Neogen Plus

Approved Indications:

• Minor Skin Infections
  Indicated for the topical treatment and prevention of superficial skin infections resulting from minor cuts, scrapes, abrasions, and burns.
• Infected Dermatoses
  Used in localized skin infections associated with conditions such as impetigo, infected eczema, or contact dermatitis.
• Prophylaxis of Superficial Wound Infection
  Applied post-surgically to minor incisions or lacerations to prevent bacterial contamination.
• Bacterial Conjunctivitis (ophthalmic formulation only)
  Used to treat superficial infections of the external eye caused by susceptible bacteria.

Clinically Accepted Off-Label Uses:

• Chronic Ulcer Care
  Sometimes used for short-term prevention of bacterial colonization in pressure ulcers or diabetic foot ulcers under medical supervision, though not appropriate for deep or systemic infections.

Adults (Topical Use):

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

Pediatrics:

• Apply a thin layer 1 to 3 times daily under adult supervision.
• Avoid application to large areas, especially in neonates or infants, due to increased systemic absorption.

Elderly:

• Use the same dosing as adults.
• Monitor for local skin reactions with prolonged use.

Renal Impairment:

• Use with extreme caution, especially if applied to broken or extensive skin surfaces, due to the risk of systemic absorption of neomycin and polymyxin B, which are both nephrotoxic.

Hepatic Impairment:

• No dose adjustment required; however, systemic exposure should be minimized.

Routes of Administration:

• Topical: For use on intact skin.
• Ophthalmic: Available in specific formulations for eye infections.
• Not for otic, nasal, or systemic use.

Duration of Treatment:

• Typically 5 to 7 days.
• Do not exceed 7 days of use unless specifically directed by a physician.

This combination offers broad-spectrum antibacterial activity through three complementary mechanisms:

• Neomycin Sulfate binds irreversibly to the 30S ribosomal subunit of bacteria, disrupting protein synthesis and leading to bacterial cell death. It is primarily effective against Gram-negative organisms.
• Bacitracin Zinc inhibits bacterial cell wall synthesis by interfering with the dephosphorylation of lipid carriers involved in peptidoglycan transport, effectively targeting Gram-positive organisms.
• Polymyxin B Sulfate interacts with the phospholipids in bacterial cell membranes, especially in Gram-negative bacteria, causing increased permeability and subsequent leakage of cellular contents, resulting in cell death.

Together, the agents offer bactericidal coverage against a broad range of Gram-positive and Gram-negative organisms.

• Absorption:
  Minimal systemic absorption occurs through intact skin. Absorption increases with application to broken skin, large areas, or with prolonged use.
• Distribution:
  If absorbed, neomycin and polymyxin B distribute mainly in extracellular fluid. Bacitracin is minimally distributed beyond local tissue.
• Metabolism:
  These antibiotics are not significantly metabolized when administered topically.
• Excretion:
  Systemically absorbed neomycin and polymyxin B are excreted unchanged via the kidneys. Bacitracin is also primarily eliminated renally.
• Half-life (if absorbed):
  Neomycin: approximately 2 to 3 hours.
  Polymyxin B: variable, dependent on renal function.
  Not clinically relevant in topical applications unless systemic absorption occurs.

Pregnancy:

• FDA Category C
  Animal studies have shown adverse fetal effects; there are no adequate and well-controlled studies in pregnant women. Should only be used if the potential benefit justifies the potential risk to the fetus.

Lactation:

• Systemic absorption through intact skin is low, making excretion into breast milk unlikely.
  Avoid application to the breast or nipple area to prevent unintentional ingestion by the infant.
  Use with caution in breastfeeding mothers.

• Topical Antibacterial Combination
• Neomycin Sulfate: Aminoglycoside antibiotic
• Bacitracin Zinc: Polypeptide antibiotic
• Polymyxin B Sulfate: Cyclic polypeptide antibiotic

• Known hypersensitivity to neomycin, bacitracin, polymyxin B, or any other component of the formulation
• History of neomycin-induced ototoxicity or nephrotoxicity
• Perforated tympanic membrane when used near the ear
• Application over large open wounds, extensive burns, or damaged skin
• Concurrent use with systemic aminoglycosides

• Systemic Absorption Risks:
  Prolonged use or application over large or broken skin areas may lead to significant systemic absorption, increasing the risk of ototoxicity and nephrotoxicity, particularly with neomycin and polymyxin B.
• Contact Sensitization:
  Neomycin is a well-known allergen. Discontinue immediately if signs of allergic contact dermatitis (e.g., redness, itching, swelling) appear.
• Secondary Infections:
  Prolonged use may result in fungal overgrowth or superinfection with resistant organisms.
• Avoid Non-Approved Routes:
  Not intended for intranasal, otic (if tympanic membrane is perforated), or systemic administration.
• Caution in Renal-Impaired or Elderly Patients:
  Monitor for toxicity signs if used on compromised skin integrity.

Common (local):

• Mild burning, stinging, or redness
• Itching or dryness at the site of application

Less Common:

• Contact dermatitis (neomycin-related)
• Skin rash or urticaria

Serious (rare):

• Ototoxicity (especially with neomycin if absorbed systemically)
• Nephrotoxicity (with prolonged or extensive use)
• Anaphylactic reactions (extremely rare)

Onset & Severity:

• Most reactions are mild and local, occurring within the first few days of use.
• Risk of severe effects increases with prolonged use, large surface area application, or broken skin.

• Systemic Aminoglycosides (e.g., gentamicin, tobramycin):
  Increased risk of cumulative nephrotoxicity and ototoxicity.
• Loop Diuretics (e.g., furosemide, bumetanide):
  May enhance the ototoxic potential of neomycin.
• Neuromuscular Blocking Agents:
  If neomycin is systemically absorbed, it may potentiate neuromuscular blockade.
• CYP450 Enzymes:
  Not significantly involved; interactions via hepatic enzyme systems are unlikely.

• Allergy Risk Acknowledgment:
  Dermatology and allergy associations have highlighted neomycin as a leading cause of contact dermatitis; caution is advised, especially with prolonged use.
• Duration Limitation Reinforced:
  Updated guidance recommends limiting use to ≤7 days to reduce risk of resistance and systemic toxicity.
• Brand Formulations in Bangladesh (Medex Verified):
  Common brands include Neobac® Plus, Neoderm®, Polynema®, and Neotopic®, available as ointments and creams.

• Temperature: Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C.
• Humidity & Light: Keep in a dry place, protected from excess moisture and direct sunlight.
• Handling Instructions:
• Do not freeze.
• Keep tightly closed after each use.
• For external use only.
• Discard after expiration or if discolored.
• Refrigeration: Not required.