SOTRET CAPSULES 20MG

Packing

Mechanism of action

Retinoid for systemic treatment of acne

Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of Sotret has not yet been elucidated, but it has been established that the 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. In addition, isotretinoin has an anti-inflammatory effect on the skin.

Hyperkeratosis of the epithelium cells of the hair follicle and the sebaceous gland leads to desquamation of the corneocytes in the duct of the gland and to the occlusion of the latter with keratin and an excess of sebaceous secretion. This is followed by the formation of comedone and, in some cases, the addition of the inflammatory process. Erase inhibits sebocyte proliferation and acts on acne, restoring the normal process of cell differentiation. Sebum - the main substrate for growthPropionibacterium acnestherefore reducing the formation of sebum suppresses bacterial colonization of the duct.

Indications and usage

Severe acne (nodular / cystic, conglobate acne or acne with the risk of scarring).
Acne, not amenable to other therapies.

Contraindications

Pregnancy, breastfeeding period (seesection "Pregnancy and lactation period"), liver failure, hypervitaminosis A, severe hyperlipidemia, concomitant Tetracycline therapy.
Hypersensitivity to the drug or its components. Children's age up to 12 years.

Pregnancy and Breastfeeding

Pregnancy is an absolute contraindication for Sotret therapy. If pregnancy occurs, despite the warnings, during treatment or within a month after the end of therapy, there is a very high risk of having a baby with severe developmental defects.

Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs at a time when a woman orally takes isotretinoin (at any dose or even a short time), there is a very high risk of having a baby with developmental disabilities.
Erase is contraindicated in women of childbearing age, unless the condition of a woman satisfies all the following criteria:

• It must suffer from severe acne that is resistant to the usual methods of treatment;
• she must certainly understand and follow the instructions of the doctor;
• she should be informed by a doctor about the danger of pregnancy during the course of treatment by Sotret, within one month after it and urgent consultation if a pregnancy is suspected;
• she should be warned about the possible ineffectiveness of contraception;
• 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 one month before treatment with Soteret, during treatment and within a month after its termination (see section “Interaction with other drugs”); It is desirable to use simultaneously 2 different methods of contraception, including barrier;
• she must have received a negative result of a reliable pregnancy test within 11 days before the start of the drug; pregnancy test is strongly recommended to be carried out monthly during treatment and 5 weeks after the end of therapy;
• she should start treatment with Eraser only for 2-3 days of the next normal menstrual cycle;
• she must understand the necessity of compulsory visits to the doctor every month;
• when treating for the recurrence of the disease, she should constantly use the same effective methods of contraception for one month before the start of treatment by Sotret, during treatment and for one month after its completion, as well as undergo the same reliable pregnancy test;
• she must fully understand the need for precautions and confirm her understanding and willingness to use reliable contraceptive methods that she explained to her
doctor.

The use of contraceptives according to the above instructions during treatment with isotretinoin should be recommended even to women who usually do not use contraceptive methods due to infertility (except for patients who have undergone hysterectomy).amenorrhea or who report that they are not sexually active.

• the patient suffers from severe acne (nodular-cystic, conglobate acne or acne with the risk of scarring); acne that is not amenable to other therapies;
• a negative result of a reliable pregnancy test was obtained before the start of the drug intake, during therapy and 5 weeks after the end of therapy; the dates and results of the pregnancy test must be documented;
• the patient uses at least 1, preferably 2 effective methods of contraception, including a barrier method, within one month before the start of treatment with Soteret, during treatment and within a month after its termination;
• the patient is able to understand and fulfill all the above requirements for the prevention of pregnancy;
• The patient meets all of the above conditions.

In accordance with existing practice, a pregnancy test with a minimum sensitivity of 25 tME / ml should be carried out in the first 3 days of the menstrual cycle:

Before initiating therapy:
• To exclude a possible pregnancy, the result and the date of the initial pregnancy test must be recorded by a doctor prior to the use of contraception. In patientswithirregular menstruation the time of the pregnancy test depends on sexual activity, it should be carried out 3 weeks after unprotected intercourse.The physician should inform the patient about contraceptive methods.
• A pregnancy test is conducted on the day of appointment Sotret or 3 days before the patient's visit to the doctor. The specialist should register the test results. The drug can be prescribed only to patients who receive effective contraception for at least 1 month prior to the initiation of therapy by Soteret.

During therapy:
The patient should visit the doctor every 28 days. The need for monthly pregnancy testing is determined in accordance with local practice and taking into account sexual activity, previous violations of the menstrual cycle. If there is evidence, a pregnancy test is carried out on the day of the visit or three days before the visit to the doctor, the test results must be recorded.

End of therapy:
5 weeks after the end of therapy, a test is performed to rule out pregnancy

A prescription to Eat woman capable of childbirth can be discharged only for 30 days of treatment, the continuation of therapy requires a new prescription of the drug by a doctor. We recommend a pregnancy test, prescription and receiving the drug in one day.
The issuance of Erased in a pharmacy should be carried out only within 7 days from the date of prescription.
Full information on teratogenic risk and strict adherence to measures to prevent pregnancy should be provided to both men and women.

Special notes

Only doctors, preferably dermatologists, who have experience with the use of systemic retinoids and are aware of the risk of drug teratogenicity, should prescribe. In order to avoid accidental effects of the drug on the body of other people, patients who receive or shortly before that (1 month) received Erase, you can not take donated blood.

It is recommended to monitor liver function and liver enzymes before treatment, 1 month after its onset, and then every 3 months or as indicated. A transient and reversible increase in hepatic transaminases is noted, in most cases within normal limits. If the level of liver transaminases exceeds the norm, it is necessary to reduce the dose of the drug or cancel it. You should also determine the level of lipids in the serum on an empty stomach before treatment, 1 month after the start, and then every 3 months or according to indications. Usually, lipid concentrations are normalized after dose reduction or withdrawal of the drug, as well as diet. It is necessary to control the clinically significant increase in triglycerides, since their elevation above 800 mg / dL or 9 mmol / L may be accompanied by the development of acute pancreatitis, possibly with a fatal outcome. If persistent hypertriglyceridemia or symptoms of pancreatitis will erase should be abolished. In rare cases, in patients who received Soot, depression, psychotic symptoms and, very rarely, suicidal attempts are described.Although their causal relationship with the use of the drug has not been established, special care must be taken in patients with depression in history and all patients should be monitored for depression during treatment with the drug, if necessary, referring them to the appropriate specialist. However, abolishing Sotret may not lead to the disappearance of symptoms and may require further observation and treatment by a specialist. In rare cases, at the beginning of therapy, acne exacerbation is noted, which disappears within 7–10 days without a dose adjustment.

A few years after using Sotret for treating dyskeratosis with a total course dose and duration of therapy, higher than those recommended for acne therapy, bone changes developed, including premature closure of epiphyseal growth zones, hyperostosis, calcification of ligaments and tendons. Therefore, when prescribing a drug to any patient, you should first carefully evaluate the ratio of possible benefits and risks.

Patients receiving Erase, it is recommended to use moisturizing ointment or body cream, lip balm to reduce dry skin and mucous membranes at the beginning of therapy. While taking Sotret, pains in muscles and joints, an increase in serum creatinine-phosphokinase of serum are possible, which may be accompanied by a decrease in the tolerance of intense physical exertion.

Deep chemical dermoabrasion and laser treatment should be avoided in patients receiving Erase,and also within 5-6 months after the end of treatment due to the possibility of enhanced scarring in atypical places and the occurrence of hyper- and hypopigmentation. During Sotret's treatment and for 6 months after it, epilation cannot be performed using wax applications because of the risk of epidermis detachment, development of scars and dermatitis.

Since some patients may experience a decrease in visual acuity at night, which sometimes persists even after the end of therapy, patients should be informed about the possibility of this condition, recommending that they be careful when driving a car at night. The state of visual acuity must be carefully monitored. Dry conjunctival eyes, corneal opacities, blurred night vision and keratitis usually disappear after discontinuation of the drug. For dryness of the mucous membrane of the eyes, you can use applications of moisturizing eye ointment or preparation of artificial tears. It is necessary to observe patients with dry conjunctiva for possible development of keratitis. Patients complaining of vision should be referred to an ophthalmologist and consider the appropriateness of abolishing Sotret. If contact lenses are intolerant, glasses should be used at the time of therapy. Exposure to sunlight and UV rays should be limited. If necessary, use a sunscreen with a high protective factor of at least 15 SPF.

Rare cases of the development of benign intracranial hypertension (“pseudo brain tumor”), including when combined with tetracyclines. In such patients, you should immediately cancel Erase.With eradication therapy, inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, you must immediately cancel Erase.

Rare cases of Anaphylactic reactions that occurred only after previous external use of retinoids have been described. Severe allergic reactions dictate the need to discontinue the drug and closely monitor the patient. Patients in the high-risk group (diabetes, obesity, chronic alcoholism, or impaired fat metabolism) may need more frequent laboratory monitoring of glucose and lipids in the treatment with Sothret. If diabetes is present or suspected, a more frequent determination of glycemia is recommended.

Each capsule contains isotretinoin 20 mg.

Standard dosing regimen
Inside, with a meal once or twice a day.

The therapeutic efficacy of Sotret and its side effects are dose dependent and vary in different patients. This dictates the need for individual dose selection during treatment.

Treatment Sotret should begin with a dose of 0.5 mg / kg per day. In most patients, the dose ranges from 0.5 to 1.0 mg / kg of body weight per day. Patients with very severe forms of the disease or with acne torso may require higher daily doses - up to 2.0 mg / kg. It is proved that the frequency of remission and prevention of recurrence is optimal when using a course dose of 120-150 mg / kg (per course of treatment), therefore the duration of therapy in specific patients varies depending on the daily dose.Complete acne remission can often be achieved within 16-24 weeks of treatment. In patients who very poorly tolerate the recommended dose, treatment can be continued at a lower dose, but it can be carried out longer.

In most patients, acne completely disappears after a single course of treatment. With a clear relapse, a repeated course of treatment with Sotret is shown in the same daily and course dose as the first. Since the improvement can continue up to 8 weeks after discontinuation of the drug, a second course should be prescribed not earlier than the end of this period.

Dosing in special cases

In patients with severe renal insufficiency, treatment should begin with a lower dose (for example, 10 mg / day) and further increase to 1 mg / kg / day or the maximum tolerated.

Most side effects of Sotret are dose dependent. As a rule, when prescribing the recommended doses, the ratio of benefits and risks, taking into account the severity of the disease, is acceptable for the patient. Usually, side effects are reversible after dose adjustment or drug withdrawal, but some may persist after stopping treatment.

Symptoms associated with hypervitaminosis A:dry skin, mucous membranes, incl. lips (cheilitis), nasal cavity (bleeding), laryngopharynx (hoarseness), eyes (conjunctivitis, reversible corneal clouding and intolerance to contact lenses).
The skin and its appendages;rash, pruritus, erythema of the face / dermatitis, sweating, pyogenic granuloma, paronychia,they goystrophies, enhanced growth of granulation tissue, persistent thinning of hair, reversible hair loss, fulminant forms of acne, hirsutism, hyperpigmentation, photo sensitization, photoallergy, slight trauma to the skin. At the beginning of treatment, acne may worsen, lasting for several weeks.
Musculoskeletal system:muscle pain with increased serum CPK levels or without it, joint pain, hyperostosis, arthritis, calcification of ligaments and tendons, other bone changes, tendonitis.
Central nervous system and mental sphere:behavioral disturbance, depression, headache, increased intracranial pressure (“psev to a brain tumor”: headache, nausea, vomiting, blurred vision, swelling of the optic nerve), seizures.
Sense organs:isolated cases of visual acuity, photophobia, impaired dark adaptation (reduction in the severity of twilight vision), rarely - color disturbance (taking place after discontinuation of the drug), lenticular cataract, keratitis, blepharitis, conjunctivitis, eye irritation, swelling of the optic nerve (as a manifestation of intracranial hypertension) ; hearing loss at certain sound frequencies.
Gastrointestinal tract;nausea, diarrhea, inflammatory bowel disease (colitis, ileitis), bleeding; pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg / dL). Rare cases of pancreatitis with a fatal outcome have been described.Transient and reversible increase in liver transaminase activity, isolated cases of hepatitis. In many of these cases, the changes did not go beyond the limits of the norm and returned to the original indicators in the course of treatment, but in some situations it was necessary to reduce the dose or cancel it.
Respiratory system:rarely - bronchospasm (more often in patients with bronchial asthma in history).
Blood system:anemia, decrease in hematocrit, leukopenia, neutropenia, increase or decrease in the number of platelets, accelerated ESR.
Laboratory values:hypertriglyceridemia, hypercholesterolemia, hyperuricemia, reduction of high-density lipoprotein levels, rarely hyperglycemia. During the reception Sotret were newly diagnosed cases of diabetes. In some patients, especially those engaged in intense physical activity, isolated cases of an increase in the activity of CK in serum have been described.
The immune system:local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus).
Other:lymphadenopathy, hematuria, proteinuria, vasculitis (Wegener's granulomatosis, allergic vasculitis), systemic hypersensitivity reactions, glomerulonephritis.

Because of the possible increase in symptoms of hypervitaminosis A, the simultaneous administration of Wet and Vitamin A should be avoided.
Since tetracyclines can also cause an increase in intracranial pressure, their use in combination with Erasers is contraindicated.
Isotretinoin can weaken the effectiveness of Progesterone drugs, so do not use contraceptives containing small doses of progesterone. Combined use with local keratolytic or exfoliative drugs for the treatment of acne is contraindicated because of a possible increase in local irritation.