Composition, form of production and packaging
Ointment for external application of white or almost white color, homogeneous.
mupirocin 2.2 g *
Excipients: Macrogol 400 - 58.7 g, macrogol 3350 - 39.1 g.
15 g - aluminum tubes (1) with a screw cap with a point for opening - packs cardboard.
* The standard series includes 10% surplus of the active substance.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
Antibiotic of a wide spectrum of action for external and local application.
Mupirocin is a new antibiotic that is obtained by fermentation of 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 in higher concentrations - bactericidal properties.
Mupirocin is an antibiotic for topical use demonstrating in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and? -hemolytic strains of Streptococcus species.
The in vitro activity spectrum includes the following bacteria:
Sensitive species: Staphylococcus aureus 1,2 ; Staphylococcus epidermidis 1,2 ; coagulase-negative Staphylococci 1,2 ; Streptococcus species 1 ; Haemophilus influenzae; Neisseria gonorrhoeae; Neisseria meningitidis; Moraxella catarrhalis; Pasteurella multocida.
1 - Clinical efficacy was demonstrated for isolates of sensitive bacteria according to registered clinical indications for use.
2 - Including strains producing? -lactamase, and methicillin-resistant strains.
Stable species: Corynebacterium species; Enterobacteriaceae; gram-negative non-fermenting sticks; Micrococcus spp .; anaerobes.
Boundary sensitivity concentrations for mupirocin (IPC) for Staphylococcus spp.
- sensitive -? 1 Ојg / ml;
- intermediate sensitivity - from 2 to 256 mcg / ml;
- stable -> 256 Ојg / ml.
Mechanisms of resistance
It was shown that a low level of resistance of staphylococci (MIC from 8 to 256 Ојg / 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 of в‰¤ 512 Ојg / 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 the low penetration of the antibiotic into the bacterial cell.
Mupirocin poorly absorbed through intact human skin.
Mupirocin is for external use only. In case of absorption through the damaged skin, mupirocin is rapidly metabolized to inactive monic acid.
Mupirocin is rapidly excreted from the body by metabolic transformation into an inactive metabolite, monium acid, which is rapidly excreted by the kidneys.
- treatment of primary skin infections: impetigo, folliculitis, furunculosis (including furuncles of the external auditory canal and auricle), ecthyma;
- treatment of secondary skin infections: infected eczema, infected trauma (abrasions, insect bites), minor (hospital-free) wounds and burns;
- prevention of bacterial infections with small wounds, cuts, abrasions and other uncontaminated skin lesions.
Ointment is used externally 2-3 times / day. A small amount of ointment is applied to the affected surface with a cotton swab or gauze. Then, a simple gauze or occlusive dressing can be applied to the application area of вЂ‹вЂ‹the ointment.
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.
There are no restrictions on the use of the drug in children . Efficacy and safety of the ointment was studied in patients aged 2 months in the framework of fundamental clinical programs.
Older patients - see the "Special instructions" section.
Patients with impaired renal function - see section "Special instructions".
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: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and < 1/1000), very rarely (<1/10 000), including individual cases.
The prevalence of frequent and infrequent adverse reactions was established on the basis of generalized data on
safety of the drug, obtained during 12 clinical trials involving 1573 patients.
The prevalence of very rare undesirable reactions has been established mainly on the basis of post-registration data and therefore is the frequency of reports of such reactions, rather than the true frequency of occurrence of these reactions.
From the immune system: very rarely - systemic allergic reactions (including anaphylaxis, generalized rash, hives and angioedema).
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.
- hypersensitivity to mupirocin or any other component included in the drug, in anamnesis.
With caution should prescribe the drug for renal failure of moderate to severe, elderly patients.
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 drugs, the use of the drug Bactroban В® in 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.
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be given to the drug for renal failure of moderate to severe severity.
APPLICATION FOR CHILDREN
There are no restrictions on the use of the drug in children .
APPLICATION IN ELDERLY PATIENTS
Caution should be given to elderly patients.
Avoid contact with 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 В® ointment should not be used in conditions where it is possible to absorb large amounts of macrogol, especially with moderate to severe renal insufficiency.
Do not use the ointment left in the tube after the treatment for the next course of treatment.
There are no restrictions for elderly patients (in the absence of symptoms of renal failure of moderate or severe degree).
Impact on the ability to drive vehicles and manage mechanisms
Symptoms: At the moment there are limited data on overdose of mupirocin.
Treatment: there is no specific treatment for overdose with mupirocin. In case of an overdose, supportive therapy is indicated and appropriate monitoring of the patient's condition, if necessary.
Do not mix the drug with other medicinal products to avoid dilution of the ointment and, consequently, decrease in antibacterial activity or a possible change in the stability of mupirocin.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years. Do not use after the expiration date stated on the package.