Ciprofloxacin

Registered South African indications:

• Corneal ulceration and conjunctivitis caused by susceptible strains of bacteria

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to quinolones

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Porphyria
• Neonates and children <1 year
  - With ophthalmia neonatorum of gonococcal or chlamydial origin
• Patients with dry eye or where the cornea may be compromised
  - Corneal ulcer
• Prolonged use
• Use of more than one topical ophthalmic medicinal product 
• Concomitant use of contact lenses
• Coadministration with corticosteroids
• May impair ability to drive and operate machinery

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

Dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Some aerobic Gram-positive organisms, such as Corynebacterium accolens, Corynebacterium auris, Corynebacterium propinquum, Corynebacterium psudodiphtheriticum, Corynebacterium striatum, Staphylococcus aureus (methicillin susceptible - MSSA), Staphylococcus capitis, Staphylococcus epidermidis (methicillin susceptible - MSSE), Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans Group; Some aerobic Gram-negative organisms, such as Acinetobacter species, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Serratia marcescens 

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 Standard Treatment Guidelines indications and dosages

Chronic suppurative otitis media (Additional agent required)
- After cleaning and drying the ear

• Ophthalmic (opd): 3-4 drops into affected ear(s), 8hrly; Treatment duration: 7 days
  (STG, Adult 2019)

Bacterial conjunctivitis
- During the day (2nd line treatment)

• Ophthalmic (opd): Day 1-2: 1 drop into affected eye(s), 2hrly; Day 3-7: 1 drop into affected eye(s), 4hrly (during waking hours)
  (STG, Adult 2019)

Suppurative keratitis
- Empiric therapy for bacterial infection until culture results become available

• Ophthalmic (opd): Day 1-3: 1 drop into affected eye(s), 1hrly; Then 1 drop into affected eye(s) 3-4hrly
  (STG, Adult 2019)

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South African registered indications and dosages

Corneal ulcers or abscesses 

• Ophthalmic (opd): Day 1: 2 drops into affected eye(s), every 15min for first 6hrs; Then 2 drops into affected eye(s), every 30min for the next 18hrs; Day 2: 2 drops into affected eye(s), 1hrly; Day 3-14: 2 drops into affected eye(s), 4hrly

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If the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of the physician

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• Ophthalmic (oin): Day 1-2: Apply 1.25cm into conjunctival sac, 1-2hrly around the clock; Day 3-14: 1.25cm into conjunctival sac, 4hrly

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The dosing may be extended at the discretion of the physician

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Bacterial conjunctivitis

• Ophthalmic (opd): Day 1-2: 1-2 drops into the conjunctival sac(s), every 2hrs while awake; Then: 1-2 drops into the conjunctival sac(s), every 4hrs while awake; Treatment duration: Until bacterial infection is resolved
• Ophthalmic (oin): Day 1-2: Apply 1.25cm into conjunctival sac (or on the lid margin, respectively), 8hrly; Day 3-7: Apply 1.25cm into conjunctival sac, 12hrly

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The dosing may be extended at the discretion of the physician

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Indications and dosages registered in other jurisdictions

Corneal ulcers

• Ophthalmic (opd): Day 1: 2 drops into affected eye(s), every 15min for first 6hrs; Then 2 drops into affected eye(s), every 30min for the next 18hrs; Day 2: 2 drops into affected eye(s), 1hrly; Day 3-14: 2 drops into affected eye(s), 4hrly; Max treatment duration: 21 days

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Ciprofloxacin must be administered in the recommended intervals, even during night time

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If the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of the attending physician

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Superficial ocular infection

Usual dose

• Ophthalmic (opd): 1-2 drops into affected eye(s), 6hrly

Severe infections

• Ophthalmic (opd): Day 1-2: 1-2 drops into affected eye(s), 2hrly while awake; Day 3 onward: 1-2 drops into affected eye(s), 6hrly; Max treatment duration: 21 days

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

Paed. dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Some aerobic Gram-positive organisms, such as Corynebacterium accolens, Corynebacterium auris, Corynebacterium propinquum, Corynebacterium psudodiphtheriticum, Corynebacterium striatum, Staphylococcus aureus (methicillin susceptible - MSSA), Staphylococcus capitis, Staphylococcus epidermidis (methicillin susceptible - MSSE), Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans Group; Some aerobic Gram-negative organisms, such as Acinetobacter species, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Serratia marcescens 

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 Standard Treatment Guidelines indications and dosages

Chronic suppurative otitis media

• Ophthalmic (opd): 2 drops into affected ear(s), 8hrly after dry mopping
  (STG, Paed. 2023)

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South African registered indications and dosages

Corneal ulcers or abscesses 

Ophthalmic drops or ointment

Younger than 2 years

• No information available

Older than 2 years

• See adult dosage

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Indications and dosages registered in other jurisdictions

Corneal ulcers
Superficial ocular infection

Ophthalmic drops

Younger than 1 year

• No information available

Older than 1 year

• See adult dosage

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Safety and effectiveness of ciprofloxacin eye drops were determined in 230 children between the ages of 0 and 12 years of age. No serious adverse drug reaction was reported in this group of patients

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The clinical experience in children <1 less than one year old, particularly in neonates, is very limited and no dosage recommendations have been made in international manufacturer recommendations for this age group

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The use of ciprofloxacin eye drops in neonates with ophthalmia neonatorum of gonococcal or chlamydial origin is not recommended as it has not been evaluated in such patients

Pregnancy

• Caution
• There are no adequate data from the use of topical ciprofloxacin in pregnant woman. Animal studies do not indicate direct harmful effects with respect to reproductive toxicity. Systemic exposure to ciprofloxacin after topical use is expected to be low. As a precautionary measure, it is preferable to avoid the use of topical ciprofloxacin during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus

Breastfeeding

• Caution
• Orally administered ciprofloxacin is excreted in the human milk. It is unknown whether ciprofloxacin is excreted in human breast milk following topical ocular administration. A risk to the breastfeeding child cannot be excluded. Therefore, caution should be exercised when topical ciprofloxacin is administered to breastfeeding women

Fertility

• Studies have not been performed in humans to evaluate the effect of topical administration of ciprofloxacin on fertility. Oral administration in animals does not indicate direct harmful effects with respect to fertility

Renal Impairment

• Caution; no information available
  No studies have been performed using ciprofloxacin eye drops in patients with renal problems
  Systemic absorption is low, therefore dose adjustment may not be required

Hepatic Impairment

• Caution; no information available
  No studies have been performed using ciprofloxacin eye drops in patients with hepatic problems
  Systemic absorption is low, therefore dose adjustment may not be required

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness

Respiratory Disorders

• Paranasal sinus hypersecretion
• Rhinitis

Gastrointestinal Disorders

• Dysgeusia
• Nausea
• Diarrhoea
• Abdominal pain

Musculoskeletal Disorders

• Tendon disorder
• Tendon rupture

Skin and Subcutaneous Tissue Disorders

• Dermatitis
• Eyelid oedema
• Eyelid margin crusting
• Eyelid exfoliation
• Erythema of eyelid
• Rash (locally applied fluoroquinolones)
• Urticaria (locally applied fluoroquinolones)
• Toxic epidermolysis (locally applied fluoroquinolones)
• Exfoliative dermatitis (locally applied fluoroquinolones)  
• Stevens-Johnson syndrome (locally applied fluoroquinolones)

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity

Sensory Disorders

• Corneal deposits
• Ocular discomfort  
• Ocular hyperaemia
• Keratopathy
• Punctate keratitis
• Corneal infiltrates
• Photophobia
• Reduced visual acuity
• Blurred vision  
• Eye pain
• Dry eye
• Eye swelling
• Eye pruritus
• Increased lacrimation
• Eye discharge
• Conjunctival oedema
• Ocular toxicity
• Keratitis
• Conjunctivitis
• Corneal epithelium defect
• Diplopia
• Hypoaesthesia eye
• Asthenopia
• Hordeolum
• Eye inflammation
• Eye irritation
• Ear pain
• Medication residue

• No significant interactions
  (See additional prescribing points)

None routine

Coadministration with other topical ophthalmic medicinal products

• If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last

The cidal and inhibitory activity of ciprofloxacin against bacteria results from an interference with the DNA gyrase, an enzyme needed by the bacterium for the synthesis of DNA. Thus the vital information from the bacterial chromosomes cannot be transcribed which causes a breakdown of the bacterial metabolism. Ciprofloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative bacteria.

Spectrum of activity: Some aerobic Gram-positive organisms, such as Corynebacterium accolens, Corynebacterium auris, Corynebacterium propinquum, Corynebacterium psudodiphtheriticum, Corynebacterium striatum, Staphylococcus aureus (methicillin susceptible - MSSA), Staphylococcus capitis, Staphylococcus epidermidis (methicillin susceptible - MSSE), Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans Group; Some aerobic Gram-negative organisms, such as Acinetobacter species, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Serratia marcescens 

Eye ointment (per g) 3mg

• Ciloxan (Novartis South Africa) originator

Eye drops (per ml) 3mg

• Ceprolen eye drops (Medivison)
• Ciloxan (Novartis South Africa) originator
• Foxin (Gulf Drug)
• Xinoct (Actor Pharma)

Also available in the following forms: Tablet, suspension, ear drop and injection.