Neo-Synalar

Combinations of Corticosteroids with Antibacterials
Topical Aminoglycosides, Plain or in Combination

Avoid contact with the eyes.
Do not bandage or otherwise cover or wrap the treated skin area. Advise parents of pediatric patients to not use tight-fitting diapers or plastic pants on a child being treated in the diaper area.

skin atrophy / Delayed / Incidence not known
nephrotoxicity / Delayed / Incidence not known
ototoxicity / Delayed / Incidence not known

contact dermatitis / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
Cushing's syndrome / Delayed / Incidence not known

striae / Delayed / Incidence not known
folliculitis / Delayed / Incidence not known
miliaria / Delayed / Incidence not known
hypertrichosis / Delayed / Incidence not known
acneiform rash / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
xerosis / Delayed / Incidence not known
skin irritation / Early / Incidence not known
skin hypopigmentation / Delayed / Incidence not known

Neo-Synalar

Rx

Topical combination of antibiotic and corticosteroid
Used for corticosteroid-responsive dermatoses with secondary infection
Not to be used under occlusive dressing due to risk for augmented absorption and associated adverse effects

Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily.

Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Metyrapone: (Major) Medications which affect pituitary or adrenocortical function, including all corticosteroid therapy, should be discontinued prior to and during testing with metyrapone. Patients taking inadvertent doses of corticosteroids on the test day may exhibit abnormally high basal plasma cortisol levels and a decreased response to the test. Although systemic absorption of topical corticosteroids is minimal, temporary discontinuation of these products should be considered if possible to reduce the potential for interference with the test results.
Voriconazole: (Moderate) Monitor for potential adrenal dysfunction with concomitant use of voriconazole and fluocinolone. In patients taking corticosteroids, voriconazole-associated CYP3A4 inhibition of their metabolism may lead to corticosteroid excess and adrenal suppression. Corticosteroid exposure is likely to be increased. Voriconazole is a strong CYP3A4 inhibitor, and fluocinolone is a CYP3A4 substrate.

Neo-Synalar Topical Cream: 3.5-0.025%

4 applications/day topically.

4 applications/day topically.

4 applications/day topically.

4 applications/day topically.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Neomycin; fluocinolone is a topical antibiotic and corticosteroid combination. Neomycin is an aminoglycoside antibiotic with bactericidal activity against many gram-positive and gram-negative bacteria. It is actively transported into the bacterial cell where it binds to receptors present on the 30S ribosomal subunit of susceptible bacteria. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial mRNA. Eventually, susceptible bacteria die because of the lack of functional proteins. Fluocinolone is a corticosteroid. Corticosteroids are naturally occurring hormones that bind to specific protein receptors on targeted tissues. This binding induces a response by modifying transcription and, ultimately, protein synthesis to achieve the steroid's intended action. The anti-inflammatory action of fluocinolone results from the inhibition of leukocyte infiltration at the site of inflammation, interference in the function of mediators of inflammatory response, and suppression of humoral immune responses. Topical corticosteroids share anti-inflammatory, anti-pruritic, and vasoconstrictive actions. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacy of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy.

Neomycin; fluocinolone is administered topically to the skin. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are excreted by the kidneys. Some topical corticosteroids and their metabolites are also excreted into the bile.

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Use topical corticosteroids during pregnancy only if the potential benefit justifies the potential risk to the fetus. Do not use topical corticosteroids extensively on pregnant patients, in large amounts, or for prolonged periods of time. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Topical corticosteroids have been shown to be teratogenic in animals when administered systemically at relatively low dosages.

Use caution when topical corticosteroids are administered to a breast-feeding woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant.