Dermidex

• Approved Indications:
• Treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as eczema, dermatitis, psoriasis, and seborrheic dermatitis.
• Management of oral inflammatory lesions such as aphthous stomatitis (when used as a dental paste).
• Adjunct treatment in chronic inflammatory conditions of the skin where corticosteroid therapy is appropriate.
• Treatment of alopecia areata in some topical formulations.
• Ocular formulations are indicated for inflammatory eye conditions, including allergic conjunctivitis and uveitis.
• Off-label/Clinically Accepted Uses:
• Treatment of lichen planus and other localized inflammatory dermatoses.
• Use in scalp psoriasis and seborrheic dermatitis with specialized formulations.
• Intravitreal implants of fluocinolone acetonide are used for chronic diabetic macular edema.

• Topical Formulations (Cream, Ointment, Solution, Oil):
• Apply a thin layer to the affected area 2 to 4 times daily.
• Duration: Usually 2 weeks; prolonged use requires medical supervision due to risk of skin atrophy.
• Avoid occlusive dressings unless directed by a physician.
• Dental Paste:
• Apply a small amount to the oral lesion 2 to 3 times daily after meals and at bedtime.
• Duration varies based on response, generally not exceeding 2 weeks.
• Ophthalmic Formulations (Eye Drops/Ointment):
• Dose varies; typically 1-2 drops in the affected eye 2-4 times daily.
• Use under ophthalmologic supervision.
• Intravitreal Implant:
• Administered via ophthalmic procedure for diabetic macular edema; dosing and frequency as per specialist guidance.
• Special Populations:
• Use cautiously in pediatric patients; limit duration to minimize systemic absorption and side effects.
• Elderly patients may be more susceptible to skin thinning and should be monitored.
• No specific dosage adjustments are typically required for renal or hepatic impairment for topical use.

Fluocinolone acetonide is a synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive effects by binding to glucocorticoid receptors within cells. This binding modulates gene expression to inhibit the release of inflammatory mediators such as prostaglandins and leukotrienes, suppresses leukocyte infiltration at the site of inflammation, and reduces capillary permeability. In the skin and mucous membranes, these effects decrease swelling, redness, and itching. When administered intraocularly, it reduces ocular inflammation by similar anti-inflammatory pathways.

• Absorption:
  Variable systemic absorption depending on the formulation, application site, and condition of the skin or mucosa; generally minimal with topical use on intact skin.
• Distribution:
  After absorption, distributed widely; crosses the placenta and is found in small amounts in breast milk.
• Metabolism:
  Metabolized primarily in the liver by hepatic enzymes to inactive metabolites.
• Elimination:
  Excreted mainly via urine.
• Half-life:
  Systemic half-life varies; with topical use, systemic levels are typically low and half-life less clinically relevant.

• Pregnancy:
  FDA Category C. Animal studies have shown adverse effects at systemic doses; topical use during pregnancy should be limited to the minimum effective amount and duration. Use only if benefits outweigh risks.
• Lactation:
  Limited data on excretion in human milk; caution is advised when applied topically to large areas. Breastfeeding mothers should avoid extensive use.

• Primary Class: Corticosteroid
• Subclass: Medium to high potency topical corticosteroid

• Known hypersensitivity to fluocinolone acetonide or any formulation excipients.
• Untreated bacterial, viral, or fungal skin infections.
• Perioral dermatitis and acne rosacea.
• Use in skin ulceration or wounds unless specifically directed by a physician.
• Hypersensitivity to corticosteroids in ocular formulations.

• Prolonged use or use under occlusion may cause skin atrophy, striae, telangiectasia, and systemic corticosteroid effects.
• Use with caution near eyes to avoid glaucoma or cataract development.
• Risk of secondary infections; monitor for signs of local infections.
• Avoid abrupt discontinuation after prolonged use to prevent rebound effects.
• Monitor intraocular pressure during ophthalmic use.
• Pediatric patients at higher risk for systemic absorption and adverse effects.
• Avoid use on large areas or broken skin to minimize systemic absorption.

• Common:
• Local skin burning, itching, irritation.
• Dryness or peeling.
• Mild folliculitis.
• Cutaneous:
• Skin thinning, atrophy, striae.
• Hypopigmentation.
• Acneiform eruptions.
• Ocular:
• Increased intraocular pressure.
• Cataract formation (long-term use).
• Eye irritation.
• Systemic (rare with topical use):
• Signs of Cushing's syndrome.
• Hyperglycemia.
• Adrenal suppression.

• Concurrent use with other topical products may increase irritation.
• Use caution with systemic corticosteroids to avoid additive systemic effects.
• Metabolism can be influenced by CYP3A4 inhibitors or inducers when systemic absorption occurs.
• Ophthalmic corticosteroids may interact with ocular hypotensive agents.

• Recent guidelines emphasize minimizing prolonged use due to risk of skin atrophy and systemic effects.
• New ophthalmic formulations approved for intravitreal use in chronic diabetic macular edema have shown improved efficacy.
• Updated warnings on neuropsychiatric effects with systemic corticosteroids have increased caution in high-dose systemic exposures.
• Regulatory bodies recommend limiting topical corticosteroid potency and duration in pediatric populations.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from excessive moisture and heat.
• Keep containers tightly closed.
• Do not freeze.
• Keep out of reach of children.