Bactopique

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

Composition:

Active substance: mupirocin;

1 g of ointment contains 20 mg of mupirocin;

Excipients: polyethylene glycol 3350, polyethylene glycol 400.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of white to almost white color.

Pharmacotherapeutic group. Antibiotics for topical use. Mupirocin.

ATC code D06AX09.

Pharmacological properties.

Pharmacodynamics.

Mupirocin is a topical antibacterial agent active against microorganisms that cause most skin infections, including Staphylococcus aureus, including methicillin-resistant strains, other staphylococci, and streptococci. The drug is also active against gram-negative microorganisms such as Escherichia coli and Haemophilus influenzae.

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 systemically absorbed, 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 skin layers increases in damaged skin areas and under occlusive dressings.

Clinical characteristics.

Indications.

Topical treatment of bacterial skin infections, such as impetigo, folliculitis, and furunculosis, caused by microorganisms sensitive to mupirocin.

Contraindications.

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

This dosage form is not intended for ophthalmic or intranasal use.

Interaction with other medicinal products and other forms of interaction.

No interactions with other medicinal products have been identified.

Special precautions for use.

Hypersensitivity reactions

If hypersensitivity reactions or severe local skin reactions occur during application of the ointment, treatment should be discontinued, the affected skin area should be washed with water to remove any residual ointment, and appropriate therapy should be initiated.

Pseudomembranous colitis

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

Antibiotic-associated pseudomembranous colitis, varying in severity from mild to life-threatening, may occur during or after antibiotic treatment. Therefore, this diagnosis should be considered in patients who develop diarrhea while or after receiving antibiotics. Although the risk of developing this condition with topical mupirocin is lower, treatment should be immediately discontinued and further diagnostic evaluation initiated if prolonged or severe diarrhea or abdominal cramps occur.

Renal impairment

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

Bactopik ointment must not be used:

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

Accidental exposure to eyes

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

Use during pregnancy or breastfeeding.

Pregnancy. Animal studies with mupirocin have not shown evidence of harmful effects on the fetus. 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. There are no data on excretion of mupirocin into human milk following topical application. Treatment of cracked nipples with the ointment may be considered if necessary; however, the nipples should be thoroughly washed before breastfeeding.

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

Ability to influence the ability to drive and use machines.

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 should be applied to the affected skin areas 2–3 times daily for up to 10 days, depending on the response to treatment.

A dressing may be applied over the treated area.

Hepatic impairment

Dose adjustment is not required.

Renal impairment

See section "Special precautions for use".

Elderly patients

No restrictions for use, unless conditions for systemic absorption of polyethylene glycol contained in Bactopik ointment occur during treatment, leading to signs of moderate or severe renal impairment.

The medicinal 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 may compromise the stability of mupirocin in the ointment.

Any remaining ointment in the tube after completion of treatment should be discarded.

Children

The product can be used in children aged 2 months and older.

Overdose

Symptoms: The toxicity of Bactopik ointment is very low. Experience regarding symptoms of mupirocin overdose is limited.

Treatment: There is no specific antidote in case of overdose following topical application or accidental ingestion. Symptomatic therapy and appropriate monitoring of the patient's condition are recommended.

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

Adverse Reactions

Adverse reactions are classified by organ systems and 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 (> 1/10000, < 1/1000), very rare (< 1/10000, 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 suspected adverse reactions. Reporting of suspected adverse reactions after marketing authorization is highly important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

15 g of ointment in an aluminum tube. 1 tube per cardboard box.

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.