NEO-SYNALAR

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NEO-SYNALAR (NEO-SYNALAR).

How it works

Neomycin (aminoglycoside) binds to bacterial 30S ribosomal subunit, inhibiting protein synthesis. Fluocinolone acetonide (corticosteroid) binds to glucocorticoid receptor, inducing anti-inflammatory proteins and suppressing inflammatory mediators.

What the body does with it

Metabolism	Not significantly metabolized topically; absorbed systemically in small amounts.
Excretion	Renal (primarily as metabolites): ~80%; biliary/fecal: ~20%.
Half-life	Approximately 2-4 hours for the corticosteroid component; clinical effect persists beyond due to cellular actions.
Protein binding	~70% bound primarily to albumin and corticosteroid-binding globulin.
Volume of Distribution	0.5-1.0 L/kg, indicating distribution into total body water.
Bioavailability	Topical: minimal systemic absorption (<1%); intranasal: <1% systemic; oral (not typical): ~20%.
Onset of Action	Topical: hours to days for anti-inflammatory effect; intranasal: 12-24 hours.
Duration of Action	Topical: effect lasts 1-2 days after single application; intranasal: up to 24 hours after dosing.

Classification & Brands

Dosing & administration

Apply a thin layer to affected area twice daily. Maximum 60 g per week.

Dosage form	CREAM
Renal impairment	No dosage adjustment required for renal impairment due to minimal systemic absorption when used topically.
Liver impairment	No dosage adjustment required for hepatic impairment due to minimal systemic absorption when used topically.
Pediatric use	Apply a thin layer to affected area twice daily. Use smallest amount needed. Limit to 15 g per week in children under 12 years.
Geriatric use	Use with caution due to increased skin fragility. Apply sparingly to affected area twice daily; reduce frequency if irritation occurs.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for NEO-SYNALAR (NEO-SYNALAR).

Breastfeeding	Unknown if excreted in breast milk; however, systemic absorption after topical application is minimal. Consider benefits of breastfeeding and potential risk of exposing infant to corticosteroids; M/P ratio not established.
Teratogenic Risk	Category C. First trimester: No adequately controlled studies; animal studies show potential risk. Second and third trimesters: Prolonged use may cause adrenal suppression in neonate; avoid use for extended periods or high doses.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Neomycin can cause nephrotoxicity and ototoxicity, even with topical use on damaged skin or prolonged use.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to neomycin, fluocinolone, or other aminoglycosides/corticosteroids.","Viral, fungal, or untreated bacterial skin infections.","Perioral dermatitis or rosacea."]

Clinical Precautions

Precautions

["Prolonged use may lead to skin atrophy, striae, and systemic corticosteroid effects.","Neomycin may cause allergic contact dermatitis.","Avoid use on large body surface areas, open wounds, or occlusive dressings.","Monitor for signs of secondary infection worsening."]

Clinical Tips & Counseling

Drug interactions

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NEO-SYNALAR

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NEO-SYNALAR (NEO-SYNALAR).

How it works

What the body does with it

Metabolism	Not significantly metabolized topically; absorbed systemically in small amounts.
Excretion	Renal (primarily as metabolites): ~80%; biliary/fecal: ~20%.
Half-life	Approximately 2-4 hours for the corticosteroid component; clinical effect persists beyond due to cellular actions.
Protein binding	~70% bound primarily to albumin and corticosteroid-binding globulin.
Volume of Distribution	0.5-1.0 L/kg, indicating distribution into total body water.
Bioavailability	Topical: minimal systemic absorption (<1%); intranasal: <1% systemic; oral (not typical): ~20%.
Onset of Action	Topical: hours to days for anti-inflammatory effect; intranasal: 12-24 hours.
Duration of Action	Topical: effect lasts 1-2 days after single application; intranasal: up to 24 hours after dosing.

Classification & Brands

Dosing & administration

Apply a thin layer to affected area twice daily. Maximum 60 g per week.

Dosage form	CREAM
Renal impairment	No dosage adjustment required for renal impairment due to minimal systemic absorption when used topically.
Liver impairment	No dosage adjustment required for hepatic impairment due to minimal systemic absorption when used topically.
Pediatric use	Apply a thin layer to affected area twice daily. Use smallest amount needed. Limit to 15 g per week in children under 12 years.
Geriatric use	Use with caution due to increased skin fragility. Apply sparingly to affected area twice daily; reduce frequency if irritation occurs.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for NEO-SYNALAR (NEO-SYNALAR).

Breastfeeding	Unknown if excreted in breast milk; however, systemic absorption after topical application is minimal. Consider benefits of breastfeeding and potential risk of exposing infant to corticosteroids; M/P ratio not established.
Teratogenic Risk	Category C. First trimester: No adequately controlled studies; animal studies show potential risk. Second and third trimesters: Prolonged use may cause adrenal suppression in neonate; avoid use for extended periods or high doses.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Neomycin can cause nephrotoxicity and ototoxicity, even with topical use on damaged skin or prolonged use.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to neomycin, fluocinolone, or other aminoglycosides/corticosteroids.","Viral, fungal, or untreated bacterial skin infections.","Perioral dermatitis or rosacea."]