Besifloxacin

Registered South African indications: 

• Bacterial conjunctivitis caused by susceptible isolates; Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius* 

*Efficacy for this organism was studied in fewer than 10 infections 

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Prolonged use
• Concomitant use with contact lenses
• Dry eye(s)
• Patients with compromised cornea(s)
• May impair ability to drive and operate machinery 

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

Infections caused by: Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African manufacturer recommendations

Bacterial conjunctivitis

• Ophthalmic (opd): 1 drop into affected eye(s), 3 times dly, with doses 4-12hrs apart; Treatment duration: 7 days 

Invert closed bottle and shake once before use 

To avoid contamination, do not let the applicator tip touch the surface of the eye, fingers, or any other surface 

Paed. forms avail. in SA and covered in this monograph: opd

Infections caused by: Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius*

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African manufacturer recommendations

Bacterial conjunctivitis

Younger than 1 year

• Not established for use

1 year and older

• See adult dosage

Invert closed bottle and shake once before use 

To avoid contamination, do not let the applicator tip touch the surface of the eye, fingers, or any other surface

Pregnancy

• Caution
• There are no available human data for the use of besifloxacin during pregnancy to inform any medicine-associated risks; however, systemic exposure to besifloxacin from ocular administration is low

Breastfeeding

• Caution
• There are no data on the presence of besifloxacin in human milk, the effects on the breastfed infant, or the effects on milk production
• However, systemic exposure to besifloxacin following topical ocular administration is low and it is not known whether measurable levels of besifloxacin would be present in maternal milk following topical ocular administration
• Developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for besifloxacin, and any potential adverse effects on the breastfed infant from besifloxacin
• Caution should be exercised when besifloxacin is administered to a breastfeeding mother

Fertility

• In a fertility and early embryonic development study in rats, besifloxacin did not impair the fertility of male or female rats at oral doses of up to 500mg/kg/day
• This dose is approximately 26 500 times higher than the mean plasma concentration measured in humans at the recommended ophthalmic use

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache 

Sensory Disorders

• Blurred vision 
• Eye irritation 
• Eye pain 
• Eye itching 
• Conjunctival redness 
• Eye pruritus 
• Conjunctivitis 
• Conjunctival haemorrhage 
• Eye discharge 
• Eyelid oedema 
• Conjunctival hyperaemia 
• Punctate keratitis 
• Ocular hyperaemia 
• Viral conjunctivitis 
• Dry eye 
• Limbal hyperaemia 
• Increased lacrimation 

None known

Specific cases may require

• Slit-lamp biomicroscopy 
• Fluorescein staining 

Additional observations

• Overgrowth of non-susceptible organisms 
• Signs and symptoms of eye irritation and dry eyes 

Administration directions

• DO NOT inject into the eye or other tissue 
• Instill into the affected eye(s) 

Besifloxacin is a broad-spectrum fluoroquinolone antibiotic that is active against Gram-positive and Gram-negative bacteria mainly due to the inhibition of both bacterial DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme required for the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division. 

Spectrum of activity: Aerococcus viridans*, CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella catarrhalis*, Moraxella lacunata*, Pseudomonas aeruginosa*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Staphylococcus warneri*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius* 

Eye drops (per 1ml) 6mg

• Besivance (Soflens) originator