Bactroban® (Bactroban®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceMupirocinMupirocin
Similar drugsTo uncover
  • Bactroban®
    ointment externally 
    GlaxoSmithKline Trading, ZAO     Russia
  • Bactroban®
    ointment nazal. 
    GlaxoSmithKline Trading, ZAO     Russia
  • Bonderm
    ointment externally 
    Beluga, medicines and cosmetics.     Croatia
  • Supirocin®
    ointment externally 
    Glenmark Pharmaceuticals Co., Ltd.     India
    • Dosage form: & nbspointment for external use
    Composition:

    Components

    Content in 100 g

    Active substance

    Mupirocin as free acid

    2,21 g

    Excipients

    Macrogol-400

    58.7 g

    Macrogol-3350

    39.1.d

    1 - The standard series includes a 10% surplus of the active substance.

    Description:

    Homogeneous ointment is white or almost white.

    Pharmacotherapeutic group:Antibiotic
    ATX: & nbsp

    D.06.A.X.09   Mupirocin

    Pharmacodynamics:

    Mechanism of action

    Mupirocin is a new antibiotic that is produced by fermentation Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase by blocking protein synthesis in a bacterial cell.

    Due to the specific mechanism of action and the unique chemical structure mupirocin is not characterized by cross-resistance with other antibiotics used in clinical practice.

    With topical application in minimal suppressive concentrations (MIC) mupirocin has bacteriostatic, and at higher concentrations bactericidal properties.

    Pharmacodynamic effects

    Activity

    Mupirocin is an antibacterial agent for topical application that demonstrates in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-hemolytic strainsStreptococcus species.

    Activity spectrum in vitro includes the following bacteria:

    Sensitive species:

    - Staphylococcus aureus1,2;

    - Staphylococcus epidermidis1,2;

    - coagulase-negative staphylococci1,2;

    - Streptococcus species1;

    - Haemophilus influenzae;

    - Neisseria gonorrhoeae;

    - Neisseria meningitidis;

    - Moraxella catarrhalis:

    - Pasteurella multocida.

    1 - Clinical efficacy demonstrated for isolates

    sensitive bacteria by registered clinical

    indications for use.

    2 - Including strains producing beta-lactamase and methicillin-

    resistant strains.

    Sustainable species

    - Corynebacterium species;

    - Enterobacteriaceae;

    - gram-negative non-fermenting sticks;

    - Micrococcus species;

    - anaerobes.

    Borderline concentration sensitivity to mupirocin (MIC) for Staphylococcus spp.

    Sensitive: less than or equal to 1 μg / ml.

    Intermediate sensitivity: 2 to 256 μg / ml.

    Stable: higher than 256 μg / ml.

    Mechanisms of resistance

    It was shown that a low level of resistance of staphylococci (MIC from 8 to 256 μg / ml) is due to changes in the native Enzyme isoleucyl transfer-RNA synthetase.It was shown that a high level of resistance of staphylococci (MIC is greater than or equal to 512 μg / ml) is due to a certain plasmid encoding of the enzyme isoleucyl transfer-RNA synthetase. The natural resistance of gram-negative bacteria, such as Enterobacteriaceae, may be due to low penetration antibiotic inside the bacterial cell.

    Pharmacokinetics:

    Suction

    Mupirocin poorly absorbed through intact human skin.

    Metabolism

    Mupirocin is for external use only. In case of absorption through the damaged skin mupirocin is rapidly metabolized to inactive monic acid.

    Excretion

    Mupirocin is rapidly excreted from the body by metabolic transformation into an inactive metabolite, monium acid, which is rapidly excreted by the kidneys.

    Indications:

    Treatment of primary and secondary infectious skin lesions caused by microorganisms susceptible to mupirocin, including:

    - primary skin infections: impetigo, folliculitis, furunculosis (including furuncles of the external auditory canal and auricle) and ecthyma;

    - secondary infections: infected eczema; infected injuries (abrasions, insect bites), minor wounds and burns (not requiring hospitalization).

    Prevention of bacterial infections with small wounds, cuts, abrasions and other uncontaminated skin lesions.

    Contraindications:

    Hypersensitivity to mupirocin or any other component of the drug in the history.

    Carefully:

    Renal failure of the middle and severe degree, elderly age.

    Pregnancy and lactation:

    There is no data on the use of the drug during pregnancy and breastfeeding.

    In animal studies, no signs of reproductive toxicity were found.

    However, as with the use of other medications, the use of the drug Bactroban® during pregnancy and during breastfeeding is possible only if the intended benefit to the mother exceeds any potential risk to the fetus.

    Breastfeeding should be stopped for the period of use of the drug to prevent bacterial infection of nipple cracks.

    Dosing and Administration:

    Outwardly.

    A small amount of ointment is applied to the affected skin surface 2-3 times a day with a cotton or gauze swab. Then, on the application area of ​​the ointment, a simple gauze or occlusal bandage. The frequency of application and the duration of treatment depend on the dynamics of the clinical picture. Do not use the drug for more than 10 days.

    If there is no effect after 5 days of treatment, it is recommended to revise the further treatment tactics taking into account the dynamics of clinical indices.

    Wash hands before and after applying the product.

    Special patient groups

    Children

    There are no restrictions on the use. Efficacy and safety of the ointment was studied in patients from 2 months in the framework of fundamental clinical programs.

    Elderly patients

    See section "Special instructions".

    Patients with impaired renal function

    See section "Special instructions".

    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), very rarely (<1/10 000), including individual cases.

    Prevalence frequent and infrequent adverse reactions was established on the basis of the general safety data for the preparation obtained in 12 clinical trials involving 1573 patients.

    Prevalence very rare adverse reactions was established mainly on the basis of post-registration data and is therefore more likely the frequency of reports of such reactions, rather than the true frequency of occurrence of these reactions.

    Frequency of occurrence of undesirable reactions

    Immune system disorders

    Rarely: systemic allergic reactions (including anaphylaxis, generalized rash, hives and angioedema).

    Disturbances from the skin and subcutaneous tissues

    Often: burning in the place of application.

    Infrequently: itching, erythema, tingling, dryness at the site of application. Skin allergic reactions to mupirocin or ointment base.

    Overdose:

    Symptoms

    At the moment, there are limited data on overdose of mupirocin.

    Treatment

    Specific treatment for overdose with mupirocin is absent.In case of an overdose, supportive therapy and appropriate patient control are indicated, if necessary.

    Interaction:

    No interaction with other drugs was noted.

    Special instructions:

    Avoid getting ointment in the eyes. In case of contact with eyes, rinse with plenty of water until all residual ointments are removed.

    In rare cases, the use of the drug may cause a reaction of increased sensitivity or severe local irritation. In this case, it is required to stop treatment, if possible remove the drug from the surface to be treated and prescribe an alternative therapy for the infection.

    As with other antibacterial drugs, with prolonged use of mupirocin, there is a risk of excessive growth of insensitive microorganisms.

    With the use of antibiotics, cases of pseudomembranous colitis have been described, the severity of which can vary from mild to life-threatening. Thus, it is important to consider the possibility of such a diagnosis in patients with diarrhea on the background or after the use of antibiotics.Although the probability of developing this phenomenon with local application of mupirocin is less, in case of prolonged or severe diarrhea or abdominal cramps, treatment should be stopped immediately and an additional examination of the patient should be carried out.

    Do not use the drug in ophthalmology, intranasally, in conjunction with the use of catheters, as well as at the site of the central venous catheter.

    Polyethylene glycol (macrogol) can be absorbed through the open wound surface or other skin lesions and excreted by the kidneys.

    Like other macrogol-based ointments, Bactroban® ointment should not be used in conditions where it is possible to absorb large amounts of macrogol, especially with moderate to severe renal failure.

    Do not mix the drug with other drugs to avoid dilution of the ointment and, therefore, reduce antibacterial activity or a possible change in the stability of mupirocin.

    Do not use the ointment left in the tube after the treatment for the next course of treatment.

    Special patient groups

    Elderly patients

    There are no restrictions (in the absence of symptoms of moderate or severe renal failure).

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

    Not studied.

    Form release / dosage:

    Ointment for external use, 2%.

    Packaging:

    For 15 grams in an aluminum tube, coated internally with a varnish, with a protective membrane and a screw cap with a point for opening.

    1 tube with instructions for use in a cardboard pack.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N014801 / 01
    Date of registration:15.12.2008 / 24.02.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO
    Information update date: & nbsp04.09.2016
    Illustrated instructions
      Instructions
      Up