Clinical and pharmacological group: & nbsp

Dermatotropona funds

Included in the formulation
  • AcneCutan®
    capsules inwards 
  • Verocutan
    capsules inwards 
    VEROPHARM SA     Russia
  • Retasol®
    solution externally 
  • Retinoic ointment
    ointment externally 
  • Roaccutane®
    capsules inwards 
    Hoffmann-La Roche Ltd.     Switzerland
  • Scratches
    capsules inwards 
  • АТХ:

    D.10.B.A.01   Isotretinoin

    Pharmacodynamics:Isotretinoin - retinoid for systemic therapy of acne. Improving the clinical picture of severe acne forms is associated with suppression of sebaceous gland activity and a decrease in their size, depriving Propionibacterium acnes of the main substrate for growth.
    The drug suppresses the proliferation of sebocytes and acts on acne, restoring the normal process of cell differentiation.
    The anti-inflammatory effect of isotretinoin on the skin has been proven.
    Pharmacokinetics:The kinetics of isotretinoin and its metabolites is linear, it does not affect the activity of hepatic enzymes involved in the metabolism of drugs.
    In patients with acne, maximum plasma concentrations in the equilibrium state after administration of 80 mg of isotretinoin on an empty stomach were 310 ng / ml and were achieved after 2-4 hours. The concentration of isotretinoin in the plasma is about 1.7 times higher than the concentration in the blood, due to the poor penetration of isotretinoin into erythrocytes.
    Isotretinoin binds to plasma proteins by 99.9%.After ingestion, three main metabolites are detected in the plasma: 4-oxo-isotretinoin, tretinoin (fully transretinic acid) and 4-oxo-retinoin. After ingestion of radiolabeled isotretinoin in urine and feces, approximately the same amount is found. The half-life of the terminal phase for the unchanged drug in patients with acne is an average of 19 hours.
    Indications:Used for the treatment of severe acne forms (nodular-cystic, conglobate acne or acne with the risk of scarring) and acne, not amenable to other types of therapy.

    XII.L60-L75.L70   Acne

    Contraindications:
    • Pregnancy
    • Breastfeeding period
    • Liver failure
    • Hypervitaminosis A
    • Expressed hyperlipidemia
    • Concomitant therapy with tetracyclines
    • Hypersensitivity to the drug or its components (including soy).
    • Children under 12 years.
    Carefully:
    • Depression in history
    • Diabetes
    • Obesity
    • Violation of lipid metabolism
    • Alcoholism
    Pregnancy and lactation:Recommendations for the FDA - category X. Contraindicated in pregnancy and lactation, has a teratogenic effect.
    Women taking isotretinoin, should use effective means of contraception during the entire period of treatment with the drug and 1 month after the end of treatment.
    Dosing and Administration:Inside, with meals once or twice a day.
    Recommended daily doses are from 0.4 to 1 mg / kg of body weight. Patients with very serious forms of disease or with acne of the trunk may need higher daily doses - up to 2.0 mg / kg. The course dose of 100 to 150 mg / kg, the duration of therapy in specific patients varies depending on the daily dose.
    The highest daily dose: 2.0 mg / kg
    Side effects:The system of hematopoiesis: anemia, neutropenia, increased erythrocyte sedimentation rate, nasal bleeding.
    Digestive system: nausea, colitis, in rare cases - hepatitis.
    Musculoskeletal system: myalgia, arthralgia, rarely - hyperostosis. Dermatological reactions: skin rash, dermatitis, dry mucous membranes, erythema, sweating, paronychia, nail dystrophy, increased granulation of tissues in affected areas, rarely - photosensitivity, vasculitis, thinning of hair. Sense organs: photophobia, conjunctivitis, corneal opacity, decreased visual acuity at twilight, hearing impairment.
    Central and peripheral nervous system: often headache, rarely depression, suicidal tendencies, convulsive seizures.
    Allergic reactions.
    Overdose:

    Signs of hypervitaminosis A.

    Treatment is symptomatic.

    Interaction:Since tetracyclines can cause an increase in intracranial pressure, their use in combination with the drug is contraindicated.
    Isotretinoin may impair the effectiveness of progesterone preparations, 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 the possible increase in local irritation.
    Special instructions:The drug should be prescribed only by doctors, preferably dermatologists with experience in the use of systemic retinoids and who are aware of the risk of teratogenicity of the drug. Patients, both female and male, must provide a copy of the brochure with information for the patient.
    In order to avoid accidental exposure of the drug to the body of other people, in patients who receive or shortly before they received the drug, you can not take donor blood during the course of treatment with the drug and 1 month after the end of treatment.
    It is recommended to monitor liver function and hepatic enzymes before treatment, 1 month after its onset, 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 activity of hepatic transaminases exceeds the norm, it is necessary to reduce the dose of the drug or to cancel it.
    The concentration of serum lipids in the serum should be determined before the treatment, 1 month after the start, and then every 3 months or according to the indications. Usually lipid concentrations are normalized after dose reduction or drug withdrawal, as well as dieting. It is necessary to monitor a clinically significant increase in triglyceride concentration, since their elevation 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, the drug should be discontinued.
    In rare cases, at the beginning of therapy, there is an exacerbation of acne, which occurs within 7-10 days without correction of the dose of the drug.
    Patients receiving the drug are recommended to use moisturizing ointment or body cream, lip balm to reduce dry skin and mucous membranes at the beginning of therapy.
    Since some patients may experience a reduction in the severity of twilight vision, which sometimes persists after the end of therapy, patients should be informed about the possibility of this condition, recommending them to use caution when driving a car at night. The state of visual acuity needs to be carefully monitored.
    Limit the effects of sunlight and ultraviolet rays. If necessary, use a sunscreen with a high protective factor of at least 15 SPF (sun protection factor).
    Rare cases of development of benign intracranial hypertension ("pseudocarcinoma of the brain") are described, including. when combined with tetracyclines. Such patients should immediately cancel the drug.
    The presence of drugs in the environment should be minimized.
    Impact on the ability to drive vehicles and work with machines and mechanisms.
    During the period of treatment, extreme care must be taken when driving vehicles, especially at night, and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
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