Baciderm (Ointment, Powder) Instructions for Use

ATC Code

D06AX (Other antibiotics for topical use)

Active Substances

Bacitracin (Rec.INN registered by WHO)

Neomycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antibiotics for topical use; other antibiotics for topical use

Pharmacological Action

A combined antibacterial agent for external use. It contains two antibiotics that have a bactericidal effect, Neomycin and Bacitracin.

Bacitracin is a polypeptide antibiotic that inhibits the synthesis of the bacterial cell wall. Bacitracin is particularly active against gram-positive microorganisms, such as β-hemolytic streptococci, staphylococci, and some gram-negative pathogens. Resistance to bacitracin is extremely rare.

Neomycin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis. Active against gram-positive and gram-negative bacteria.

Due to the use of a combination of these two antibiotics, a broad spectrum of action of this agent and a synergism of action against a number of microorganisms, for example, staphylococci, is achieved.

Pharmacokinetics

The active substances are generally not absorbed (even through damaged skin); nevertheless, high concentrations of them are present in the skin.

The tissue tolerance of this combination is considered excellent; inactivation by biological products, blood, and tissue components is not observed.

Indications

It is used in appropriate dosage forms for the treatment and prevention of infections caused by microorganisms sensitive to neomycin and/or bacitracin: bacterial skin infections of limited prevalence, including boils, carbuncles (after surgical treatment), staphylococcal sycosis, periporitis, deep folliculitis, suppurative hidradenitis, paronychia, contagious impetigo, infected trophic ulcers of the lower extremities, infected eczema, bacterial diaper dermatitis, bacterial complications of viral infections caused by Herpes simplex or Herpes zoster (including infection of vesicles in chickenpox); prevention of umbilical infection in newborns; prevention of infection after surgical procedures, for additional treatment in the postoperative period (after tissue excision, cauterization, episiotomy, treatment of fissures, perineal rupture, weeping wounds and sutures), in cosmetic surgery, during skin transplantation.

ICD codes

Dosage Regimen

Apply a thin layer of ointment or a light dusting of powder to the affected skin area two to three times daily.

Cleanse and dry the affected area thoroughly before each application.

For minor wounds, burns, and abrasions, apply the preparation and cover with a sterile bandage if necessary.

For infected dermatoses such as impetigo or infected eczema, apply directly to the lesions.

In post-surgical wound care, apply to the suture line or graft site to prevent infection.

The duration of treatment is typically 5 to 7 days; do not use for more than 10 days unless directed by a physician.

For prevention of umbilical infection in newborns, apply a small amount to the umbilical stump until it heals.

Discontinue use and consult a physician if no improvement is seen within 3-5 days, if the condition worsens, or if signs of irritation or allergic reaction appear.

Avoid application to large areas of damaged skin, severe burns, or chronic ulcers without medical supervision due to increased risk of systemic absorption and toxicity.

Do not apply in or near the eyes; if accidental contact occurs, rinse thoroughly with water.

Adverse Reactions

From the immune system rarely – allergic reactions (if there is a history of allergic reactions to Neomycin, cross-allergy to other aminoglycosides is possible in 50% of cases); frequency unknown – increased sensitivity to various substances, including Neomycin (usually observed when used in the therapy of chronic dermatoses), in some cases allergic reactions may appear as a lack of effect from the therapy.

From the nervous system frequency unknown – damage to the vestibular nerve, neuromuscular blockade.

From the organ of hearing and labyrinthine disorders frequency unknown – ototoxicity.

From the skin and subcutaneous tissues rarely – allergic reactions manifesting as contact dermatitis, allergic reaction to Neomycin; frequency unknown – allergic reactions in the form of redness and dryness of the skin, skin rashes and itching (with prolonged use).

From the kidneys and urinary tract frequency unknown – nephrotoxicity.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, the patient should immediately inform the doctor.

Contraindications

Hypersensitivity to bacitracin, neomycin or other aminoglycosides; extensive skin lesions (risk of developing an ototoxic effect accompanied by hearing loss); severe excretory function impairment due to cardiac or renal failure in patients with pre-existing lesions of the vestibular and cochlear systems in cases where absorption of active substances is possible; infections of the external auditory canal with perforation of the eardrum; simultaneous use with systemic aminoglycoside antibiotics (risk of cumulative toxicity); not for use in the treatment of eye infections.

With caution

Patients with impaired liver and/or kidney function, acidosis, severe myasthenia gravis or other neuromuscular diseases.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible only after consultation with a doctor if the intended benefit to the mother outweighs the potential risk to the fetus or infant.

It should be remembered that Neomycin, like all antibiotics of the aminoglycoside group, can cross the placental barrier. With systemic use of aminoglycoside antibiotics in high doses, intrauterine hearing loss in the fetus has been described.

Use in Hepatic Impairment

Should be used with caution in patients with impaired liver function.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

If use in children is necessary, a doctor should be consulted beforehand.

Geriatric Use

No dose adjustment is required for elderly patients.

Special Precautions

Since the risk of toxic effects increases with reduced liver and/or kidney function, patients with hepatic and/or renal insufficiency should undergo blood and urine tests along with audiometric testing before and during therapy with this combination.

If the components of the combination are absorbed, attention should be paid to the potential blockade of neuromuscular conduction, especially in patients with acidosis, myasthenia gravis or other neuromuscular diseases. In this case, calcium preparations or neostigmine methylsulfate may prevent the development of such blockades.

During long-term treatment, attention should be paid to the possible growth of resistant microorganisms. In such situations, appropriate treatment tactics should be chosen.

In case of use in children, patients with impaired liver and kidney function, as well as with a large area of the treated surface, prolonged use and deep skin lesions, a doctor should be consulted beforehand.

If allergic reactions and superinfection develop, use should be discontinued.

Drug Interactions

With systemic absorption of the active components of the combination, simultaneous use of cephalosporins or aminoglycoside antibiotics may increase the likelihood of nephrotoxic reactions.

Simultaneous use with a combination of diuretics such as ethacrynic acid or furosemide may provoke oto- and nephrotoxic effects.

Absorption of the active components of the combination may enhance the phenomena of neuromuscular conduction blockade in patients receiving opioid analgesics, anesthetics and/or muscle relaxants.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.