Sotret, 10 mg, capsules, 30 pcs.
The drug Sotret should be prescribed only by doctors, preferably dermatologists, who have experience in the use of systemic retinoids and are aware of the risk of teratogenicity of the drug.
Precautionary measures
To avoid accidental exposure of the drug to the body of other people, donated blood should not be taken from patients who are taking or have recently (1 month) taken the drug Sotret.
Disorders of the liver and biliary tract
It is recommended to monitor liver function and liver enzymes before treatment, 1 month after treatment, and then every 3 months unless more frequent testing is indicated. An unstable and reversible increase in “liver” transaminases was noted, in most cases within normal values. If the activity of “liver” transaminases exceeds the norm, it is necessary to reduce the dose of the drug or discontinue it.
Lipid metabolism
Serum lipid levels should be checked before starting treatment (fasting), one month after starting treatment, and then successively at three-month intervals unless more frequent testing is indicated. Elevated serum lipid levels usually return to normal values with dose reduction, drug discontinuation, or diet. Isotretinoin causes an increase in plasma triglyceride levels. If hypertriglyceridemia is not controlled to an acceptable level or if symptoms of pancreatitis occur, isotretinoin should be discontinued. Triglyceride levels greater than 800 mg/dL (9.01 mmol/L) can sometimes be due to acute pancreatitis, which can be fatal.
Mental disorders
Depression, depression, excitability, aggressiveness, mood swings, psychotic symptoms, and, very rarely, suicidal ideation, suicide attempts, and suicide have been reported in patients taking isotretinoin. Particular attention should be paid to patients with a history of depression, and all patients should be monitored for signs of depression and, if necessary, receive appropriate treatment. However, discontinuation of isotretinoin may not be sufficient to relieve symptoms, and therefore further psychiatric or psychological evaluation of the patient's condition may be required.
Skin and subcutaneous tissue disorders
An acute attack of acne is occasionally observed during the initial stage of treatment, but with continued treatment it subsides within 7-10 days, and dosage adjustment is usually not required.
Avoid exposure to intense sunlight and ultraviolet radiation. If necessary, use sunscreen with a high protection factor, minimum SPF 15.
Intensive chemical dermabrasion and laser skin treatment are contraindicated in patients taking isotretinoin for 5–6 months after discontinuation of treatment due to the risk of hypertrophic scar formation in atypical areas and, less commonly, post-inflammatory hyper- or hypopigmentation in treated areas. Patients taking isotretinoin are also contraindicated for waxing due to the risk of epidermal detachment.
Concomitant use of isotretinoin and topical keratolytic or exfoliating agents should be avoided as local irritation may increase. Patients are advised to use moisturizing ointments or creams and lip balm when starting to take isotretinoin, as dry skin and lips may occur when starting to take isotretinoin.
Serious skin reactions associated with isotretinoin have been reported several times (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). Because these adverse events may be difficult to distinguish from other possible cutaneous reactions, patients should be counseled about the possibility and signs of such symptoms and should be closely monitored for serious adverse reactions. If a serious adverse reaction is suspected, isotretinoin should be discontinued.
Allergic reactions
There are rare reports of anaphylactic reactions, in some cases occurring after topical use of retinoids. In rare cases, allergic skin reactions have been reported. Severe cases of allergic vasculitis of the extremities, often with purpura and additional areas of skin affected, have also been reported. If serious allergic reactions occur, discontinuation of the drug and careful monitoring of the patient are necessary.
Musculoskeletal system disorders
Several years after the use of isotretinoin for the treatment of dyskeratosis, at a total course dose and duration of therapy higher than those recommended for the treatment of acne, changes in the bones developed, including premature closure of the epiphyseal growth plates, hyperostosis, calcification of ligaments and tendons. While taking isotretinoin, myalgia and arthralgia and an increase in serum CPK are possible, which, in particular, can appear during intense physical activity.
Visual impairment
Because some patients may experience decreased night vision acuity, which sometimes persists after therapy has ended, patients should be advised of the possibility of this condition. Visual acuity must be carefully monitored. Dryness of the conjunctiva of the eyes, corneal opacities, deterioration of night vision and keratitis usually disappear after discontinuation of the drug. If the mucous membrane of the eyes is dry, you can use applications of a moisturizing eye ointment or an artificial tear preparation. Patients with dry conjunctiva should be monitored for possible development of keratitis. Patients with visual complaints should be referred to an ophthalmologist and discontinuation of isotretinoin should be considered. If you are intolerant to contact lenses, you should use glasses during therapy. Exposure to sunlight and UV rays should be limited.
Benign intracranial hypertension
Rare cases of the development of benign intracranial hypertension (“pseudotumor cerebri”) have been described, including when used in combination with tetracyclines. Signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, blurred vision, and papilledema. In such patients, you should immediately stop taking Sotret.
Renal dysfunction
Impaired renal function and renal failure do not affect the pharmacokinetics of isotretinoin. Therefore, isotretionine can be prescribed to patients with impaired renal function. However, it is recommended that such patients begin taking isotretinoin with low doses and gradually increase it to the maximum tolerated dose.
Digestive system disorders
Isotretinoin is a cause of inflammatory bowel disease in patients without a history of bowel disorders. In patients with severe hemorrhagic diarrhea, the drug Sotret should be immediately discontinued.
For high-risk patients
High-risk patients (diabetes, obesity, alcoholism, or lipid disorders) may require more frequent laboratory monitoring of blood glucose and lipid levels when treated with isotretinoin. Elevated blood sugar levels and new cases of diabetes have been reported while taking isotretinoin.
Impact on the ability to drive vehicles and machinery
Since the decrease in twilight visual acuity while taking isotretinoin can be sudden, the patient should be informed about the possibility of such a situation.
Drowsiness, dizziness and visual disturbances have been observed very rarely. Patients should be warned that if these symptoms occur, they should not drive, use machinery, or take part in any activity where such symptoms could put them or others at risk.
Will erase
The drug should be prescribed only by physicians, preferably dermatologists, who have experience in the use of systemic retinoids and are aware of the risk of teratogenicity of the drug.
Precautionary measures
To avoid accidental exposure of the drug to the body of other people, donated blood should not be taken from patients who are taking or have recently (1 month) taken the drug.
Disorders of the liver and biliary tract
It is recommended to monitor liver function and liver enzymes before treatment, 1 month after treatment, and then every 3 months unless more frequent testing is indicated. An unstable and reversible increase in “liver” transaminases was noted, in most cases within normal values. If the activity of “liver” transaminases exceeds the norm, it is necessary to reduce the dose of the drug or discontinue it.
Lipid metabolism
Serum lipid levels should be checked before starting treatment (fasting), one month after starting treatment, and then successively at three-month intervals unless more frequent testing is indicated.
Elevated serum lipid levels usually return to normal values with dose reduction, drug discontinuation, or diet. Isotretinoin causes an increase in plasma triglyceride levels. If hypertriglyceridemia cannot be controlled to an acceptable level or if symptoms of pancreatitis are observed, the drug should be discontinued. Triglyceride levels greater than 800 mg/dL (9.01 mmol/L) can sometimes be due to acute pancreatitis, which can be fatal.
Mental disorders
Depression, depression, excitability, aggressiveness, mood swings, psychotic symptoms, and, very rarely, suicidal ideation, suicide attempts, and suicide have been reported in patients taking isotretinoin. Particular attention should be paid to patients with a history of depression, and all patients should be monitored for signs of depression and, if necessary, receive appropriate treatment. In this case, discontinuation of the drug may not be enough to relieve symptoms, and therefore further psychiatric or psychological assessment of the patient's condition may be required.
Skin and subcutaneous tissue disorders
An acute attack of acne is occasionally observed during the initial stage of treatment, but with continued treatment it subsides within 7-10 days, and dosage adjustment is usually not required.
Avoid exposure to intense sunlight and ultraviolet radiation. If necessary, use sunscreen with a high protection factor, minimum SPF 15.
Intensive chemical dermabrasion and laser treatment of the skin are contraindicated in patients taking the drug for 5-6 months after the end of treatment due to the risk of hypertrophic scars in atypical areas, and, less commonly, post-inflammatory hyper- or hypopigmentation in the treated areas. Patients taking isotretinoin are also contraindicated for waxing due to the risk of epidermal detachment.
Concomitant use of isotretinoin and topical keratolytic or exfoliating agents should be avoided as local irritation may increase. Patients are advised to use moisturizing ointments or creams and lip balm when starting isotretinoin, as dry skin and lips may occur when starting to take it.
Serious skin reactions associated with isotretinoin have been reported several times (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis). Because these adverse events may be difficult to distinguish from other possible cutaneous reactions, patients should be counseled about the possibility and signs of such symptoms and should be closely monitored for serious adverse reactions. If a serious adverse reaction is suspected, the drug should be discontinued.
Allergic reactions
There are rare reports of anaphylactic reactions, in some cases occurring after topical use of retinoids. In rare cases, allergic skin reactions have been reported. Severe cases of allergic vasculitis of the extremities, often with purpura and additional areas of skin affected, have also been reported. If serious allergic reactions occur, discontinuation of the drug and careful monitoring of the patient are necessary.
Musculoskeletal system disorders
Several years after the use of isotretinoin for the treatment of dyskeratosis, at a total course dose and duration of therapy higher than those recommended for the treatment of acne, changes in the bones developed, including premature closure of the epiphyseal growth plates, hyperostosis, calcification of ligaments and tendons. While taking isotretinoin, myalgia and arthralgia and an increase in serum CPK are possible, which, in particular, can appear during intense physical activity.
Visual impairment
Because some patients may experience decreased night vision acuity, which sometimes persists after therapy has ended, patients should be advised of the possibility of this condition. Visual acuity must be carefully monitored. Dryness of the conjunctiva of the eyes, corneal opacities, deterioration of night vision and keratitis usually disappear after discontinuation of the drug. If the mucous membrane of the eyes is dry, you can use applications of a moisturizing eye ointment or an artificial tear preparation. Patients with dry conjunctiva should be monitored for possible development of keratitis. Patients with vision complaints should be referred to an ophthalmologist and discontinuation of the drug should be considered. If you are intolerant to contact lenses, you should use glasses during therapy. Exposure to sunlight and UV rays should be limited.
Benign intracranial hypertension
Rare cases of the development of benign intracranial hypertension (“pseudotumor cerebri”) have been described, including when used in combination with tetracyclines. Signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, blurred vision, and papilledema. In such patients, the drug should be stopped immediately.
Renal dysfunction
Impaired renal function and renal failure do not affect the pharmacokinetics of isotretinoin. Therefore, the drug can be prescribed to patients with impaired renal function. However, it is recommended that such patients begin taking isotretinoin with low doses and gradually increase it to the maximum tolerated dose.
Digestive system disorders
Isotretinoin is a cause of inflammatory bowel disease in patients without a history of bowel disorders. In patients with severe hemorrhagic diarrhea, the drug should be discontinued immediately.
For high-risk patients
High-risk patients (diabetes, obesity, alcoholism, or lipid disorders) may require more frequent laboratory monitoring of blood glucose and lipid levels when treated with isotretinoin. Elevated blood sugar levels and new cases of diabetes have been reported while taking isotretinoin.
Impact on the ability to drive vehicles and machinery:
Since the decrease in twilight visual acuity while taking isotretinoin can be sudden, the patient should be informed about the possibility of such a situation.
Drowsiness, dizziness and visual disturbances have been observed very rarely. Patients should be warned that if these symptoms occur, they should not drive, use machinery, or take part in any activity where such symptoms could put them or others at risk.
