Fluocinolone: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Intravitreal
Diabetic macular oedema

Adult: In patients who are insufficiently responsive to available treatment: As 0.19 mg ocular implant: Administer 1 implant in the affected eye via intravitreal inj. Not recommended for concurrent administration to both eyes. Refer to the product-specific guideline for further instructions on pre-treatment and administration.

Intravitreal
Chronic non-infectious uveitis of posterior segment of eye

Adult: As 0.18 mg ocular implant: Administer 1 implant in the affected eye via intravitreal inj. As 0.59 mg ocular implant: Administer 1 implant (containing a silicone-encased tab) into the posterior segment of the affected eye via intravitreal inj. Refer to the product-specific guideline for further instructions on pre-treatment and administration.

Otic/Aural
Chronic eczematous otitis externa

Adult: As 0.01% oil ear drops: Instil 5 drops into the affected ear(s) bid for 1-2 weeks.
Child: ≥2 years As 0.01% oil ear drops: Same as adult dose.

Topical/Cutaneous
Corticosteroid-responsive dermatoses

Adult: As 0.025% cream, 0.00625% or 0.025% ointment, 0.01% solution: Apply a thin layer to the affected area(s) 2-4 times daily depending on the condition.
Child: ≥1 year Same as adult dose. Treatment duration: Up to 5 days without using occlusion.

Topical/Cutaneous
Atopic dermatitis

Adult: As 0.01% body oil: Apply a thin film to affected area(s) 3 times daily. Apply the least amount to cover the affected area.
Child: For moderate to severe cases: As 0.01% body oil: ≥3 months Moisten the skin then apply a thin film to affected area(s) bid for up to 4 weeks. Apply the least amount to cover the affected area.

Topical/Cutaneous
Scalp psoriasis

Adult: As scalp oil: Apply a thin film on wet or dampened scalp, massage well, and cover with a shower cap. Leave on overnight or for at least 4 hours before washing off using a regular shampoo then rinse thoroughly.

Topical/Cutaneous
Seborrhoeic dermatitis of scalp

Adult: As 0.01% shampoo: Apply no more than 1 ounce to the scalp once daily; work into a lather and remain on the scalp for approx 5 minutes before rinsing off thoroughly.

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).

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.

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.

Pregnancy Category (US FDA)

Ophth/Otic/Topical: C

Patient Counseling Information

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).

Action

Description:
Mechanism of Action: Fluocinolone acetonide is a corticosteroid which has anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces phospholipase A₂ inhibitory proteins (lipocortins) and sequentially inhibits the release of arachidonic acid, thereby depressing the formation, release, and activity of endogenous chemical mediators of inflammation (e.g. kinins, histamine, liposomal enzymes, prostaglandins).
Duration: Intravitreal: 0.18 mg and 0.19 mg ocular implant: Designed to release fluocinolone acetonide at an initial rate of 0.25 mcg daily and lasting 36 months. 0.59 mg ocular implant: Designed to release fluocinolone acetonide at an initial rate of 0.6 mcg daily, decreasing over the 1st month to a steady-state release rate of 0.3-0.4 mcg daily for approx 30 months.
Pharmacokinetics:
Absorption: May be absorbed percutaneously (topical).
Distribution: Distributed in the aqueous and vitreous humour (0.59 mg ocular implant).

Chemical Structure

Storage

Topical: Store at 25°C. Otic drops: Store between 20-25°C. Ocular implant: Store between 15-25°C. Do not refrigerate or freeze.

MIMS Class

Ear Corticosteroids / Eye Corticosteroids / Topical Corticosteroids

ATC Classification

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.
D07AC04 - fluocinolone acetonide ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.

References

Anon. Fluocinolone (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/09/2020.

Anon. Fluocinolone (Otic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/09/2020.

Anon. Fluocinolone (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/09/2020.

Buckingham R (ed). Fluocinolone Acetonide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/09/2020.

Capex Shampoo (Galderma Laboratories, L.P.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 11/12/2020.

Derma-Smoothe/FS Body Oil (Royal Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/10/2020.

Derma-Smoothe/FS Scalp Oil (Royal Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/10/2020.

DermOtic Oil Ear Drops (Royal Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/10/2020.

Flac Otic Oil (Patrin Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/12/2020.

Iluvien 190 micrograms Intravitreal Implant in Applicator (Alimera Sciences Limited). MHRA. https://products.mhra.gov.uk/. Accessed 17/12/2020.

Iluvien Implant (Alimera Sciences, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/12/2020.

Joint Formulary Committee. Fluocinolone Acetonide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/09/2020.

Retisert Implant (Bausch & Lomb Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 17/12/2020.

Synalar Cream (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 18/12/2020.

Synalar Ointment (Medimetriks Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/12/2020.

Synalar Ointment 1 in 4 Dilution (Reig Jofre UK Limited). MHRA. https://products.mhra.gov.uk/. Accessed 11/12/2020.

Synalar Solution (Medimetriks Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/10/2020.

Yutiq Implant (EyePoint Pharmaceuticals US, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/09/2020.

Disclaimer: This information is independently developed by MIMS based on Fluocinolone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com