Bactroban - instructions for use, doses, side effects, contraindications

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: & nbspmNasal

Composition:

Components	Content, mg / g
Active ingredient
Mupirocin calcium *	21.5
Excipients
Paraffin white soft	929,6
Софтизан 649	48,9

* - equivalent to 20.0 mg of free mupirocin.

Description:

Ointment is white or almost white.

Pharmacotherapeutic group:Antibiotic for topical use

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 againstStaphylococcus aureus (including methicillin-resistant strains), S.epidermidis and beta-hemolytic strainsStreptococcus species.

Activity spectrum in vitro includes the following bacteria:

Sensitive species:

- Staphylococcus aureus^1,2;

- Staphylococcus epidermidis^1,2;

- coagulase-negative staphylococci^1,2;

- 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 a low level of penetration of the antibiotic into the bacterial cell.

Pharmacokinetics:

Suction

Absorption of mupirocin through the damaged and healthy mucous membrane of the nose is insignificant (less than 1% of the applied dose is excreted in urine in the form of monic acid).

Metabolism

The drug is intended for topical 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:

- Carrier of staphylococcal infections in the nasal cavity, including carriage Staphylococcus aureus (including methicillin-resistant strains);

- prevention of infection Staphylococcus aureus patients on hemodialysis or continuous ambulatory peritoneal dialysis.

Contraindications:

- Hypersensitivity to mupirocin or any other component included in the formulation in anamnesis;

- application of the drug in children under 12 years of age (safety and efficacy evaluation was not performed in children under 12 years of age, so the drug is not recommended for this age group).

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® during pregnancy and during breastfeeding is possible only if the intended benefit to the mother exceeds any potential risk to the fetus and the baby.

Dosing and Administration:

For intranasal use.

Adults and children over 12 years of age

To apply the ointment as an applicator, you should use a cotton swab.

Apply a small amount of ointment volume approximately from the match head (approximately 30 mg of ointment) to the nasal mucosa in each nasal passage twice a day for 5 days.

After applying the ointment, several times tighten the nose simultaneously from both sides, which ensures a uniform distribution of the ointment over the mucous membrane.

Wash hands before and after applying the product.

Usually nasal carriage disappears for 3-5 days of treatment. Do not use the drug for more than 5 days.

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

Do not use the ointment left in the open tube at the end of treatment for the next course of treatment.

Special patient groups

Children over 12 years old

Correction of the dose is not required.

Elderly patients

Correction of the dose is not required.

Patients with impaired renal function

Correction of the dose is not required.

Patients with impaired hepatic function

Correction of the dose is not required.

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), including individual cases.

Frequency categories were formed on the basis of clinical studies of the drug and postgistrational observation.

The prevalence of infrequent adverse reactions was established on the basis of generalized data on the safety of the drug, obtained during 12 clinical trials involving 422 patients.

The prevalence of very rare undesirable reactions was determined 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.

Frequency of occurrence of undesirable reactions

Immune system disorders

Very rarely: local reactions of hypersensitivity, systemic allergic reactions (including anaphylaxis, generalized rash, hives and angioedema).

Disturbances from the respiratory system, chest and mediastinal organs

Infrequently: reactions from the mucous membrane of the nose (itching, redness, burning, tingling).

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:

The drug is not intended for use in ophthalmic practice.

Avoid getting ointment in the eyes. In case of contact with eyes, rinse immediately with plenty of water until the remnants of the ointment are completely 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 mucosa 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.

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:

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

Form release / dosage:

Nasal ointment, 2%.

Packaging:

3 g of ointment in an aluminum tube, coated internally with an epoxy-based varnish, with a plastic tip and a screw cap made of polyethylene.

1 tube with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N012295 / 01

Date of registration:09.07.2007 / 31.08.2010

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Trading, ZAO GlaxoSmithKline Trading, ZAO Russia

Manufacturer: & nbsp

GLAXO OPERATIONS UK, Limited United Kingdom

Representation: & nbspGlaxoSmithKline Trading, ZAOGlaxoSmithKline Trading, ZAO

Information update date: & nbsp04.09.2016

Illustrated instructions

Instructions

Bactroban® (Bactroban®)