Fluorometholone/ Neomycin Sulfate

Registered South African indications:

• Infectious conjunctivitis due to organisms sensitive to neomycin
• Anterior segment inflammatory disorders complicated by bacteria sensitive to neomycin
• Removal of foreign bodies before and after surgery, where there is a possibility of infection with susceptible organisms

Registered South African contraindications

• Hypersensitivity to fluorometholone, neomycin sulfate, or any of the excipients
• Acute untreated purulent ocular infections caused by micro-organisms not sensitive to neomycin
• Acute superficial keratitis and conjunctivitis due to herpes simplex (dendritic keratitis)
• Fungal diseases of ocular structures
• Vaccinia, varicella, and most other viral diseases of the conjunctiva and cornea
• Ocular tuberculosis
• Mycobacterial ocular infections
• Glaucoma
• Pregnancy
• Lactation

South African recommendations

Caution in the following patient groups

• Renal impairment
• Hepatic impairment
• Elderly

Prolonged use of corticosteroids in eye drops

• Eye drops containing corticosteroids, such as in fluorometholone/ neomycin, should not be used for more than one week unless under strict medical supervision with regular checks for intraocular pressure
• Prolonged use of fluorometholone/ neomycin may increase intraocular pressure (IOP), leading to the potential development of glaucoma, optic nerve damage, defects in visual acuity and fields of vision, and delayed wound healing
• Reports indicate that posterior subcapsular lenticular opacities may occur after prolonged or heavy use of topical ophthalmic corticosteroids, as contained in fluorometholone/ neomycin
• Acute ocular infections with secretion may be masked or enhanced by the presence of fluorometholone in fluorometholone/ neomycin
• Systemic hypercorticoidism has been reported after the use of topical corticosteroids, such as those in fluorometholone/ neomycin
• Prolonged use may suppress the immune response, increasing the risk of secondary ocular infections, which may lead to corneal ulceration or thinning, with the risk of keratic perforation

History of herpes simplex

• Use of fluorometholone/ neomycin in patients with a history of herpes simplex requires great caution and frequent slit-lamp microscopy

Fungal infections

• Fungal infections of the cornea have been reported with long-term local steroid applications. Fungal invasion may be suspected in any persistent corneal ulceration where fluorometholone/ neomycin has been used or is in use over a prolonged period

Corneal abscess, fungal keratopathy, and glaucoma

• Due to the possibility of inducing corneal abscess, fungal keratopathy, or glaucoma, refer patients to an ophthalmologist if the eye has not responded within 48 hours

Neomycin-resistant infections

• In diseases caused by micro-organisms resistant to neomycin, infection may be masked or enhanced by the steroid in fluorometholone/ neomycin. Prolonged use may lead to overgrowth of non-susceptible organisms

Hypersensitivity to neomycin

• There has been an increase in hypersensitivity reactions to neomycin. If sensitivity or other adverse reactions occur, discontinue use of fluorometholone/ neomycin

Visual disturbances

• Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids

Excipients: Benzalkonium chloride

• Fluorometholone/ neomycin contains benzalkonium chloride, which may be absorbed by soft contact lenses, causing irritation and discolouration. Contact lenses should be removed before instillation and reinserted 15 minutes after administration
• Benzalkonium chloride may affect corneal permeability and disrupt the corneal epithelium with prolonged or repeated use. Regular ophthalmologic examinations are required for patients using benzalkonium chloride preserved preparations for an extended period, especially those with extensive ocular surface disease

Excipients: Sodium phosphate

• Fluorometholone/ neomycin contains sodium phosphate. Cases of corneal calcification have been reported with the use of phosphate-containing eye drops in patients with damaged corneas

Effects on ability to drive and use machines

• Fluorometholone/ neomycin may influence the ability to drive and use machines. If blurred vision occurs, patients should wait until their vision clears before driving or using machines

Forms avail. in SA and covered in this monograph: opd

Infectious conjunctivitis due to organisms sensitive to neomycin
Anterior segment inflammatory disorders complicated by bacteria sensitive to neomycin
Removal of foreign bodies before and after surgery, where there is a possibility of infection with susceptible organisms

Fluorometholone/ Neomycin Sulfate
1/5 (mg/ml)

• Ophthalmic (opd): 1-2 drops in the conjunctival sac 2-4 times dly; During the initial 24-48hrs, the dosage may be safely increased to 1 drop every hr

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Do not freeze
Shake well before use

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To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for a few minutes immediately after instillation of each drop. Patients should be advised to complete the course of treatment

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To prevent contamination, care should be taken to avoid touching the bottle tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection

Safety and efficacy in children aged 2 years or younger has not been established

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no information available

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Fluorometholone
Gastrointestinal Disorders

•  Dysgeusia

Skin and Subcutaneous Tissue Disorders

• Rash

Immune System Disorders

• Hypersensitivity

Sensory Disorders

• Increased intraocular pressure
• Eye irritation
• Conjunctival or ocular hyperaemia
• Eye pain
• Visual disturbance
• Foreign body sensation in eyes
• Eyelid oedema 
• Blurred vision
• Eye discharge
• Eye pruritis
• Increased lacrimation
• Eye oedema or eye swelling 
• Mydriasis
• Cataract 
• Ulcerative keratitis
• Ocular infection 
• Visual field defect
• Punctate keratitis

Neomycin
Central Nervous System Disorders

• Headache 

Genitourinary Disorders

• Nephrotoxicity 

Skin and Subcutaneous Tissue Disorders

• Dermatitis 
• Itching 

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity 

Sensory Disorders

• Ocular discomfort
• Keratitis
• Eye irritation
• Ototoxicity

No information available 

None routine. Specific cases may require

• Intraocular pressure

Fluorometholone
Glucocorticoids bind to cytoplasmic receptors and control the synthesis of inflammatory mediators thus reducing swelling, fibrin deposition, capillary dilatation, phagocyte migration, capillary proliferation, collagen deposition and scarring.

Neomycin
Neomycin is an aminoglycoside antibiotic which acts by binding to a specific protein on the 30S ribosomal subunit of the microbe. This results in faulty alignment or recognition with respect to mRNA and probably tRNA during initiation of microbial peptide chain formation. The mRNA is misread on the recognition region of the ribosome, resulting in the wrong amino acid being inserted into the peptide. This result in production of non-functional peptide chains.

COMBINATION PREPARATIONS

Fluorometholone/ Neomycin/ Polyvinyl alcohol

Eye drops (per ml) 1mg/5mg/14mg

• FML Neo Liquifilm (Allergan) originator