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Pronunciation:

(floo oh SIN oh lone)

U.S. Brand Names:

Capex™; Derma-Smoothe/FS®; Synalar®

Synonyms:

Fluocinolone Acetonide

Generic Available:

Yes; Excludes oil, shampoo

Canadian Brand Names:

Capex™; Derma-Smoothe/FS®; Fluoderm; Synalar®

Use:

Relief of susceptible inflammatory dermatosis [low, medium, high potency topical corticosteroid]; psoriasis of the scalp; atopic dermatitis in children 2 years of age

Pregnancy Risk Factor:

Pregnancy Implications:

There are no adequate and well-controlled studies in pregnant women. In general, the use of topical corticosteroids during pregnancy is not considered to have significant risk, however, intrauterine growth retardation in the infant has been reported (rare). The use of large amounts or for prolonged periods of time should be avoided.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to fluocinolone or any component of the formulation; TB of skin, herpes (including varicella)

Warnings/Precautions:

Adverse systemic effects may occur when used on large areas of the body, denuded areas, for prolonged periods of time, with an occlusive dressing, and/or in infants or small children. Infants and small children may be more susceptible to adrenal axis suppression from topical corticosteroid therapy. Derma-Smoothe/FS® contains peanut oil; use caution in peanut-sensitive children.

Adverse Reactions:

Frequency not defined.

Dermatologic: Acneiform eruptions, allergic contact dermatitis, burning, dryness, folliculitis, irritation, itching, hypertrichosis, hypopigmentation, miliaria, perioral dermatitis, skin atrophy, striae

Endocrine & metabolic: Cushing's syndrome, HPA axis suppression

Miscellaneous: Secondary infection

Overdosage/Toxicology:

Topically-applied products may be absorbed in sufficient amounts to produce systemic effects, particularly if applied to large surface area or to inflamed/damaged skin. Systemic hypercorticism and adrenal suppression may occur; in those cases, discontinuation and withdrawal of the corticosteroid should be done judiciously.

Drug Interactions:

No data reported

Stability:

Store at controlled room temperature in tightly-closed container.

Capex™: Prior to dispensing, the contents of the capsule should be emptied into the liquid shampoo; shake well. Discard after 3 months.

Mechanism of Action:

A synthetic corticosteroid which differs structurally from triamcinolone acetonide in the presence of an additional fluorine atom in the 6-alpha position on the steroid nucleus. The mechanism of action for all topical corticosteroids is not well defined, however, is believed to be a combination of anti-inflammatory, antipruritic, and vasoconstrictive properties.

Pharmacodynamics/Kinetics:

Absorption: Dependent on strength of preparation, amount applied, nature of skin at application site, vehicle, and use of occlusive dressing; increased in areas of skin damage, inflammation, or occlusion

Distribution: Throughout local skin; absorbed drug is distributed rapidly into muscle, liver, skin, intestines, and kidneys

Metabolism: Primarily in skin; small amount absorbed into systemic circulation is primarily hepatic to inactive compounds

Excretion: Urine (primarily as glucuronide and sulfate, also as unconjugated products); feces (small amounts)

Dosage:

Topical:

Children 2 years: Atopic dermatitis (Derma-Smoothe/FS®): Moisten skin; apply to affected area twice daily; do not use for longer than 4 weeks

Children and Adults: Corticosteroid-responsive dermatoses: Cream, ointment, solution: Apply a thin layer to affected area 2-4 times/day; may use occlusive dressings to manage psoriasis or recalcitrant conditions

Adults:

Atopic dermatitis (Derma-Smoothe/FS®): Apply thin film to affected area 3 times/day

Scalp psoriasis (Derma-Smoothe/FS®): Massage thoroughly into wet or dampened hair/scalp; cover with shower cap. Leave on overnight (or for at least 4 hours). Remove by washing hair with shampoo and rinsing thoroughly.

Seborrheic dermatitis of the scalp (Capex™): Apply no more than 1 ounce to scalp once daily; work into lather and allow to remain on scalp for ~5 minutes. Remove from hair and scalp by rinsing thoroughly with water.

Administration:

Apply thin film to affected area; avoid eyes.

Monitoring Parameters:

HPA axis suppression (ACTH stimulation test, AM plasma cortisol test, urinary free cortisol test); signs of bacterial or fungal infection

Patient Education:

For external use only. Do not use for eyes, mucous membranes, or open wounds. Use exactly as directed and for no longer than the period prescribed. Before using, wash and dry area gently. Apply in a thin layer (may rub in lightly). Apply light dressing (if necessary) to area being treated. Do not use occlusive dressing unless so advised by prescriber. Avoid prolonged or excessive use around sensitive tissues, genital, or rectal areas. Avoid exposing treated area to direct sunlight. Inform prescriber if condition worsens (redness, swelling, irritation, signs of infection, or open sores) or fails to improve. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Cream, as acetonide: 0.01% (15 g, 60 g); 0.025% (15 g, 60 g)

Synalar®: 0.025% (15 g, 60 g)

Oil, as acetonide:

Derma-Smoothe/FS® [eczema oil]: 0.01% (120 mL) [contains peanut oil]

Derma-Smoothe/FS® [scalp oil]: 0.01% (120 mL) [contains peanut oil; packaged with shower caps]

Ointment, as acetonide (Synalar®): 0.025% (15 g, 60 g)

Shampoo, as acetonide (Capex™): 0.01% (120 mL)

Solution, as acetonide: 0.01% (60 mL)

Synalar®: 0.01% (20 mL, 60 mL)

International Brand Names:

Adermina® (CL); Atoactive® (IT); Capex™ (CA); Cinolon® (ID); Co-Fluocin® (ES); Co Fluocin Fuerte® (ES); Cortamide® (IT); Cortiespec® (ES); Cortoderm® (ZA); Derma Cort® (DO); Dermalar® (IL); Derma-Smoothe/FS® (CA); Dermasolon® (ID); Dermobeta® (IT); Dermolin® (IT); Duoflu® (AR); Esacinone® (IT); Fluacet® (HR, SI); Fluciderm® (TH); Flucinar® (CZ, DE, HU, PL, RU); Flucort® (IN, RU); Flunolone-V® (SG, TH); Fluocid® (ES); Fluocinolon Acetonid® (RO); Fluocinolon® (RO); Fluoderm (CA, IL, ZA); Fluodermo® (ES); Fluomix Same® (IT); Fluonid® (HK); Fluovitef® (IT); Flupollon® (JP); Flusolgen® (ES); Fluvean® (IT, JP); Fluzon® (JP); Fulone® (TH); Gelargin® (CZ); Gelidina® (ES); Jellin® (DE); Jellisoft® (DE); Localyn® (IT); Luci® (IN); Omniderm® (IT); Panolon® (YU); Sinaflan® (RU); Sinoderm® (YU); Sterolone® (IT); Supralan® (TH); Synalar® (AR, AT, BE, BG, BR, CA, CH, CZ, DK, ES, FR, GB, HK, HU, IE, LU, MX, NO, NZ, PT, RO, SE, TH, ZA); Synalar Gamma® (AR, BE, LU); Ultraderm® (IT)

References

Reed, BR, "Dermatologic Drugs, Pregnancy, and Lactation. A Conservative Guide,"Arch Dermatol, 1997, 133(7):894-8.

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