Indoxyl (Indoxyl)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBenzoyl peroxide + ClindamycinBenzoyl peroxide + Clindamycin
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  • Indoxyl
    gel externally 
    GlaxoSmithKline Trading, ZAO     Russia
    • Dosage form: & nbspGel for external use.
    Composition: Active substances
    Benzoyl peroxide - 66.711
    (in terms of anhydrous benzoyl peroxide) - 50.0) mg
    Clindamycin phosphate2 - 12,811
    (in terms of clindamycin) 10.0 mg
    Excipients
    Carbomer - 2.00%
    Dimethicone - 0.10%
    Disodium lauryl sulfosuccinate - 0.04%
    Disodium edetate - 0.10%
    Glycerol 4.00%
    Silicon dioxide colloidal - 0,25%
    Poloxamer 182 - 0.20%
    Sodium hydroxide 0.31%
    Purified water - up to 1000 mg

    1 - the amount of active substances can be adjusted depending on the purity of the series of substances.

    2 - In the production of clindamycin, phosphate is incorporated with a 2% excess.

    Description:Homogeneous gel from white to yellowish color.
    Pharmacotherapeutic group:Acne rash remedy
    ATX: & nbsp

    D.10.A.F.51   Clindamycin in combination with other drugs

    Pharmacodynamics:

    Clindamycin is a lincosamide antibiotic with bacteriostatic action against Gram-positive aerobic microorganisms and a wide range of anaerobic bacteria. Lincosamides such as clindamycin, contact with 50S subunit of the bacterial ribosome and inhibit the early stages of protein synthesis.

    Action of clindamycin is predominantly bacteriostatic, although - high concentrations may have a slow bactericidal action against - sensitive strains.

    Although clindamycin is inactive in vitro, fast in vivo Hydrolysis converts this compound into an antibacterially active clindamycin.

    Clindamycin activity was demonstrated in clinical trials with treatment of comedones in patients suffering from acne, while clindamycin Active against most strains Propionibacteium acnes. Clindamycin in vivo inhibits all tested strains Propionibacterium, acnes (minimum inhibitory concentration 0.4 μg / ml). After application of clindamycin, the percentage of free fatty acids on the skin surface decreases from approximately 14% to 2%.

    Benzoyl peroxide has some keratolytic action against comedones at all stages of their development. Benzoyl, the peroxide is a highly lipophilic oxidant that exhibits bactericidal activity against strains Propionibacterium acnes, causing common acne (acne vulgaris). In addition, he is an ebostatik, counteracting the excessive production of sebum associated with acne. Adding benzoyl peroxide reduces the possibility of the emergence of microorganisms resistant to clindamycin. There is a cross-resistance between clindamycin and linkomycin. The presence of two active ingredients in the gel is more convenient in comparison with monocomponent drugs and promotes greater adherence to treatment by patients.

    Pharmacokinetics:

    The percutaneous absorption of clindamycin is negligible (0.043 % of the used dose). The presence of benzoyl peroxide in the composition of the drug did not affect the transdermal absorption of clindamycin. Studies with radio labeling have shown that the absorption of benzoyl peroxide through the skin can occur only after its conversion to benzoic acid. Benzoic acid in the form of benzoate is excreted through the kidneys.

    Indications:Acne (acne vulgaris) of mild and moderate severity, especially with the predominance of inflammatory skin lesions.
    Contraindications:

    Hypersensitivity to clindamycin, lincomycin, benzoyl peroxide and / or to any of the components of the drug.

    Children under 12 years.

    Lactation period.

    Crohn's disease, ulcerative colitis, pseudomembranous colitis, including in the anamnesis.

    Carefully:

    Indoxil should be used with caution. patients with atopic dermatitis, who may have increased dryness of the skin, as well as in patients with allergic diseases.

    Indoxil should be used with caution in the simultaneous use of muscle relaxants of peripheral action.

    It is necessary to apply with caution the drug Indoxil on-sensitive areas of the skin (skin areas in the area around the eyes, neck area).

    Pregnancy and lactation:

    Fertility.

    There are no contraindications to the use of the drug in women of childbearing age, using adequate methods of contraception. Nevertheless, since clinical studies of the use of the drug in pregnant women have not been carried out, Indoxyl should be used with caution in the event that adequate contraceptive measures are not used.

    Pregnancy

    Safety of use of the drug Indoxil in women during pregnancy is not established, so the drug should be prescribed when the intended benefit for a woman exceeds the potential risk to the fetus.

    Preclinical studies showed no evidence of impaired fertility or fetal damage due to clindamycin.

    Lactation

    There are no restrictions on the use of benzoyl peroxide during breastfeeding. There is no data on the excretion of clindamycin into human breast milk with the use of Indoxyl, but with oral and parenteral use of clindamycin preparations, clindamycin was detected in breast milk. Based this, the use of Indoxil during lactation is not recommended.

    Dosing and Administration:

    Adults and teenagers over 12 years of age

    The drug Indoxil should be applied once a day in the evening on the affected areas after thorough cleansing of the skin. The frequency of application can be reduced in when an intensive inflammatory reaction or excessive dryness of the skin at the site of application.

    Treatment with the drug should not exceed 12 weeks of continuous use.

    On average, to achieve the full therapeutic effect, use the drug Indoxil for 4-6 weeks.

    Side effects:

    Adverse events; presented below, are listed depending on the anatomical and physiological classification and frequency, occurrence. Frequency of occurrence is defined as follows: Often (>1/10), often (> 1/100 and <1/10), infrequently, (> 1/1000 and <1/100), rarely (> 1/10000 and <1/1000), rarely (<1/10000, including individual cases). Frequency categories were formed on the basis of. clinical drug studies and post-registration surveillance.

    Frequency of occurrence of undesirable phenomena

    From the nervous system

    Infrequently: paresthesia.

    From the skin and subcutaneous fat

    Often: erythema, peeling, dry skin;

    Often: burning, itching, photosensitivity.

    Infrequently: aggravation of the clinic of acne.

    Rarely: contact dermatitis.

    Rarely: allergic reactions (including skin rash, hives).

    According to the post-registration data, this frequency of adverse events was significantly lower.

    There are separate reports of cases of development of pseudomembranous colitis or diarrhea in susceptible patients due to the use of other topical drugs containing, clindamycin. With prolonged use of the drug Indoxil, the resistance of microorganisms to the drug may develop.

    As part of post-registration observation, individual cases of allergic reactions were noted, which can be sudden and severe.

    Overdose:Given that the drug is intended for external use, an overdose of Indoxil is unlikely.
    Interaction:

    It is necessary to avoid the simultaneous use of Indoxil and topical medications containing vitamin A derivatives for the treatment of acne.

    Clindamycin shows antagonism with erythromycin. There is a potential synergy between clindamycin and gentamicin. It is established thatinYesmicentnersandne. violates neuromuscular transmission and, therefore, can enhance the action muscle relaxants of peripheral action.

    Special instructions:

    When combining antibiotics for external use, moss and cleansing agents, cosmetics with a strong drying effect, as well as agents with a high concentration of alcohol and / or astringents, a cumulative irritant effect can be observed.

    It is necessary to avoid contact of the drug with the eye mucosa, other mucous membranes, lips, as well as damaged and eczematous areas of the skin. In case of contact with the product, rinse with plenty of water.

    If the patient experiences prolonged or severe diarrhea or intestinal colic, treatment with gel should be stopped immediately, as these symptoms may indicate a colitis that is associated with antibiotics. A suitable diagnosis should be made, including the definition of the strain Clostridium difficile and its toxin, if necessary, to perform a colonoscopy, as well as to consider treatment options for colitis.

    The drug Indoxil can discolor hair or colored tissue.

    Benzoyl peroxide can cause photosensitivity, therefore it is recommended to avoid planned or long stay in the sun and not to visit the solarium during the period of use of Indoxyl. In case sun exposure can not be avoided, sunscreen cosmetics should be used for the skin and clothing that protects from sunlight.

    Effect on the ability to drive transp. cf. and fur:The drug indoxyl does not affect the ability to drive and other mechanisms.
    Form release / dosage:Gel for external use, 50 mg + 10 mg / 1 g of gel.
    Packaging:By 5 g, 10 g, 15 g or 25 g in an aluminum tube, closed with a cap with a cut of high-density polyethylene. 1 tuba together with instructions for medical use in a pack of cardboard.
    Storage conditions:

    Store at 2-8 ° C. Do not freeze.

    .Closed tube: Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    18 months.

    Covered tuba: 2 months.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:PL-000822
    Date of registration:07.10.2011
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspZAO "GlaxoSmithKline Trading"ZAO "GlaxoSmithKline Trading"
    Information update date: & nbsp06.02.2015
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