Contraindications
Topical: Untreated fungal, bacterial or viral skin lesions; acne, rosacea, anogenital pruritus, perioral dermatitis. Intravitreal: Suspected or active ocular or periocular infections, including most viral disease of the cornea and conjunctiva, and active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, bacterial, mycobacterial and fungal infections of the eye; glaucoma (0.19 mg ocular implant).
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Special Precautions
Intravitreal: Patient with glaucoma or increased intraocular pressure (at baseline); not recommended for use in patients with history of ocular herpes simplex. Children. Pregnancy and lactation. Patient Counselling Intravitreal: This drug may cause temporary visual blurring after administration, if affected, do not drive or operate machinery. Monitoring Parameters Intravitreal: Following the inj, monitor for increased intraocular pressure, signs of endophthalmitis, perfusion of optic nerve head, tonometry within 30 minutes, and biomicroscopy between 2-7 days. Check intraocular pressure at least every 3 months thereafter. Monitor the integrity of implant by visual inspection periodically (for 0.59 mg ocular implant).
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Adverse Reactions
Significant: Hypothalamic-pituitary-adrenal (HPA) axis suppression or hypercortisolism (prolonged use); allergic contact dermatitis, Kaposi's sarcoma (prolonged use), local effects (e.g. skin atrophy, burning, itching, irritation, dryness, hypopigmentation, miliaria, striae, telangiectasia, acneiform eruptions), secondary infection, systemic effects (e.g. manifestations of Cushing's syndrome, hyperglycaemia, glycosuria). Intravitreal: Posterior subscapular cataract formation, glaucoma, eye inflammation, increased intraocular pressure, endophthalmitis, choroidal or retinal detachment, hypotony, vitreous haemorrhages or loss, wound dehiscence, secondary ocular infections, ocular perforation.
Blood and lymphatic system disorders: Anaemia (intravitreal).
Eye disorders: Eye pain and irritation, reduced visual acuity, vitreous floaters, blurred vision, ocular or conjunctival hyperaemia, conjunctival haemorrhage.
Gastrointestinal disorders: Nausea, vomiting (intravitreal).
Immune system disorders: Local hypersensitivity reactions.
Infections and infestations: Pneumonia (intravitreal).
Musculoskeletal and connective tissue disorders: Back pain, limb pain, arthralgia (intravitreal).
Nervous system disorders: Headache, dizziness (intravitreal).
Renal and urinary disorders: Renal failure (intravitreal).
Skin and subcutaneous tissue disorders: Rash; erythema.
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CIMS Class
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ATC Classification
D07AC04 - fluocinolone acetonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
C05AA10 - fluocinolone acetonide ; Belongs to the class of products containing corticosteroids for topical use. Used in the treatment of hemorrhoids and anal fissures. S01BA15 - fluocinolone acetonide ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye. S02BA08 - fluocinolone acetonide ; Belongs to the class of corticosteroids used in the treatment of inflammation of the ear. |