Fluocinolone Acetonide + Neomycin Sulfate

Approved Indications:

• Inflammatory Dermatoses with Secondary Bacterial Infection, including:
• Atopic dermatitis
• Contact dermatitis (irritant or allergic)
• Seborrheic dermatitis
• Eczematous dermatoses
• Chronic Otitis Externa with associated inflammation and bacterial infection
• Infected Psoriasis (limited, non-extensive)
• Lichen simplex chronicus with secondary infection
• Scalp Conditions such as infected seborrheic dermatitis or infected eczema

Clinically Accepted Off-label Uses:

• Intertrigo with bacterial superinfection (short-term use)
• Perianal inflammatory lesions with secondary infection
• Infected insect bites or stings (short-term, localized)

Route of Administration: Topical (cream, ointment, lotion, ear drops)

General Adult Dosage:

• Apply a thin layer to the affected area 2 to 3 times daily, depending on the severity of the condition.
• For ear drops: Instill 2 to 4 drops into the affected ear 2–3 times daily.

Pediatric Use:

• Safe for short-term use in children above 2 years under close supervision.
• Apply a thin layer no more than twice daily.
• Avoid in infants <2 years unless specifically prescribed.

Geriatric Use:

• Same dosage as adults.
• Caution advised due to increased risk of skin atrophy.

Duration of Therapy:

• Limit continuous use to 7–10 days to avoid corticosteroid-related adverse effects.
• In chronic conditions, intermittent use is preferred under medical supervision.

Renal/Hepatic Impairment:

• No dosage adjustment typically required for topical use, but systemic absorption of neomycin can occur—avoid prolonged use over large areas.

Fluocinolone Acetonide is a medium-potency synthetic corticosteroid that works by suppressing the formation, release, and activity of inflammatory mediators such as prostaglandins, kinins, histamine, and leukotrienes. It binds to glucocorticoid receptors, regulating gene transcription and ultimately reducing inflammation, itching, redness, and swelling in the skin.
Neomycin Sulfate, an aminoglycoside antibiotic, binds irreversibly to the 30S ribosomal subunit of bacteria, inhibiting protein synthesis and leading to bacterial death. The combination provides both anti-inflammatory and antibacterial action in localized infected dermatoses.

Fluocinolone Acetonide:

• Absorption: Minimal systemic absorption when applied to intact skin; increased with occlusion or broken skin.
• Distribution: High affinity for skin tissue.
• Metabolism: Primarily metabolized in the liver after systemic absorption.
• Elimination: Excreted via urine as inactive metabolites.
• Half-life: Varies depending on extent of absorption; systemic half-life not clinically significant in topical use.

Neomycin Sulfate:

• Absorption: Poorly absorbed through intact skin; systemic absorption increases with damaged or inflamed skin.
• Distribution: If absorbed, widely distributed in extracellular fluid.
• Metabolism: Not significantly metabolized.
• Elimination: Primarily excreted unchanged via kidneys.
• Half-life: ~2–3 hours if absorbed systemically.

Pregnancy:

• Fluocinolone Acetonide: Not assigned a formal FDA category post-2015; animal studies have shown fetal toxicity at high systemic doses. Topical use during pregnancy should be limited to small areas for short durations.
• Neomycin Sulfate: Potential risk of ototoxicity in fetus if systemically absorbed. Avoid prolonged use, especially on large or broken skin areas.

Lactation:

• Excretion into breast milk is not expected with topical application. However, caution is advised:
• Avoid application to the breast area if nursing.
• Do not allow infant contact with treated skin.

Recommendation: Use only if clearly needed and for the shortest possible duration under medical supervision.

• Fluocinolone Acetonide: Topical Corticosteroid (medium potency)
• Neomycin Sulfate: Topical Aminoglycoside Antibiotic
• Combination Class: Topical Anti-inflammatory and Antibacterial Agent

• Known hypersensitivity to fluocinolone, neomycin, other aminoglycosides, or formulation excipients
• Viral skin infections (e.g., herpes simplex, chickenpox)
• Fungal or tubercular skin infections
• Perforated tympanic membrane (for otic use)
• Application to the eyes or mucosal surfaces
• Acne vulgaris or rosacea

• Systemic Absorption Risk: Use with caution in children or when applying to large areas or under occlusion.
• Ototoxicity & Nephrotoxicity: With systemic absorption of neomycin—particularly when used on broken or inflamed skin.
• Skin Atrophy & Hypopigmentation: With prolonged use of corticosteroids.
• Secondary Infection Risk: Long-term steroid use may mask or exacerbate secondary infections.
• Avoid Long-Term Use: Limit to 7–10 days unless otherwise instructed.
• Monitor for Superinfection: Discontinue if no improvement is seen within 7 days or if infection worsens.

Common:

• Burning or stinging sensation at application site
• Skin dryness or irritation
• Mild pruritus or erythema

Less Common:

• Folliculitis
• Acneiform eruptions
• Skin thinning
• Telangiectasia

Serious (Rare):

• Allergic contact dermatitis
• Ototoxicity (from systemic absorption of neomycin)
• Adrenal suppression (with prolonged use or occlusion)
• Permanent hearing loss (if used in otitis with perforated tympanic membrane)

Onset & Severity:

• Most side effects occur within days to weeks of use.
• Severity increases with prolonged use, high surface area application, or occlusion.

• Live vaccines (e.g., BCG, smallpox): Avoid concurrent use with topical corticosteroids due to immunosuppressive effects.
• Other ototoxic drugs (e.g., furosemide, cisplatin): Risk of additive ototoxicity if neomycin is systemically absorbed.
• CYP450 enzymes: Not significantly involved in topical use; minimal systemic metabolism.
• Cosmetic products or irritants: May increase skin irritation if applied concurrently.

• Topical corticosteroid-antibiotic combinations are increasingly advised for short-term use only to avoid resistance and side effects.
• Recent guidelines recommend:
• Avoiding chronic or prophylactic use in inflammatory dermatoses.
• Limiting use to localized lesions to reduce systemic absorption risks.
• The use of neomycin-containing combinations is declining in favor of newer agents due to potential for contact sensitization.

• Temperature: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C–30°C.
• Humidity: Store in a dry place, away from excessive moisture.
• Light Protection: Keep in the original container, protected from direct sunlight.
• Handling Precautions:
• Do not freeze.
• Shake lotion formulations well before use.
• Do not use past expiration date.