Roaccutane dosage per 50 kg of weight. Roaccutane for acne. Dosing in special cases

Acne is a chronic relapsing disease sebaceous glands And hair follicles(2). The disease is widespread in adolescence. Less often acne occurs in infants and adults. The main role in the genesis of acne is played by hereditary predisposition, which determines the amount, size and increased sensitivity receptors of sebaceous gland cells for the male sex hormone testosterone and its metabolites (3, 5).

The initial stage of acne development is the formation 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 excretory duct sebaceous gland and comedonal formation (6, 7).

Under the created anaerobic conditions, Propionibacterium acnes multiplies. Despite the key importance of this microorganism, staphylococci are also involved in the development inflammatory process in the area of ​​the sebaceous glands. The growth of bacteria initiates the development of the inflammatory process, forming inflammatory elements acne- papules, pustules, nodes 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 antibiotics, topical agents, as well as various cosmetic effects 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 against the background of standard therapy not only contribute to the formation of post-acne, but also have unfavorable psychological impact for patients adolescence, lead to the formation of dysmorphophobia, depression, and in some cases, suicidal thoughts.

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

IN last years Dermatovenereologists have begun to increasingly use drugs from this group in the treatment of acne patients. This is due to the accumulated experience of their application 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 phenomenon of follicular hyperkeratosis and indirectly inhibit growth 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 Russian society dermatovenerologists considered it appropriate to recommend practitioners new strategy management of patients with moderate to severe forms of the disease using a “low-dose” isotretinoin regimen (1). This strategy is primarily aimed at the management of patients suffering from recurrent acne. medium degree severity, in which a good therapeutic result was observed from the use of topical drugs, but the process resumed again after discontinuation topical therapy.

Table 1.

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

Laboratory indicatorDonorsPatients with acne before treatment (n=40)Patients with acne who received Roaccutane for 1 month (n=40)Patients with acne who received Roaccutane for 2 months (n=40)Patients with acne who received Roaccutane for 3 months (n=40)
Cholesterol, µmol/l3.7±0.15.0±0.75.1±0.75.3±1.25.2±2.7>0,05
Triglycerides, µmol/l1.7±0.011.8±0.021.9±0.021.8±0.41.9±0.8>0,05
AST, U/l32±0.534±0.935±0.935±0.735±0.8>0,05
ALT, U/l24±0.825±0.725±0.825±1.725±1.9>0,05

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 carrying out 2 or more courses of adequate topical therapy for the disease with subsequent relapses of acne; signing 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 analysis blood; presence of mild or severe forms of acne; presence of pregnancy; 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 different kinds 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 effect - 35 (87,5%); combination drugs- 19 (47.5%). It is noteworthy that, according to the recommendations of specialists, all 40 previously observed used other various topical agents, which, from the point of view evidence-based medicine are ineffective against 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 that contributed to additional irritation skin. On the contrary, 5 (12.5%) study participants did not carry out any activities at all hygienic care 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), manufactured by F. Hoffmann-La-Roche Ltd., 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), pronounced positive dynamics were 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 ADI index to 5.1±0.1 (p<0,001). Ко 2-му месяцу терапии изотретиноином (Роаккутаном) данный показатель снизился до 3,1±0,1 (р<0,001), клинически отражая исчезновение комедонов, уменьшение количества папулезных узлов и полное исчезновение пустулезных эффлоресценций. Через 3 месяца от начала лечения изотретиноином (Роаккутана) у подавляющего большинства пациентов полностью разрешились комедоны, папулы, пустулы, а величина индекса ADI достигла 0,6±0,01 (р<0,001) (рис. 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. In 18 patients (45%) the presence of retinoid dermatitis of the face was noted, in 22 patients (55%) - dryness of the 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

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

3. Layton A.M., 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 M.J., Cox N.H., Bowser A. Advice on the safe introduction and continued use of isotretinoin in acne in the U.K. 2010.Br J Dermatol., 2010 Jun; 162(6):1172-9.

6. Roodsari M.R., Akbari M.R., Sarrafi-rad 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 V.K. Efficacy of low-dose isotretinoin in acne vulgaris. Indian J Dermatol Venereol Leprol., 2010 Jan-Feb; 76 (1): 7-13.

9. Ingram J.R., Grindlay D.J., Williams H.C. Management of acne vulgaris: an evidence-based update. Clin Exp Dermatol., 2010, Jun; 35(4): 351-4.

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

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

12. Kontaxakis V.P., 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 S.J., Lane M.A. 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.

Instructions for use:

Acnekutan – a remedy for acne; inhibits the activity and proliferation of the sebaceous glands and helps reduce their size, suppressing bacterial colonization of the duct, restoring the normal process of cell differentiation, stimulating regeneration, and providing an anti-inflammatory effect on the skin.

Release form and composition

Dosage form - hard gelatin capsules: 8 mg - size No. 3, brown, 16 mg - size No. 1, green cap and white body; capsule contents – orange-yellow waxy paste (10 pcs in a blister, in a cardboard pack of 2, 3, 5, 6, 9 or 10 blisters; 14 pcs in a blister, in a cardboard pack of 1, 2, 4 or 7 blisters).

1 capsule of Acnecutan contains:

  • Active ingredient: isotretinoin – 8 or 16 mg;
  • Auxiliary components: purified soybean oil, Gelucir 50/13 (a mixture of stearic acid esters of glycerol and polyethylene oxide), Span 80 (sorbitan oleate - mixed esters of sorbitol and oleic acid);
  • Capsule body and cap: titanium dioxide (E171), gelatin; No. 3/No. 1 – red iron oxide dye (E172)/indigo carmine (E132), yellow iron oxide dye (E172).

Indications for use

  • Conglobate, nodular cystic and other severe forms of acne, including those with a risk of scarring;
  • Acne that does not respond to other treatment methods.

Contraindications

  • Hypervitaminosis A;
  • Severe form of hyperlipidemia;
  • Liver failure;
  • Concomitant use of tetracyclines;
  • Breastfeeding period;
  • Pregnancy is established or planned (high probability of embryotoxic and teratogenic effects);
  • Age up to 12 years;
  • Individual intolerance to the components of the drug.

The occurrence of pregnancy during the period of use or during the first month after completion of the course of therapy carries a potential threat of severe malformations in the newborn.

For women of childbearing age, Acnecutane therapy is allowed only in severe forms of acne that are not amenable to conventional treatment methods. In this case, the woman must:

  • Understand and unconditionally follow all the doctor’s instructions;
  • Obtain information from the doctor about the danger of pregnancy during therapy, for 1 month after it and the need for urgent consultation in case of suspected pregnancy;
  • Confirm understanding of the need for precautions and the degree of responsibility;
  • Receive information about possible ineffectiveness of contraceptives;
  • Understand the need and constantly use the most effective methods of contraception for 1 month before Acnecutane therapy, during treatment and for 1 month after its completion;
  • Use (if possible) two different methods of contraception at the same time, including barrier;
  • Receive a negative result from a reliable pregnancy test 11 days before taking the drug;
  • Conduct a pregnancy test monthly during treatment and 5 weeks after completion of therapy;
  • Start therapy only 2-3 days after the start of the normal menstrual cycle;
  • Recognize the need to visit a doctor every month;
  • Use the same effective methods of contraception when treating a relapse of the disease, for 1 month before therapy, during treatment and for 1 month after its completion, and undergo the same reliable pregnancy test;
  • Understand the need for precautions and confirm your understanding and desire to use reliable methods of protection recommended by your doctor.

Use of contraception according to the above recommendations during isotretinoin therapy is necessary even for women who do not usually use contraception due to amenorrhea, infertility (with the exception of patients who have undergone a hysterectomy), or who report that they are not sexually active.

Directions for use and dosage

Capsules are taken orally 1-2 times a day, preferably with meals.

The doctor prescribes the dose of the drug individually, taking into account the therapeutic effectiveness and the presence of side effects in the patient.

Recommended dosage: initial dose - at the rate of 0.4 mg per 1 kg of patient weight per day, if necessary, it is possible to prescribe 0.8 mg per 1 kg per day. For the treatment of acne of the trunk or severe forms of the disease, the dose may be 2 mg per 1 kg per day.

The optimal cumulative dose for a course of therapy is 100-120 mg per 1 kg of weight. It usually takes 4-6 months to achieve complete remission.

For patients with poor tolerance to Acnecutane, the recommended daily dose can be reduced by extending the period of therapy.

Acne usually disappears completely after one course of treatment.

In case of relapse, a second course can be prescribed no earlier than 2 months after the end of treatment, since symptoms of improvement may be somewhat delayed. The second course is carried out in the initial daily and cumulative dose.

In patients with severe chronic renal failure, the initial dose should be reduced to 8 mg per day.

Side effects

  • Digestive system: nausea, diarrhea, dry mouth, inflammation of the gums, bleeding from the gums, intestinal bleeding, inflammatory bowel pathologies (ileitis, colitis), pancreatitis, including fatal outcomes (more often with hypertriglyceridemia above 800 mg/dl); in some cases - hepatitis, a reversible transient increase in the activity of liver enzymes;
  • Dermatological reactions: during the first few weeks of use, acne may worsen; peeling of the skin of the soles and palms, itching, rash, dermatitis or erythema of the face, sweating, paronychia, pyogenic granuloma, onychodystrophy, persistent thinning of hair, increased proliferation of granulation tissue, reversible hair loss, hirsutism, fulminant forms of acne, photosensitivity, hyperpigmentation, easy skin trauma ;
  • Nervous system: headache, fatigue, increased intracranial pressure (pseudotumor cerebri: nausea, vomiting, headache, papilledema, blurred vision), seizures; rarely – psychosis, depression, suicidal thoughts;
  • Musculoskeletal system: joint pain, muscle pain (with or without increased serum creatine phosphokinase activity), arthritis, hyperostosis, tendinitis, calcification of tendons and ligaments;
  • Sense organs: photophobia, impaired visual acuity (isolated cases), xerophthalmia, impaired dark adaptation (decreased twilight visual acuity); rarely - transient disturbance of color vision (recovers on its own after withdrawal), optic neuritis, keratitis, lenticular cataract, conjunctivitis, blepharitis, eye irritation, papilledema (as a manifestation of intracranial hypertension), in patients with contact lenses - difficulty wearing, impaired hearing perception of certain sound frequencies;
  • Hematopoietic system: decreased hematocrit, anemia, leukopenia, neutropenia, changes in platelet count, acceleration of erythrocyte sedimentation rate;
  • Respiratory system: rarely - bronchospasm (more often with a history of bronchial asthma);
  • Laboratory indicators: hypercholesterolemia, hypertriglyceridemia, decreased levels of high-density lipoproteins, hyperuricemia; rarely – hyperglycemia; cases of newly diagnosed diabetes mellitus; more often during intense physical activity – increased activity of creatine phosphokinase in the serum; systemic or local infections caused by Staphylococcus aureus (gram-positive pathogens);
  • Other: proteinuria, hematuria, lymphadenopathy, vasculitis (including allergic etiology, Wegener's granulomatosis), glomerulonephritis, systemic hypersensitivity reactions.

Symptoms associated with hypervitaminosis A: dryness of the mucous membranes of the pharynx and larynx (hoarseness), lips (cheilitis), eyes (reversible clouding of the cornea, conjunctivitis, intolerance to contact lenses), nasal cavity (bleeding), skin.

Embryotoxic and teratogenic effects of Acnecutan: congenital deformities - hydrocephalus, microcephaly, microphthalmia, underdevelopment of cranial nerves, malformations of the parathyroid glands and cardiovascular system, disorders of skeletal formation (underdevelopment of the skull, digital phalanges, cervical vertebrae, ankles, femur, bones forearm, cleft palate, facial skull), underdevelopment and/or low location of the ears, complete absence or underdevelopment of the external auditory canal, hernia of the spinal cord and brain, fusion of the toes and hands, bone fusions, developmental disorders of the thymus gland, fetal death in perinatal period, miscarriage, premature birth, early closure of epiphyseal growth zones, in animal experiments - pheochromocytoma.

special instructions

Prescription of the drug to each patient should be carried out after a thorough preliminary assessment of the ratio of expected benefits and potential risks.

The drug is not indicated for the treatment of acne during puberty.

The use of Acnecutane requires regular monitoring of liver function and liver enzymes before treatment, after one month of therapy, and then every 3 months. If the level of liver transaminases exceeds the normal level, the dose of the drug should be reduced or discontinued.

In addition, before starting treatment, the patient should determine the level of lipids in the blood serum, then, after one month of use, and every 3 months or as indicated. Typically, lipid levels are normalized by reducing the dose, following a diet, or discontinuing the drug.

Since an increase in triglyceride levels above 9 mmol/l or 800 mg/dl can cause the development of acute pancreatitis, including death, the patient needs to monitor their content. In case of persistent hypertriglyceridemia or symptoms of pancreatitis, the drug should be discontinued.

Due to the risk of psychotic symptoms, depression, and suicide attempts, it is recommended to prescribe the drug with extreme caution if there is a history of depression and to monitor the appearance of symptoms of depression in all patients.

Acne exacerbation that occurs at the beginning of therapy goes away within 7-10 days without dose adjustment.

At the beginning of therapy, it is recommended to use moisturizing body cream or ointment and lip balm to reduce dry skin.

Since the effect of the drug can cause a decrease in the acuity of night vision (sometimes persisting even after the end of treatment), the doctor should inform the patient about the possibility of this condition and recommend that he be careful when driving a car at night. Dryness of the conjunctiva can cause the development of keratitis, therefore, to moisturize the mucous membrane of the eyes, it is recommended to use artificial tears, moisturizing eye ointments. If your visual acuity worsens, you should consult an ophthalmologist.

Ultraviolet therapy and exposure to direct sunlight should be avoided; it is recommended to use a cream with a high sun protection factor (15 SPF or more).

If inflammatory bowel disease occurs, you should consult a doctor. In case of severe hemorrhagic diarrhea, the drug should be stopped immediately.

Due to the risk of increased scarring, hypo- and hyperpigmentation, patients are contraindicated for laser treatment and deep chemical dermoabrasion both during the period of taking Acnecutane and for 5-6 months after the end of therapy.

There is a risk of epidermal detachment, dermatitis and scars when performing hair removal using wax applications. Procedures cannot be performed during therapy and for six months after discontinuation of the drug.

Severe allergic reactions are grounds for immediate discontinuation of the capsules.

Patients with obesity, diabetes mellitus, chronic alcoholism, and lipid metabolism disorders require more frequent laboratory monitoring of lipid and glucose levels.

Blood should not be collected from potential donors during isotretinoin therapy, or for 1 month after completion of treatment.

During the period of use of Acnecutane, patients must be careful when driving vehicles and working with complex mechanisms.

Drug interactions

Before simultaneous use of Acnecutane with other medications, you should consult your doctor to avoid the development of side effects.

Analogs

Analogs of Acnecutane are: Verocutan, Isotretinoin, Retasol, Roaccutane, Retin ointment, Sotret.

Terms and conditions of storage

Store in a dry place, protected from light, at temperatures up to 25 °C. Keep away from children.

Shelf life – 2 years.

Roaccutane is a potent internal acne treatment for severe acne only. It can be drunk only as prescribed by a dermatologist, strictly according to the indicated doses. Roaccutane for acne may be prescribed initially if other types of treatment have not helped, and the form of acne is extremely severe. The drug has a lot of side effects and only 50% are completely cured of acne when taking Roaccutane.

How Roaccutane treats acne

The principle of operation of Roaccutane has not been fully established, but doctors attribute this to the suppression of sebum production and a reduction in the size of comedones with the help of the main active substance isotretinoin. Isotretinoin has been proven to have antiseptic effects.

Isotretinoin also thins the stratum corneum of the epidermis to make it easier to penetrate deep into the affected area. Due to the fact that Roaccutane suppresses the secretion of sebum by reducing the sebaceous glands themselves, this reduces the migration of bacteria in the ducts. And due to the fact that the stratum corneum is thinned, sebum has a way out, which does not cause blockage of the pore and, as a result, a pimple.

Roaccutane for acne, we repeat once again, is prescribed only by a doctor and, preferably, a dermatologist. For mild and moderate forms of acne, you should not immediately start with Roaccutane. Its effectiveness is not always justified: the number of side effects exceeds the possibility of having a clean face. Only half of those treated for acne with Roaccutane completely got rid of them. The rest did not get relief at all or suffered an aggressive relapse after stopping the drug.

We will not prescribe doses here, because... Only a doctor can prescribe them specifically for your condition. But it is sold in pharmacies in dosages of 10 mg and 20 mg. On average, acne treatment with Roaccutane lasts from 4 to 6 months. Long-term use of the drug is not recommended. Your doctor should monitor you at all times during treatment. Often in the first days of treatment there is a sharp exacerbation of acne, and after stopping treatment the skin condition may not improve. Roaccutane is taken in capsule form with food. You must undergo a complete blood count and other tests prescribed by your doctor every month. If you notice any side effects, immediately tell your doctor.

Interaction of Roaccutane with other drugs and procedures

Roaccutane should not be combined with vitamin A; hypervitaminosis A may occur. It should not be used with tetracyclines and contraceptives containing progesterone.

Due to the thinning of the stratum corneum of the skin, you should not stay in the sun or use sunscreens with a high SPF level. During treatment and for 1 year after treatment, hair removal, surgical and cosmetic interventions, laser interventions, and dermabrasion are prohibited. This is associated with a high risk of scarring and age spots.

Pregnant and breastfeeding women should never treat acne with Roaccutane, because this directly affects the fetus. Before prescribing treatment, the doctor forces you to take a pregnancy test twice. During treatment with Roaccutane, you must strictly adhere to contraceptives, otherwise the child may not be born.

Side effects of Roaccutane

Roaccutane for acne has many terrifying side effects that have a chance of occurring when using the drug. They are described in detail in the instructions for the drug, and here we will describe the most common ones.

  • Bone pain, dry skin, mucous membranes, headache, fever, nausea, rash, itching, nosebleeds, intolerance to contact lenses - observed in most patients, because this is due to hypervitaminosis A.
  • swelling, numbness of the extremities, abdominal pain, insomnia and, conversely, excessive drowsiness, sensitivity to light, facial dermatitis, rash, sweating - in about 10%
  • aggressive or withdrawn behavior, depression, suicidal state, convulsions, intracranial pressure, internal bleeding, intestinal diseases and more.

There is another similar drug, Acnecutan. It appeared on the Russian market quite recently since 2010 and has fewer side effects, although it is also based on isotretinoin, but a smaller amount of isotretinoin passes through the blood, and the amount of active ingredients is the same as with Roaccutane. But we have a separate article about this drug.

How much does Roaccutane cost?

Roaccutane, in addition to all its dangerous side effects, also has a high price, depending on the dosage, from 1300 to 2900 rubles per pack of 30 capsules.

  • 10 mg each - about 1500 rubles
  • 20 mg each - about 2600 rubles

Roaccutane Reviews

I was in a very dangerous condition - my whole face was full of potholes and inflammations, nothing was helping: neither a cosmetologist, nor a dermatologist, nor vitamins, injections, blood transfusions, etc. The dermatologist prescribed Roaccutane and, lo and behold, a week later my face became even worse than before. I came to her in a rage, but she reassured me that many people react this way, first with aggravation, then easier. Dear capsules, 1 package was enough for me for a month. I was treated for half a year. My face has become noticeably better, it’s not as scary as before, but the acne hasn’t gone away completely, there are potholes, spots and inflammation too. Now I have a break in treatment, the dermatologist wants me to take the course again in 2 months and says that after the end of treatment there will either be a new relapse or it will improve.

The dermatologist suggested that I immediately start with Roaccutane. I studied the instructions and was shocked. After it, you can’t give birth for at least another 2 years and, sorry, but I’m not ready to sacrifice my health and my child for the sake of some illusory improvements. I refused treatment with Roaccutane, I’d rather just take vitamin A. By the way, when I became pregnant, my acne went away on its own and my acne wasn’t very bad, like in the photos.

Having struggled with decisions for a long time, I finally decided to take Roaccutane. There were a lot of abscesses all over the face, 2-3 popped up every day, a lot of them subcutaneous. External medications and antibiotics did not help. I started taking Roaccutane, in the first 2 weeks it got even worse, but then it calmed down and my face slowly began to clear up, BUT a terrible depression came almost to the end, my liver hurt badly and I constantly wanted to sleep. But I completed the entire course, persevered and now I walk around with a clean face and happy. Thank you everyone, Roaccutane saved me, although it made me feel its terrible power.

33 comments on Roaccutane for acne:

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Calculation of the dose of the drug Acnecutan®

Acnecutane is a systemic retinoid (active ingredient isotretinoin) used to treat acne. This drug is recommended for severe acne and for the treatment of moderate acne when other types of therapy are ineffective (resistant forms of acne).

Dosing of the drug

Treatment with the drug Acnecutan® can lead to clinical recovery of the patient and long-term remission of the disease, but the maximum therapeutic effect from treatment can be expected if the recommended daily and course doses of Acnecutan are observed.

Acnekutan® is produced using the patented Belgian Lidose technology, which allows you to reduce the daily and course doses of the drug, while fully maintaining therapeutic effectiveness, and potentially reducing the severity of side effects. Lidose technology also helps reduce the dependence of isotretinoin absorption on food intake.

It is not recommended to take breaks in treatment with the drug for more than a day due to the increased risk of relapse of the disease with an intermittent course of treatment with this drug. If for some reason the daily dose of Acnecutane cannot be prescribed in the recommended range, the duration of treatment should be proportionally increased to the course dose of the drug.

Acnecutane is used orally, preferably with meals, 1 or 2 times a day.

In most patients, acne symptoms completely disappear after a single course of treatment.

In case of relapse, it is possible to carry out a second course of treatment at the same daily and course dose. A second course is prescribed no earlier than 8 weeks after the first, since the improvement may be delayed.

The number of packages of Acnekutan corresponds to the course dose of isotretinoin 115–120 mg/kg.

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Prescription and treatment of prescription drugs should be carried out by specialists.

Aknekutan

Instructions for use:

Prices in online pharmacies:

Acnekutan – a remedy for acne; inhibits the activity and proliferation of the sebaceous glands and helps reduce their size, suppressing bacterial colonization of the duct, restoring the normal process of cell differentiation, stimulating regeneration, and providing an anti-inflammatory effect on the skin.

Release form and composition

Dosage form - hard gelatin capsules: 8 mg - size No. 3, brown, 16 mg - size No. 1, green cap and white body; capsule contents – orange-yellow waxy paste (10 pcs in a blister, in a cardboard pack of 2, 3, 5, 6, 9 or 10 blisters; 14 pcs in a blister, in a cardboard pack of 1, 2, 4 or 7 blisters).

1 capsule of Acnecutan contains:

  • Active ingredient: isotretinoin – 8 or 16 mg;
  • Auxiliary components: purified soybean oil, Gelucir 50/13 (a mixture of stearic acid esters of glycerol and polyethylene oxide), Span 80 (sorbitan oleate - mixed esters of sorbitol and oleic acid);
  • Capsule body and cap: titanium dioxide (E171), gelatin; No. 3/No. 1 – red iron oxide dye (E172)/indigo carmine (E132), yellow iron oxide dye (E172).

Indications for use

  • Conglobate, nodular cystic and other severe forms of acne, including those with a risk of scarring;
  • Acne that does not respond to other treatment methods.

Contraindications

  • Hypervitaminosis A;
  • Severe form of hyperlipidemia;
  • Liver failure;
  • Concomitant use of tetracyclines;
  • Breastfeeding period;
  • Pregnancy is established or planned (high probability of embryotoxic and teratogenic effects);
  • Age up to 12 years;
  • Individual intolerance to the components of the drug.

The occurrence of pregnancy during the period of use or during the first month after completion of the course of therapy carries a potential threat of severe malformations in the newborn.

For women of childbearing age, Acnecutane therapy is allowed only in severe forms of acne that are not amenable to conventional treatment methods. In this case, the woman must:

  • Understand and unconditionally follow all the doctor’s instructions;
  • Obtain information from the doctor about the danger of pregnancy during therapy, for 1 month after it and the need for urgent consultation in case of suspected pregnancy;
  • Confirm understanding of the need for precautions and the degree of responsibility;
  • Receive information about possible ineffectiveness of contraceptives;
  • Understand the need and constantly use the most effective methods of contraception for 1 month before Acnecutane therapy, during treatment and for 1 month after its completion;
  • Use (if possible) two different methods of contraception at the same time, including barrier;
  • Receive a negative result from a reliable pregnancy test 11 days before taking the drug;
  • Conduct a pregnancy test monthly during treatment and 5 weeks after completion of therapy;
  • Start therapy only 2-3 days after the start of the normal menstrual cycle;
  • Recognize the need to visit a doctor every month;
  • Use the same effective methods of contraception when treating a relapse of the disease, for 1 month before therapy, during treatment and for 1 month after its completion, and undergo the same reliable pregnancy test;
  • Understand the need for precautions and confirm your understanding and desire to use reliable methods of protection recommended by your doctor.

Use of contraception according to the above recommendations during isotretinoin therapy is necessary even for women who do not usually use contraception due to amenorrhea, infertility (with the exception of patients who have undergone a hysterectomy), or who report that they are not sexually active.

Directions for use and dosage

Capsules are taken orally 1-2 times a day, preferably with meals.

The doctor prescribes the dose of the drug individually, taking into account the therapeutic effectiveness and the presence of side effects in the patient.

Recommended dosage: initial dose - at the rate of 0.4 mg per 1 kg of patient weight per day, if necessary, it is possible to prescribe 0.8 mg per 1 kg per day. For the treatment of acne of the trunk or severe forms of the disease, the dose may be 2 mg per 1 kg per day.

The optimal cumulative dose for a course of therapy is mg per 1 kg of weight. It usually takes 4-6 months to achieve complete remission.

For patients with poor tolerance to Acnecutane, the recommended daily dose can be reduced by extending the period of therapy.

Acne usually disappears completely after one course of treatment.

In case of relapse, a second course can be prescribed no earlier than 2 months after the end of treatment, since symptoms of improvement may be somewhat delayed. The second course is carried out in the initial daily and cumulative dose.

In patients with severe chronic renal failure, the initial dose should be reduced to 8 mg per day.

Side effects

  • Digestive system: nausea, diarrhea, dry mouth, inflammation of the gums, bleeding from the gums, intestinal bleeding, inflammatory bowel pathologies (ileitis, colitis), pancreatitis, including fatal outcomes (more often with hypertriglyceridemia above 800 mg/dl); in some cases - hepatitis, a reversible transient increase in the activity of liver enzymes;
  • Dermatological reactions: during the first few weeks of use, acne may worsen; peeling of the skin of the soles and palms, itching, rash, dermatitis or erythema of the face, sweating, paronychia, pyogenic granuloma, onychodystrophy, persistent thinning of hair, increased proliferation of granulation tissue, reversible hair loss, hirsutism, fulminant forms of acne, photosensitivity, hyperpigmentation, easy skin trauma ;
  • Nervous system: headache, fatigue, increased intracranial pressure (pseudotumor cerebri: nausea, vomiting, headache, papilledema, blurred vision), seizures; rarely – psychosis, depression, suicidal thoughts;
  • Musculoskeletal system: joint pain, muscle pain (with or without increased serum creatine phosphokinase activity), arthritis, hyperostosis, tendinitis, calcification of tendons and ligaments;
  • Sense organs: photophobia, impaired visual acuity (isolated cases), xerophthalmia, impaired dark adaptation (decreased twilight visual acuity); rarely - transient disturbance of color vision (recovers on its own after withdrawal), optic neuritis, keratitis, lenticular cataract, conjunctivitis, blepharitis, eye irritation, papilledema (as a manifestation of intracranial hypertension), in patients with contact lenses - difficulty wearing, impaired hearing perception of certain sound frequencies;
  • Hematopoietic system: decreased hematocrit, anemia, leukopenia, neutropenia, changes in platelet count, acceleration of erythrocyte sedimentation rate;
  • Respiratory system: rarely - bronchospasm (more often with a history of bronchial asthma);
  • Laboratory indicators: hypercholesterolemia, hypertriglyceridemia, decreased levels of high-density lipoproteins, hyperuricemia; rarely – hyperglycemia; cases of newly diagnosed diabetes mellitus; more often during intense physical activity – increased activity of creatine phosphokinase in the serum; systemic or local infections caused by Staphylococcus aureus (gram-positive pathogens);
  • Other: proteinuria, hematuria, lymphadenopathy, vasculitis (including allergic etiology, Wegener's granulomatosis), glomerulonephritis, systemic hypersensitivity reactions.

Symptoms associated with hypervitaminosis A: dryness of the mucous membranes of the pharynx and larynx (hoarseness), lips (cheilitis), eyes (reversible clouding of the cornea, conjunctivitis, intolerance to contact lenses), nasal cavity (bleeding), skin.

Embryotoxic and teratogenic effects of Acnecutan: congenital deformities - hydrocephalus, microcephaly, microphthalmia, underdevelopment of cranial nerves, malformations of the parathyroid glands and cardiovascular system, disorders of skeletal formation (underdevelopment of the skull, digital phalanges, cervical vertebrae, ankles, femur, bones forearm, cleft palate, facial skull), underdevelopment and/or low location of the ears, complete absence or underdevelopment of the external auditory canal, hernia of the spinal cord and brain, fusion of the toes and hands, bone fusions, developmental disorders of the thymus gland, fetal death in perinatal period, miscarriage, premature birth, early closure of epiphyseal growth zones, in animal experiments - pheochromocytoma.

special instructions

Prescription of the drug to each patient should be carried out after a thorough preliminary assessment of the ratio of expected benefits and potential risks.

The drug is not indicated for the treatment of acne during puberty.

The use of Acnecutane requires regular monitoring of liver function and liver enzymes before treatment, after one month of therapy, and then every 3 months. If the level of liver transaminases exceeds the normal level, the dose of the drug should be reduced or discontinued.

In addition, before starting treatment, the patient should determine the level of lipids in the blood serum, then, after one month of use, and every 3 months or as indicated. Typically, lipid levels are normalized by reducing the dose, following a diet, or discontinuing the drug.

Since an increase in triglyceride levels above 9 mmol/l or 800 mg/dl can cause the development of acute pancreatitis, including death, the patient needs to monitor their content. In case of persistent hypertriglyceridemia or symptoms of pancreatitis, the drug should be discontinued.

Due to the risk of psychotic symptoms, depression, and suicide attempts, it is recommended to prescribe the drug with extreme caution if there is a history of depression and to monitor the appearance of symptoms of depression in all patients.

Acne exacerbation that occurs at the beginning of therapy goes away within 7-10 days without dose adjustment.

At the beginning of therapy, it is recommended to use moisturizing body cream or ointment and lip balm to reduce dry skin.

Since the effect of the drug can cause a decrease in the acuity of night vision (sometimes persisting even after the end of treatment), the doctor should inform the patient about the possibility of this condition and recommend that he be careful when driving a car at night. Dryness of the conjunctiva can cause the development of keratitis, therefore, to moisturize the mucous membrane of the eyes, it is recommended to use artificial tears, moisturizing eye ointments. If your visual acuity worsens, you should consult an ophthalmologist.

Ultraviolet therapy and exposure to direct sunlight should be avoided; it is recommended to use a cream with a high sun protection factor (15 SPF or more).

If inflammatory bowel disease occurs, you should consult a doctor. In case of severe hemorrhagic diarrhea, the drug should be stopped immediately.

Due to the risk of increased scarring, hypo- and hyperpigmentation, patients are contraindicated for laser treatment and deep chemical dermoabrasion both during the period of taking Acnecutane and for 5-6 months after the end of therapy.

There is a risk of epidermal detachment, dermatitis and scars when performing hair removal using wax applications. Procedures cannot be performed during therapy and for six months after discontinuation of the drug.

Severe allergic reactions are grounds for immediate discontinuation of the capsules.

Patients with obesity, diabetes mellitus, chronic alcoholism, and lipid metabolism disorders require more frequent laboratory monitoring of lipid and glucose levels.

Blood should not be collected from potential donors during isotretinoin therapy, or for 1 month after completion of treatment.

During the period of use of Acnecutane, patients must be careful when driving vehicles and working with complex mechanisms.

Drug interactions

Before simultaneous use of Acnecutane with other medications, you should consult your doctor to avoid the development of side effects.

Analogs

Analogs of Acnecutane are: Verocutan, Isotretinoin, Retasol, Roaccutane, Retin ointment, Sotret.

Terms and conditions of storage

Store in a dry place, protected from light, at temperatures up to 25 °C. Keep away from children.

Shelf life – 2 years.

Conditions for dispensing from pharmacies

Dispensed by prescription.

Acnecutane capsules 8 mg 30 pcs.

Acnecutane capsules 8 mg 30 pcs.

Acnecutane caps. 8mg n30

Acnecutane 8 mg N30 caps

Acnecutane capsules 16 mg 30 pcs.

Acnecutane caps. 16mg n30

Acnecutane capsules 16 mg 30 pcs.

Information about the drug is generalized, provided for informational purposes and does not replace official instructions. Self-medication is dangerous to health!

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Acnekutan: instructions for use of capsules

Active ingredient: Isotretinoin

Manufacturer: SMB Technology SA (Belgium)

Dispensed from the pharmacy: By prescription

The drug Acnekutan is developed for the treatment of various severe forms of acne that cannot be cured by other means.

Composition and dosage forms

The drug is presented in two dosages: with 8 and 16 mg of isotretinoin in one pill. The compositions of the auxiliary components are identical, they differ only in quantity: in Acnekutan 16 mg pills the content of components is twice as large.

Components of the 8 mg capsule

  • Auxiliary ingredients: Gelucir 50/13, Span-80, soybean oil
  • Body and lid: gelatin, E172 (red), E171.

Capsules – brown, gelatin. The filling is a yellow-orange pasty mass. The pills are packaged in blisters of 10 and 14 pieces. In cardboard packaging - 2, 3, 5, 6, 9, 10 plates of 10 capsules or 1, 2, 4, 7 blisters of 14 capsules, instructions for use.

Components of the 16 mg capsule

  • Excipients: Gelucir 50/13, Span-80, soybean oil
  • Body: gelatin E171, cover: – gelatin, E171, E172 (yellow), E132 (indigo + carmine).

The capsules are hard, with a white body and a green cap. The filling of the pills is a yellow-orange pasty mass. Capsules are packaged in 10 or 14 pieces in blisters. In a cardboard pack: 2/3/5/6/9/10 plates of 10 capsules or 1/2/4/7 blisters of 14 capsules, instructions for use.

Medicinal properties

The purpose of the drug is the treatment of acne, for which it contains isotretinoin. The substance is one of the forms of vitamin A, or more precisely, carboxylic acid, or all-trans retinoic acid. It is a first-generation retinoid, actively used in the treatment of acne and keratosis pilaris.

Researchers have not yet thoroughly studied the mechanism of action of this compound, but suggest that the therapeutic effect is achieved due to the ability to suppress excessive activity of the sebaceous glands and reduce their size. Since sebum produced by the endocrine glands is a breeding ground for the growth of the population of pathogens, reducing its production minimizes bacterial colonies.

Acnecutane restores normal cell formation, activates tissue regeneration and processes occurring in the skin, suppresses inflammation in the layers of the dermis and sebaceous ducts.

The drug has high bioavailability, which increases when taken with food. Excreted from the body with urine and bile. The production of the endogenous substance is restored, on average, two weeks after discontinuation of Acnecutane.

The drug is prohibited for patients with liver dysfunction, since it is not yet known exactly how it affects the organ.

Mode of application

Average cost: (30 pcs.) – 1304 rubles.

Acnekutan capsules, according to the instructions for use, should be taken during meals - once or twice a day. The remaining nuances - dosage, how to take the drug, duration of the course - are determined only by the attending doctor.

The therapeutic effect of the drug and its side effects vary depending on the dosage, the severity of acne and differ for each patient. Therefore, the specifics of therapy and drug calculation are always determined individually.

The dose of the drug used should be calculated by the doctor in accordance with the patient’s weight and the severity of acne. The lowest daily dosage, which is prescribed at the beginning of therapy and for mild acne, is 0.4 mg per 1 kg of body weight. In some patients it can be doubled - 0.8 mg/kg. Therapy of severe forms of skin pathology is treated with a dosage of up to 2 mg/kg.

Complete cure is achieved, on average, after a course of weeks. If the patient has difficulty accepting treatment with Acnecutane, then a different regimen is used: the dosage is reduced and at the same time the duration of therapy is increased.

Due to the strong effect of the drug, for most patients it is enough to take one course of Acnecutane to completely recover from skin pathology.

If the pathology returns, repeated treatment with the drug in the same dosage is allowed. It is recommended to repeat the course 2 months after the previous one, since a delayed therapeutic effect of Acnekutan is possible.

If the functioning of the organ is insufficient, the dosage of the drug is reduced to 8 mg per day in several doses.

It is forbidden to use Acnekutan for acne while pregnant and planning pregnancy, since the active substance of the drug has a strong teratogenic effect. If, despite all precautions, a woman becomes pregnant during therapy or immediately after its completion, then there is a very high probability that the child will be born with severe pathologies and developmental anomalies.

Due to the powerful teratogenic effect of isotrerioin, drugs containing it should not be taken not only by pregnant women, but also by women planning motherhood. After all, even small doses of a substance can have a toxic effect on the intrauterine development of a child. For this reason, the drug is prescribed to all women of reproductive age with great precautions and reservations. If Acnecutane cannot be replaced with other medications, then the doctor can prescribe it only if the patient meets a number of requirements:

  • Diagnosed with severe acne, the disease is not amenable to other methods of therapy.
  • The patient understands the peculiarities of the drug, its effect and possible consequences. Obliges to strictly follow the doctor's instructions.
  • Aware of the danger of conception during a course of Acnecutane, aware of the need for protection during the period of treatment and for a month after its completion. If you suspect pregnancy, contact your doctor immediately.
  • The patient is warned that contraceptives may be ineffective, understands the teratogenic effect of the drug, knows how to combine contraceptives, which of them are most effective.
  • 11 days before starting to take the capsules, I verified that I was not pregnant using a test. During treatment and a month after its completion, its presence/absence will be checked weekly.
  • Knows that taking drugs can be started only on the 2-3rd day of the MC.
  • Understands the need for monthly examination by a specialist.
  • If the disease returns, she will use the same contraceptives that were used before the course, during and after it for a month, and regularly take a pregnancy test.
  • The patient should be fully aware of all the consequences of non-compliance with contraceptive measures and follow medical instructions.

Average cost: (30 pcs.) – 2279 rub.

In addition, such precautions should be taken not only by fertile patients, but also by those who do not usually use contraception due to infertility (except for women with a hysterectomy), amenorrhea, or those patients who do not have sexual intercourse.

When prescribing medications for acne, the doctor must make sure that:

  • The patient has a severe stage of acne that cannot be cured by other methods of therapy.
  • There is a confirmed negative pregnancy test before the start of the course, during it and within a month after its completion. All results must be documented and attached to the medical history.
  • The patient is aware of the need for contraception and uses two reliable contraceptives during treatment and for a month after discontinuation of therapy.
  • A woman taking Acnekutan is aware of the increased requirements to prevent pregnancy and follows them.
  • The patient meets all treatment conditions.

Taking a pregnancy test

The test can be carried out at the lowest sensitivity (25 mIU per 1 ml) for three days from the start of MC:

To exclude the possibility of pregnancy before treatment with Acnecutane, a pregnancy test must be done in advance. A negative result is documented and, together with the date of the analysis, is entered in the Aknekutan diary. For patients with irregular MC, the timing of the test should be adjusted according to sexual activity and carried out within 3 weeks after unprotected sexual intercourse.

A pregnancy test is carried out on the day of examination and appointment of Acnecutane or three days before visiting the doctor. All test data must be recorded by the doctor and entered into the medical history. The drug can be prescribed exclusively to those patients who have used reliable contraceptives for at least a month before the start of the Acnecutane course.

Women taking Acnecutane must see a doctor once every 28 days. The need for monthly pregnancy testing is determined by sexual activity and the presence/absence of MC disorder. A pregnancy test is carried out on the day of examination by the doctor or three days before the visit to him. Its results must be recorded in Aknekutan’s diary.

A pregnancy test is performed 5 weeks after the end of therapy. Prescribing Acnekutan, a prescription for the drug is written out to a patient of reproductive age for only one month; a repeat course requires a new permit to purchase drugs and conduct a test.

If, despite all the measures taken, conception still occurs (during treatment and after completing the course for a month), then the medicine is immediately canceled. The advisability of continuing pregnancy should be discussed with a specialist in teratogenic substances, since there is a high chance of developing pathologies and malformations in the child.

Acnekutan is not prescribed to nursing women due to the fact that it can be excreted into milk.

Contraindications and precautions

The acne remedy should not be used for therapy if:

  • Pregnancy (confirmed, suspected or planned)
  • Lactation
  • Intolerance or high level of sensitivity to components (especially for people with soy intolerance)
  • Liver failure
  • Hypervitaminosis group A
  • High hyperlipidemia
  • Treatment with tetracycline antibiotics
  • Up to 12 years of age.

Relative contraindications (prescription is possible, but with great precautions) are:

  • Diabetes
  • History of depression
  • Overweight, obesity
  • Lipid metabolism disorder
  • Alcoholism.

If Acnekutan is prescribed to patients in this risk group, the course of therapy should be monitored by physicians.

Interaction with other drugs

Treatment with Acnecutane should be carried out taking into account possible negative reactions when combined with other drugs:

  • Antibiotic drugs of the tetracycline group reduce the effect of isotretinoin.
  • Due to the ability of tetracyclines to increase ICP, they should not be combined with an acne medication.
  • Combining Acnecutane with drugs that increase the photosensitivity of the skin increases the risk of sunburn.
  • Combination with medications containing any form of retinol contributes to the occurrence of hypervitaminosis A.
  • Isotretinoin has the ability to reduce the effect of progesterone-containing contraceptives, therefore, during the Acnecutane course, you must use reliable means of contraception (preferably two) and replace oral contraceptives with a small content of the hormone with more concentrated ones.
  • While taking Acnecutane, you should refrain from using medicinal or cosmetic products with a keratolytic effect to avoid severe local irritation or skin damage.

Side effects

The intensity of undesirable symptoms is dose-dependent. Typically, the adverse effects of taking Acnecutane decrease when the dosage is reduced or the drug is discontinued, but in some patients they may persist even after cessation of therapy.

Side effects of Acnekutan caused by hypervitaminosis A manifest themselves in the form of various disturbances in the normal functioning of various organs:

  • Skin: dry dermis and mucous tissues (including lips), nosebleeds, hoarseness/hoarseness of voice, conjunctivitis, allergies to contact lenses, temporary clouding of the cornea. Also observed: peeling of the palms, plantar surfaces, rashes, itching, hyperhidrosis, erythema/dermatitis of the face, periungual panaritium, dystrophy of the nail plates, hair loss (reversible), male pattern hair growth, hyperpigmentation, sensitivity to light and UV radiation, increased trauma skin. At the beginning of the course of therapy, there is an exacerbation of acne, which can persist for several weeks.
  • Locomotor system: muscle and joint pain, arthritis, hyperostosis, tendonitis.
  • Central nervous system, psyche: fatigue, increased high-frequency pressure, headaches, nausea, blurred vision, convulsions, depression, suicidal tendencies.
  • Visual organs: xerophthalmia, decreased visual acuity, photosensitivity, exacerbation of twilight vision, keratitis, conjunctivitis, distorted color perception, swelling of the optic nerve, sensitivity to contact lenses.
  • Gastrointestinal tract: dry mouth, bleeding and inflammation of the gums, pancreatitis (the death of the patient is not excluded).
  • Respiratory system: bronchospasm (mainly in people with a history of asthma).
  • Hematopoietic system: anemia, increased or decreased platelet levels, leukopenia.
  • Immunity: infections caused by staphylococci.
  • Other disorders: individual allergies, vasculitis, lymphadenopathy, proteinuria.

Overdose

The vitamin A derivative has low toxicity, but despite this, accidental or intentional intake of overdoses of Acnecutane can cause hypervitaminosis A. Symptoms manifest themselves in the form of headaches, nausea and vomiting, sleep disturbances, drowsiness, increased irritability, itching. In mild forms of overdose, the symptoms go away on their own, without the need for therapy. But in some cases, the victim may need gastric lavage.

special instructions

During Acnecutane therapy, the condition of the liver should be systematically checked: an analysis of the functioning of the organ and its enzymes is carried out a month before the start of treatment, 30 days after the first dose and then every three months or as necessary.

During therapy, a temporary and reversible increase in the level of intracellular liver compounds is possible. If their content is higher than normal levels, then the dosage of the drug is reduced or the drug is completely discontinued.

Lipid levels are checked 1 month before the start of the course, 1 month after the first dose, then every 3 months or as needed, depending on the indications. As a rule, the quality of lipid metabolism improves after reducing the dosage of Acnecutane, its discontinuation or nutritional correction.

Triglyceride levels should also be kept under control, since if they exceed normal levels, the risk of acute pancreatitis, which can be fatal, increases.

If during treatment hypertriglyceridemia that cannot be corrected develops or signs of pancreatitis appear, then therapy should be discontinued.

Depression and suicidal tendencies during a course of Acnecutane are quite rare, and their connection with the drug is considered unproven. However, if there is a history of such conditions, the patient should be under the supervision of doctors so that if signs of mental abnormalities appear, they can be promptly referred to a specialist. It should also be taken into account that discontinuation of the drug may not affect the elimination of depression or thoughts of suicide, but may continue after treatment. Therefore, such patients should be observed by specialists for some time, and, if necessary, undergo appropriate therapy.

Exacerbation of acne at the beginning of a course of Acnecutane, although rare, does happen. Usually it goes away on its own as the course continues. No dosage reduction is required.

When prescribing Acnecutane, the doctor must study and correctly assess the benefit/harm ratio for each individual patient.

The use of Acnecutane can cause increased dryness of the dermis and its peeling, therefore, to normalize the condition of the skin and mucous tissues, the use of moisturizers is necessary.

The drug can contribute to the occurrence of painful syndrome in muscles and joints, accompanied by a decrease in physical endurance.

During the course of Acnecutane and for six months after its completion, it is extremely undesirable to use aggressive methods of influencing the skin (chemical or laser peeling), since there is a high probability of scarring, hypo- or hyperpigmentation. You should also refrain from depilation with wax for six months, so as not to provoke dermal detachment, scars and pigmentation disorders.

The drug can cause deterioration in visual acuity in the evening and at night during the course and persist for some time after drug withdrawal, increased sensitivity to contact lenses. In case of dryness of the mucous tissues of the eye, it is recommended to use moisturizing ophthalmic drugs, artificial tears preparations. You will also need supervision from a specialist to prevent the development of keratitis. If vision deteriorates, the question of discontinuing Acnekutan is raised.

Due to increased photosensitivity of the skin, the time spent in the sun should be reduced, and the dosage of UV therapy should be suspended or reduced. To protect the skin from unwanted exposure to light, it is recommended to apply creams with a high degree of protection before going out.

Combining Acnecutane and alcohol is extremely undesirable, so as not to increase the load on the liver and provoke unpredictable reactions.

If benign ICH, intestinal inflammation, or anaphylaxis are suspected, the drug should be discontinued immediately.

Diabetics, obese or alcohol dependent people need to check their glucose and lipid levels more often.

Patients undergoing treatment with Acnecutane and for a month after its completion are prohibited from donating blood as donors in order to exclude the possibility of transfusion to pregnant women and subsequent teratogenic effects on the fetus.

During the Acnecutane course, care should be taken when operating complex mechanisms or vehicles.

Analogs

For the treatment of severe forms of acne, there are other drugs based on isotretionine. To select analogues for Acnekutan capsules, the patient should contact a treating specialist. Retasol, Roaccutane, Dermoretin and Sotret have a similar effect.

Will erase

Average cost: 10 mg (10 caps.) – 1126 rubles, 20 mg (30 caps.) – 1948 rubles.

Isotretinoin-based drugs are used to treat severe forms of acne. It is also produced in two types of capsules with different concentrations of the active ingredient. When choosing Sotret or Acncutane, which is better for therapy, you must take into account that the first product contains more active substance - 10 and 20 mg in one capsule. Therefore it is more powerful.

The application regimen is identical, the dose is calculated in accordance with the patient’s indications.

  • Good result
  • More affordable price compared to other drugs
  • Minor difference in composition.

Acnecutane how to calculate the dose

dermatovenerologist Agapov S.A.

Consult your doctor

Welcome to my website. Here you can find out the time,

schedule, procedure and conditions for an appointment with a dermatologist - venereologist in Rostov-on-Don, the cost of medical services of a dermatovenerologist for the diagnosis and treatment of skin diseases and sexually transmitted diseases, as well as my answers to frequently asked questions about sexually transmitted infections and skin diseases.

Sincerely, Agapov Sergey Anatolyevich

dermatologist - venereologist

  • 34 years of work experience
  • Doctor's degree with honors
  • Specialist Certificate
  • Medical category
  • License from the Ministry of Health
  • Anonymous reception and treatment
  • Every day, including weekends
  • No queues
  • Transport stop and parking
  • Low prices
  • Medical organization: Individual entrepreneur Agapov S.A.
  • Address of the place of medical activities: Rostov-on-Don, Lenin Ave., 251
  • Certificate OGR No. 000092, series 61 No., issued by the Inspectorate of the Federal Tax Service of Russia for the Voroshilovsky district of Rostov-on-Don on September 13, 2005.
  • License for the right to carry out medical activities in the specialty of dermatovenerology No. LO919 dated January 21, 2016, issued by the Ministry of Health of the Russian Federation (344029, Rostov-on-Don, 1st Cavalry Army St., 33, tel.)
  • Diploma with honors in the specialty of general medicine ZhV No. issued on June 22, 1983.
  • Internship for medical staff in the specialty of dermatovenerology. Certificate No. 58 dated March 18, 1986.
  • Certificate of specialist in the specialty of dermatovenerology No. 4288/15 issued on November 25, 2015.
  • First medical category in the specialty of dermatovenerology. Certificate No. 945, issued by the Ministry of Health of the Rostov region on October 21, 2010.
  • Monday, Thursday 07.00 - 9.00
  • Tuesday, Wednesday, Friday 07.00-11.30
  • Saturday-Sunday 10..00
  • email:
  • Ministry of Health of the Rostov Region, Rostov-on-Don, st. 1 Cavalry Army, 33. tel..
  • Office of Rospotrebnadzor for the RO, Rostov-on-Don, st. 18 line, 17, tel.
  • Office of Roszdravnadzor for the RO, Rostov-on-Don, st. Chentsova, 71/63 b, tel.
  • Diagnosis and treatment of skin diseases and sexually transmitted infections from the perspective of evidence-based medicine
  • Application of modern domestic and foreign standards of medical care and clinical recommendations
  • No unnecessary tests, procedures or medications
  • Economical, fast and effective treatment of skin diseases and sexually transmitted diseases

Official website of dermatologist-venerologist Sergey Anatolyevich Agapov

Reception: Rostov-on-Don, Lenin Ave., 251

Dosage form

Capsules 8 mg and 16 mg

Compound

One capsule contains

active substance - isotretinoin 8.00 mg or 16.00 mg,

excipients: stearoyl macrogolglycerides, purified soybean oil, sorbitol oleate,

composition of gelatin capsules No. 3 (lid and body): gelatin, red iron oxide (E 172), titanium dioxide (E 171),

composition of gelatin capsules No. 1:

cap: gelatin, iron oxide yellow (E 172), indigo carmine (E 132), titanium dioxide (E 171), titanium dioxide (E 171),

body: gelatin, titanium dioxide (E 171).

Description

Gelatin capsules No. 3, with an orange cap and body (for a dosage of 8 mg).

Gelatin capsules No. 1, with a green cap and a white body (for a dosage of 16 mg).

The contents of the capsules are an orange waxy paste.

Pharmacotherapeutic group

Preparations for the treatment of acne.

Retinoids for systemic treatment of acne. Isotretinoin.

ATX code D10BA01

Pharmacological properties

Pharmacokinetics

Suction

After oral administration, absorption is variable, the bioavailability of isotretinoin is low and variable - due to the proportion of dissolved isotretinoin in the drug and may also increase when taking the drug with food.

In patients with acne, maximum plasma concentrations (Cmax) at steady state after taking 80 mg of isotretinoin on an empty stomach were 310 ng/ml (range 188 - 473 ng/ml) and were achieved after 2-3 hours. The concentration of isotretinoin in plasma is 1.7 times higher than in the blood due to poor penetration into red blood cells.

Distribution
Isotretinoin is almost completely (99.9%) bound to plasma proteins, mainly albumin.

Equilibrium concentrations of isotretinoin in the blood 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. The concentration of isotretinoin in the epidermis is two times lower than in serum.

Metabolism
Isotretinoin is metabolized to form three main metabolites in the plasma: 4-oxo-isotretinoin, tretinoin (all-trans-retinoic acid) and 4-oxo-retinoin, as well as less significant metabolites, which also include glucuronides. The main metabolite is 4-oxo-isotretinoin, its plasma level at steady state is 2.5 times higher than the concentration of the parent drug. Several enzymes of the cytochrome system are involved in the conversion of isotretinoin to 4-oxo-isotretinoin and tretinoin: CYP2C8, CYP2C9, CYP2B6 and, probably, CYP3A4, as well as CYP2A6 and CYP2E1. However, none of the isoforms appears to play a dominant role.

Isotretinoin metabolites have high biological activity. The clinical effects of the drug in patients may be the result of the pharmacological activity of isotretinoin and its metabolites. The enterohepatic circulation may play a significant role in the pharmacokinetics of isotretinoin in humans.

Removal

The terminal phase half-life for unchanged isotretinoin in patients with acne averages 19 hours. The terminal phase half-life of 4-oxo-isotretinoin is longer, averaging 29 hours.

Isotretinoin is excreted by the kidneys and bile in approximately equal amounts.

Isotretinoin is a natural (physiological) retinoid. Endogenous concentrations of retinoids are restored approximately 2 weeks after stopping Acnecutane.
Pharmacokinetics in special cases

Since data on the pharmacokinetics of the drug in patients with impaired liver function are limited, isotretinoin is contraindicated in this group of patients.

Mild to moderate renal impairment does not affect the pharmacokinetics of isotretinoin.

Pharmacodynamics

Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin).

The exact mechanism of action of isotretinoin has not yet been identified, 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. Sebum is the main substrate for the growth of Propionibacterium acnes, so reducing sebum production inhibits bacterial colonization in the duct.

The anti-inflammatory effect of isotretinoin on the skin has been proven.

Directions for use and doses

Acnecutane should only be prescribed by a physician or used under the supervision of a physician experienced in the use of systemic retinoids to treat severe forms of acne and who understands the risks of Acnecutane therapy and the necessary monitoring of their use.

The therapeutic effectiveness of Acnecutane and its side effects depend on the dose and vary among different patients. Therefore, it is important to individually select doses during treatment.

Capsules are taken with meals, once or twice a day.

The initial dose of Acnekutan is 0.4 mg/kg per day, in some cases up to 0.8 mg/kg body weight per day.

The optimal course cumulative dose is 100-120 mg/kg. Complete remission of acne can often be achieved within 16-24 weeks of treatment.

If the recommended dose is poorly tolerated, treatment can be continued at a lower daily dose, but for a longer period. Increasing the duration of treatment may increase the risk of relapse. To ensure maximum possible effectiveness in such patients, treatment should be continued at the maximum tolerated dose for the usual duration.

In most patients, acne completely disappears after a single course of treatment.

In case of obvious relapse, a second course of treatment is indicated in the same daily and cumulative dose of Acnecutane as the first. Since improvement may be delayed, up to 8 weeks after discontinuation of the drug, a repeat course should be prescribed no earlier than after the end of this period.

Dosing in special cases

In patients with severe renal impairment, treatment should be started at a low dose (eg, 8 mg/day). The dose should then be increased to 0.8 mg/kg/day or the maximum tolerated dose.

No studies have been conducted in persons under 18 years of age, so a dosage regimen for this group has not been established.

Side effects

Very common (≥ 1/10)

Anemia, increased erythrocyte sedimentation rate, thrombocytopenia, thrombocytosis

Blepharitis, conjunctivitis, dry eye mucosa, eye irritation

Increased transaminases

Cheilitis, dermatitis, dry skin, peeling of the skin of the palms and soles, itching,

erythematous rash, easy skin traumatization (risk of trauma)

Arthralgia, myalgia, back pain

Hypertriglyceridemia, decreased high-density lipoprotein

Often (≥ 1/100,< 1/10)

Neutropenia

Headache

Nosebleeds, dry nasal mucosa, nasopharyngitis

Alopecia

Hypercholesterolemia, hyperglycemia, hematuria, proteinuria

Rarely (≥ 1/10,000,< 1/1 000)

Allergic skin reactions, anaphylactic reactions, hypersensitivity

Depression, worsening depression, tendencies towards aggression, anxiety, mood lability

Very rare (≤ 1/10,000)

Infections caused by gram-positive pathogens

Lymphadenopathy

Diabetes mellitus, hyperuricemia

Conduct disorder, psychosis, suicidal ideation, suicide attempts, suicide

Drowsiness, increased intracranial pressure, convulsions

Impaired visual acuity, cataracts, impaired color vision (which resolves after discontinuation of the drug), intolerance to contact lenses, corneal opacities, impaired dark adaptation (decreased twilight visual acuity), keratitis, optic neuritis (as a sign of intracranial hypertension), photophobia

Impaired hearing acuity

Vasculitis (Wegener's granulomatosis, allergic vasculitis)

Bronchospasm (especially in patients with asthma), hoarseness

Colitis, ileitis, dry throat, gastrointestinal bleeding, hemorrhagic diarrhea and inflammatory diseases of the gastrointestinal tract, nausea, pancreatitis

Hepatitis

Acne fulminans, exacerbation of acne, erythema (facial), exanthema, hair diseases, hirsutism, nail dystrophy, paronychia, photosensitivity, pyogenic granuloma, skin hyperpigmentation, sweating

Arthritis, calcification (calcification of ligaments and tendons), premature closure of the epiphyseal growth plate, exostosis (hyperostosis), decreased bone density, tendonitis

Glomerulonephritis

Increased granulomatous tissue, malaise

Increased blood creatine phosphokinase

Frequency unknown

Rhabdomyolysis

Contraindications

Hypersensitivity to isotretinoin or auxiliary components of the drug, including soybean oil. The drug is contraindicated in patients with soy allergies.

Concomitant therapy with tetracyclines

Liver failure

Hypervitaminosis A

Hyperlipidemia

Children and teenagers up to 18 years of age

Pregnancy, lactation period

Women of childbearing age, unless all conditions of the Pregnancy Prevention Program are met

Carefully

Diabetes

History of depression

Obesity

Lipid metabolism disorder

Alcoholism

Drug interactions

Due to a possible increase in the symptoms of hypervitaminosis A, the simultaneous administration of Acnecutane and drugs containing vitamin A should be avoided.

Simultaneous use with other retinoids, incl. acitretin, tretinoin, retinol, tazarotene, adapalene, also increases the risk of hypervitaminosis A.

Since tetracyclines reduce effectiveness and can also cause increased intracranial pressure, their use in combination with Acnecutane is contraindicated.

Acnecutane may weaken the effectiveness of progesterone preparations, so you should not use contraceptives containing small doses of progesterone.

Concomitant use with drugs that increase photosensitivity (including sulfonamides, thiazide diuretics) increases the risk of sunburn. Combined use with topical keratolytic drugs for the treatment of acne is not recommended due to the possible increase in local irritation.

special instructions

Acnecutane should only be prescribed by physicians, preferably dermatologists, who have experience in the use of systemic retinoids and are aware of the drug's teratogenicity risk.

Most of the side effects of Acnecutane depend on the dose. Side effects are usually reversible after dose adjustment or drug discontinuation, but some may persist after treatment is stopped.

Benign intracranial hypertension

Cases of benign intracranial hypertension have been reported, some of which have been associated with concomitant administration of tetracycline antibiotics. Signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, visual disturbances, and papilledema. If patients develop benign intracranial hypertension, Acnecutane therapy should be immediately discontinued.

Psychiatric disorders

In rare cases, depression, psychotic symptoms and suicidal attempts have been described in patients treated with Acnecutane. 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 Acnecutane may not be sufficient to alleviate symptoms and, therefore, additional psychiatric consultation may be necessary.

Diseases of the skin and subcutaneous tissues

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.

Exposure to solar radiation and UV therapy should be limited. If necessary, use sunscreen with a high protection factor (SPF 15 or higher).

Deep chemical dermoabrasion and laser treatment should be avoided in patients receiving Acnecutane, as well as for 5-6 months after the end of treatment due to the possibility of increased scarring in atypical areas and, less commonly, with the risk of post-inflammatory hyper- or hypopigmentation in the treated areas. During treatment with Acnecutane 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 treatment, the use of topical keratolytic or exfoliative anti-acne agents should be avoided due to the possibility of increased local irritation.

Diseases of the musculoskeletal system

After using Acnecutane in large doses for many years for the treatment of dyskeratosis, bone changes developed, including premature closure of epiphyseal growth plates, calcification of tendons and ligaments, therefore, when prescribing the drug, the ratio of possible benefits and risks should first be carefully assessed.

While taking Acnecutane, pain in the muscles and joints and an increase in the level of creatine phosphokinase in the serum are possible, which may be accompanied by a decrease in tolerance to intense physical activity.

Visual impairment

Dry eyes, corneal opacities, decreased night vision, and keratitis usually disappear after completion of therapy. Symptoms of dry eye can be relieved by using eye ointment or tear replacement therapy. Intolerance to contact lenses may occur, which may result in the need to wear glasses during therapy.

Deterioration in night vision began suddenly in some patients. Patients with visual impairments should be referred for consultation to an ophthalmologist. In some cases, discontinuation of Acnecutane may become necessary.

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.

Patients with dry conjunctiva should be monitored for possible development of keratitis.

Gastrointestinal disorders

Treatment with isotretinoin is associated with exacerbations of inflammatory diseases of the gastrointestinal tract, in particular regional elitis, in patients without prerequisites for such disorders. In patients with severe hemorrhagic diarrhea, Acnecutane should be immediately discontinued.

Hepatobiliary disorders

It is recommended to monitor liver function 1 month before treatment, 1 month after treatment, and then every 3 months, unless special medical circumstances warrant more frequent monitoring. 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 1 month before treatment, 1 month after initiation, and then every 3 months unless more frequent monitoring is 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 fatal. In case of persistent hypertriglyceridemia or symptoms of pancreatitis, Acnecutane should be discontinued.

Allergic reactions

Rare cases of anaphylactic reactions have been described, which sometimes occurred after previous external use of retinoids. Skin allergic reactions are extremely rare. Cases of severe allergic vasculitis, often accompanied by purpura (ecchymosis or petechiae), have been reported. Acute allergic reactions dictate the need to discontinue the drug and carefully monitor the patient.

High risk patients

Patients at high risk (with diabetes, obesity, alcoholism or lipid metabolism disorders) may require more frequent laboratory monitoring of glucose and lipid levels when treated with Acnecutane. During treatment with isotretinoin, an increase in fasting blood glucose levels was observed, as well as cases of onset of diabetes.

During the treatment period and for 30 days after its completion, it is necessary to completely exclude blood sampling from potential donors to completely eliminate the possibility of this blood getting into pregnant patients (high risk of developing teratogenic and embryotoxic effects).

Both female and male patients should be provided with patient information.

Additional precautions:

Patients should be warned never to give this medicinal product to another person and to return unused capsules to their pharmacist at the end of therapy.

Pregnancy and lactation

The drug has a teratogenic effect!

Fetal malformations associated with Acnecutane exposure include central nervous system abnormalities (hydrocephalus, cerebellar malformations/abnormalities, microcephaly), facial dysmorphism, cleft palate, external ear defects (absent external ear, small or absent external auditory canals), visual disturbances (microophthalmia), cardiovascular disorders (malformations such as tetralogy of Fallot, transposition of the major vessels, septal defects), thymus gland abnormalities and parathyroid gland abnormalities. A higher rate of miscarriages was also observed.

If pregnancy occurs in women treated with Acnecutane, the pregnancy should be terminated and the patient should be referred to a specialized physician with extensive experience in teratology for evaluation and advice.

Isotretinoin is contraindicated in women of childbearing age unless all requirements set out in the Pregnancy Prevention Program are met:

The patient has severe acne (such as acne nodoses, nodules, or other acne leaving significant scars) that is resistant to classical treatment consisting of systemic antibiotics and topical treatment

She understands the risk of malformations

She understands the need for regular monthly check-ups

She understands the need for effective continuous contraception, and takes it a month before the start of the course of treatment, throughout the course and a month after the end of the course of treatment. It is necessary to use at least one, and preferably two methods of complete contraception, including mechanical.

Even with amenorrhea, the patient should follow all appropriate measures for effective contraception

It is necessary to correctly use the contraceptives that are prescribed to her.

She is informed and understands all the possible consequences of a possible pregnancy and the need for immediate consultation with a doctor if there are risks of becoming pregnant

She understands and accepts the need for pregnancy tests before, during and five weeks after treatment.

It confirms that you are aware of all the risks and precautions that come with taking isotretinoin.

These precautions also apply to women who do not have any sexual activity, unless the prescriber makes a compelling case that there is no possibility of pregnancy.

The appointer must confirm that:

The patient meets the requirements of the Pregnancy Prevention Program listed previously and, if she has confirmed that she has an adequate level of understanding

The patient is familiar with the stated requirements

The patient used two means of effective contraception, including mechanical, one month before, during and one month after treatment.

Pregnancy tests must be negative before, during and 5 weeks after the end of treatment. Test results should be recorded in the patient's chart.

The use of contraception, as indicated above, during treatment with Acnecutane should be recommended even for those women who do not usually use contraceptive methods due to infertility (with the exception of patients who have undergone a hysterectomy) or who report that they are not sexually active.

Pregnancy prevention information should be given to patients both verbally and in writing.

Contraception

Patients should be given full information about preventing pregnancy and should be referred for contraceptive counseling if they are not using effective contraception.

As a minimum requirement, patients at risk of pregnancy should use at least one effective method of contraception. It is advisable that the patient use two additional methods of contraception, including a barrier method. The use of contraception should continue for at least 1 month after the end of treatment with Acnecutane, even in patients with amenorrhea.

Pregnancy test

According to the established procedure, medical examination for pregnancy is recommended during the first three days of the menstrual cycle as follows.

Before starting therapy:

To rule out the possibility of pregnancy before starting contraception, it is recommended that an initial pregnancy test be performed under medical supervision and the date and result recorded. In patients without a regular menstrual cycle, the timing of this pregnancy test should depend on the patient's sexual activity; The test should be carried out approximately 3 weeks after the last unprotected sexual intercourse. The doctor should provide the patient with complete information about contraception.

A supervised pregnancy test should also be performed at the time of the first isotretinoin prescription, or three days before that prescription. The date of this test may be delayed until the patient has been off contraception for at least 1 month. The purpose of this test is to confirm that the patient was not pregnant at the start of isotretinoin treatment.

Subsequent visits

Follow-up visits should be arranged at intervals of 28 days. The need for repeated medically supervised pregnancy tests every month should be determined according to local guidelines, taking into account the patient's sexual activity and menstrual cycle (abnormal menses, periods of amenorrhea). If indicated, follow-up pregnancy tests should be performed on the day of the doctor's visit during which the drug is prescribed or 3 days before the doctor's visit.

End of therapy

Five weeks after stopping therapy, women should have a definitive pregnancy test to rule out pregnancy.

Restrictions on appointment and leave

For women of childbearing age, treatment with isotretinoin can be prescribed for no longer than 30 days; continuation of treatment requires a new prescription. Under ideal conditions, the pregnancy test, prescription and dispensing of isotretinoin should be performed on the same day. Isotretinoin should be dispensed a maximum of 7 days after its prescription.

Male patients

There is no reason to believe that treatment with isotretinoin will have an effect on potency or other problems in men. However, men need to be reminded that they should not share the drug with anyone, especially women.

Lactation period

Acnecutane is highly lipophilic, therefore, isotretinoin is very likely to pass into mother's milk. Due to the likelihood of adverse events in the mother and child, the use of Acnecutane is contraindicated in nursing mothers.

The drug contains sorbitol; Acnecutane is not recommended for patients with fructose intolerance.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

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 or operating machinery at night.

Overdose

Isotretinoin is a derivative of vitamin A. Manifestations of short-term toxic effects of hypervitaminosis A include severe headache, nausea and vomiting, drowsiness, irritability and itching. These symptoms are considered reversible and improve without the need for treatment.

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

On prescription

Manufacturer

SMB Technology S.A., Rue du Parc Industrial 39-6900 Marche-en-Famenne, Belgium

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