Isotretinoin | Will erase 10 mg capsules, 30 pcs.

Release form

Capsules.

Packing

30 pcs.

Pharmacological action

Retinoid for systemic treatment of acne

Isotretinoin is a stereoisomer of fully trans-retinoic acid (tretinoin). The exact mechanism of action of Sotret has not yet been clarified, but it has been established that the improvement of the clinical picture of severe forms of acne is associated with a suppression of the activity of the sebaceous glands and a histologically confirmed decrease in their size. In addition, the anti-inflammatory effect of isotretinoin on the skin has been proven.

Hyperkeratosis of epithelial cells of the hair bulb and sebaceous gland leads to desquamation of corneocytes in the duct of the gland and to blocking the latter with keratin and excess sebum secretion. This is followed by the formation of gum and, in some cases, the joining of the inflammatory process. Sotret inhibits the proliferation of sebocytes and acts on acne, restoring the normal process of cell differentiation. Sebum is the main substrate for the growth of Propionibacterium acnes, therefore, a decrease in sebum formation inhibits bacterial colonization of the duct.

Indications

Severe forms of acne (nodular-cystic, conglobate acne or acne with a risk of scar formation).

Acne not amenable to other types of therapy.

Contraindications

Pregnancy, lactation period (see section "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.

Use during pregnancy and lactation

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

Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs during the period when a woman is taking isotretinoin orally (at any dose, or even for a short time), there is a very great risk of having a baby with developmental defects.

This eraser is contraindicated for women of childbearing age, unless the woman’s condition meets all of the following criteria:

• she must suffer from severe acne that is resistant to conventional

treatments • she must understand and follow the doctor’s instructions

• she must be informed by the doctor about the dangers pregnancy during treatment with Sotret, within one month after it and urgent consultation in case of suspected pregnancy

• she should be warned about the possible

contraceptive failure • she must confirm including barrier

• she should have a negative result of a reliable pregnancy test within 11 days before taking the drug, a pregnancy test is strongly recommended monthly during treatment and 5 weeks after the end of

therapy • she should start treatment with Sotret only 2 -3 day of the next normal menstrual cycle

• she must understand the need for a mandatory visit to the doctor every month

• during treatment for relapse she must constantly enjoy the same effective methods of contraception for one month before starting treatment erase, during treatment and for one month after its completion, and also undergo the same reliable pregnancy test

• she must fully understand the need for precautionary measures and confirm her understanding and desire to use reliable contraception methods, which the doctor explained to her

.

The use of contraceptives according to the above directions during treatment with isotretinoin should be recommended even to those women who usually do not use contraceptive methods due to infertility (with the exception of patients who underwent hysterectomy), or who report that they do not have sex.

The doctor must be sure that: • the patient suffers from severe acne (nodular-cystic, conglobate acne or acne with a risk of scar formation) acne, non-resistant to other types of

therapy • a negative result of a reliable pregnancy test was obtained before 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 uses at least 1, preferably 2 effective methods contraception, including the barrier method, within one month before the commencement of treatment with Sotret, during treatment and within a month after its completion

• the patient is able to understand and perform all of the above requirements for the prevention of pregnancy

• The patient complies with all conditions above.

Pregnancy test

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

Before starting treatment: • To exclude a possible pregnancy, the result and date of the initial pregnancy test should be registered by a doctor before starting contraception. In patients with irregular menstruation, the time for a pregnancy test depends on sexual activity, it should be done 3 weeks after unprotected intercourse. The doctor should inform the patient about contraception methods.

• A pregnancy test is performed on the day of Sotret's appointment or 3 days before the patient's visit to the doctor. The specialist should record the test results. The drug can be prescribed only to patients receiving effective contraception for at least 1 month before starting Sotret therapy.

During therapy: The patient should 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 there is evidence, a pregnancy test is performed on the day of the visit or three days before the visit to the doctor, the test results must be recorded.

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

A prescription for a woman with a fertility can only be prescribed for 30 days of treatment, continued therapy requires a new prescription. It is recommended that a pregnancy test, prescription and receipt of the drug be carried out in one day.

The issue of Sotret at the pharmacy should be carried out only within 7 days from the date of prescription.

Complete information on teratogenic risk and strict adherence to pregnancy prevention must be provided to both men and women.

Specific instructions

Sotret should be prescribed only by doctors, preferably dermatologists, who are experienced in the use of systemic retinoids and who are aware of the risk of teratogenicity of the drug. To avoid accidental effects of the drug on the body of other people, donor blood should not be taken from patients who receive or shortly before (1 month) received Sotret.

It is recommended to monitor liver function and liver enzymes before treatment, 1 month after its start, and then every 3 months or as indicated. A transient and reversible increase in hepatic transaminases was noted, 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. You should also determine the level of lipids in fasting serum before treatment, 1 month after the start, and then every 3 months or as indicated. Typically, lipid concentrations are normalized after a dose reduction or drug withdrawal, as well as dieting. It is necessary to control a clinically significant increase in the level of triglycerides, since their rise above 800 mg / dl or 9 mmol / l may be accompanied by the development of acute pancreatitis, possibly with a fatal outcome. With persistent hypertriglyceridemia or symptoms of pancreatitis, Sotret should be canceled. In rare cases, patients treated with Sotret have described depression, psychotic symptoms and very rarely suicidal attempts. Although their causal relationship with the use of the drug has not been established, special care must be taken in patients with a history of depression and all patients should be monitored for depression during treatment with the drug, if necessary referring them to the appropriate specialist. However, the withdrawal of 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, exacerbation of acne is noted, which disappears within 7-10 days without dose adjustment.

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

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

Avoid deep chemical dermabrasion and laser treatment in patients receiving Sotret, and also 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 Sotret and for 6 months after it, it is impossible to carry out epilation with the help of wax applications because of the risk of detachment of the epidermis, the development of scars and dermatitis.

Since some patients may experience a decrease in visual 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. The state of visual acuity must be carefully monitored. Dry conjunctiva of the eyes, clouding of the cornea, deterioration of night vision and keratitis usually disappear after discontinuation of the drug. When the mucous membrane of the eyes is dry, applications of a moisturizing eye ointment or an artificial tear preparation can be used. 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 advisability of canceling Sotret. In case of intolerance to contact lenses, glasses should be used during therapy. Limit exposure to sunlight and UV rays. 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, the Sotret should be withdrawn immediately. With Sotret therapy, an inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, it is necessary to immediately cancel the Sotret.

Rare cases of anaphylactic reactions that occurred only after previous external use of retinoids are described. Severe allergic reactions dictate the need for drug withdrawal and close monitoring of the patient. Patients from the high-risk group (with diabetes mellitus, obesity, chronic alcoholism or impaired fat metabolism) during treatment with Sotret may require more frequent laboratory monitoring of glucose and lipids. If you have or suspect diabetes, a more frequent definition of glycemia is recommended.

Composition

Each capsule contains 10 mg isotretinoin.

Dosage and administration of

Standard dosing regimen

Inside, with food, 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.

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

In most patients, acne completely disappears after a single course of treatment. With a clear relapse, a second course of treatment with Sotret is shown in the same daily and course dose as the first. Since improvement can continue up to 8 weeks after discontinuation of the drug, a second course should be prescribed no earlier than the end of this period.

Dosage in special cases

In patients with severe renal impairment, treatment should be started with a lower dose (for example, 10 mg / day) and then increased to 1 mg / kg / day or as tolerated as possible.

Side effects of

Most side effects of Sotret are dose dependent. As a rule, when prescribing recommended doses, the ratio of benefit to risk, given the severity of the disease, is acceptable to the patient. Usually, side effects are reversible after dose adjustment or drug withdrawal, but some may persist after treatment is discontinued.

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

Skin and its appendages rash, itching, erythema of the face / dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased growth of granulation tissue, persistent thinning of hair, reversible hair loss, fulminant forms of acne, hirsutism, hyperpigmentation, photo sensibil injured skin. At the beginning of treatment, exacerbation of acne may occur, lasting several weeks.

Musculoskeletal system: muscle pain with an increase in 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: impaired behavior, depression, headache, increased intracranial pressure (“pseudo-brain tumor”: headache, nausea, vomiting, visual impairment, optic nerve edema), convulsive seizures.

Sensory organs: individual cases of visual acuity, photophobia, impaired dark adaptation (decreased twilight visual acuity), rarely - color perception disorder (after drug withdrawal), lenticular cataract, keratitis, blepharitis, conjunctivitis, eye irritation, optic nerve edema (as manifestation of intracranial hypertension) hearing impairment 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 are described. Transient and reversible increase in hepatic transaminase activity, individual cases of hepatitis. In many of these cases, the changes did not go beyond the normal range and returned to the initial indicators during the treatment process, however, in some situations it was necessary to reduce the dose or cancel Sotret.

Respiratory organs: rarely - bronchospasm (more often in patients with a history of bronchial asthma).

Blood system: anemia, decreased hematocrit, leukopenia, neutropenia, increased or decreased platelet count, accelerated ESR.

Laboratory indicators: hypertriglyceridemia, hypercholesterolemia, hyperuricemia, decreased levels of high density lipoproteins, rarely hyperglycemia. During the reception of Sotret, cases of newly diagnosed diabetes were recorded. In some patients, especially those involved in intense physical activity, individual cases of increased activity of CPK in serum are described.

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.

Drug interaction

Due to the possible intensification of symptoms of hypervitaminosis A, the simultaneous administration of Sotret and vitamin A.

should be avoided. Since tetracyclines can also cause increased intracranial pressure, their use in combination with Sotret is contraindicated.

Isotretinoin can weaken the effectiveness of progesterone preparations, therefore, do not use contraceptives containing small doses of progesterone. Combined use with topical keratolytic or exfoliative drugs for the treatment of acne is contraindicated because of the possible increase in local irritation.

Overdose

In the event of an overdose, signs of hypervitaminosis A. may occur in the first few hours after overdose.

Expiration

2 years.

Pharmacy terms Pharmacies

In retseptu

lekarstvennaja form

kapsul

Indications

Severe acne

Possible product names

COLLECT 0.01 N30 CAPS

Wipe 10mg Caps. X30

SOCKET 10MG. No. 30 CAPS.

Erase caps. 10mg N30 India

WILL Erase CAPS. 10MG No. 30

Ranbaxy Laboratoriz Limited, India