Fluorometholone


Concise Prescribing Info
Indications/Uses
Ocular inflammation.
Dosage/Direction for Use
Adult : Ophthalmic Treatment of steroid-responsive inflammation of bulbar and palpebral conjunctiva, cornea, and anterior segment of the globe: As 0.1% eye drops susp: Instil 1-2 drops into the conjunctival sac 2-4 times/day. Dosage may be increased to 2 drops hourly or 1 drop 4 hourly during the initial 24-48 hours of treatment. As 0.25% eye drop susp: Instil 1 drop into the conjunctival sac 2-4 times/day; may be increased to 1 drop 4 hourly during the initial 24-48 hours of treatment. As 0.1% ointment: Apply small amount or approx 1/2 inch ribbon to the conjunctival sac 1-3 times/day; may be increased to 4 hourly during the initial 24-48 hours of treatment. As 0.1% fluorometholone acetate eye drop susp: Instil 1-2 drops into the conjunctival sac 4 times/day; may be increased to 2 drops 2 hourly during the initial 24-48 hours of treatment.
Dosage Details
Ophthalmic
Ocular inflammation
Adult: For the treatment of steroid-responsive inflammation of bulbar and palpebral conjunctiva, cornea, and anterior segment of the globe: As 0.1% eye drops susp: Instil 1-2 drops into the conjunctival sac 2-4 times daily; may be increased to 2 drops hourly or 1 drop 4 hourly during the initial 24-48 hours of treatment. As 0.25% eye drop susp: Instil 1 drop into the conjunctival sac 2-4 times daily; may be increased to 1 drop 4 hourly during the initial 24-48 hours of treatment. As 0.1% ointment: Apply small amount or approx 1/2 inch ribbon to the conjunctival sac 1-3 times daily; may be increased to 4 hourly during the initial 24-48 hours of treatment. Re-evaluate therapy if symptoms do not improve after 2 days. As 0.1% fluorometholone acetate eye drop susp: Instil 1-2 drops into the conjunctival sac 4 times daily; may be increased to 2 drops 2 hourly during the initial 24-48 hours of treatment. Re-evaluate therapy if symptoms do not improve after 14 days.
Child: ≥2 years Same as adult dose.
Contraindications
Viral diseases of the cornea and conjunctiva (e.g. epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial eye infection, fungal disease of ocular structures, acute purulent untreated bacterial eye infections.
Special Precautions
Patient with glaucoma; history of herpes simplex, undiagnosed red eye, disease causing thinning of corneal or scleral tissue. Use after cataract surgery. Avoid abrupt withdrawal (particularly in chronic conditions). Children. Pregnancy and lactation.
Adverse Reactions
Significant: Posterior subcapsular cataract formation, corneal and scleral thinning leading to perforation, optic nerve damage, defects in visual acuity and fields of vision, delayed corneal wound healing, secondary ocular infection (e.g. fungal infection), increased intraocular pressure and/or glaucoma (prolonged use); increased incidence of bleb formation (after cataract surgery), blurred vision. Rarely, central serous chorioretinopathy.
Eye disorders: Eye pain, irritation, pruritus, and swelling; transient burning and stinging sensation of eyes, ocular hyperaemia, eyelid oedema, mydriasis, increased lacrimation, foreign body sensation in the eyes, eye discharge.
Gastrointestinal disorders: Dysgeusia.
Immune system disorders: Hypersensitivity reaction.
Skin and subcutaneous tissue disorders: Rash.
Patient Counseling Information
This drug may cause transient blurred vision; if affected, do not drive or operate machinery. Remove contact lenses before administration and wait at least 15 minutes prior to reinsertion.
MonitoringParameters
Monitor intraocular pressure regularly particularly when used for ≥10 days and in patients with glaucoma; signs and symptoms of secondary infection. Perform frequent slit lamp microscopy particularly in patients with history of herpes simplex.
Drug Interactions
May delay the healing of ophthalmic tissue when used with ophthalmic NSAIDs. May increase the risk of systemic adverse effects with CYP3A4 inhibitors (e.g. cobicistat-containing agents, ritonavir).
Action
Description: Fluorometholone is a synthetic corticosteroid that readily penetrates cells to induce the production of lipocortins, the proteins responsible for modulating the action of prostaglandins and leukotrienes. It also blocks the inflammatory response including oedema, capillary dilatation, leukocyte migration, and scar formation.
Pharmacokinetics:
Absorption: Mainly absorbed into the aqueous humour.
Chemical Structure

Chemical Structure Image
Fluorometholone

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9878, Fluorometholone. https://pubchem.ncbi.nlm.nih.gov/compound/Fluorometholone. Accessed Oct. 27, 2020.

Storage
Ophthalmic susp: Store between 2-25°C. Do not freeze. Ophthalmic ointment: Store between 15-25°C.
MIMS Class
ATC Classification
S01BA07 - fluorometholone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
References
Anon. Fluorometholone. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/10/2020.

Anon. Fluorometholone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/10/2020.

Buckingham R (ed). Fluorometholone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/10/2020.

Flarex (Novartis Pharmaceuticals [HK] Ltd). MIMS Hong Kong. http://www.mims.com/hongkong. Accessed 08/10/2020.

Fluorometholone Solution/Drops (Pacific Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/10/2020.

FML Forte Suspension/Drops (Allergan, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/10/2020.

FML Liquifilm Ophthalmic 1 mg/mL Eye Drops, suspension (Allergan Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 08/10/2020.

FML Ointment (Allergan, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/10/2020.

Joint Formulary Committee. Fluorometholone. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/10/2020.

Novartis New Zealand Limited. Flucon 0.1% Eye Drops Suspension data sheet 30 July 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 08/10/2020.

Disclaimer: This information is independently developed by MIMS based on Fluorometholone 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in