BACTOPICK

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BACTOPIC (BACTOPIC®)

Composition:

Active substance: mupirocin calcium;

1 g of ointment contains mupirocin calcium, calculated as mupirocin – 20 mg;

Excipients: white soft paraffin, Softisan 649.

Pharmaceutical form. Nasal ointment.

Main physicochemical properties: homogeneous ointment from white to almost white in color.

Pharmacotherapeutic group. Antibiotics and chemotherapeutic agents for dermatological use. ATC code D06AX09.

Pharmacodynamics.

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

Mupirocin has bacteriostatic properties at minimum inhibitory concentrations, and exhibits bactericidal properties at higher concentrations, such as those achieved with topical application.

*Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications.

Breakpoints for mupirocin susceptibility (MIC) for Staphylococcus aureus:

Susceptible: ≤ 1 mg/L.

Resistant: > 256 mg/L.

Pharmacokinetics.

Studies have shown that systemic absorption of mupirocin following topical application is minimal. To evaluate potential increased systemic penetration of mupirocin when applied to damaged skin areas or vascular sites such as mucous membranes, studies with intravenous administration of mupirocin were conducted. Mupirocin was rapidly eliminated from plasma by metabolism into monic acid, which in turn was excreted predominantly in urine.

Clinical characteristics.

Indications.

Local treatment of nasal cavity infections caused by Staphylococcus aureus, including methicillin-resistant strains.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

No interactions with other medicinal products have been observed.

Usage characteristics.

Hypersensitivity reactions

If hypersensitivity reactions or severe local skin reactions occur during application of the ointment, treatment should be discontinued, any residual ointment should be removed, and appropriate therapy should be initiated.

Pseudomembranous colitis

As with other antibacterial agents, prolonged use of mupirocin may lead to overgrowth of resistant microorganisms.

The use of antibiotics may result in the development of pseudomembranous colitis, the severity of which may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after antibiotic therapy. Although the likelihood of this occurring with topical application of mupirocin is lower, treatment should be discontinued immediately and further diagnostic evaluation initiated if prolonged or severe diarrhea or abdominal cramps occur.

Accidental exposure to eyes

Mupirocin nasal ointment is not intended for ophthalmic use.

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

Use during pregnancy or breastfeeding.

Pregnancy.

Animal studies with mupirocin have not shown evidence of harmful effects on the fetus. However, there are no clinical data on the use of mupirocin ointment during pregnancy. Bactopik ointment should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period.

There are no data on the excretion of mupirocin into breast milk following topical administration.

Fertility. There are no data on the effect of mupirocin on human fertility. Animal studies have not shown any effect on fertility.

Ability to affect reaction speed when driving or operating machinery.

No adverse reactions affecting the ability to drive or operate machinery have been reported.

Method of Administration and Dosage

Adults, children and elderly patients

A small amount of ointment (approximately the size of a match head) should be applied to the nasal mucosa in each nostril 2–3 times daily using the little finger or a cotton swab. After application, the nose should be gently squeezed several times from both sides to ensure even distribution of the ointment over the mucosal surface. Eradication of pathogens from the nasal cavity usually occurs within 3–5 days after initiation of treatment. Treatment should not last longer than

10 days.

The medication is intended for topical use only.

Hands should be thoroughly washed after applying the medication.

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.

Dosage adjustment is not required in patients with hepatic or renal impairment.

Children

The medication can be used for treatment of children aged 12 years and older. The safety of use in children under 12 years of age has not been established.

Overdose

Symptoms: Experience regarding symptoms of mupirocin overdose is limited.

Treatment: There is no specific antidote. Symptomatic treatment and appropriate patient monitoring are recommended.

Adverse reactions.

The adverse reactions listed below are those reported during clinical trials and in the post-marketing period. Frequency of adverse reactions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), including isolated cases, and not known (cannot be estimated from available data).

Immune system disorders: very rare – skin hypersensitivity reactions, systemic allergic reactions, including anaphylaxis, generalized rash, urticaria, and angioedema.

Respiratory, thoracic and mediastinal disorders: uncommon – reactions of the nasal mucosa: itching, burning sensation, redness, as well as rhinitis, sneezing, nasal congestion, cough, pharyngitis.

Nervous system disorders: not known – headache, taste disturbances.

Reporting of adverse reactions

Healthcare professionals may report suspected adverse reactions through the national reporting system, as well as to the marketing authorization holder via the feedback form on the website: https://kusum.ua/pharmacovigilance/.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging.

3 g in an aluminum tube with a nozzle and a screw-on cap. One tube per cardboard box with the instruction for medical use.

Prescription status.

Prescription only.

Manufacturer.

Kusum Healthcare Pvt Ltd.

Manufacturer's address and location of operations.

SP-289 (A), RIICO Industrial Area, Chopanki, Bhiwadi, Dist. Alwar (Rajasthan), India.