Instructions Bactroban ointment 2% tube 15 g
Composition
active ingredient: mupirocin;
1 g of ointment contains 20 mg of mupirocin;
excipients: polyethylene glycol 400 and polyethylene glycol 3350.
Dosage form
Ointment.
Main physicochemical properties: ointment is almost white in color.
Pharmacotherapeutic group
Dermatological preparations. Antibiotics and chemotherapeutic agents for use in dermatology. Antibiotics for topical use. Other antibiotics for topical use. Mupirocin. ATC code D06A X09.
Pharmacological properties
Pharmacodynamics
Bactroban™ is a topical antibacterial agent active against organisms that cause most skin infections, including Staphylococcus aureus, including methicillin-resistant strains, other staphylococci, and streptococci. It is also active against gram-negative organisms such as Escherichia coli and Haemophilus influenzae.
Bactroban™ (mupirocin) is a potent inhibitor of bacterial protein and RNA synthesis by inhibiting isoleucyl transfer RNA synthetase.
Pharmacokinetics
Following topical application of Bactroban™ ointment, mupirocin is minimally absorbed systemically, and the amount absorbed is rapidly metabolized to the microbiologically inactive metabolite monic acid. Penetration of mupirocin into the deeper epidermal and dermal layers of the skin is increased in damaged skin areas and under occlusive dressings.
Indication
Topical treatment of bacterial skin infections, such as impetigo, folliculitis, furunculosis.
Contraindication
Hypersensitivity to mupirocin or to any other component of the drug.
Bactroban™ in this dosage form is not intended for ophthalmic or intranasal use.
Interaction with other medicinal products and other types of interactions
There are no messages.
Application features
In the event of isolated hypersensitivity reactions or severe local irritation during application of the ointment, treatment should be discontinued, the skin area should be washed with water to remove any remaining ointment, and an alternative drug should be prescribed to treat the lesion.
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 may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after antibiotic use, although it 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.
Kidney failure
Elderly patients: there are no restrictions on use, unless during treatment there are conditions for absorption of polyethylene glycol, which is part of Bactroban™ ointment, and there are no signs of moderate or severe renal failure.
Bactroban™ ointment should not be used:
for the treatment of eye diseases; intranasally; in combination with catheters; in the area of central venous catheterization.
Avoid getting the ointment in the eyes. If this happens, the eyes should be thoroughly rinsed with water until all traces of the ointment are removed.
Polyethylene glycol can be absorbed through wound surfaces or otherwise damaged skin and excreted by the kidneys. Like other polyethylene glycol-based ointments, Bactroban™ should not be used in conditions of increased absorption of polyethylene glycol, especially in moderate to severe renal failure.
Ability to influence reaction speed when driving vehicles or other mechanisms
No harmful effects on the ability to drive or use other mechanisms have been identified.
Use during pregnancy or breastfeeding
Fertility: There are no data on the effect of the ointment on human fertility. Animal studies have shown no effect on fertility.
Pregnancy: Animal reproduction studies with mupirocin have not shown any harmful effects on the fetus. There are no adequate clinical data on the use of the ointment during pregnancy. The ointment should be used during pregnancy only if the potential benefit to the woman outweighs the potential risk to the fetus.
Breastfeeding: There is insufficient data on the use of the ointment during breastfeeding. If necessary, it is possible to treat cracked nipples with the ointment, but they should be washed thoroughly before feeding the baby.
Method of administration and doses
Adults, children and elderly patients
A small amount of ointment should be applied in a thin layer to the affected areas of the skin 2–3 times a day for a period of up to 10 days, depending on the course of the disease.
A bandage can be applied to the area of skin treated with the ointment.
Liver failure
No dose adjustment is required.
Polyethylene glycol can be absorbed through open wounds and broken skin. As with other polyethylene glycol-based ointments, Bactroban™ should not be used in conditions where large amounts of polyethylene glycol are absorbed, especially if there is evidence of moderate or severe renal impairment.
The drug is intended for external use.
After applying the drug to the skin, wash your hands thoroughly.
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 2 months of age.
Overdose
Symptoms: Experience with overdose with mupirocin is currently limited.
Treatment: There is no specific treatment for mupirocin overdose. In case of overdose, symptomatic therapy is necessary.
The toxicity of Bactroban™ ointment is very low. In case of accidental ingestion of the ointment, symptomatic treatment should be applied.
In case of accidental ingestion of a large amount of ointment, renal function should be carefully monitored in patients with renal insufficiency, taking into account the possible side effects of polyethylene glycol.
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 (> 1/10000, < 1/1000), very rare (< 1/10000, including isolated cases).
On the part of the immune system:
very rare: systemic allergic reactions, including anaphylaxis, generalized rash, urticaria and angioedema.
Skin and subcutaneous tissue disorders:
common: burning sensation in the area of application of the ointment, eczema;
uncommon: itching, erythema, pain and dryness of the skin at the site of application of the ointment.
Skin hypersensitivity reactions: rash, increased exudation, swelling at the site of ointment application, contact dermatitis.
From the nervous system: headache, dizziness.
On the part of the digestive tract: nausea, abdominal pain, ulcerative stomatitis.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
15 g of ointment in an aluminum tube with a polypropylene cap. 1 tube in a cardboard box.
Vacation category
According to the recipe.
Producer
Glaxo Operations UK Ltd, United Kingdom.
Location of the manufacturer and its business address
Harmire Road, Barnard Castle, DL12 8DT, United Kingdom.
