Ciprofloxacin/ Dexamethasone

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Acute otitis media with tympanostomy tubes
• Acute otitis externa

Contraindications

Registered South African contraindications

• History of hypersensitivity to ciprofloxacin, to other quinolones, to dexamethasone or to any of the excipients in this combination product
• Viral and fungal otic infections
• Untreated parasitic otic infections

Cautions

• Pregnancy
• Breastfeeding
• Porphyria
• Persistent otorrhea
• Prolonged use

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

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Infections caused by: Some aerobic Gram-positive microorganisms, such as Staphylococcus aureus (methicillin-susceptible), Streptococcus pneumoniae; Some aerobic Gram-negative microorganisms, such as Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa

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

Acute otitis media with tympanostomy tubes (AOMT) 
Acute otitis externa (AOE) 

Ciprofloxacin/ Dexamethasone

3/1 (mg/ml)

• Otic (ear): Instil 4 drops in affected ear(s), 12hrly; Treatment duration: 7 days

To prevent contamination of the dropper tip, care should be taken not to touch the auricle or the external ear canal and surrounding areas or other surfaces with the dropper tip of the bottle. Bottlle should be tightly sealed when not in use 

The suspension should be shaken well before use and warmed by holding the bottle in the hand for 1-2min to avoid dizziness, which may result from the instillation of a cold suspension

The patient should lie with the affected ear upward and then the drops should be instilled. For patients with acute otitis media with tympanotomy tubes, the tragus should then be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear 

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

Paed. dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Infections caused by: Some aerobic Gram-positive microorganisms, such as Staphylococcus aureus (methicillin-susceptible), Streptococcus pneumoniae; Some aerobic Gram-negative microorganisms, such as Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa

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

Acute otitis media with tympanostomy tubes (AOMT) 

Younger than 6 months

• Not established for use

6 months and older

• See adult dosage

Acute otitis externa (AOE) 

Younger than 1 year

• Not established for use

1 year and older

• See adult dosage

Ciprofloxacin/ dexamethasone has been shown to be safe and effective in paediatric patients for the age ranges provided above and can be used at the same dose as in adults

Pregnancy

• Caution; not recommended
• Corticosteroids are teratogenic in laboratory animals. Since no animal reproduction studies or no adequate or well-controlled studies in pregnant women have been conducted, ciprofloxacin/ dexamethasone should not be used during pregnancy

Breastfeeding

• Caution
• Ciprofloxacin and corticosteroids, as a class, appear in milk following oral administration. It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised if ciprofloxacin/ dexamethasone is administered during breastfeeding

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Paraesthesia (tingling in ear)
• Crying
• Dizziness
• Irritability

Cardiovascular Disorders

• Flushing

Skin and Subcutaneous Tissue Disorders

• Rash
  - Scaly rash

Immune, Blood and Lymphatic System Disorders

• Candidal infection
• Overgrowth of non-susceptible organisms
  - Yeast
  - Fungi
• Hypersensitivity reactions
  - Cardiovascular collapse
   - Loss of consciousness
  - Angioedema (including laryngeal, pharyngeal or facial oedema)
  - Airway obstruction, dyspnoea
  - Urticaria
  - Itching

Sensory Disorders

• Ear pain
• Ear congestion
• Ear discomfort
• Ear pruritus
• Ear disorder
• Hyperacusis
• Tinnitus
• Dysgeusia
• Fungal otitis externa
• Cerumen impaction

Others

• Medication residue
• Migration of implant (tympanotomy tube blockage)

No significant interactions

None routine

Special precautions

• If otorrhoea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumour

The combination ear drop formulation contains the fluoroquinolone, ciprofloxacin which has cidal and inhibitory activity against bacteria resulting in 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 any longer, which causes a breakdown of the bacterial metabolism. Ciprofloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative microorganisms: anaerobes are less susceptible. The combination ear drop formulation also contains an anti-inflammatory agent, the corticosteroid dexamethasone. The beneficial anti-inflammatory activity of dexamethasone is exerted by mechanisms that are not completely understood. Dexamethasone has been added to aid in the resolution of the inflammatory response accompanying bacterial infection.

Spectrum of activity: Some aerobic Gram-positive microorganisms, such as Staphylococcus aureus, Enterococcus faecalis, Staphylococcus caprae, Staphylococcus epidermidis, Streptococcus pneumoniae; Some aerobic Gram-negative microorganisms, such as Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa 

COMBINATION PREPARATIONS

Ciprofloxacin/ Dexamethasone

Ear drop (per ml) 3mg/1mg

• Cilodex (Novartis South Africa)