Neotracin

Approved Medical Uses:

• Minor Skin Infections
  Indicated for the topical treatment and prevention of superficial skin infections caused by minor cuts, scrapes, and abrasions.
• Infected Dermatoses
  Effective in treating superficial bacterial infections associated with eczema, impetigo, dermatitis, and other mild skin conditions.
• Surgical Wound Prophylaxis
  Applied as a prophylactic agent on minor surgical incisions, sutured wounds, or abrasions to prevent secondary bacterial infection.

Clinically Accepted Off-Label Uses:

• Colonization Control in Chronic Ulcers or Pressure Sores
  Occasionally used under medical supervision to prevent bacterial colonization in chronic non-healing wounds, though prolonged use is discouraged due to resistance and hypersensitivity risks.

Adults:

• Apply a thin layer to the affected area 2 to 5 times daily.
• A sterile dressing may be applied if needed.

Pediatric Patients:

• Apply a thin layer 1 to 3 times daily under supervision.
• Avoid large surface area application, especially in neonates and infants, due to increased percutaneous absorption.

Elderly:

• Same dosing as adults. Monitor for dermatologic sensitivity with prolonged use.

Patients with Renal Impairment:

• Use with extreme caution. Avoid use over large areas or for prolonged durations due to risk of systemic absorption of neomycin, which may lead to nephrotoxicity.

Patients with Hepatic Impairment:

• No dosage adjustment necessary. Use with general caution.

Route of Administration:

• Topical application to intact skin only.
• Do not apply to eyes, ears (if tympanic membrane is perforated), mucous membranes, or large open wounds.

Treatment Duration:

• Typically not more than 7 days unless otherwise directed by a physician.

Neomycin Sulfate is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by irreversibly binding to the 30S ribosomal subunit, preventing the formation of functional initiation complexes, and causing misreading of mRNA. This results in bacterial cell death. Bacitracin Zinc is a cyclic polypeptide antibiotic that inhibits the dephosphorylation of bactoprenol pyrophosphate, interfering with bacterial cell wall synthesis in Gram-positive organisms. When combined, these agents offer broad-spectrum topical antimicrobial activity, covering both Gram-positive and Gram-negative pathogens.

• Absorption:
  Minimal systemic absorption through intact skin. Systemic absorption increases if applied to damaged skin, large surface areas, or burns.
• Distribution:
  If absorbed, neomycin distributes in extracellular fluids, while bacitracin is distributed poorly and remains largely localized.
• Metabolism:
  Both agents are minimally metabolized when used topically.
• Excretion:
  Systemically absorbed neomycin is excreted unchanged via the kidneys. Bacitracin is eliminated renally.
• Half-Life:
  Not clinically significant in topical use due to minimal absorption.

Pregnancy:

• FDA Category C
  Animal studies have shown adverse effects; human studies are lacking. Use only if potential benefits outweigh risks, especially in large or prolonged applications.

Lactation:

• Excretion into breast milk is unlikely with topical use on intact skin.
  Avoid application to the breast area to prevent unintentional oral ingestion by infants.

• Topical Antibacterial Combination
• Neomycin: Aminoglycoside antibiotic
• Bacitracin Zinc: Polypeptide antibiotic

• Hypersensitivity to neomycin, bacitracin, or any formulation components
• Previous history of neomycin-induced ototoxicity
• Perforated tympanic membrane (if used in ear canal)
• Extensive burns, deep wounds, or large open lesions
• Concurrent systemic use of aminoglycosides

• Systemic Toxicity Risk:
  Neomycin may be absorbed systemically in large surface area applications, potentially causing ototoxicity or nephrotoxicity, especially in renal-impaired patients.
• Allergic Reactions:
  Risk of contact dermatitis is significant with neomycin; discontinue if rash, itching, or swelling occurs.
• Superinfection:
  Prolonged use may lead to overgrowth of fungi or non-susceptible bacteria.
• Avoid Misuse:
  Not for ocular, oral, or intranasal use. Do not apply inside the ear canal if tympanic membrane is perforated.

Common (by body system):

• Dermatologic:
• Mild erythema
• Pruritus
• Dryness
• Burning or stinging sensation

Less Common / Serious:

• Contact dermatitis (neomycin-related allergic reaction)
• Ototoxicity (hearing loss or tinnitus with prolonged or large-area use)
• Nephrotoxicity (with excessive systemic absorption)
• Delayed wound healing or secondary fungal infections

Onset:
May occur within a few days of therapy initiation. Risk increases with high-frequency or prolonged use.

• Systemic Aminoglycosides:
  Additive nephrotoxic and ototoxic effects if absorbed significantly.
• Loop Diuretics (e.g., furosemide, bumetanide):
  Increased risk of ototoxicity with systemic neomycin absorption.
• Neuromuscular Blocking Agents:
  Rare interaction with absorbed neomycin may potentiate neuromuscular blockade.
• Enzymatic Pathways:
  No significant CYP450-mediated metabolism; drug interactions via cytochrome pathways are not clinically relevant.

• Antibiotic Stewardship Caution:
  Multiple dermatological societies caution against excessive or prolonged topical antibiotic use due to rising cases of neomycin-induced allergic contact dermatitis and resistance.
• Regulatory Notes:
  Updated labeling in several regions includes stronger warnings for prolonged use, particularly in children and those with renal impairment.
• Local Market Verification (Bangladesh):
  Commonly available as Neobac®, Bacimycin®, Neobac Plus®, in ointment or cream forms (Medex.com.bd confirmed).

• Temperature: Store at 20°C to 25°C (68°F to 77°F). Acceptable between 15°C to 30°C.
• Humidity & Light: Store in a dry place, away from direct sunlight and excessive moisture.
• Handling Instructions:
• Keep the tube tightly closed after use.
• Do not freeze.
• For external use only.
• Special Notes:
• No refrigeration required.
• Discard if tube content becomes discolored or shows signs of separation.