Fluocinolone acetonide

Fluocinolone acetonide is an active ingredient used to treat inflammation and allergic reactions. It belongs to the group of glucocorticoids and is a topical drug. This means that fluocinolone acetonide is applied to the skin to treat inflammatory and allergic skin conditions. It is available as a white powder that is insoluble in water. The active ingredient is available as a cream, ointment or suppository. Other areas of application include use as a shampoo additive to prevent dandruff, use as ear drops for eczematous ear infections, for the treatment of inflammation of the middle skin of the eye (uveitis) and to reduce eye pressure.

Fluocinolone acetonide acts by binding to the intracellular glucocorticoid receptors. Binding leads to vasoconstriction, reduced permeability of the cell membrane (membrane permeability), a decrease in the cell division rate, as well as a reduced immune response and an associated inhibition of the release of inflammatory mediators.

When small amounts of fluocinolone acetonide enter the bloodstream, it is metabolized in the liver via the CYP enzymes, mainly via CYP3A4. As it is a topical agent, only a very small amount or none at all enters the bloodstream. The half-life, i.e. the time the body needs to excrete half of the active ingredient, is 1.3-1.7 hours.

Always take fluocinolone acetonide exactly as described in the package leaflet or as advised by your doctor.

Adults:

The usual recommended dose is 0.075-0.1 mg fluocinolone acetonide every 12 hours. This dose should be applied to the affected area. Treatment should last for a maximum of 7 days.

Children & adolescents:

The usual recommended dose is 0.075-0.1 mg fluocinolone acetonide every 12 hours. This dosage should be applied to the affected area. Treatment should last for a maximum of 7 days.

The following side effects may occur:

Frequent:

• Discomfort in the ear
• Earache
• Itching in the ear
• Taste disturbances

Occasional:

• Noises in the ears (tinnitus)
• Residues of the medication
• Closure of the tympanic tube
• Tingling in the ear
• Accumulation of secretions
• Reduced hearing ability
• skin rash
• redness
• Fungal infections of the ear canal
• Discharge (otorrhea)
• Swelling of the auricle
• Disease of the eardrum
• Wound healing tissue (granulation tissue)
• Inflammation of the middle ear on the opposite side
• Infections with yeast fungi (candidiasis)
• Irritability
• Crying
• dizziness
• Reddening of the skin (flushing)
• headache
• vomiting
• Tiredness

Frequency unknown:

• blurred vision

Interactions may occur if the following medications are taken at the same time:

• When taking other medications to be applied to the ear at the same time

Fluocinolone acetonide must NOT be taken in the following cases:

• if you are allergic to fluocinolone acetonide
• in the case of an infection caused by viruses or fungi

Fluocinolone acetonide can be used as indicated from 6 months.

During pregnancy, fluocinolone acetonide should only be used after a careful risk-benefit assessment by a doctor, as a toxic effect on the unborn baby was observed in animal studies with systemic administration of low doses of corticosteroids. There are no such controlled studies on fluocinolone acetonide in particular.

During breastfeeding, fluocinolone acetonide should only be used after careful risk-benefit assessment by a doctor, as systemically administered corticosteroids pass into breast milk and can have a growth-inhibiting effect or influence corticosteroid production. No information is available on the extent to which this applies to topical corticosteroids.