Aknekutan: instructions for use. How to take Roaccutane correctly: treatment regimen Material and research methods

14.07.2020 Analyzes

Roaccutane is a drug belonging to the retinoid group. The tool is actively used to treat acne and acne. Produced in capsules, the main active substance in which isotretinoin. What is the optimal scheme for using Roaccutane, the rules of use, the features of the action and contraindications, we will consider below in the article.

Prescribing the drug

Roaccutane is used to treat severe types of skin rashes, namely:

conglobate;
nodular-cystic;
other types of rashes that subsequently provoke scarring.

IMPORTANT! The drug is prescribed to a person only in cases where other methods of therapy do not bring any result.

For each patient suffering from severe acne, the Roaccutane regimen is selected individually. The tool can only be used after a detailed examination and appointment by a dermatologist. Self-medication is categorically contraindicated.

How acne appears

Inside each pore is a gland that secretes sebum. Its main task is to protect the skin from the adverse effects of the external environment. Unfortunately, pores are a fertile environment for bacteria to grow. That is, if the gland becomes more active, begins to secrete a lot of sebum, then the pores begin to clog and microbes quickly multiply in them. Additionally, everything is aggravated by dead particles of the stratum corneum.

Further, the body's defense mechanism turns on, namely the release of leukocytes to fight bacteria. Consequently, in such places redness and swelling appear, with which each person has met in his life. Against the background of too active sebaceous glands and penetration of harmful microorganisms into the pores provokes the occurrence of a severe form of acne.

The mechanism of action of the drug

Isotretonoim, the active ingredient of the drug, has a direct effect on the gland, significantly reducing the production of sebum. Decrease in parallel inflammatory processes and the appearance of acne on the skin is reduced. Additionally, when taking Roaccutane, the proliferation of sebocytes is suppressed, as a result of which the normalization of cell differentiation occurs.

Thanks to this, severe acne can disappear after the first course of treatment. medicinal product... At the same time, the probability of a recurrence of the disease is only 15%. In the event that it does occur, then the attending specialist can prescribe a repeated course of Roaccutane use, however, already in small doses.

Features of taking the drug

Many people suffering from severe skin rashes are often interested in how to take the drug correctly. Given that Roaccutane is a potent substance, the doctor initially prescribes its use in small doses (up to 10 mg per day). Reception is carried out 1 or 2 times during the consumption of food.

Additionally, it should be borne in mind that during use medicinal product the stratum corneum is reduced, and therefore the patient must minimize the time spent in the sun or use protective creams and oils.

Also, during and after treatment, it is strictly prohibited:

Surgical intervention.
Laser hair removal.
Cosmetic procedures.
Going to the solarium.

Otherwise, scars or pigmentation may develop on the skin.

Drug dosage

Given that the effectiveness of Roaccutane directly depends on the state of the human body, as well as on the appearance of side effects, the dosage of the drug is determined exclusively by the doctor, and may be adjusted during the course of treatment. As a rule, it is 0.5 mg / kg / day throughout the entire course of treatment.

Also, before and during drug therapy, the patient should periodically undergo an examination of the functions of the liver and kidneys. In the event that Roaccutane is tolerated by a person without consequences, then a specialist can increase the dosage to 1 mg / kg / day.

IMPORTANT! In severe acne, the daily intake can be up to 2 mg / kg / day. However, such a dosage is possible only if the patient does not face any side effects of the drug.

When the first positive shifts come

Before starting treatment, many are curious about when improvement occurs? It should be said right away that you should not expect a miracle from the first pill. Moreover, usually the course of therapy is quite long and its duration is determined by the doctor depending on the complexity of the disease and physiological characteristics the patient.

However, the first positive results can be observed after the first month of using Roaccutane. Of course, the drug acts rather slowly, but after a full course of therapy, a person completely gets rid of acne.

Interaction with other drugs

When using Roaccutane, you need to be as careful as possible when taking other drugs. For example, the interaction of isotretinoin with tetracycline antibiotics significantly reduces the effectiveness of treatment.

Diuretics of the sulfamide and thiazide groups increase sensitivity to ultraviolet rays, resulting in a risk of burns even after a short exposure to the sun. Tetracyclines are completely contraindicated to combine with the drug, since this is fraught with the occurrence of intracranial pressure.

In addition, under no circumstances should Roaccutane be "mixed" with other drugs that treat acne, pimples and papules, such as Retinol, Tretinoin, Tazaroten, etc. This combination may be fraught with hypervitaminosis A.

Who is this medicine contraindicated for?

Due to availability potent substance isotretinoin in the composition, the drug is not suitable for every person.

So, Roaccutane is contraindicated in the following categories of persons:

Patients who have hypersensitivity to individual components in the composition of the drug.
Pregnant women or during the period of breastfeeding.
Obese people.
Patients with diabetes mellitus 1 and 2 categories.
People who wear contact lenses for the eyes.
Children under 12 years old.
People who have liver or kidney disease.

In addition, the medicine is intended to eliminate complex forms of acne. Use it to treat moderate to mild forms skin diseases not desirable.

Side effects

During therapy with Roaccutane, patients often have side effects... In some cases, you can get rid of them by adjusting the dose, in other cases, the effects of use may persist even after you stop taking the pills. So, the consequences of using the drug can be expressed in violations.

From the epidermis and mucous membranes:

Periodic clouding of the cornea of the eye.
The appearance of an itchy skin rash.
Dry lips.
The appearance of dermatitis.
Increased sweating.
Nosebleeds.
Thinning hair.
Hyperpigmentation.
Conjunctivitis.
Pain when wearing contact lenses.

From the side of the central nervous system:

High intracranial pressure.
Recurrent headaches.
Convulsions.
Depressive state.

From the gastrointestinal tract:

Flatulence.
Diarrhea.
Nausea.

From the side musculoskeletal system:

Arthritis.
Recurrent pain in muscles and joints.

Also, in some cases, the following effects may be observed:

Violation of color perception (reversible effect).
Reversible impairment of vision adaptation in low light.
The emergence of photophobia.
Puffiness optic nerve.
Hearing impairment at certain frequencies.

IMPORTANT! Usually complications arise due to the appearance of sensitivity to the components or if the patient does not follow the instructions and dosage prescribed by the specialist.

On the video about the use of Roaccutane

Of course, Roaccutane is a remedy that can effectively combat severe forms of acne in humans. However, due to the fact that the medicine has a number of contraindications and side effects, experienced specialists, before prescribing it to a patient to eliminate skin diseases, carefully weigh the pros and cons. In addition, in order to prevent complications from occurring, a person undergoing therapy should be examined at a medical facility.

Roaccutane is a retinoid; drug for the treatment of acne.

Release form and composition

10 mg capsules: oval, opaque, brown-red, with a black inscription on the surface "ROA 10"; content - a homogeneous suspension from yellow to dark yellow (10 pcs. in blisters, 3 or 10 blisters in a cardboard box);
capsules 20 mg: oval, opaque, one half white, the other brown-red, with a black inscription on the surface "ROA 20"; contents - a homogeneous suspension from yellow to dark yellow (10 pcs. in blisters, 3 or 10 blisters in a cardboard box).

Active ingredient: isotretinoin, in 1 capsule - 10 or 20 mg.

Auxiliary components: yellow beeswax, soybean oil, hydrogenated and partially hydrogenated soybean oil.

The composition of the capsule shell: gelatin, glycerol 85%, Karion 83 (mannitol, hydrolyzed potato starch, sorbitol), titanium dioxide (E171), iron dye red oxide (E172).

Ink composition: iron oxide black oxide (E172) and shellac; it is possible to use ready-made ink Opacode Black S-1-27794.

Indications for use

severe acne: conglobata, nodular-cystic and acne with the risk of scarring;
acne that does not respond to other treatments.

Contraindications

Absolute:

severe hyperlipidemia;
hypervitaminosis A;
liver failure;
age up to 12 years;
the period of pregnancy and breastfeeding;
concomitant use of tetracyclines;
hypersensitivity to the components of Roaccutane.

Relative:

violation of lipid metabolism;
obesity;
diabetes;
a history of depression;
alcoholism.

Method of administration and dosage

Roaccutane should be taken orally with meals 1-2 times a day.

The dose for each patient is selected by the doctor, depending on the effectiveness and individual tolerance of the drug.

The recommended starting dose is 0.5 mg / kg per day. For most patients, a sufficient daily dose is 0.5–1 mg / kg, but in severe forms of the disease and acne of the trunk, an increase in the dose to 2 mg / kg / day is possible.

It has been established that the optimal course dose (for the full course of treatment), allowing to reduce the frequency of acne remission, is 120–150 mg / kg.

The duration of treatment depends on the daily dose used. Complete remission of the disease is usually achieved within 16-24 weeks of therapy. Patients who do not tolerate the drug in the prescribed dose are advised to reduce the dose, but to carry out the treatment longer.

In most patients, acne completely disappears after one course of therapy. In the case of a clear relapse, a second course is prescribed in the same doses as the first time, but not earlier than after 8 weeks (this is how much the improvement of the condition usually continues).

Patients with severe renal failure the initial dose is reduced (usually up to 10 mg per day), and subsequently gradually increased to the maximum tolerated dose or up to 1 mg / kg / day.

Side effects

from the central nervous system and psyche: headache, behavioral disturbances, seizures, depression, increased intracranial pressure ("pseudotumor of the brain": nausea, headache, vomiting, optic nerve edema, visual impairment);
from the side digestive system: inflammatory bowel disease (ileitis, colitis), diarrhea, nausea, bleeding, transient and reversible increase in the activity of hepatic transaminases, pancreatitis (especially in patients with concomitant hypertriglyceridemia above 800 mg / dl; rare cases of pancreatitis with fatal outcome have been described); in some cases - hepatitis;
from the respiratory system: rarely - bronchospasm (more often in patients with bronchial asthma history);
from the senses: rarely - edema of the optic nerve (as a manifestation intracranial hypertension), transient color vision disorder, eye irritation, conjunctivitis, keratitis, lenticular cataract, blepharitis, hearing impairment at certain sound frequencies; in some cases - a violation of dark adaptation (decrease in the acuity of twilight vision), photophobia, impaired visual acuity;
from the musculoskeletal system: calcification of ligaments and tendons, joint pain, tendinitis, arthritis, hyperostosis, muscle pain (including with an increase in serum creatine phosphokinase), other bone changes;
on the part of the hematopoietic system: accelerated ESR, neutropenia, leukopenia, anemia, an increase or decrease in the number of platelets, a decrease in hematocrit;
from the side immune system: local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus);
dermatological reactions: at the beginning of treatment - exacerbation of acne (usually disappears within 7-10 days without adjusting the dose of the drug); erythema of the face or dermatitis, itching, rash, paronychia, pyogenic granuloma, onychodystrophies, sweating, increased growth of granulation tissue, photosensitivity, hyperpigmentation, easy skin trauma, photoallergy, hirsutism, fulminant forms of acne, reversible hair loss, persistent hair loss;
effects due to hypervitaminosis A: dry eyes (intolerance to contact lenses, conjunctivitis and reversible corneal opacities), mucous membranes, including lips (cheilitis), laryngopharynx (hoarseness), nasal cavity (bleeding), skin;
laboratory parameters: a decrease in the level of high-density lipoproteins, hypercholesterolemia, hypertriglyceridemia, hyperuricemia; rarely - hyperglycemia, first-onset diabetes mellitus; in some cases, in patients engaged in intense physical activity - an increase in serum creatine phosphokinase activity;
other: systemic hypersensitivity reactions, proteinuria, hematuria, glomerulonephritis, lymphadenopathy, vasculitis (allergic vasculitis, Wegener's granulomatosis);
side effects identified during post-marketing surveillance: severe skin reactions such as toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Most of the side effects of Roaccutane are dose-dependent. The balance of benefits, taking into account the severity of acne and risks, when prescribing optimal doses of the drug, is usually acceptable to the patient. Adverse Reactions usually disappear after dose reduction or discontinuation of the drug, but some may persist even after discontinuation of therapy.

special instructions

Roaccutane should only be taken as directed by a physician, preferably a dermatologist, experienced in the use of systemic retinoids and aware of the risk of teratogenicity. The drug can be prescribed only after a careful assessment of the balance of benefits and possible risks to the patient.

Each person should be given a copy of the patient information brochure when prescribing Roaccutane.

Before prescribing the drug, 1 month after the start of treatment, then every 3 months or according to indications, it is recommended to monitor liver enzymes and liver function. If the level of hepatic transaminases exceeds the norm, you need to reduce the dose of the drug, or cancel it altogether.

Fasting serum lipids should be measured at the same intervals. In case of exceeding the norm, it is also necessary to reduce the dose of the drug or cancel it. In some cases, the normalization of lipid concentration can be achieved through adherence to the diet.

In addition, during treatment, it is necessary to control a clinically significant increase in triglyceride levels, since their increase in excess of 800 mg / dL or 9 mmol / L can lead to the development of acute pancreatitis and even death. With persistent hypertriglyceridemia or the appearance of symptoms of pancreatitis, Roaccutane is canceled.

In order to avoid accidental exposure of isotretinoin to the body of other people, donor blood must not be donated / taken for 1 month after the end of treatment.

In rare cases, patients receiving Roaccutane experienced psychotic symptoms, depression, and very rarely, suicidal attempts. Although a causal relationship with retinoid use has not been established, patients with a history of depression should be monitored closely. medical supervision... Moreover, the withdrawal of the drug does not always lead to the disappearance of symptoms, therefore, further observation and treatment by a specialist may be required.

At the beginning of therapy, to reduce dryness of mucous membranes and skin, patients are advised to use a lip balm, moisturizer or body ointment.

During treatment with Roaccutane and within 5-6 months after its completion, patients should not undergo laser therapy and deep chemical dermoabrasion (associated with the risk of hyper- and hypopigmentation, increased scarring in atypical places), and also carry out waxing(the risk of epidermal detachment, dermatitis and scarring increases).

Due to the likelihood of a decrease in night vision acuity during treatment, it is recommended to be careful when driving a car in the evening. Visual acuity must be carefully monitored.

Deterioration of night vision, corneal opacity, keratitis and dryness of the conjunctiva of the eyes usually disappear after the withdrawal of Roaccutane. If the mucous membrane of the eyes is dry, artificial tear preparations or application of a moisturizing eye ointment can be used. In the event of complaints of vision, the patient should be referred for a consultation with an ophthalmologist.

If you are intolerant of contact lenses, glasses should be used during treatment.

During the period of therapy, it is necessary to limit exposure to sunlight and ultraviolet rays, in extreme cases - to use a sunscreen with high value protective factor (SPF not less than 15).

With the development of severe hemorrhagic diarrhea, Roaccutane is immediately canceled.

Heavy allergic reactions are also an indication for immediate discontinuation of the drug.

In the presence or suspicion of diabetes mellitus, it is worth more often to determine the glycemia.

Patients at risk (with impaired fat metabolism, obesity, diabetes mellitus, chronic alcoholism) during therapy, more frequent laboratory monitoring of lipid and glucose levels may be required.

Pregnancy is an absolute contraindication to the appointment of Roaccutane. If, despite all the warnings, pregnancy occurs during treatment or within a month after its end, there is a very high risk of having a child with severe malformations.

Such severe congenital malformations of the fetus associated with the use of Roaccutane have been documented: microphthalmia, cerebellar malformations, microcephaly, hydrocephalus, cardiovascular anomalies (transposition of great vessels, tetrad of Fallot, septal defects), external ear anomalies (absence or narrowing external auditory canal, microtia), pathology of the parathyroid glands, malformations of the thymus gland and face (cleft palate).

For this reason, women of childbearing age are only prescribed Roaccutane if they have severe acne that is resistant to conventional therapies. At the same time, a woman should be informed about all the risks and warned about the possible ineffectiveness of contraceptives. The woman must confirm that she understands the essence of all precautions, the need to strictly follow the doctor's instructions and use reliable methods of contraception (at least one, and preferably two, including the barrier method) for the entire period of retinoid treatment and 1 month after its end.

The drug can be prescribed only to those patients who have used effective methods of contraception for at least 1 month before starting the use of Roaccutane. Treatment begins on day 2-3 of the next normal menstrual cycle after a negative valid pregnancy test is obtained. In addition, it is recommended to do a pregnancy test monthly during the entire course of treatment and 5 weeks after it ends. The patient must see a doctor every 28 days.

The use of effective contraception is recommended even for women who report that they are not sexually active, usually do not use contraceptive methods due to amenorrhea or infertility (except for patients who have undergone a hysterectomy).

In connection with the above, a prescription for Roaccutane is prescribed for a woman of childbearing age only for 30 days. If continuation of therapy is required, a new prescription of the drug by a doctor is necessary. It is recommended to take a pregnancy test, write a prescription and receive the drug on the same day.

The dispensing of the drug in pharmacies is carried out only within 7 days from the date of the prescription.

To help patients, doctors and pharmacists prevent the negative effects of isotretinoin on the fetus, the Roaccutane company has created a "Pregnancy Prevention Program", the goal of which is to prevent the drug from teratogenicity and to emphasize the absolutely mandatory use of effective contraception by women who are fertile. It contains the following materials:

for medical professionals: a guide for a physician on the prescription of Roaccutane to women, a form for recording the prescription of a drug for women, an informed consent form for a patient;
for patients: what you need to know about contraception, patient information brochure;
for the Pharmacist: A Pharmacist's Guide to Dispensing Roaccutane.

Full information on the teratogenic effect of isotretinoin and the need for strict adherence to measures to prevent pregnancy should be provided not only to women, but also to men.

Drug interactions

It is contraindicated to simultaneously prescribe tetracyclines, since they, like isotretinoin, can increase intracranial pressure.

Due to the risk of increased local irritation, local keratolytic or exfoliative agents should not be used simultaneously to treat acne.

Isotretinoin can reduce the effectiveness of drugs containing progesterone, therefore, oral contraceptives containing small doses of progesterone should not be taken during treatment.

Terms and conditions of storage

Store in a dry, dark place, out of reach of children, at temperatures up to 25 ºС.

Shelf life is 3 years.

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Active substance

Isotretinoin * (Isotretinoinum)

ATX:

Pharmacological group

Nosological classification (ICD-10)

Composition

Description of the dosage form

8 mg capsules: hard, gelatinous, No. 3, brown.

16 mg capsules: hard, gelatinous, No. 1, white body, green lid.

Contents of capsules- yellow-orange waxy paste.

pharmachologic effect

pharmachologic effect - stimulating regeneration, anti-seborrheic, anti-inflammatory .

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 improvement clinical picture severe acne is associated with suppression of the activity of the sebaceous glands and a histologically confirmed decrease in their size. Sebum is the main substrate for growth Propionibacterium acnes therefore, reducing sebum production inhibits bacterial colonization of the duct.

Acnecutan inhibits the proliferation of sebocytes and acts on acne, restoring the normal process of cell differentiation, stimulates regeneration processes.

In addition, the anti-inflammatory effect of isotretinoin on the skin has been proven.

Pharmacokinetics

Since the kinetics of isotretinoin and its metabolites is linear, its plasma concentration during therapy can be predicted based on data obtained after a single dose. This property of the drug also suggests that it does not affect the activity of liver microsomal enzymes involved in drug metabolism.

The high bioavailability of Acnecutan is due to the large proportion of dissolved isotretinoin in the drug and can increase if the drug is taken with food.

In patients with acne, plasma C max in steady state after taking 80 mg of isotretinoin on an empty stomach was 310 ng / ml (range 188-473 ng / dl) and was reached after 2-4 hours. Plasma isotretinoin concentration was 1.7 times higher, than in the blood, due to poor penetration of isotretinoin into red blood cells. The connection with plasma proteins (mainly albumin) is 99.9%.

The C ss of isotretinoin in the blood of patients with severe acne who took 40 mg of the drug 2 times a day ranged from 120 to 200 ng / ml. The concentration of 4-oxo-isotretinoin (the main metabolite) in these patients was 2.5 times higher than that of isotretinoin.

The concentration of isotretinoin in the epidermis is 2 times lower than in serum.

It is metabolized to form 3 main biologically active metabolites - 4-oxo-isotretinoin (main), tretinoin (completely trans-retinoic acid) and 4-oxo-retinoin, as well as less significant metabolites, including glucuronides. Insofar as in vivo isotretinoin and tretinoin are reversibly converted into each other, the metabolism of tretinoin is associated with the metabolism of isotretinoin. 20-30% of the dose of isotretinoin is metabolized by isomerization. In the pharmacokinetics of isotretinoin in humans, enterohepatic recirculation may play a significant role.

Research in vitro showed that several isozymes of cytochrome P450 are involved in the conversion of isotretinoin to 4-oxo-isotretinoin and tretinoin, with none of the isoforms apparently playing a dominant role. Isotretinoin and its metabolites do not significantly affect the activity of cytochrome P450 isoenzymes.

T 1/2 of the terminal phase for isotretinoin - an average of 19 hours; for 4-oxo-isotretinoin - an average of 29 hours.

Isotretinoin is excreted by the kidneys and bile in approximately equal amounts. Refers to natural (physiological) retinoids. Endogenous concentrations of retinoids are restored approximately 2 weeks after the end of the drug intake.

Pharmacokinetics in special clinical situations

Since the data on the pharmacokinetics of the drug in patients with impaired liver function are limited, isotretinoin is contraindicated for use in this group of patients. Renal failure mild and medium severity does not affect the pharmacokinetics of isotretinoin.

Indications of the drug

severe forms of acne (nodular-cystic, conglobate, acne with a risk of scarring);

acne that is not amenable to other types of therapy.

Contraindications

hypersensitivity to the drug or its components;

liver failure;

hypervitaminosis A;

severe hyperlipidemia;

concomitant tetracyclines therapy;

pregnancy, established and planned (possibly teratogenic and embryotoxic effect);

lactation period;

childhood up to 12 years old.

Carefully: diabetes mellitus, history of depression, obesity, lipid metabolism disorders, alcoholism.

Application during pregnancy and lactation

Pregnancy is an absolute contraindication for Acnecutan therapy.

If pregnancy occurs (despite precautions) during treatment or within a month after the end of therapy, there is a very high risk of giving birth to a child with severe malformations.

Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs at a time when a woman is taking isotretinoin orally (in any dose and even for a short time), there is a very high risk of having a child with developmental defects. Acnecutan is contraindicated in women of childbearing age, unless the woman's condition meets all of the following criteria:

She must have severe acne that is resistant to conventional treatments;

She must accurately understand and follow the instructions of the doctor;

She should be informed by the doctor about the danger of pregnancy during treatment with Acnecutan, within 1 month after it and the need for urgent consultation if pregnancy is suspected;

She should be warned about the possible ineffectiveness of contraceptives;

She must confirm that she understands the essence of the precautions;

She must understand the need for and continuously use effective methods of contraception for 1 month before treatment with Acnecutan, during treatment and within 1 month after its completion (see "Interaction"); it is desirable to use simultaneously 2 different methods of contraception, including barrier;

She must have obtained a negative valid pregnancy test result within 11 days of starting the drug; a pregnancy test should be performed monthly during treatment and 5 weeks after the end of therapy;

She should start treatment with Acnecutan only on the 2-3rd day of the next normal menstrual cycle;

She must understand the need for a mandatory visit to the doctor every month;

When treating for a relapse of the disease, she should constantly use the same effective methods of contraception for 1 month before starting treatment with Acnecutan, during therapy and within a month after its completion, and also undergo the same reliable pregnancy test;

She must fully understand the need for precautions and confirm her understanding and willingness to use reliable contraception as recommended by her doctor.

The use of contraception according to the above directions during treatment with isotretinoin should be recommended even for those women who usually do not use contraceptive methods due to infertility (except for patients who have undergone a hysterectomy), amenorrhea, or report not having sex.

The doctor must be sure that:

The patient suffers from severe acne (nodular-cystic, conglobate or acne with a risk of scarring) or acne that does not respond to other types of therapy;

A negative result of a reliable pregnancy test was obtained before the start of taking the drug, during therapy and 5 weeks after the end of therapy (the dates and results of the pregnancy test must be documented);

The patient preferably uses two effective methods of contraception, including a barrier method, within 1 month before the start of treatment with Acnecutan, during treatment and within a month after its termination;

The patient is able to understand and fulfill all of the above requirements for preventing pregnancy;

The patient meets all of the above conditions.

Pregnancy test

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

Before starting therapy:

To exclude possible pregnancy Before contraception is started, the result and date of the initial pregnancy test must be recorded by the doctor. In patients with irregular periods The timing of the pregnancy test depends on sexual activity and should be done 3 weeks after unprotected intercourse. The doctor should inform the patient about contraceptive methods;

A pregnancy test is performed on the day Acnecutan is prescribed or 3 days before the patient's visit to the doctor. Test results should be recorded by the technician. The drug can be prescribed only to patients receiving effective contraception for at least 1 month before starting therapy with Acnecutan.

During therapy:

The patient must see a doctor every 28 days. The need for monthly pregnancy testing is determined in accordance with local practice and taking into account sexual activity, previous menstrual irregularities. If indicated, a pregnancy test is carried out on the day of the visit or 3 days before the visit to the doctor, the test results must be recorded.

End of therapy:

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

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

If despite Taken measures precautions, during treatment with Acnecutan or within a month after its termination, pregnancy has still occurred, there is a very high risk of severe fetal malformations.

If pregnancy occurs, therapy with Acnecutan is discontinued. The feasibility of maintaining the pregnancy should be discussed with a physician specializing in teratology.

Since isotretinoin is highly lipophilic, it is highly likely that it will enter breast milk... Due to the possible side effects, Acnecutan should not be prescribed to nursing mothers.

Male patients. Existing data indicate that in women, the exposure of the drug received from the semen and seminal fluid of men taking Acnecutan is insufficient for the manifestation of the teratogenic effects of Acnecutan.

Men should exclude the possibility of taking the drug by others, especially women.

Side effects

Most side effects are dose dependent. Side effects are usually reversible after dose adjustment or drug withdrawal, but some may persist after treatment is discontinued.

Symptoms associated with hypervitaminosis A: dry skin, mucous membranes, incl. lips (cheilitis), nasal cavity (bleeding), larynx and pharynx (hoarseness), eyes (conjunctivitis, reversible corneal opacity and contact lens intolerance).

On the part of the skin and its appendages: peeling of the skin of the palms and soles, rash, itching, facial erythema / dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased growth of granulation tissue, persistent hair thinning, reversible hair loss, fulminant forms of acne, hirsutism, skin hyperpigmentation, photosensitivity ... At the beginning of treatment, acne may worsen and last for several weeks.

From the musculoskeletal system: muscle pain with or without increased serum creatine phosphokinase (CPK) levels, joint pain, hyperostosis, arthritis, calcification of ligaments and tendons, tendinitis.

From the side of the central nervous system and mental sphere: excessive fatigue, headache, increased ICP (pseudotumor of the brain: headache, nausea, vomiting, blurred vision, swelling of the optic nerve), seizures, rarely - depression, psychosis, suicidal thoughts.

From the senses: xerophthalmia, isolated cases of visual acuity impairment, photophobia, impaired dark adaptation (decreased acuity of twilight vision), rarely - impaired color perception (passing after drug withdrawal), lenticular cataract, keratitis, blepharitis, conjunctivitis, eye irritation, optic neuritis, optic nerve edema (as a manifestation of intracranial hypertension); hearing impairment at certain sound frequencies, difficulty wearing contact lenses.

From the digestive tract: dryness of the oral mucosa, bleeding from the gums, inflammation of the gums, nausea, diarrhea, inflammatory bowel disease (colitis, ileitis), bleeding; pancreatitis (especially with concomitant hypertriglyceridemia - above 800 mg / dL). Rare cases of fatal pancreatitis have been reported. Transient and reversible increase in the activity of hepatic transaminases, isolated cases of hepatitis. In many cases, the changes did not go beyond the normal range and returned to the baseline values during treatment, but in some situations it became necessary to reduce the dose or cancel Acnecutan.

From the respiratory system: rarely - bronchospasm (more often in patients with a history of bronchial asthma).

From the blood system: anemia, decreased hematocrit, leukopenia, neutropenia, increased or decreased platelet count, accelerated ESR.

Laboratory indicators: hypertriglyceridemia, hypercholesterolemia, hyperuricemia, decreased HDL cholesterol, rarely hyperglycemia. In the course of taking Acnecutan, cases of newly diagnosed diabetes mellitus were reported. In some patients, especially those with intense physical activity, cases of increased serum CPK activity have been described.

From the immune system: local or systemic infections caused by gram-positive pathogens ( Staphylococcus aureus).

Others: lymphadenopathy, hematuria, proteinuria, vasculitis (Wegener's granulomatosis, allergic vasculitis), systemic hypersensitivity reactions, glomerulonephritis.

Teratogenic and embryotoxic effects: congenital deformities - hydro- and microcephaly, underdevelopment of the cranial nerves, microphthalmia, malformations of the CVS, parathyroid glands, impaired skeletal formation - underdevelopment of the digital phalanges, skull, cervical vertebrae, femurs, ankles, forearm bones, facial part of the skull, , low location of the auricles, underdevelopment of the auricles, underdevelopment or complete absence of the external auditory canal, hernia of the head and spinal cord, bone adhesions, fusion of fingers and toes, thymus developmental disorders; fetal death during the perinatal period, premature birth, miscarriages; premature closure of the epiphyseal growth zones; in an experiment on animals - pheochromocytoma.

Interaction

Antibiotics of the tetracycline series, GCS reduce the effectiveness.

Simultaneous use with drugs that increase photosensitivity (including sulfonamides, tetracyclines, thiazide diuretics) increases the risk of sunburn.

Simultaneous use with other retinoids (including acitretin, tretionin, retinol, tazarotene, adapalene) increases the risk of hypervitaminosis A.

Isotretinoin can weaken the effectiveness of progesterone medications, so contraceptives containing small doses of progesterone should not be used.

Combined use with keratolytic drugs for topical application not recommended for acne treatment due to possible increased local irritation.

Since tetracyclines increase the risk of increased ICP, concomitant use with isotretinoin is contraindicated.

Method of administration and dosage

Inside, preferably with meals, 1-2 times a day.

The therapeutic efficacy of Acnecutan and its side effects depend on the dose and vary in different patients. This makes it necessary to individually select the dose during treatment.

The initial dose of Acnecutan is 0.4 mg / kg / day, in some cases - up to 0.8 mg / kg / day. In severe forms of the disease or patients with acne of the trunk, a dose of up to 2 mg / kg / day may be required.

The optimal course cumulative dose is 100-120 mg / kg. Complete remission is usually achieved within 16-24 weeks. If the recommended dose is poorly tolerated, treatment can be continued with a lower dose, but for a longer period.

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

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

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

Overdose

Symptoms: development of signs of hypervitaminosis A is possible.

Treatment: in the first few hours after an overdose, gastric lavage may be necessary.

special instructions

It is recommended to monitor liver function and the level of liver enzymes before treatment, 1 month after its start, and then every 3 months or according to indications. There was a transient and reversible increase in hepatic transaminases, in most cases within normal values... If the level of hepatic transaminases exceeds the norm, it is necessary to reduce the dose of the drug or cancel it. Fasting serum lipids should also be determined before treatment, 1 month after initiation, and then every 3 months or as indicated.

Usually, the concentration of lipids is normalized after dose reduction or discontinuation of the drug, as well as following a diet. It is necessary to control a clinically significant increase in triglyceride levels, since their rise above 800 mg / dL or 9 mmol / L may be accompanied by the development of acute pancreatitis, possibly fatal.

With persistent hypertriglyceridemia or symptoms of pancreatitis, Acnecutan should be canceled.

In rare cases, depression, psychotic symptoms and, very rarely, suicidal attempts have been described in patients receiving Acnecutan. Although their causal relationship with the use of the drug has not been established, special care should be taken in patients with a history of depression and all patients should be monitored for depression during drug treatment, referring them to an appropriate specialist if necessary. However, the withdrawal of Acnecutan may not lead to the disappearance of symptoms, and further observation and treatment by a specialist may be required.

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

When prescribing the drug, any patient should first carefully assess the ratio possible benefits and risk.

While taking Acnecutan, pain in muscles and joints, an increase in blood serum CPK are possible, which may be accompanied by a decrease in the tolerance of intense physical activity.

Avoid deep chemical dermabrasion and laser treatment of patients receiving Acnecutan, as well as within 5-6 months after the end of treatment due to the possibility of increased scarring in atypical places and the occurrence of hyper- and hypopigmentation. During treatment with Acnecutan and within 6 months after it, epilation cannot be performed using wax applications due to the risk of epidermal detachment, the development of scars and dermatitis.

Since some patients may experience a decrease in night vision, which sometimes persists even after the end of therapy, patients should be informed about the possibility of this condition, advising them to be careful when driving at night. The state of visual acuity must be carefully monitored. Dryness of the conjunctiva of the eyes, corneal opacity, deterioration of night vision and keratitis usually resolve after discontinuation of the drug. If the mucous membrane of the eyes is dry, applications of a moisturizing eye ointment or artificial tear preparation can be used. It is necessary to monitor patients with dry conjunctiva to prevent the possible development of keratitis. Patients presenting with vision complaints should be referred to an ophthalmologist and the advisability of canceling Acnecutan should be considered. If you are intolerant of contact lenses, glasses should be used during therapy.

Exposure to sun exposure and UV therapy should be limited. If necessary, you should use a sunscreen with a high SPF value (at least 15 SPF).

Rare cases of the development of benign intracranial hypertension (pseudotumor of the brain), incl. when combined with tetracyclines. In such patients, Acnecutan should be discontinued immediately.

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

Described are rare cases of anaphylactic reactions that occurred only after the previous external use of retinoids. Severe allergic reactions dictate the need to discontinue the drug and closely monitor the patient.

Patients from a high-risk group (with diabetes mellitus, obesity, chronic alcoholism or disorders of fat metabolism) during treatment with Acnecutan may require more frequent laboratory monitoring of glucose and lipid levels. If you have or suspect diabetes, more frequent definition blood glucose levels.

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially dangerous species activities requiring increased concentration of attention and speed of psychomotor reactions (when taking the first dose).

Dosage form"type =" checkbox ">

Dosage form

Capsules 8 mg and 16 mg

Composition

One capsule contains

active substance - isotretinoin 8.00 mg or 16.00 mg,

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

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

composition of gelatin capsules No. 1:

cover: gelatin, yellow iron oxide (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 lid and body (for a dosage of 8 mg).

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

The contents of the capsules are an orange waxy paste.

Pharmacotherapeutic group

Medications for the treatment of acne.

Retinoids for systemic treatment acne. Isotretinoin.

ATX code D10BA01

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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 can also increase when the drug is taken with food.

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

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

Equilibrium blood concentrations of isotretinoin 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 plasma: 4-oxo-isotretinoin, tretinoin (all-trans-retinoic acid) and 4-oxo-retinoin, as well as less significant metabolites, including glucuronides. The main metabolite is 4-oxo-isotretinoin, its plasma level in the equilibrium 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. In this case, none of the isoforms, most likely, plays 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. In the pharmacokinetics of isotretinoin in humans, enterohepatic circulation may play a significant role.

Withdrawal

The terminal phase elimination half-life for unchanged isotretinoin in patients with acne is 19 hours on average. The half-life of the terminal phase of 4-oxo-isotretinoin is longer, on average, 29 hours.

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

Isotretinoin belongs to natural (physiological) retinoids. Endogenous concentrations of retinoids are restored approximately 2 weeks after the end of Acnecutan intake.
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.

Renal failure of mild to moderate severity 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 an improvement in the clinical picture of severe forms of acne is associated with the suppression of the activity of the sebaceous glands and a histologically confirmed decrease in their size. Sebum is the main substrate for the growth of Propionibasterium acnes, so reducing sebum production inhibits bacterial colonization in the duct.

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

Method of administration and dosage

Acnecutan should be prescribed only by a physician or used under the supervision of a physician who has experience in the use of systemic retinoids for the treatment of severe forms of acne and understands the risks of Acnecutan therapy and the necessary monitoring of their use.

The therapeutic efficacy of Acnecutan and its side effects depend on the dose and vary from patient to patient. Therefore, it is important to individually select doses during treatment.

The capsules are taken with meals, once or twice a day.

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

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

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

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

With a clear relapse, a second course of treatment is shown in the same daily and cumulative dose of Acnecutan as the first one. Since the improvement can be delayed, up to 8 weeks after discontinuation of the drug, a second 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 with persons under the age of 18, so the dosage regimen for this group has not been established.

Side effects

Very often (≥ 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, slight skin trauma (risk of trauma)

Arthralgia, myalgia, back pain

Hypertriglyceridemia, decreased high-density lipoprotein

Often (≥ 1/100,< 1/10)

Neutropenia

Headache

Epistaxis, dry nasal mucosa, rhinopharyngitis

Alopecia

Hypercholesterolemia, hyperglycemia, hematuria, proteinuria

Rarely (≥ 1/10 000,< 1/1 000)

Allergic skin reactions, anaphylactic reactions, hypersensitivity

Depression, worsening of 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, attempted suicide, suicide

Drowsiness, increased intracranial pressure, convulsions

Impaired visual acuity, cataract, color vision impairment (passing after drug withdrawal), contact lens intolerance, corneal opacity, dark adaptation impairment (decreased twilight vision), keratitis, optic neuritis (as a sign of intracranial hypertension), photophobia

Hearing impairment

Vasculitis (Wegener's granulomatosis, allergic vasculitis)

Bronchospasm (especially in asthma patients), hoarseness

Colitis, ileitis, dry throat, gastrointestinal bleeding, hemorrhagic diarrhea, and inflammatory conditions gastrointestinal tract, nausea, pancreatitis

Hepatitis

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

Arthritis, calcification (calcification of ligaments and tendons), premature closure of the growth zone of the pineal gland, exostosis (hyperostosis), decreased bone density, tendinitis

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 allergy.

Concomitant tetracyclines therapy

Liver failure

Hypervitaminosis A

Hyperlipidemia

Children and adolescents up to 18 years old

Pregnancy, lactation period

Women of childbearing age, if all the conditions of the Pregnancy Prevention Program are not met

Carefully

Diabetes

History of depression

Obesity

Violation of lipid metabolism

Alcoholism

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Drug interactions

Due to the possible intensification of the symptoms of hypervitaminosis A, the simultaneous administration of Acnecutan and preparations 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 the effectiveness, and can also cause an increase in intracranial pressure, their use in combination with Acnecutan is contraindicated.

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

Simultaneous 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"type =" checkbox ">

special instructions

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

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

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 swelling of the optic papilla. If patients develop benign intracranial hypertension, Acnecutan therapy should be immediately canceled.

Psychiatric disorders

In rare cases, depression, psychotic symptoms and suicidal attempts have been described in patients receiving Acnecutan. Although their causal relationship with the use of the drug has not been established, special care should be taken in patients with a history of depression and all patients should be monitored for depression during drug treatment, referring them to an appropriate specialist if necessary.

However, discontinuing Acnecutan may not be sufficient to alleviate symptoms and, therefore, may require additional psychiatric consultation.

Diseases of the skin and subcutaneous tissues

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

Exposure to sun exposure and UV therapy should be limited. If necessary, a sunscreen with a high SPF value (SPF 15 or higher) should be used.

Avoid deep chemical dermoabrasion and laser treatment for patients receiving Acnecutan, as well as for 5-6 months after the end of treatment due to the possibility of increased scarring in atypical places and, less often, with the risk of post-inflammatory hyper- or hypopigmentation in the treated areas. During treatment with Acnecutan and for 6 months after it, you cannot carry out epilation using wax applications due to the risk of epidermal detachment, the development of scars and dermatitis.

During treatment, the use of local keratolytic or exfoliative anti-acne substances should be avoided, due to the possibility of increasing local irritation.

Diseases of the musculoskeletal system

After the use of Acnecutan in high doses for many years for the treatment of dyskeratosis, bone changes developed, including premature closure of the epiphyseal growth zones, calcification of tendons and ligaments, therefore, when prescribing the drug, the ratio of possible benefits and risks should be carefully evaluated beforehand.

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

Visual impairment

Dry eyes, corneal opacities, decreased night vision, and keratitis usually resolve after therapy ends. Dry eye symptoms can be relieved by applying a lubricating ointment or tear replacement therapy. Contact lens intolerance may occur, which may lead to the need to wear glasses during therapy.

The deterioration of night vision began suddenly in some patients. Patients with visual impairments should be referred for consultation with an ophthalmologist. In some cases, the cancellation of Acnecutan may become necessary.

It is necessary to observe patients with dry conjunctiva for the possible development of keratitis.

Gastrointestinal Disorders

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

Hepatobiliary Disorders

It is recommended to monitor liver function 1 month before treatment, 1 month after its start, and then every 3 months, except for special medical circumstances that warrant more frequent monitoring. If the level of hepatic transaminases exceeds the norm, it is necessary to reduce the dose of the drug or cancel it.

Fasting serum lipids should also be measured 1 month before treatment, 1 month after initiation, and then every 3 months, unless there is an indication for more frequent monitoring. Typically, lipid concentrations return to normal after dose reduction or drug withdrawal, as well as following dietary intake. It is necessary to control a clinically significant increase in triglyceride levels, since their rise above 800 mg / dL may be accompanied by the development of acute pancreatitis, possibly with a fatal outcome. With persistent hypertriglyceridemia or symptoms of pancreatitis, Acnecutan should be canceled.

Allergic reactions

Rare cases of anaphylactic reactions are described, which sometimes occurred after the previous external use of retinoids. Allergic skin 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 closely monitor the patient.

High-risk patients

Patients from a high-risk group (with diabetes mellitus, obesity, alcoholism or disorders of fat metabolism) during treatment with Acnecutan may require more frequent laboratory monitoring of glucose and lipid levels. During treatment with isotretinoin, an increase in fasting blood glucose was observed, as well as cases of diabetes onset.

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

Both female and male patients need to be provided with patient information.

Additional Precautions:

Patients should be advised not to ever transfer this medication to another person, but 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 Acnecutan exposure include abnormalities of the central nervous system (hydrocephalus, cerebellar malformations / abnormalities, microcephaly), facial dysmorphism, cleft palate, external ear defects (absence of the external ear, small or absent external auditory canals), disorders of the organ of vision (microphthalmia), cardiovascular disorders (malformations such as tetrad of Fallot, transposition of major vessels, septal defects), thymus abnormalities and parathyroid abnormalities. A higher incidence of miscarriages was also observed.

If pregnancy occurs in women treated with Acnecutan, the pregnancy should be terminated and the patient should be referred to a specialized doctor with extensive experience in teratology for assessment and recommendations.

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

The patient has an acute acne rash (such as nodose, globular, or other acne that leaves significant scars) that is resistant to the classic treatment of systemic antibiotics and topical treatment

She understands the risk of developmental abnormalities

She understands the need for regular monthly checkups

She understands the need for effective continuous contraception, and takes 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 must 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 everything possible consequences possible pregnancy and the need for immediate consultation with a doctor if there are risks of getting pregnant

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

It confirms the awareness of all the risks and precautions that arise when taking isotretinoin

These precautions also apply to women who are not sexually active, unless the prescriber makes a compelling case that there is indeed no possibility of pregnancy.

The appointer must confirm that:

The patient meets the requirements of the "Pregnancy Prevention Program" listed earlier 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 effective methods of contraception, including mechanical, one month before the start of treatment, during it and one month after

Pregnancy tests must be negative before, during, and 5 weeks after treatment ends. The test results must be recorded on the patient's record.

The use of contraception, as indicated above, during treatment with Acnecutan should be recommended even to those women who usually do not 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.

Information on preventing pregnancy should be given to patients both orally and in writing.

Contraception

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

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

Pregnancy screening

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

Before starting therapy:

To exclude the possibility of pregnancy, it is recommended that an initial pregnancy test is carried out under medical supervision and that the date and result are recorded before starting contraception. 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 done approximately 3 weeks after the last unprotected intercourse. The doctor must provide the patient with full information about contraception.

A pregnancy test under the supervision of a specialist should also be done at the time of the first prescription of isotretinoin, or three days before that prescription. The date of this test may be delayed until the patient has been using contraceptives 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.

Follow-up visits

Follow-up visits must be arranged at intervals of 28 days. The need for repeated pregnancy tests under medical supervision every month should be determined according to the local established procedure, taking into account the patient's sexual activity and menstrual cycle(abnormal menstruation, periods of amenorrhea). If indicated, follow-up pregnancy tests should be done on the day of the doctor's appointment during which the drug is prescribed, or 3 days before the doctor's appointment.

End of therapy

Women should have a definitive pregnancy test five weeks after stopping therapy to rule out pregnancy.

Restrictions on appointment and leave

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

Male patients

There is no reason to believe that treatment with isotretinoin can affect potency or other problems in men. However, men need to be reminded not to share the drug with anyone, especially women.

Lactation period

Acnecutane is highly lipophilic, therefore, it is very likely that isotretinoin will enter the mother's milk. Due to the likelihood of development adverse events in mother and child, the use of Acnecutan is contraindicated in nursing mothers.

The drug contains sorbitol; patients with fructose intolerance are not recommended to use Acnecutan.

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

Overdose

Isotretinoin is a vitamin A derivative. The 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 printed on the package.