinetics in special clinical situations Since isotretinoin is contraindicated in patients with impaired liver function, data on the pharmacokinetics of the drug in this group of patients are limited. Renal failure does not affect the pharmacokinetics of isotretinoin.

Indications for use

- severe forms of acne (nodulocystic, conglobate acne or acne with a risk of scarring); - acne that does not respond to other types of therapy.

Directions for use and doses

Orally, during meals, once or twice a day. The therapeutic effectiveness of Roaccutane and its side effects depend on the dose and vary among different patients. This dictates the need for individual dose selection during treatment. Treatment with Roaccutane should begin with a dose of 0.5 mg/kg body weight/day. In most patients, the dose ranges from 0.5 to 1.0 mg/kg body weight per day. Patients with very severe forms of the disease or with acne of the trunk may require higher daily doses - up to 2.0 mg/kg/day. It has been proven that the frequency of remission and prevention of relapses are optimal when using a course dose of 120-150 mg/kg (per course of treatment), therefore the duration of therapy in specific patients varies depending on the daily dose. Complete remission of acne can often be achieved within 16-24 weeks of treatment. In patients who tolerate the recommended dose very poorly, treatment can be continued at a lower dose, but last longer. In most patients, acne completely disappears after a single course of treatment. In case of obvious relapse, a second course of treatment with Roaccutane is indicated in the same daily and course dose as the first. Since improvement can continue up to 8 weeks after discontinuation of the drug, a second course should be prescribed no earlier than the end of this period. Dosing in special cases In patients with severe renal impairment, treatment should be initiated at a lower dose (eg, 10 mg/day) and further increased to 1 mg/kg/day or the maximum tolerated.

Use during pregnancy and lactation

Pregnancy is an absolute contraindication for Roaccutane therapy. If pregnancy occurs, despite warnings, during treatment or within a month after the end of therapy, there is a very high risk of giving birth to a child with severe malformations. Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs during a period when a woman takes isotretinoin orally (at any dose and even for a short time), there is a very high risk of giving birth to a child with developmental defects. Roaccutane is contraindicated in women of childbearing age unless the woman's condition meets all of the following criteria: - she must have severe acne that is resistant to conventional treatments; - she must certainly understand and follow the doctor’s instructions; - she must be informed by the doctor about the danger of pregnancy during treatment with Roaccutane, within one month after it, and urgent consultation if pregnancy is suspected; - she should be warned about the possible ineffectiveness of contraceptives; — she must confirm that she understands the essence of the precautionary measures; - she must understand the need and continuously use effective methods of contraception for one month before treatment with Roaccutane, during treatment and for a month after its completion (see section “Interaction with other drugs”); it is advisable to use 2 different methods of contraception at the same time, including barrier; - she must have received a negative result from a reliable pregnancy test within 11 days before starting the drug; A pregnancy test is strongly recommended monthly during treatment and 5 weeks after the end of therapy; - she should start treatment with Roaccutane only on the 2-3 day of the next normal menstrual cycle; - she must understand the need for mandatory visits to the doctor every month; - when being treated for a relapse of the disease, she must constantly use the same effective methods of contraception for one month before starting treatment with Roaccutane, during treatment and for a month after its completion, as well as undergo the same reliable pregnancy test; - She must fully understand the need for precautions and confirm her understanding and desire to use reliable methods of contraception as explained to her by the doctor. Use of contraception as directed above during treatment with isotretinoin should be recommended even in women who do not routinely use contraception due to infertility (except in patients who have had a hysterectomy), amenorrhea, or who report not being sexually active. The doctor must be sure that: - the patient suffers from severe acne (nodulocystic, conglobate acne or acne with risk of scarring); acne that does not respond to other types of therapy; - a negative result from a reliable pregnancy test was obtained before starting the drug, during therapy and 5 weeks after the end of therapy; the dates and results of the pregnancy test must be documented; - the patient uses at least 1, preferably 2 effective methods of contraception, including a barrier method, for one month before starting treatment with Roaccutane, during treatment and for a month after its completion; — the patient is able to understand and fulfill all of the above requirements for pregnancy protection; — the patient meets all of the above conditions. Pregnancy test In accordance with current practice, a pregnancy test with a minimum sensitivity of 25 mIU/ml should be performed in the first 3 days of the menstrual cycle: Before starting therapy To exclude possible pregnancy, the result and date of the initial pregnancy test should be recorded by a doctor before starting contraception. . In patients with irregular menstruation, the timing of a pregnancy test depends on sexual activity and should be performed 3 weeks after unprotected intercourse. The doctor should inform the patient about contraceptive methods. A pregnancy test is carried out on the day of Roaccutane's prescription or 3 days before the patient's visit to the doctor. The specialist should record the test results. The drug can only be prescribed to patients receiving effective contraception for at least 1 month before starting Roaccutane therapy. During therapy, the Patient must visit the doctor every 28 days. The need for monthly pregnancy testing is determined in accordance with local practice and taking into account sexual activity and previous menstrual irregularities. If indicated, a pregnancy test is performed on the day of the visit or three days before the visit to the doctor, the test results must be recorded. End of therapy 5 weeks after the end of therapy, a test is performed to exclude pregnancy. A prescription for Roaccutane for a woman capable of childbearing can be issued only for 30 days of treatment; continuation of therapy requires a new prescription of the drug by a doctor. It is recommended that a pregnancy test, writing a prescription and receiving the drug be carried out on the same day. Roaccutane should be dispensed at a pharmacy only within 7 days from the date of issuing the prescription. To help doctors, pharmacists and patients avoid the risk of fetal exposure to Roaccutane, the company aims to warn about the drug's teratogenicity and emphasize the absolute mandatory use of reliable contraceptive measures for women of childbearing age. The program contains the following materials: for doctors: - a doctor’s guide to prescribing Roaccutane to women; — informed consent form for the patient; — a form for recording the prescription of the drug to women. for the patient: - patient information brochure; — what you need to know about contraception. for the pharmacist: - a guide for the pharmacist on the dispensing of Roaccutane. Full information about teratogenic risk and strict adherence to measures to prevent pregnancy should be provided to both men and women. Male patients Existing data indicate that in women, exposure to the drug from the semen and seminal fluid of men taking Roaccutane is not sufficient to cause the teratogenic effects of Roaccutane. Men should exclude the possibility of taking the drug by other persons, especially women. If, despite the precautions taken, pregnancy does occur during treatment with Roaccutane or within a month after its end, there is a high risk of very severe fetal malformations (in particular, from the central nervous system, heart and large blood vessels). In addition, the risk of spontaneous miscarriage increases. If pregnancy occurs, Roaccutane therapy is discontinued. The advisability of maintaining it should be discussed with a doctor specializing in teratology. Severe congenital malformations of the fetus in humans associated with the use of Roaccutane have been documented, including hydrocephalus, microcephaly, cerebellar malformations, anomalies of the external ear (microtia, narrowing or absence of the external auditory canal), microphthalmia, cardiovascular anomalies (tetralogy of Fallot, transposition of the great vessels, septal defects), malformations of the face (cleft palate), thymus gland, pathology of the parathyroid glands. Because isotretinoin is highly lipophilic, it is very likely that it passes into breast milk. Due to possible side effects, Roaccutane should not be prescribed to nursing mothers.

Precautionary measures

Contraindication: liver failure. In patients with severe renal impairment, treatment should be started with a lower dose (eg, 10 mg/day) and further increased to 1 mg/kg/day or the maximum tolerated. Contraindication: children under 12 years of age.

Interaction with other drugs

Due to a possible increase in the symptoms of hypervitaminosis A, the simultaneous administration of Roaccutane and vitamin A should be avoided. Since tetracyclines can also cause an increase in intracranial pressure, their use in combination with Roaccutane is contraindicated. Isotretinoin may reduce the effectiveness of progesterone preparations, so contraceptives containing low doses of progesterone should not be used. Combined use with topical keratolytic or exfoliative drugs for the treatment of acne is contraindicated due to the possible increase in local irritation.

Contraindications

- liver failure; - hypervitaminosis A; - severe hyperlipidemia; - concomitant therapy with tetracyclines; - pregnancy; - period of breastfeeding; - children under 12 years of age; - hypersensitivity to the drug or its components. With caution: history of depression, diabetes mellitus, obesity, lipid metabolism disorders, alcoholism.

Compound

Isotretinoin 20 mg Excipients: soybean oil - 215.84 mg, yellow beeswax - 15.36 mg, hydrogenated soybean oil - 15.36 mg, partially hydrogenated soybean oil - 61.44 mg. Composition of the capsule shell: glycerol 85% - 49.835 mg, gelatin - 120.66 mg, Karion 83 (hydrolyzed potato starch, mannitol, sorbitol) - 12.86 mg, red iron oxide dye (E172) - 0.145 mg, titanium dioxide (E171) - 1.97 mg . Ink composition: shellac, black iron oxide dye (E172); Ready-made ink Opacode Black S-1-27794 can be used.

Overdose

In case of overdose, signs of hypervitaminosis A may appear. In the first few hours after an overdose, gastric lavage may be necessary.

Side effect

Most of the side effects of Roaccutane depend on the dose. As a rule, when prescribing the recommended doses, the benefit-risk ratio, taking into account the severity of the disease, is acceptable for the patient. Side effects are usually reversible after dose adjustment or drug discontinuation, but some may persist after treatment is stopped. From the central nervous system and the mental sphere: behavioral disturbances, depression, headache, increased intracranial pressure (“pseudotumor cerebri”: headache, nausea, vomiting, blurred vision, papilledema), seizures. From the senses: isolated cases of impaired visual acuity, photophobia, impaired dark adaptation (decreased acuity of twilight vision), rarely - impaired color vision (passing after discontinuation of the drug), lenticular cataract, keratitis, blepharitis, conjunctivitis, eye irritation, papilledema ( as a manifestation of intracranial hypertension); hearing loss at certain sound frequencies. From the digestive system: nausea, diarrhea, inflammatory bowel diseases (colitis, ileitis), bleeding; pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg/dl). Rare cases of pancreatitis with a fatal outcome have been described. Transient and reversible increase in the activity of liver transaminases, isolated cases of hepatitis. In many of these cases, the changes did not go beyond the normal range and returned to the initial values ​​during treatment, but in some situations there was a need to reduce the dose or discontinue Roaccutane. From the hematopoietic system: anemia, decreased hematocrit, leukopenia, neutropenia, increase or decrease in the number of platelets, acceleration of ESR. From the respiratory system: rarely - bronchospasm (more often in patients with a history of bronchial asthma). From the musculoskeletal system: muscle pain with or without increased serum CPK levels, joint pain, hyperostosis, arthritis, calcification of ligaments and tendons, other bone changes, tendinitis. Dermatological reactions: rash, itching, facial erythema/dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased proliferation of granulation tissue, persistent hair thinning, reversible hair loss, fulminant forms of acne, hirsutism, hyperpigmentation, photosensitivity, photoallergy, easy skin trauma. At the beginning of treatment, acne may worsen and persist for several weeks. Effects caused by hypervitaminosis A: dry skin, mucous membranes, incl. lips (cheilitis), nasal cavity (bleeding), hypopharynx (hoarseness), eyes (conjunctivitis, reversible corneal opacity and contact lens intolerance). Laboratory indicators: hypertriglyceridemia, hypercholesterolemia, hyperuricemia, decreased levels of high-density lipoproteins, rarely - hyperglycemia. Cases of newly diagnosed diabetes mellitus have been reported while taking Roaccutane. In some patients, especially those involved in intense physical activity, isolated cases of increased CK activity in the serum have been described. From the immune system: local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus). Other: lymphadenopathy, hematuria, proteinuria, vasculitis (Wegener's granulomatosis, allergic vasculitis), systemic hypersensitivity reactions, glomerulonephritis. Post-marketing surveillance During post-marketing surveillance with the use of Roaccutane, cases of the development of severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been described (see also section “Special instructions”).

Storage conditions

Store at a temperature not exceeding 25°C, protected from light and moisture. Keep out of the reach of children.

The use of systemic retinoids in a “low dose” mode in patients with moderate to severe forms of acne

Application of Systemic Retinoids In the mode of small doses in patients with moderate-severe form of acne

Acne is a chronic, recurrent disease of the sebaceous glands and hair follicles (2).
The disease is widespread in adolescence. Acne is less common in infants and adults. The main role in the genesis of acne is played by hereditary predisposition, which determines the number, size and increased sensitivity of sebaceous gland cell receptors to the male sex hormone testosterone and its metabolites (3, 5). The initial stage of acne development is the formation of retention hyperkeratosis at the mouth of the hair follicle. Hyperandrogenemia leads to hyperplasia and hypersecretion of the sebaceous glands. Hyperkeratosis and excessive sebum production lead to obstruction of the sebaceous gland duct and the formation of comedones (6, 7).

Under the created anaerobic conditions, Propionibacterium acnes multiplies. Despite the key importance of this microorganism, staphylococci are also involved in the development of the inflammatory process in the sebaceous glands. The growth of bacteria initiates the development of the inflammatory process, forming inflammatory elements of acne - papules, pustules, nodules or cysts. Recurrent ruptures of cysts with their subsequent re-epithelialization lead to the formation of epithelial tracts, which are often accompanied by disfiguring scars.

Severe forms of acne, as well as the tendency of the disease to recur, are usually genetically determined. In this regard, traditional therapy with antibiotics, topical agents, as well as various cosmetic treatments do not allow achieving a lasting therapeutic result. Often the use of topical agents (topically acting retinoids and antibiotics, azelaic acid, combination drugs) turns out to be very effective directly in the treatment of patients. However, frequent relapses of the disease during standard therapy not only contribute to the formation of post-acne, but also have an adverse psychological effect on adolescent patients, leading to the formation of dysmorphophobia, depression, and in some cases, suicidal thoughts.

Systemic retinoids are effective therapeutic agents for severe forms of acne, ineffectiveness of antibacterial drugs, and the formation of hypertrophic and keloid scars (4, 8, 9, 15).

In recent years, dermatovenerologists have begun to increasingly use drugs from this group in the treatment of acne patients. This is due to the accumulated experience of their use in real clinical practice in Russia, as well as the emerging confidence of specialists in the high safety of systemic retinoids with long-term use in people with severe forms of acne.

Of no small importance in the popularity of isotretinoin is its universal mechanism of action, which allows it to have a beneficial effect on all four components of acne pathogenesis. Isotretinoin is able to suppress sebum production by 80%; effectively reduce the phenomena of follicular hyperkeratosis and indirectly inhibit the growth of anaerobic bacteria, reducing inflammation of the sebaceous glands and hair follicles (10, 11).

Moreover, when using standard doses and dosage regimens, isotretinoin induces long-term remission of the disease or leads to permanent cure of patients (12, 13, 14).

At the same time, in 2010, the expert council of the Russian Society of Dermatovenerologists considered it appropriate to recommend to practitioners a new strategy for managing patients with moderate to severe forms of the disease using a “low-dose” isotretinoin regimen (1). First of all, this strategy is aimed at managing patients suffering from recurrent acne of moderate severity, who had a good therapeutic result from the use of topical agents, but the process resumed again after discontinuation of topical therapy.

Table 1.

Dynamics of main laboratory parameters in patients with acne who used the “small dose” regimen of Roaccutane (M±m)

Note: p - significance of differences between the group of people treated with Roaccutane and donors

In such cases, the initial dose of the drug should be calculated in the range of 0.1-0.15-0.3 mg/kg/day. in permanent (daily) or intermittent (every other day) regimens, or prescribed in a standard dose of 10 mg per day, regardless of body weight, followed by a stepwise reduction (after 1 month - up to 5 times a week; after another month - up to 3 times a week a week, after another month - up to 2 times a week; after another month - up to 1 time a week). The duration of treatment with isotretinoin according to the “low-dose” regimen should not on average exceed 3 to 6 months. From a practical point of view, an important advantage of this method of using isotretinoin is that there is no need to calculate the total course dose of the drug.

The purpose of our study was to study the effectiveness and safety of the use of isotretinoin (Roaccutane) in a “low dose” regimen in patients with recurrent acne of moderate severity.

Material and research methods

We observed 40 patients with acne aged 18 to 27 years (women - 25 (62.5%); men - 15 (37.5%). In all study participants, acne manifested itself at puberty.

The inclusion criteria for the study were: the presence of moderate to severe acne; good therapeutic effect from 2 or more courses of adequate topical therapy for the disease with subsequent relapses of acne; signing an informed consent to participate in the study.

Exclusion criteria were: a history of indications for therapy with systemic retinoids, antiandrogen drugs; the fact of use of systemic antibiotics or topical retinoids during the last 3 months; the presence of clinically significant changes in hematological and (or) biochemical blood tests; presence of mild or severe forms of acne; presence of pregnancy; the presence of chronic liver failure or Gilbert's syndrome.

Inflammatory efflorescences were predominantly recorded on the skin in the form of multiple papules and papulopustules of a bright pink color, small in size (up to 0.5 cm in diameter) with uneven outlines, slightly rising above the surface of the skin. In 8 (20%) cases, single nodes (cysts) were also visualized.

Against this background, all patients had severe seborrhea, as well as the presence of non-inflammatory forms of acne - open and closed comedones. Despite a long history of acne, the observed individuals did not have scars or other post-acne lesions on their skin.

In 32 (80%) of the observed patients with acne, skin lesions were limited to the facial area. In 8 (20%) cases, multiple papulopustular elements were also localized in the upper third of the chest and back.

All patients had previously received various types of therapy. 18 (45%) patients received systemic antibiotics more than 3 months before participating in the study. Topical retinoids had previously been used by 26 (65%) patients; azelaic acid preparations - 11 (27.5%) respectively; topical agents with antibacterial action - 35 (87.5%); combination drugs - 19 (47.5%). It is noteworthy that, according to the recommendations of specialists, all 40 patients previously observed used other various topical agents, which, from the point of view of evidence-based medicine, are ineffective for acne.

Facial skin care in 16 (40%) patients with acne was ineffective and consisted of repeated use throughout the day of various cleansing gels, scrubs, as well as alcohol-containing products, which contributed to additional irritation of the skin. On the contrary, 5 (12.5%) study participants did not carry out any hygienic care measures for oily or dry skin in seborrheic areas.

To assess the severity and extent of the disease, the Acne Dermatology Index (ADI) was used, which takes into account the number of comedones, papules, pustules, and nodules in the subject being examined.

All patients were prescribed isotretinoin (Roaccutane), Switzerland, at a standard dose of 10 mg/day for three months.

A study of the content of triglycerides, cholesterol, ALT, AST in the blood serum of observed individuals with acne was carried out before the start of treatment with isotretinoin (Roaccutane), and was also carried out during therapy with “small doses” of the drug once a month for three months. 40 healthy individuals were examined as a control group.

After completing a 3-month course of isotretinoin monotherapy, patients were prospectively monitored for 6 months.

Results and its discussion. In all patients, before treatment, the presence of many miliary and lenticular papules of a conical shape of a bright pink color, pustules with a tense cap, cloudy contents, single nodes of a purplish-bluish color, dense consistency, without signs of fluctuation, associated with an increase in the ADI index to 9, was detected. 7±0.5 (Fig. 1) on the back, chest and face.

By the 7th day from the start of therapy with isotretinoin (Roaccutane), 25 patients (62.5%) registered the development of a peculiar reaction of exacerbation of dermatosis, manifested by the appearance of fresh nodules and miliary pustules on the face and back. However, already on the 14th day of treatment, a clear decrease in the signs of seborrhea was recorded in all patients receiving isotretinoin (Roaccutane). After 3-4 weeks from the start of taking isotretinoin (Roaccutane), a pronounced positive dynamics was noted in the skin pathological process (papules flattened, faded, pustules shriveled into crusts, nodes decreased in size), which was accompanied by a statistically significant decrease in the value of the ADI index to 5. 1±0.1 (p<0.001). By the 2nd month of therapy with isotretinoin (Roaccutane), this indicator decreased to 3.1±0.1 (p<0.001), clinically reflecting the disappearance of comedones, a decrease in the number of papular nodes and the complete disappearance of pustular efflorescence. After 3 months from the start of treatment with isotretinoin (Roaccutane), the vast majority of patients had complete resolution of comedones, papules, and pustules, and the ADI index reached 0.6 ± 0.01 (p < 0.001) (Fig. 1).

Rice. 1. Dynamics of the ADI index in patients with acne who used the “low-dose” isotretinoin (Roaccutane) regimen.

Six months after the start of isotretinoin (Roaccutane) therapy, it was possible to prospectively assess the condition of the skin process in 38 patients (two patients dropped out of the observation group for personal reasons). Thus, in the 36 individuals we observed, there were no signs of seborrhea and acne; the value of the ADI index was zero. Only in two patients were single lenticular pale pink nodular efflorescences recorded on the back against the background of a complete absence of pustules, comedones, nodes and seborrhea (ADI index = 2.4 ± 0.1) (Fig. 1).

It was also found that isotretinoin (Roaccutane) was generally well tolerated by patients, and side effects were minimal in severity and spectrum. Thus, all patients (100%) developed cheilitis on the 7th–14th day of treatment. 18 patients (45%) had retinoid dermatitis of the face, and 22 patients (55%) had dry nasal mucosa. The above-mentioned side effects did not require discontinuation of isotretinoin (Roaccutane) and were easily and quickly relieved by the prescription of moisturizers, in particular the drug Clobeyz.

Upon re-examination, laboratory parameters in all patients (in particular AST, ALT, triglycerides) at the end of the three-month course of isotretinoin (Roaccutane) therapy were comparable to control values. In 2 patients, an increase in the concentration of cholesterol in the blood was noted, but no significant differences were obtained with the control group (p>0.05) (Table 1).

conclusions

1. The use of a mild dosing regimen of isotretinoin (Roaccutane) in patients with moderate to severe forms of acne is very appropriate.

2. The use of small doses of isotretinoin (Roaccutane) allows for rapid and lasting resolution of skin rashes, prevents relapses, minimizes the risk of side effects, and also does not require any additional therapy for both the main disease and side effects identified during treatment. effects.

A.L. Bakulev, S.S. Kravchenya

Saratov State Medical University named after V.I. Razumovsky

Bakulev Andrey Leonidovich - Doctor of Medical Sciences, Professor of the Department of Skin and Venereal Diseases

Literature:

1. Acne. Clinical recommendations of the Russian Society of Dermatovenerologists / ed. A.A. Kubanova. - M.: DEX-Press, 2010. - 28 p.

2. Samtsov A.V. Acne and acneiform dermatoses. - M., 2009. - P. 32-45.

3. Layton AM, Knaggs H, Taylor J et al. Isotretinoin for acne vulgaris - 10 years later: a safe and successful treatment. Br J Dermatol., 1993; 129: 292-296.

4. Goodfield MJ, Cox NH, Bowser A. Advice on the safe introduction and continued use of isotretinoin in acne in the UK 2010. Br J Dermatol., 2010 Jun; 162(6):1172-9.

5. Layton A. The use of isotretinoin in acne. Dermatoendocrinol., 2009, May; 1(3): 162-9.

6. Roodsari MR, Akbari MR, Sarrafirad N. et al. The effect of isotretinoin treatment on plasma homocysteine ​​levels in acne vulgaris. Clin Exp Dermatol. 2010 Aug; 35 (6): 624-6.

7. Li L., Tang L., Baranov E. et al. Selective induction of apoptosis in the hamster flank sebaceous gland organ by a topical liposome 5-alpha-reductase inhibitor: a treatment strategy for acne. J Dermatol., 2010 Feb; 37 (2): 156-62.

8. Sardana K., Garg VK Efficacy of low-dose isotretinoin in acne vulgaris. Indian J Dermatol Venereol Leprol., 2010 Jan-Feb; 76 (1): 7-13.

9. Ingram JR, Grindlay DJ, Williams HC Management of acne vulgaris: an evidence-based update. Clin Exp Dermatol., 2010, Jun; 35(4): 351-4.

10. Merritt B., Burkhart CN, Morrell DS Use of isotretinoin for acne vulgaris. Pediatr Ann., 2009, Jun; 38 (6): 311-20.

11. Bener A., ​​Lestringant GG, Ehlayel MS et al. Treatment outcome of acne vulgaris with oral isotretinoin. J Coll Physicians Surg Pak., 2009, Jan; 19 (1): 49-51.

12. Kontaxakis VP, Skourides D, Ferentinos P et al. Isotretinoin and psychopathology: a review. Ann Gen Psychiatry., 2009, Jan 20; 8:2.

13. Degitz K., Ochsendorf F. Pharmacotherapy of acne. Expert Opin Pharmacother, 2008, Apr; 9 (6): 955-71.

14. O'Reilly K., Bailey SJ, Lane MA Retinoid-mediated regulation of mood: possible cellular mechanisms. Exp Biol Med (Maywood), 2008, Mar; 233(3):251-8.

15. Berbis P. Systemic retinoids (acitretin, isotretinoin). Ann Dermatol Venereol., 2007, Dec; 134 (12): 935-41.