Active substanceIsotretinoin + ErythromycinIsotretinoin + Erythromycin
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  • Isotrexin
    gel externally 
  • Dosage form: & nbsp
    gel for external use
    Composition:

    1 g of gel contains:

    Components

    Content

    Active substances:


    Isotretinoin

    0,511 (0.5 mg)

    Erythromycin

    22,02 (20 mg)

    Excipients:


    Giprolase

    30 mg

    Butylhydroxytoluene

    0.1 mg

    Ethanol

    up to 1 g

    1 - includes 2% excess.

    2 - includes 10% excess.

    Description:Gel is a light yellow color.
    Pharmacotherapeutic group:Treatment for acne
    ATX: & nbsp

    D.10.A.D.54   Isotretinoin in combination with other drugs

    Pharmacodynamics:

    Isotretinoin is one of the biologically active forms of vitamin A, which has a regulating effect on the growth of epithelial cells and their differentiation. It inhibits terminal differentiation of sebocytes and hyperproliferation of the epithelium of excretory ducts of the sebaceous glands, normalizes the composition of their secretions and facilitates its evacuation. This reduces the production of sebum and reduces the inflammatory reaction around the glands. Isotretinoin affects comedogenesis, inhibits follicular keratinization, suppresses acne caused by Propionibacterium acne. Isotretinoin has anti-seborrheic, anti-inflammatory, keratolytic action.

    Erythromycin is an antibiotic from the macrolide group, which has an inhibitory effect on protein synthesis in bacteria by reversible binding of ribosomal subgroups. In the treatment of acne, the effectiveness of erythromycin is manifested in a decrease in the population of Propionibacterium acne.

    Isotretinoin as a component of the drug Isotrexin is effective in the comedonal phase of the disease, while erythromycin It is effective in treating inflammations of acne of mild to moderate severity.

    Pharmacokinetics:The percutaneous absorption of isotretinoin and erythromycin is negligible. During the study of local absorption of the two components of Isotrexin in the treatment of patients suffering from acne, only a slight increase in levels of isotretinoin compared with baseline levelsisotretinoin usually determined in blood plasma). The indices remained below 5 ng / ml and did not increase in the presence of erythromycin. The levels of erythromycin in the blood plasma were not determined.
    Indications:Treatment of acne of mild and moderate severity.
    Contraindications:

    - Known hypersensitivity to active ingredients or any other component included in the formulation;

    - children's age till 12 years;

    - pregnancy (due to insufficient data on effectiveness and safety);

    - the period of breastfeeding (due to the lack of data on efficacy and safety).

    Carefully:

    The drug should be used with caution in patients with allergies to any of the components that make up the drug.

    The drug should be used with caution in patients with local irritation reactions or photosensitivity in a history.

    Due to isotretinoin an irritant, it should be used with caution on sensitive skin areas such as the neck, at the phenomena of irritation or skin eczematization, as well as in the treatment of patients with inflammatory skin diseases which may be accompanied by acne, e.g., perioral dermatitis or rosacea.

    The drug should be used with caution in patients with ulcerative colitis with regional enteritis; colitis associated with taking antibiotics, or with these diseases in history (including pseudomembranous colitis).

    Isotrexin should be used with caution in patients with a predisposition to skin cancer according to a personal or family history in connection with the possible development of photosensitization, which may increase the risk of sunburn.

    Pregnancy and lactation:

    Fertility

    There are no data on the effect of the drug (or its individual components when applied externally) on human fertility. When administered orally in therapeutic doses isotretinoin does not affect the number, mobility and morphology of spermatozoa.

    Pregnancy

    It is not recommended to use the drug in women during pregnancy or in women capable of giving birth, if they do not use effective methods of contraception.

    There are limited data on the use of the drug in pregnant women. It does not require specific methods of contraception when the drug is used in men.

    Breastfeeding period

    The effect of the drug during breastfeeding has not been studied.

    Percutaneous absorption of erythromycin is low, but it is not known whether erythromycin with breast milk after external use. Erythromycin is excreted in breast milk after oral and parenteral use.

    Information on the isolation of isotretinoin with breast milk for external use is limited.

    The risk to newborns and infants who are breastfed can not be ruled out.

    Assessing the benefits of breastfeeding for a child and the benefits of treatment for a woman should decide whether to stop breastfeeding or refrain from treatment with the drug.

    Dosing and Administration:

    For external use only.

    Before applying the drug, gently wash skin with a mild cleanser and completely dry. The drug is applied a thin layer on the entire damaged surface 1 or 2 times a day, avoiding contact with the eyes, lips and other mucous membranes. After use, wash hands thoroughly.

    To achieve therapeutic effect, the duration of treatment can be up to 8 weeks. Evaluation of the efficacy and safety of the drug in acne has not been studied in clinical studies lasting more than 12 weeks.

    Special patient groups

    Children

    The safety and efficacy of the drug for treatment were not assessedchildren younger than 12 years, so the drug is not recommended for this group of patients.

    Elderly patients

    Special recommendations for the use of the drug in this group of patients are absent.

    Patients with impaired renal function

    Correction of the dose is not required.

    Since external application of the combination of isotretinoin and erythromycin shows low systemic absorption, it is not expected that impaired renal function can lead to clinically significant systemic effects.

    Patients with impaired hepatic function

    Correction of the dose is not required.

    Since external application of the combination of isotretinoin and erythromycin shows low systemic absorption, it is not expected that a dysfunction of the liver can lead to clinically significant systemic effects.

    Side effects:

    The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: Often (1/10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1,000 and <1/100), rarely (≥1 / 10,000 and <1/1 000), rarely (<1/10 000). The following are undesirable reactions,Both with the use of a combination of isotretinoin and erythromycin, and with the use of these active substances separately.

    Clinical Trials Data

    Disturbances from the skin and subcutaneous tissues

    Very often: rashes, dryness, erythema, peeling, burning sensation and itching, skin irritation.

    General disorders and disorders at the site of administration

    Very often: pain.

    Often: reactions at the site of application, including eczema, exfoliative dermatitis and dry skin.

    Post-registration data

    In addition to unwanted reactions registered during clinical trials, the following adverse reactions were reported during the post-marketing period.

    Immune system disorders

    Rarely: an allergic reaction.

    Disorders from the gastrointestinal tract

    Rarely: a feeling of discomfort in the abdomen, pain in the upper departments of the abdomen, diarrhea. Impaired skin and subcutaneous tissue

    Rarely: photosensitization, discoloration of the skin, hyperpigmentation of the skin, hypopigmentation of the skin, urticaria.

    General disorders and disorders at the site of administration

    Rarely: swelling of the face.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms

    If swallowed accidentally, unwanted reactions from the gastrointestinal tract (eg, nausea, vomiting, diarrhea) may occur.

    Treatment

    Skin irritation due to excessive use of the drug should be treated symptomatically.

    In case of accidental ingestion, symptomatic treatment should be carried out in accordance with the clinical picture.

    Interaction:

    No drug interaction studies were conducted.

    The drug should not be used in combination with drugs containing clindamycin, in connection with possible antagonism to clindamycin.

    Do not use together with oxidizing agents, such as benzoyl peroxide, as this may reduce the effectiveness of treatment with isotretinoin. If combination therapy is necessary, the drugs should be used at different times of the day (for example, one drug in the morning and the other in the evening).

    Special instructions:

    If a patient has a sunburn, it must be cured before using the drug.

    Extreme weather conditions, such as wind or cold, can exacerbate irritation in patients who use drugs containing isotretinoin.

    The physician should assess the benefits of continuing treatment beyond 12 weeks of continuous use, given that the risk of microbial resistance increases.

    Increasing the dose or frequency of the drug does not improve its effectiveness, but may increase the risk of skin irritation.

    If skin irritation occurs (redness, flaking or discomfort), you can use a moisturizer if necessary, also reduce the frequency of application or temporarily stop treatment. After the disappearance of skin irritation, the normal frequency of application should be resumed. Discontinue treatment if irritation persists. The effectiveness of the drug at a frequency of application less than once a day was not evaluated.

    Patients should avoid smoking or staying close to an open flame during application and immediately after use,that the drug is highly flammable.

    Effect on the ability to drive transp. cf. and fur:

    Studies of the effect of the drug on the ability to drive vehicles and mechanisms have not been carried out.

    According to the described undesirable reactions, the use of the drug does not adversely affect the ability to drive vehicles or mechanisms.

    Form release / dosage:
    Gel for external use, 0.5 mg / g + 20 mg / g.
    Packaging:

    6 g, 25 g, 30 g, 40 g, 50 g in an aluminum tube sealed with a membrane and sealed with a screw cap made of white polypropylene.

    Each tube together with the instruction for use is placed in a pack of cardboard.

    Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
    Shelf life:
    18 months. Do not use after the expiration date stated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014054 / 01
    Date of registration:24.12.2007
    Expiration Date:Unlimited
    Date of cancellation:2016-03-10
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO
    Information update date: & nbsp09.11.2017
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