Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Neo-Synalar: Neomycin sulfate 0.5% and fluocinolone acetonide 0.025% (60 g) [contains cetyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]
Kit, External:
Neo-Synalar: Neomycin sulfate 0.35% and fluocinolone acetonide 0.025% [contains cetyl alcohol, edetate disodium, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
Pharmacology
Mechanism of Action
Neomycin interferes with bacterial protein synthesis by binding to 30S ribosomal subunits.
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Fluocinolone has low to intermediate range potency (dosage-form dependent).
Use: Labeled Indications
Corticosteroid-responsive dermatoses with secondary infection: Treatment of corticosteroid-responsive dermatoses with secondary infection. Use of this combination has not shown greater benefit than the steroid component alone after 7 days of treatment.
Contraindications
Hypersensitivity to fluocinolone, neomycin, or any component of the formulation; use in external auditory canal if eardrum is perforated
Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Dosage and Administration
Dosing: Adult
Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time. Therapy should be discontinued when control is achieved.
Corticosteroid-responsive dermatoses: Topical: Apply a thin film to affected area 2 to 4 times daily depending on severity of condition.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Dosage should be based on severity of disease and patient response; use smallest amount for shortest period of time. Therapy should be discontinued when control is achieved.
Corticosteroid-responsive dermatoses: Topical: Children and Adolescents: Refer to adult dosing.
Administration
Topical: For external use only; not for oral use. Unless otherwise directed by health care professional, do not use with occlusive dressing.
Storage
Store between 15°C and 25°C (59°F and 77°F); avoid freezing and excessive heat above 40°C (104°F).
Drug Interactions
Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy
Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy
Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
See individual agents.
Warnings/Precautions
Concerns related to adverse effects:
- Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis.
- Local effects: Local adverse reactions may occur (eg, skin atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection miliaria); may be irreversible. Local adverse reactions are more likely to occur with occlusive and/or prolonged use. If irritation develops, discontinue use and institute appropriate therapy.
- Ototoxicity: Neomycin may increase the risk of ototoxicity with extended use. Do not use in any patient with a perforated tympanic membrane.
- Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, or application to large surface areas.
Special populations:
- Pediatric: Children may absorb proportionally larger amounts after topical application and may be more prone to systemic effects. HPA axis suppression, intracranial hypertension, and Cushing syndrome have been reported in children receiving topical corticosteroids. Prolonged use may affect growth velocity; growth should be routinely monitored in pediatric patients.
Other warnings/precautions:
- Appropriate use: Not for oral use. Unless otherwise directed by healthcare professional, do not use with occlusive dressing; do not use on children's skin covered by diapers or plastic pants.
Monitoring Parameters
Growth in pediatric patients; HPA axis suppression (eg, ACTH stimulation test, morning plasma cortisol test, urinary free cortisol test); signs of bacterial or fungal infection
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed with corticosteroids in animal reproduction studies.
