Active substanceIsotretinoinIsotretinoin
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  • Dosage form: & nbspCapsules.
    Composition:

    Each 10 mg capsule contains:

    Active substance: isotretinoin 10 mg.

    Excipients: soybean oil, hydrogenated oil - 7.65 mg, hydrogenated vegetable oil - 32.13 mg, beeswax white - 9.18 mg, disodium edetate - 0.08 mg, butyl hydroxy anisole - 0.016 mg, soybean oil refined oil - 100.944 mg.

    Gelatine capsule: gelatin -56.00 mg, glycerol-29.277 mg, iron-oxide red oxide-0.0325 mg, titanium dioxide-0.190 mg, purified water - q.s., paraffin liquid light * - q.s., isopropanol * - q.s.

    Food ink black S-1-17823 - 0.75 mg.

    Composition of food black ink S-1-17823: shellac 45% (20% esterified) in ethanol 0.333 mg, iron dye oxide black 0.175 mg, isopropanol * 0.202 mg, n-butanol * 0.017 mg, propylene glycol 0.015 mg, ammonium hydroxide * 0.008 mg. * The solvent is not present in the final product, evaporates during the production process.


    Each 20 mg capsule contains:

    Active substance: isotretinoin 20 mg.

    Excipients: soybean oil, hydrogenated oil - 15.30 mg, hydrogenated vegetable oil - 64.26 mg, beeswax white - 18.36 mg, disodium edetate - 0.16 mg, butyl hydroxy anisole - 0.032 mg, soybean oil refined oil-201.888 mg.

    Gelatine capsule: gelatin - 123,651 mg, glycerol - 64,645 mg, allur color red - 0,198 mg, colorant diamond blue FCF - 0.011 mg, titanium dioxide - 0.495 mg, purified water - q.s., paraffin liquid light * - q.s., isopropanol * - q.s.

    Food ink black S-1-17823 - 1.5 mg.

    Composition Food black ink S-1-17823: Shellac 45% (20% esterified) in

    ethanol - 0,666 mg, iron dye oxide black - 0.350 mg, isopropanol * - 0.404 mg,

    n-butanol * -0.034 mg, propylene glycol-0.030 mg, ammonium hydroxide * -0.016 mg.

    * The solvent is not present in the final product, evaporates in the process production.

    Description:

    Capsules 10 mg

    Oval opaque soft gelatin capsules of light pink color, with printed black food inks "RR", containing an orange-yellow oily suspension. There are seams on the sides of the capsules.


    Capsules 20 mg

    Oval opaque soft gelatin capsules of burgundy color, with a printed black food ink "RR", containing orange-yellow oily suspension. There are seams on the sides of the capsules.

    Pharmacotherapeutic group:A remedy for acne.
    ATX: & nbsp

    D.10.B.A.01   Isotretinoin

    Pharmacodynamics:
    Isotretinoin is a stereoisomer of polytransretinoic acid (tretinoin). The precise mechanism of action of isotretinoin has not yet been clarified, but it has been established that the improvement of the clinical picture of severe acne forms is associated with suppression of sebaceous gland activity and 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 hair follicles and sebaceous glands leads to shedding of corneocytes into the duct and gland plugging last keratin and excess sebaceous secretion. This is followed by the formation of a comedon and, in some cases, the attachment of an inflammatory process. Isotretinoin suppresses the proliferation of sebocytes and acts on acne, restoring the normal process of cell differentiation. Skin fat is the main substrate for the growth of Propionibacterium acnes, so reducing the formation of sebum suppresses the bacterial colonization of the duct.
    Pharmacokinetics:

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

    Suction

    Absorption of isotretinoin from the gastrointestinal tract is directly proportional to the dose in the therapeutic range. Absolute bioavailability of isotretinoin was not determined, since the drug in the dosage form for intravenous use of isotretinoin in humans is not. However, extrapolation of the data obtained in the pre-clinical study suggests a rather low and variable systemic bioavailability. In patients with acne, the maximum concentration in the blood plasma (CmOh) in the equilibrium state after administration of 80 mg of fasting isotretinoin were 310 ng / ml (range 188-473 ng / ml) and were achieved after 2-4 hours. The concentration of isotretinoin in the blood plasma is approximately 1.7 times higher than the concentration in the blood, due to poor penetration of isotretinoin into erythrocytes.

    The intake of isotretinoin with food increases its bioavailability by a factor of 2 compared with

    reception on an empty stomach.

    Distribution

    Isotretinoin is largely associated with blood plasma proteins, mainly with albumin (99.9%).

    The volume of isotretinoin distribution in humans has not been determined, since there is no dosage form for intravenous administration.

    Equilibrium concentrations of isotretinoin in the blood (Cmin ss) in patients with severe acne, taking 40 mg of isotretinoin 2 times a day, ranged from 120 to 200 ng / ml. Data on the penetration of isotretinoin in human tissue is extremely small. The concentration of isotretinoin in the epidermis is half that of serum.

    The concentration of isotretinoin in the blood plasma is approximately 1.7 times higher than the concentration in the blood as a whole, which is caused by a low level of penetration of isotretinoin into erythrocytes.

    Metabolism

    After ingestion, three major metabolites are detected in the blood plasma: 4-oxo-isotretinoin, tretinoin (polytransretinoic acid) and 4-oxo-tretinoin. The main metabolite is 4-oxo-isotretinoin, the plasma concentrations of which in the equilibrium state are 2.5 times higher than the concentrations of the initial preparation. There are also less significant metabolites, including also glucuronides, but the structure of not all metabolites is established.

    Metabolites of isotretinoin have biological activity, confirmed in several studies in vitro. Thus, the clinical effects of the drug in patients can be the result of the pharmacological activity of isotretinoin and its metabolites.

    Because the in vivo isotretinoin and tretinoin (polytransretinic acid) reversibly convert 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, a significant role in humans can be played by hepatic intestinal recirculation. Metabolic Studies in vitro showed that in the conversion of isotretinoin to 4-oxo-isotretinoin and tretinoin Several enzymes of cytochrome P450 are involved. Apparently, none of the isoforms plays the dominant role. Isotretinoin and its metabolites have no significant effect on the activity of cytochrome P450 enzymes.

    Excretion

    After ingestion of isotretinoin labeled with radioactive isotopes, approximately the same amount is found in urine and feces. The half-life of the terminal phase for the unchanged active component in patients with acne is an average of 19 hours.The half-life of the terminal phase for 4-oxo-isotretinoin appears to be longer, and its average duration is 29 hours.

    Isotretinoin refers to natural (physiological) retinoids. Endogenous concentrations of retinoids are reached approximately 2 weeks after the end of isotretinoin intake.

    Pharmacokinetics in special cases

    Because the isotretinoin Contraindicated in the violation of liver function, data on the pharmacokinetics of the drug in this group of patients are limited. Renal failure does not significantly reduce the clearance of isotretinoin or 4-oxo-isotretinoin in blood plasma.

    Indications:
    Heavy forms of acne (nodular-cystic, conglobate acne or aki with the risk of scar formation).
    Acne, not amenable to other types of therapy.
    Contraindications:
    - pregnancy, the period of breastfeeding (see the section "Pregnancy and the period of breastfeeding");
    - ability to procreate in women who do not comply with contraception when taking Sotret;
    - liver failure;
    - hypervitaminosis A;
    - severe hyperlipidemia;
    - concomitant therapy with tetracyclines;
    - hypersensitivity to isotretinoin or excipients of the drug Sotret;
    - allergy to peanuts and soybeans (the preparation contains soybean oil, hydrogenated oil, vegetable hydrogenated oil, soybean oil refined oil);
    - children under 12 years.
    Carefully:Depression in history, diabetes, obesity, lipid metabolism, alcoholism.
    Pregnancy and lactation:

    Pregnancy is an absolute contraindication for therapy with Sotret, the active substance of which is isotretinoin. Isotretinoin has a strong teratogenic effect. If pregnancy occurs, despite warnings, during treatment with isotretinoin (inside, at any dose and even for a short time) or for a month after the end of therapy, there is a very big risk of a child with severe developmental defects.

    Pregnancy Pregnancy Program

    The drug Sotret contraindicated in women of childbearing age, unless the condition of a woman meets all of the following criteria:

    - she should have a severe form of acne, resistant to conventional methods of treatment;

    - she must accurately understand the need for thorough monthly medical follow-up and follow the doctor's instructions;

    - she is informed by the doctor about the danger of pregnancy during treatment with Sotret and within one month after treatment, and about the need for urgent consultation with the risk of pregnancy;

    - she should be warned about the possible ineffectiveness of contraceptives;

    - she must confirm that she understands and understands the risk factors and the essence of precautionary measures;

    - she understands the need to use and must continuously use effective contraceptive methods within one month before treatment with Sotret, during treatment and for a month after the end of treatment; It is desirable to use at the same time 2 different methods of contraception, including barrier;

    - the patient realizes and accepts that the pregnancy test must be performed monthly during treatment and 5 weeks after the end of therapy;

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

    - when treating for a relapse of the disease, she must constantly use the same effective methods of contraception within one month before starting treatment with Sotret,during treatment and within a month after its completion, as well as undergo the same reliable pregnancy test;

    - she fully understands the need for precautionary measures and confirms her understanding and desire to apply reliable methods of contraception, which the doctor explained to her;

    - Even with amenorrhea, the patient should follow all recommendations for effective contraception.

    The use of contraceptives in accordance with 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 underwent a hysterectomy), amenorrhea, or who report that they do not have sex.

    The doctor should be sure that:

    - the patient suffers from severe acne (nodular-cystic, conglobate acne or acne with the risk of scarring); acne, not amenable to other types of therapy;

    - a negative result of a valid pregnancy test was obtained prior to 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 of contraception, including the barrier method, for at least one month before starting treatment with Sotret, during treatment and for a month after its termination;

    - the patient is able to understand and fulfill all of the above requirements for protection from pregnancy;

    - the patient meets all of the above conditions;

    - The patient confirmed the understanding of the above conditions and the agreement with them.

    Contraception

    Female patients should be provided with comprehensive information on the prevention of pregnancy and receive advice on contraception if they do not use effective methods of contraception.

    The minimum requirement for patients with a potential risk of pregnancy is the use of at least one method of contraception. It is better for the patient to use two complementary methods of contraception, including the barrier method. The use of contraception, even in patients with amenorrhea, should continue for at least 1 month after discontinuation of isotretinoin.

    Pregnancy test

    In accordance with current practice, a pregnancy test with a minimum sensitivity of 25 mME/ ml should be carried out in the first 3 days of the menstrual cycle: Before the start of therapy:

    - To exclude a possible pregnancy before the application of contraception, the result and the date of the initial pregnancy test must be recorded by the doctor. In patients with irregular menstruation, the timing of the pregnancy test depends on sexual activity, it should be performed 3 weeks after unprotected intercourse. The doctor should inform the patient about the methods of contraception.

    - The pregnancy test is carried out on the day of prescribing the drug Sotret or 3 days before

    visit of the patient to the doctor. The specialist should record the results

    testing. The drug can be prescribed only to patients receiving

    effective contraception at least 1 month before the start of therapy with Sotret.

    During therapy:

    - The patient must visit the doctor every 28 days. The need for a monthly pregnancy test is determined in accordance with local practice and taking into account the sexual activity preceding the menstrual cycle disorders.If there is evidence, a pregnancy test is conducted on the day of the visit or three days before the visit to the doctor, the test results must be recorded.

    End of therapy:

    - After 5 weeks after the end of therapy, a test is performed to exclude pregnancy. Prescription for the drug Sotret to a woman capable of childbirth can be discharged only for 30 days of treatment, continued therapy requires a new prescription of the drug by a doctor. It is recommended that a pregnancy test, a prescription and preparation be conducted on the same day.

    The drug Sotret in the pharmacy should be dispensed only within 7 days from the date of prescription.

    Complete information on teratogenic risk and strict adherence to preventive measures should be provided to both men and women.

    To male patients

    Existing evidence suggests that in women the exposure of isotretinoin, derived from the semen and semen of men taking isotretinoin, is insufficient for the appearance of teratogenic effects of isotretinoin. Male patients should be reminded that they should not share their medication with anyone, especially women.

    In case of pregnancy

    If, during treatment with Sotret, or within a month after the end, despite the precautionary measures described in the pregnancy prevention program, the patient's pregnancy does occur, there is a high risk of very serious fetal malformations (in particular, from the central nervous system , heart and large blood vessels). In addition, the risk of spontaneous miscarriages increases.

    When pregnancy occurs, therapy with Sotret is stopped. It should be discussed the expediency of its preservation with a doctor specializing in teratology. Heavy congenital malformations of the fetus in humans associated with the administration of isotretinoin, including hydrocephalus, microcephaly, malformations of the cerebellum, anomalies of the external ear (microtia, narrowing or absence of the external auditory canal, absence of the external ear), microphthalmia, cardiovascular anomalies (tetrad Fallot, transposition of the main vessels, defects of the septa), developmental defects of the face (wolf mouth), thymus gland, parathyroid gland pathology.

    Because the isotretinoin has a high lipophilicity, it is very likely that he enters the breast milk. Because of possible side effects isotretinoin can not prescribe to nursing mothers.

    Dosing and Administration:

    Standard dosing regimen

    Inside, with meals twice a day.

    The therapeutic effectiveness of the drug Sotret and its side effects depend on the dose and vary in different categories of patients. This dictates the need for individual dosing during treatment.

    Adults, including adolescents, and elderly patients:

    Treatment with Sotret should be started at 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 disease or with acne of the trunk may need higher daily doses - up to 2.0 mg / kg. Expect significant additional benefit with a total dose of more than 120-150 mg / kg should not be. The duration of treatment depends on the individual daily dose. To achieve remission, usually a course of treatment lasting 16-24 weeks is sufficient. In patients who are very poorly tolerated the recommended dose, treatment can continue at a lower dose, but 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 exchange rate as the first. Since the improvement can continue up to 8 weeks after drug withdrawal, the repeated course should be appointed no earlier than the end of this period.

    Dosing in special cases

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

    Patients with intolerance to the recommended dose.

    Patients who are intolerant to the recommended dose can continue taking the drug at a lower dose, given the effects of longer-term therapy and a higher risk of recurrence. To achieve the highest possible efficacy, such patients should continue treatment, taking the maximum tolerated dose of the drug.

    Side effects:

    Most side effects of isotretinoin are dose dependent. As a rule, with the appointment of recommended doses, the benefit-risk ratio, taking into account 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 discontinuation of treatment. The most commonly reported symptoms of undesirable phenomena associated with isotretinoin: dry skin, dry mucous membranes, such as lips (cheilitis), nose (epistaxis) and eyes (conjunctivitis). The frequency of this or that side effect is determined as follows: very often (>1/10 cases), often (>1/100 and <1/10 cases), infrequently (>1/1000 and <1/100 cases), rarely (>1/10000 and <1/1000 cases), very rarely (<1/10000 cases), the frequency is unknown (it is impossible to estimate the frequency of occurrence according to available data).

    From the side of metabolism:

    Rarely: diabetes, hyperuricemia.

    Allergic reactions:

    Rarely: allergy, anaphylactic reaction, hypersensitivity, systemic hypersensitivity reactions.

    From the central nervous system:

    Rarely: depression, worsening of depression, aggressive behavior, excitability, frequent change of mood;

    Rarely: inadequate behavior, psychotic disorder, suicidal thoughts, suicidal attempts, suicide.

    From the nervous system:

    Often: headache;

    Rarely: benign intracranial hypertension ("pseudotumor brain": headache, nausea, vomiting, impaired vision, edema of the optic nerve), convulsions, drowsiness, dizziness.

    Frequency unknown (including individual messages): excessive fatigue.

    From the skin:

    Often: dermatitis, dry skin and mucous membranes, oiiohystrophy, increased proliferation of granulation tissue, rash, itching, face erythema, cheilitis, slight trauma of the skin;

    Rarely: alopecia;

    Rarely: increased perspiration, pyogenous granuloma, paronychia, persistent thinning of hair, reversible hair loss, nail dystrophy, fulminant forms of acne, hirsutism, hyperpigmentation, photosensitivity, photodermatosis, vasculitis (Wegener's granulomatosis, allergic vasculitis). At the beginning of treatment, there may be an exacerbation of acne, which lasts for several weeks.

    Frequency is unknown (including individual messages): Stevens-Johnson syndrome,

    toxic epidermal necrolysis, peeling of the skin of the palms and soles.

    From the urinary system:

    Often: hematuria, proteinuria;

    Rarely: glomerulonephritis.

    From the musculoskeletal system:

    Often: myalgia (with increased activity of creatinine phosphokinase (CK) in the serum or without it) *, arthralgia;

    Rarely: hyperostosis, arthritis, calcification of ligaments and tendons, other bone changes, tendinitis;

    Frequency is unknown (including individual messages): rhabdomyolysis, in some cases

    with a lethal outcome.

    From the digestive system:

    Often: transient and reversible increase in the activity of "liver" transaminases **;

    Rarely: nausea, diarrhea, inflammatory bowel disease (colitis, ileitis), gastrointestinal bleeding; Pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg / dl), dry throat, hepatitis.

    Frequency is unknown (including individual messages): dryness of the oral mucosa, bleeding from the gums, inflammation of the gums. Rare cases of pancreatitis with a lethal outcome are described.

    From the hematopoiesis:

    Often: anemia, increased erythrocyte sedimentation rate, thrombocytopenia,

    thrombocytosis;

    Often: neutropenia;

    Rarely: lymphadenopathy.

    Frequency unknown (including individual messages): a decrease in hematocrit, and leukopenia.

    From the respiratory system:

    Often: nasal cavity bleeding, dry nasal and laryngeal mucosa, nasopharyngitis;

    Rarely: bronchospasm (more often in patients with bronchial asthma in anamnesis), hoarseness.

    From the sense organs:

    Often: blepharitis, conjunctivitis, dry eye syndrome, eye irritation;

    Rarely: individual cases of visual impairment, decreased visual acuity, contact lens intolerance, corneal opacity, color blindness and other color perception abnormalities, cataract, keratitis, optic disc swelling (as a manifestation of benign intracranial hypertension), visual disturbances, hearing impairment. Laboratory indicators:

    Often: hypertriglyceridemia, a decrease in high-density lipoproteins;

    Often: hypercholesterolemia, hyperglycemia;

    Rarely: increased activity of CK in serum.

    Other:

    Rarely: local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus).

    * In some patients, especially those engaged in intensive physical activity,

    Some cases of increased activity of CK in serum are described.

    ** In many of these cases, the changes did not go beyond the limits of the norm and returned to baseline in the treatment process, but in some There is a need to reduce the dose or cancel the drug Sotret.

    Overdose:Isotretinoin is a derivative of vitamin A. Despite the fact that acute toxicity of vitamin A is low, with an occasional overdose, there may be signs of hypervitaminosis (dry skin and mucous membranes, cheilitis, nasal bleeding, hoarseness, conjunctivitis, reversible corneal opacity, intolerance to contact lenses). The manifestation of acute toxicity of vitamin A is expressed in severe headache, nausea or vomiting, drowsiness, irritability and skin itching.
    The signs and symptoms of an accidental or intentional overdose of isotretinoin should be similar. These symptoms probably should be reversible and pass without any treatment.
    Interaction:
    Because of the possible increase in symptoms of hypervitaminosis A, joint use of isotretinoin with vitamin A and other retinoids should be avoided (including with acitretin, tretinoin, retinol, tazarotene, adapalene).
    Since tetracyclines can also cause an increase in intracranial pressure, their use in combination with isotretinoin is contraindicated.
    Isotretinoin may impair the effectiveness of progesterone preparations, so do not use contraceptives containing small doses of progesterone.
    The combined use of isotretinoin with local keratolytic or exfoliative drugs for the treatment of acne is contraindicated because of the possible increase in local irritation.
    Special instructions:

    The drug Sotret 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.

    Precautionary measures

    In order to avoid accidental exposure of the drug to the body of other people, patients who take or shortly before (1 month) took Sotret, you can not take donor blood.

    Disturbances from the liver and bile ducts

    It is recommended that liver function and hepatic enzymes be monitored before treatment, 1 month after its onset, and then every 3 months unless more frequent analysis is indicated.An unstable and reversible increase in "hepatic" transaminases is noted, in most cases within the limits of normal values. If the activity of "liver" transaminases exceeds the norm, it is necessary to reduce the dose of the drug or cancel it.

    Lipid metabolism

    The level of serum lipids should be checked before starting treatment (fasting), one month after the start of treatment and then consistently at three-month intervals, unless more frequent analysis is indicated.

    Elevated levels of serum lipids usually return to normal values ​​when the dose is reduced, the drug is withdrawn, and when the diet is applied. Isotretinoin is the cause of the increase in the level of triglycerides in the blood plasma. In the event that hypertriglyceridemia is not amenable to control at an acceptable level or if symptoms of pancreatitis are observed, isotretinoin should be discontinued. The level of triglycerides, exceeding 800 mg / dl (9.01 mmol / l), can sometimes be caused by acute pancreatitis, which can lead to death.

    Mental disorders

    Depression, depression, excitability, aggressiveness, mood swings,psychotic symptoms, and, very rarely, suicidal ideation, suicide attempts and suicide were documented in patients taking isotretinoin. Particular attention should be given to patients who have a history of depression, with all patients should be observed for signs of depression and, if necessary, receive appropriate treatment. In this case, cancellation of isotretinoin may not be enough to alleviate the symptoms, and hence further psychiatric or psychological assessment of the patient's condition may be required.

    Disturbances from the skin and subcutaneous tissues

    Acute attack of acne is sometimes observed at the initial stage of treatment, but with the continuation of treatment it fades within 7-10 days, with dose adjustment usually not required.

    Avoid exposure to intense sunlight and ultraviolet radiation. If necessary, use sunscreens with a high protection factor, a minimum SPF 15.

    Intensive chemical dermabrasion and laser treatment of the skin are contraindicated in patients taking isotretinoin within 5-6 months after the end of the reception because of the risk of the formation of hypertrophic scars on atypical sites, and, less often,post-inflammatory hyper- or hypopigmentation in the treated areas. Patients receiving isotretinoin, it is also contra-indicated the procedure of epilation with the use of wax because of the risk of exfoliation of the epidermis.

    Avoid simultaneous administration of isotretinoin and external keratolytic or exfoliating agents, as local irritation may increase. Patients are advised to use moisturizing ointments or creams and lip balm from the beginning of taking isotretinoin, since dryness of the skin and lips can occur at the beginning of taking isotretionine.

    Several times, serious skin reactions associated with isotretinoin (erythema polymorph, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported several times. Since these adverse events may be difficult to distinguish from other possible skin reactions, patients should be instructed about the occurrence and symptoms of such symptoms and should be closely monitored for serious adverse reactions. If you are suspected of a serious undesirable reaction, you should stop taking isotretinoin.

    Allergic reactions

    There are rare reports of anaphylactic reactions, in some cases occurred after topical application of retinoids. In rare cases, the onset of skin allergic reactions is reported. Also reported are serious cases of allergic vasculitis of the extremities, often with purpura and affected additional areas of the skin. If serious allergic reactions occur, stop taking the medication and carefully observe the patient.

    Disorders from the musculoskeletal system

    A few years after the use of isotretinoin for the treatment of dyskeratosis at a common course rate and duration of therapy, higher than those recommended for acne therapy, bone changes, including premature closure of epiphyseal growth zones, hyperostosis, calcification of ligaments and tendons, developed. Against the background of taking isotretinoin, myalgia and arthralgia, an increase in the serum CK, are possible, which, in particular, can occur with intense physical exertion.

    Visual impairment

    Since some patients may experience decreased visual acuity, which sometimes persists after the end of therapy,patients should be informed about the possibility of this condition. The state of visual acuity needs to be carefully monitored. Dryness of the conjunctiva of the eyes, opacity of the cornea, worsening of night vision and keratitis usually pass after drug withdrawal. With dry eye mucosa, you can use moisturizing ointment applications or artificial tears. It is necessary to observe patients with dryness of the conjunctiva for possible development of keratitis. Patients who complain about vision should be referred to an ophthalmologist and consider whether it is worthwhile to cancel isotretinoin. If intolerance of contact lenses for the duration of therapy should be used glasses. Limit exposure to sunlight and UV rays.

    Benign intracranial hypertension

    Rare cases of development of benign intracranial hypertension ("pseudocarcinoma of the brain"), including when combined with tetracyclines, are described. Signs and symptoms of benign intracranial hypertension include headache, nausea and vomiting, visual impairment and edema of the optic nerve.Such patients should immediately stop taking Sotret.

    Impaired renal function

    Impaired renal function and renal failure do not affect the pharmacokinetics of isotretinoin. Therefore, isotretiostine can be administered to patients with impaired renal function. However, it is recommended that such patients start taking isotretinoin from small doses and gradually bring to the maximum tolerated dose.

    Disorders from the digestive system

    Isotretinoin is the cause of inflammatory bowel disease in patients who have no history of intestinal disorders. Patients with severe hemorrhagic diarrhea should immediately abolish the drug Sotret.

    Patients in high-risk groups

    Patients in the high-risk group (with diabetes, obesity, alcoholism, or lipid metabolism disorders) in the treatment of isotretinoin may need more frequent laboratory monitoring of glucose and lipid levels in the blood. There was reported increased blood sugar and new cases of diabetes on the background of taking isotretinoin.

    Effect on the ability to drive transp. cf. and fur:
    Since the reduction in the severity of twilight vision against the background of taking isotretinoin may be sudden, the patient should be informed of the possibility of such a situation.
    Very rarely observed drowsiness, dizziness and visual disturbance. Patients should be warned that in case of such events, they should not drive vehicles, use a variety of mechanisms, as well as to take part in any activities where these symptoms could jeopardize their or other people.
    Form release / dosage:Capsules 10 mg, 20 mg.
    Packaging:
    10 capsules in blisters ( "rip" blister) of transparent PVC film laminated with polyethylene, the coated film of PVDC having a substrate of aluminum foil and paper.
    10 capsules in a contour squeeze box ("blown through" blister) from a transparent PVC film with laminated polyethylene coated with PVDC film, having a substrate of aluminum foil, paper and polyester film. 1, 3 or 6 blisters with instructions for use in a cardboard bundle.
    Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C.
    Shelf life:2 years.The drug should not be used after the expiry date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000828
    Date of registration:07.10.2011
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp22.09.2015
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