Instructions Bactroban nasal ointment 2% tube 3 g
Composition
active ingredient: mupirocin;
1 g of ointment contains 20 mg of mupirocin (in the form of mupirocin calcium);
excipients: white soft paraffin, softizan 649.
Dosage form
Nasal ointment.
Main physicochemical properties: soft tube containing an almost white ointment.
Pharmacotherapeutic group
Antibiotics for topical use. ATX code D06A X09.
Pharmacological properties
Pharmacodynamics.
Mupirocin is a novel antibiotic developed exclusively for topical use. Its spectrum of in vivo antibacterial activity includes Staphylococcus aureus (including methicillin-resistant strains), Staphylococcus epidermidis, Streptococcus species, and certain gram-negative bacteria, including Haemophilus influenzae and Escherichia coli. Other gram-negative bacteria are less susceptible, and Pseudomonas aeruginosa is resistant.
Mupirocin is the main antibacterial component of a group of structure-dependent metabolites produced by fermentation of Pseudomonas fluorescens. Mupirocin has a novel mechanism of action, which is the inhibition of bacterial isoleucyl-transfer RNA synthetase, due to which cross-resistance with other antibiotics is not expected.
Pharmacokinetics.
Studies have shown that systemic absorption of mupirocin is very low when applied topically. Intravenous mupirocin studies were conducted to simulate the possible increased systemic absorption of mupirocin when applied to damaged skin or vascular areas such as mucosa. Mupirocin was rapidly eliminated from plasma by metabolism to monic acid, which was excreted primarily in the urine.
Indication
Topical treatment of nasal infections caused by Staphylococcus aureus, including methicillin-resistant strains.
Contraindication
Hypersensitivity to mupirocin or to any of the other components of the drug.
Interaction with other medicinal products and other types of interactions
There are no messages.
Application features
Bactroban, a nasal ointment, should not be used to treat eye diseases.
Avoid contact with the eyes. If the ointment accidentally gets into the eyes, rinse them thoroughly with water until all traces of the ointment are removed. The use of Bactroban, nasal ointment, for the treatment of the eyes in the study resulted in severe reactions such as burning sensation in the eyes and tearing. These symptoms resolved within a period of several days to several weeks after discontinuation of the ointment.
In the event of isolated hypersensitivity reactions or severe local irritation observed with the use of nasal ointment, treatment should be discontinued, the remaining ointment should be removed and an alternative drug for the treatment of inflammation should be prescribed.
As with other antibacterial drugs, prolonged use of the ointment may lead to overgrowth of non-susceptible microorganisms, including fungal microflora.
Pseudomembranous colitis has been reported with antibiotic use and can range from mild to life-threatening. Therefore, it is important to consider the diagnosis in patients who develop diarrhea during or after antibiotic use. Although this is less likely with topical mupirocin, if diarrhea is prolonged or severe or the patient experiences abdominal pain, treatment should be discontinued immediately and the patient evaluated.
Use during pregnancy or breastfeeding
Fertility: There are no data on the effect of nasal ointment on human fertility. Animal studies have shown no effect on fertility.
Pregnancy. Animal reproduction studies with Bactroban have not shown any adverse effects on the fetus. Due to the lack of clinical experience with the use of nasal ointment during pregnancy, Bactroban should be used in pregnant women only if the potential benefit outweighs the potential risk.
Breastfeeding: There are no data on the excretion of Bactroban into breast milk.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
Adults, children and elderly patients
Place a small amount of ointment (about the size of a match head) into each nostril 2-3 times a day for 5 days.
In case of hepatic and renal insufficiency, there is no need to change the dose.
After applying the ointment, close the nose with your fingers, pressing several times on the ala of the nose on both sides, and gently rub the ala of the nose for better distribution of the ointment inside the nose.
The nasal cavity is usually cleared of pathogens after 3-5 days of treatment.
Treatment should not last more than 10 days.
Do not mix the ointment with other drugs, because when diluting the ointment, its antibacterial activity decreases and the stability of the active ingredient of the ointment may be lost.
Children.
It is used to treat children from 12 years of age. The safety of the drug in children under 12 years of age has not been established.
Overdose
Not observed. The toxicity of mupirocin is very low. In case of overdose, symptomatic therapy is carried out.
Adverse reactions
Adverse reactions are classified by system organ class and frequency. The frequency of adverse reactions is defined as follows: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000), including isolated cases.
Immune system
Very rare: cutaneous hypersensitivity reactions; systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema.
Respiratory system
Uncommon: reactions from the nasal mucosa: itching, burning sensation, redness, as well as runny nose, sneezing, nasal congestion, cough, pharyngitis.
Nervous system: headache, change in taste.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
3 g of ointment in an aluminum tube with a polyethylene cap. One tube in a cardboard box.
Vacation category
According to the recipe.
Producer
Glaxo Operations UK Limited, United Kingdom.
Location of the manufacturer and address of its place of business
Glaxo Operations UK Limited, Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom.
