BONADERM

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BONDERM

Composition:

Active substance: mupirocin;

1 g of ointment contains 20 mg of mupirocin;

Excipients: polyethylene glycol 400, polyethylene glycol 3350.

Pharmaceutical form. Ointment.

Main physicochemical properties: semitransparent white ointment.

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

Pharmacological properties.

Pharmacodynamics.

Mupirocin is the main antibacterial component of a group of structurally related metabolites produced by fermentation of Pseudomonas fluorescens. Mupirocin has a novel mechanism of action through inhibition of bacterial isoleucyl-tRNA synthetase, thus cross-resistance with other antibiotics is not expected.

Pharmacokinetics.

After topical application of mupirocin ointment, the drug is minimally absorbed into the systemic circulation. The absorbed fraction is rapidly metabolized to the microbiologically inactive metabolite monic acid and excreted by the kidneys. 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.

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

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use

If isolated hypersensitivity reactions or severe local irritation occur during the application of the ointment, treatment should be discontinued, the 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 antibiotic use, ranging from mild to life-threatening conditions. 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 discontinued immediately and the patient should be evaluated.

Renal impairment

Elderly patients: no restrictions in use unless conditions arise during treatment that promote absorption of polyethylene glycol—a component of Bonderm ointment—accompanied by signs of moderate or severe renal impairment.

Bonderm ointment must not be used:

• for treatment of eye diseases;
• 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 wound surfaces or other damaged skin and excreted by the kidneys. As with other polyethylene glycol-based ointments, Bonderm 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.

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 to the woman outweighs the potential risk to the fetus.

Breastfeeding period

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

Fertility

There are no data on the effect of the ointment on human fertility. Animal studies have shown no effect on fertility.

Ability to affect reaction speed when 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 the ointment should be applied thinly to the 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 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, Bonderm should not be used when there is potential for absorption of large amounts of polyethylene glycol, especially in the presence of signs of moderate or severe renal impairment.

The medication is intended for topical use only.

Hands should be thoroughly washed after applying the medication to the skin.

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

Children

The ointment can be used for treatment of 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 therapy should be administered.

The toxicity of Bonderm ointment is very low. In case of accidental ingestion of the ointment, symptomatic treatment should be administered.

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.

Adverse Reactions

Adverse reactions are classified by organ systems and frequency of occurrence. The frequency of adverse reactions is defined according to the following criteria: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000), including isolated cases.

Immune system disorders

Very rare: systemic allergic reactions, including anaphylaxis, generalized rash, urticaria, and angioneurotic edema.

Skin and subcutaneous tissue disorders

Common: burning sensation at the application site, eczema.

Uncommon: itching, redness, pain, and dryness of the skin at the application site; hypersensitivity skin reactions: rash, increased exudation, swelling at the application site, contact dermatitis.

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: nausea, abdominal pain, ulcerative stomatitis.

Shelf life.

18 months.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

15 g in a tube. 1 tube in a cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Belupo, medicines and cosmetics, Inc. / Belupo, pharmaceuticals and cosmetics, Inc.

Manufacturer's address and location of operations.

Ulica Danica 5, 48 000 Koprivnica, Croatia / Ulica Danica 5, 48 000 Koprivnica, Croatia.