Fluocinolone (Synalar) Adverse Reactions
- acneiform rash
- adrenocortical insufficiency
- blepharitis
- blurred vision
- cataracts
- conjunctival hyperemia
- contact dermatitis
- corneal edema
- Cushing’s syndrome
- erythema
- folliculitis
- glycosuria
- growth inhibition
- headache
- hyperglycemia
- hypertrichosis
- hypothalamic-pituitary-adrenal (HPA) suppression
- hypotonia
- impaired wound healing
- increased intracranial pressure
- infection
- macular edema
- miliaria
- ocular discharge
- ocular hemorrhage
- ocular hypertension
- ocular inflammation
- ocular irritation
- ocular pruritus
- papilledema
- photophobia
- photopsia
- pruritus
- ptosis
- retinal hemorrhage
- skin atrophy
- skin hypopigmentation
- skin irritation
- skin ulcer
- striae
- telangiectasia
- tolerance
- visual impairment
- withdrawal
- xerosis
Fluocinolone (Synalar) Adverse Reactions
Topical Administration:
The following adverse reactions (listed in decreasing order of occurrence) are reported infrequently with topical corticosteroids such as fluocinolone, but may occur more often when used with an occlusive dressing: skin irritation (including burning), pruritus, xerosis (dry skin), folliculitis, erythema, hypertrichosis, acneiform rash/eruptions, skin hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, telangiectasia, and miliaria. Although skin atrophy usually occurs after prolonged use of fluocinolone, this effect may occur even with short-term use of fluocinolone on intertriginous or flexor areas, or on the face. A flare of atopic dermatitis has been reported in patients with peanut hypersensitivity treated with Derma-Smoothe/FS®. The anti-inflammatory activity of topical corticosteroids may also mask manifestations of infection.
Case reports describe visual impairment patients using topical corticosteroids for eczema of the face. The visual impairment was secondary to the onset of ocular hypertension. Such adverse effects, if they occur, could lead to blindness. Cataracts have also been reported, usually with large doses or therapy > 6 months. Any patient who develops changes in vision during topical corticosteroid therapy should be evaluated for ocular hypertension. Low potency corticosteroids (e.g., hydrocortisone, dexamethasone) have been reported to be safer for short-term use around the eye area.
Systemic absorption of topical corticosteroids such as fluocinolone can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency after stopping treatment. In some patients, systemic absorption can produce manifestations of Cushing’s syndrome, hyperglycemia, and glycosuria. Percutaneous absorption of fluocinolone is dependent on many factors, including the vehicle, the integrity of the epidermal barrier, duration of use, and use of an occlusive dressing. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenocortical insufficiency in children include linear growth inhibition and delayed weight gain. Increased intracranial pressure has also been reported in children receiving topical corticosteroids; manifestations of increased intracranial pressure include bulging fontanelles, head pain/ache, and bilateral papilledema. Patients applying fluocinolone to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (using the ACTH stimulation test, A.M. plasma cortisol test, and urinary free cortisol test). To minimize risk of HPA axis suppression, patients should be treated for no more than 2 weeks at a time and only small areas should be treated. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or substitute a less potent corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids.
In general, excessive use of corticosteroids can lead to impaired wound healing. Topical fluocinolone should not be applied directly or near healing wounds. A propensity for skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.
Tolerance may occur with the prolonged use of topical corticosteroids. Tolerance is usually described as a decreased acute vasoconstrictive response to the agent after a period of days to weeks. This may explain the dramatic responses noted initially by patients early in topical corticosteroid treatment and an apparent diminished response with time. Tolerance is reversible and may be attenuated by interrupted or cyclic schedules of application (e.g., fluocinolone is given for 2 - 3 weeks, followed by a 1-week intermission).
Intravitreal Implant Administration:
Following surgical implantation of fluocinolone intravitreal implants (Retisert™), the most frequently reported ocular adverse events, reported in 50 - 90% of patients in clinical trials, were cataracts, increased intraocular pressure (ocular hypertension), procedural complication, and ocular pain. Based on clinical trials with fluocinolone intravitreal implants, within approximately 2 years of the implantation procedure, nearly all phakic eyes are expected to develop cataracts and require cataract surgery. Within 34 weeks post-implantation, approximately 60% of patients will require intraocular pressure lowering medications. Procedural complications relating specifically to the implant included implant expulsion, mechanical complication of implant, and migration of implant.
Following surgical implantation of fluocinolone intravitreal implants (Retisert™), ocular adverse events that occurred in approximately 10 - 35% of patients included reduced visual acuity, conjunctival hemorrhage (ocular hemorrhage), conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, ocular irritation, hypotonia, ocular pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, ocular inflammation, eyelid edema, increased tearing, and dry eye.
Following surgical implantation of fluocinolone intravitreal implants (Retisert™) ocular adverse events that occurred in approximately 5 - 9% of patients included macular edema, visual disturbance, ocular discharge, conjunctival edema/chemosis, photophobia, blepharitis, corneal edema, photopsia, retinal hemorrhage, choroidal detachment, vitreous opacities, and eye swelling.
The most frequently reported non-ocular adverse event following surgical implantation of fluocinolone intravitreal implants (Retisert™) was headache (31%). Other non-ocular adverse events that occurred in approximately 5 - 15% of patients were nasopharyngitis, arthralgia, sinusitis, dizziness, pyrexia, nausea, cough, influenza, upper respiratory tract infection, vomiting, limb pain, back pain, rash, and pain.
[ Last revised: 4/13/2005 7:55:00 PM ]
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