Bactroban

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BACTROBAN (BACTROBAN)

Composition:

Active substance: mupirocin;

1 g of ointment contains 20 mg of mupirocin;

Excipients: polyethylene glycol 400 and polyethylene glycol 3350.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment is almost white in color.

Pharmacotherapeutic group. Dermatologicals. Antibiotics and chemotherapeutic agents for dermatological use. Antibiotics for topical use. Other antibiotics for topical use. Mupirocin. ATC code D06AX09.

Pharmacological Properties.

Pharmacodynamics.

Bactroban is a topical antibacterial agent active against organisms responsible for 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 suppressing isoleucyl-transfer RNA synthetase.

Pharmacokinetics.

After topical application of Bactroban ointment, mupirocin is minimally absorbed systemically, and the small amount that is absorbed is rapidly metabolized to the microbiologically inactive metabolite, monic acid. Penetration of mupirocin into deeper epidermal and dermal layers of the skin increases in damaged skin areas and under occlusive dressings.

Clinical characteristics.

Indications.

Topical treatment of bacterial skin infections, such as impetigo, folliculitis, and furunculosis.

Contraindications.

Hypersensitivity to mupirocin or to any other component of the medicinal product.

Bactroban in this pharmaceutical form is not intended for ophthalmic or intranasal use.

Interaction with other medicinal products and other forms of interaction.

No reports available.

Special precautions for use.

If isolated hypersensitivity reactions or severe local irritation occur during the application of the ointment, treatment should be discontinued, the affected skin area should be washed with water to remove any residual ointment, and an alternative treatment for the lesion should be prescribed.

As with other antibacterial agents, prolonged use of the ointment may lead to overgrowth of resistant microorganisms, including fungal flora.

There have been reports of pseudomembranous colitis associated with the use of antibiotics, ranging from mild to life-threatening forms. Therefore, this diagnosis should be considered in patients who develop diarrhea during or after antibiotic therapy, although it is less likely with topical application of mupirocin. If diarrhea is persistent or severe, or if the patient experiences abdominal pain, treatment should be immediately discontinued and the patient evaluated.

Renal impairment

Elderly patients: no restrictions for use are necessary unless conditions arise during treatment that promote systemic absorption of polyethylene glycol, a component of Bactroban ointment, leading to signs of moderate or severe renal impairment.

Bactroban ointment must not be used:

• for treatment of eye disorders;
• intranasally;
• in combination with catheters;
• at the site of central venous catheterization.

Contact of the ointment with the eyes should be avoided. If contact occurs, the eyes should be thoroughly rinsed with water until all traces of the ointment are removed.

Polyethylene glycol may be absorbed through wounds or other damaged skin and excreted by the kidneys. As with other polyethylene glycol-based ointments, Bactroban should not be used under conditions of increased absorption of polyethylene glycol, particularly in cases of moderate to severe renal impairment.

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: reproductive studies of mupirocin in animals have not shown any harmful effects on the fetus. However, sufficient clinical data on the use of the ointment during pregnancy are lacking. The ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breastfeeding: data on the use of the ointment during breastfeeding are insufficient. Treatment of nipple fissures with the ointment may be considered if necessary, but the nipples should be thoroughly washed before breastfeeding.

Ability to affect driving or operating machinery.

No adverse effects on the ability to drive or operate machinery have been observed.

Method of Administration and Dosage

Adults, children, and elderly patients

A small amount of ointment should be applied thinly to affected skin areas 2–3 times daily for up to 10 days, depending on the course of the disease.

A dressing may be applied over the area of skin treated with the ointment.

Hepatic impairment

Dose adjustment is not required.

Renal impairment

Polyethylene glycol may be absorbed through open wounds and damaged skin. As with other polyethylene glycol-based ointments, Bactroban should not be used when large amounts of polyethylene glycol may be absorbed, particularly in the presence of moderate or severe renal impairment.

The product is intended for topical use only.

After applying the product to the skin, hands should be thoroughly washed.

Do not mix the ointment with other medicinal products, as dilution of the ointment may reduce its antibacterial activity and compromise the stability of the active ingredient.

Children

The ointment is indicated for use in children aged 2 months and older.

Overdose

Symptoms
Experience with mupirocin overdose is limited to date.

Treatment
There is no specific antidote for mupirocin overdose. In case of overdose, symptomatic treatment should be administered.

The toxicity of Bactroban ointment is very low. In case of accidental ingestion of the ointment, symptomatic treatment is recommended.

In the event of accidental ingestion of a large amount of ointment, renal function should be closely monitored in patients with renal impairment due to the potential adverse effects of polyethylene glycol.

Side effects

Adverse reactions are classified by organs and systems and by frequency of occurrence. The frequency of adverse effects 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 disorders:

very rare: systemic allergic reactions, including anaphylaxis, generalized rash, urticaria, and angioedema.

Skin and subcutaneous tissue disorders:

common: burning sensation at the site of ointment application, eczema;

uncommon: pruritus, erythema, pain, and dryness of the skin at the site of ointment application.

Skin hypersensitivity reactions: rash, increased exudation, swelling at the site of ointment application, contact dermatitis.

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: nausea, abdominal pain, ulcerative stomatitis.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions to the medicinal product during the post-marketing period is important. It enables continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients can report suspected adverse reactions to GlaxoSmithKline Pharmaceuticals Ukraine LLC via the 24-hour hotline (044) 585-51-85 or by email at [email protected].

Shelf life. 2 years.

Storage conditions.

Store below 25 °C. Keep out of reach of children.

Packaging. 15 g of ointment in an aluminum tube with a polypropylene cap. One tube per cardboard box.

Prescription status. Prescription only.

Manufacturer. Glaxo Operations UK Ltd, United Kingdom.

Manufacturer's address and place of business.

Harmire Road, Barnard Castle, DL12 8DT, United Kingdom.