Moxifloxacin

Registered South African indications:

• Bacterial conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible organisms
• Preoperative and postoperative sterilisation for ophthalmic surgery

• Breastfeeding
• Elderly
• Prolonged use
• Conjunctivitis in neonates
• Chlamydia trachomatis in children <2 years
• Prophylaxis or empiric treatment of gonococcal conjunctivitis
  - Including gonococcal ophthalmia neonatorum
  - Neonates with ophthalmia neonatorum
• Concomitant use of contact lenses
• Coadministration with corticosteroids
• May impair ability to drive or operate machinery

Registered contraindications in South Africa & other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• History of hypersensitivity to moxifloxacin or other quinolones

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

Infections caused by: Aerobic gram-positive microorganisms such as Corynebacterium species including Corynebacterium diphtheriae; Staphylococcus aureus (methicillin-susceptible); Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus viridans group; Aerobic gram-negative microorganisms such as Enterobacter cloacae; Haemophilus influenzae; Klebsiella oxytoca; Moraxella catarrhalis; Serratia marcescens; Anaerobic microorganisms such as Propionibacterium acnes; Other microorganisms such as Chlamydia trachomatis

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 registered indications and dosages

Bacterial conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible organisms

• Ophthalmic (opd): Instil 1 drop into the affected eye(s), 3 times a day; Treatment duration: 7 days; Increase or decrease of frequency of instillation can be adjusted according to the symptoms

Preoperative and postoperative sterilisation for ophthalmic surgery
- Before ophthalmic surgery

• Ophthalmic (opd): Instil 1 drop into the affected eye(s), 5 times a day; Treatment duration: 2 days

- After ophthalmic surgery

• Ophthalmic (opd): Instil 1 drop into the affected eye(s), 3 times a day; Treatment duration: 14 days

For ocular use. Not for injection. Moxifloxacin eye drops should not be injected sub-conjunctivally or introduced directly into the anterior chamber of the eye

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle

After cap is removed, if tamper evident snap collar is loose, remove before using product

Patients should be instructed to take at least 5 minutes between administrations if using moxifloxacin eye drops concurrently with other ophthalmic solutions

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

Infections caused by: Aerobic gram-positive microorganisms such as Corynebacterium species including Corynebacterium diphtheriae; Staphylococcus aureus (methicillin-susceptible); Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus viridans group; Aerobic gram-negative microorganisms such as Enterobacter cloacae; Haemophilus influenzae; Klebsiella oxytoca; Moraxella catarrhalis; Serratia marcescens; Anaerobic microorganisms such as Propionibacterium acnes; Other microorganisms such as Chlamydia trachomatis

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 registered indications and dosages

Bacterial conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible organisms

• See adult dosage

Moxifloxacin eye drops have been shown to be safe and effective for bacterial infection treatment in paediatric patients including neonates and can be used at the same dose as in adults

Use of moxifloxacin eye drops for surgical sterilisation in paediatric patients has not been studied

There is no evidence that the ophthalmic administration of moxifloxacin ophthalmic has any effect on weight-bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals

Pregnancy

• Safe
• There are no or limited amount of data from the use of moxifloxacin in pregnant women
• However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible
• The medicinal product can be used during pregnancy

Breastfeeding

• Caution
• It is unknown whether moxifloxacin/metabolites are excreted in human milk
• Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin. However, at therapeutic doses of moxifloxacin eye drops no effects on the breastfeeding child are anticipated
• The medicinal product can be used during breastfeeding

Fertility

• Studies have not been performed to evaluate the effect of ocular administration of moxifloxacin on fertility

• No dose adjustment recommended

• No dose adjustment recommended

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Headache
• Paraesthesia
• Dizziness

Cardiovascular Disorders

• Palpitations

Respiratory Disorders

• Nasal discomfort
• Pharyngolaryngeal pain
• Sensation of foreign body (throat)
• Dyspnoea

Gastrointestinal Disorders

• Nausea and vomiting

Hepatobiliary Disorders

• Increased alanine aminotransferase
• Increased gamma-glutamyltransferase

Skin and Subcutaneous Tissue Disorders

• Erythema
• Rash
• Pruritus
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Decreased haemoglobin
• Hypersensitivity

Sensory Disorders

• Eye pain
• Eye irritation
• Punctate keratitis
• Dry eye
• Conjunctival haemorrhage
• Ocular hyperaemia
• Eye pruritis
• Eyelid oedema
• Ocular discomfort
• Corneal epithelium defect
• Conjunctivitis
• Blepharitis
• Eye swelling
• Conjunctival oedema
• Blurred vision
• Reduced visual acuity
• Asthenopia
• Erythema of eyelid
• Endophthalmitis
• Ulcerative keratitis
• Corneal erosion
• Corneal abrasion
• Increased intraocular pressure
• Corneal opacity
• Corneal infiltrates
• Corneal deposits
• Eye allergy
• Keratitis
• Corneal oedema
• Photophobia
• Increased lacrimation
• Eye discharge
• Foreign body sensation in eyes
• Dysgeusia

None known

None routine

Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination.

Spectrum of activity: Aerobic gram-positive microorganisms such as Corynebacterium species including Corynebacterium diphtheriae; Staphylococcus aureus (methicillin-susceptible); Streptococcus pneumoniae; Streptococcus pyogenes; Streptococcus viridans group; Aerobic gram-negative microorganisms such as Enterobacter cloacae; Haemophilus influenzae; Klebsiella oxytoca; Moraxella catarrhalis; Serratia marcescens; Anaerobic microorganisms such as Propionibacterium acnes; Other microorganisms such as Chlamydia trachomatis

Eye drops (per ml) 5mg

• Genfloc (Gen-Eye)
• Vigamox (Novartis South Africa) originator

Also available in the following forms: Injection and tablet.