Ciprofloxacin/ Fluocinolone Acetonide

Registered South African indications:

• Acute otitis externa (AOE) due to Staphylococcus aureus, and Pseudomonas aeruginosa
• Acute otitis media in patients with tympanostomy tubes (AOMT) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa

Registered South African contraindications

• Hypersensitivity to the active ingredients or any of the excipients in this combination product
• Hypersensitivity to any member of the quinolone class of antimicrobial medicine
• Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

Anaphylactic reactions

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones
• Serious acute hypersensitivity reactions may require immediate emergency treatment
• If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within six months, further evaluation recommended to exclude underlying condition such as cholesteatoma, foreign body, or a tumour
• If after the treatment some signs and symptoms persist, further evaluation recommended to reassess disease and treatment

Skin rash

• Ciprofloxacin/fluocinolone acetonide should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity

Superinfection

• As with other antibiotic preparations, the use of ciprofloxacin and fluocinolone acetonide may result in overgrowth of nonsusceptible organisms, including bacterial strains, yeast and fungi
• If superinfection occurs, appropriate therapy should be initiated

Photoallergic reactions

• Some patients taking systemic quinolones have shown moderate to severe skin sensitivity to the sun
• Due to the site of administration, it is unlikely that ciprofloxacin and fluocinolone acetonide may produce photoallergic reactions

Corticosteroids

• Corticosteroids may reduce resistance to, and aid in, the establishment of bacterial, viral, or fungal infections and mask the clinical signs of an infection, preventing recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to substances in ciprofloxacin and fluocinolone acetonide

Visual disturbance

• Visual disturbance may be reported 
• If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of 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

Effects on ability to drive and use machines

• Ciprofloxacin/fluocinolone acetonide has no or negligible influence on the ability to drive and operate machinery due to the route of administration and the conditions of use. Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that ciprofloxacin/fluocinolone acetonide do not adversely affect their ability to do so safely

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

South African registered indications and dosages

Infections caused by: Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis

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 externa (AOE) due to Staphylococcus aureus, and Pseudomonas aeruginosa
Acute otitis media in patients with tympanostomy tubes (AOMT) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa

Ciprofloxacin/ Fluocinolone Acetonide

3/0.25 (mg/ml)

• Otic (ear): Instil 6 to 8 drops in affected ear(s), twice a day; Treatment duration: 7 days

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Method of administration

- Auricular use
Precautions to be taken before handling or administering ciprofloxacin/fluocinolone acetonide ear drops:
- The solution should be warmed before its use, by holding the bottle in the hand for several minutes. This will avoid the discomfort that may result from the instillation of a cold solution into the ear canal
- The patient should lie with the affected ear upward and then for patients with otitis externa the drops should be instilled pulling several times on the auricle
- For patients with acute otitis media with tympanostomy tubes, the tragus should be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for around 1 minute to facilitate penetration of the drops into the ear
- Repeat, if necessary, for the opposite ear

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Ciprofloxacin/fluocinolone acetonide is for auricular use only, not for ophthalmic use, inhalation or injection. Should not be swallowed or injected

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

South African registered indications and dosages

Infections caused by: Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis

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 externa (AOE) due to Staphylococcus aureus, and Pseudomonas aeruginosa
Acute otitis media in patients with tympanostomy tubes (AOMT) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Pseudomonas aeruginosa

Ciprofloxacin/ Fluocinolone Acetonide

3/0.25 (mg/ml)

Younger than 6 months

• Not established for use

6 months and older

• See adult dosage

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The safety and efficacy of ciprofloxacin/fluocinolone acetonide in children younger than 6 months has not yet been established

Pregnancy

South African recommendations

• Caution
• Safety in pregnancy has not been established
• As there is very little systemic absorption, ciprofloxacin/fluocinolone acetonide may be used during pregnancy

Breastfeeding

South African recommendations

• Caution
• Safety in lactation has not been established
• As there is very little systemic absorption, ciprofloxacin/fluocinolone acetonide may be used during breastfeeding

Fertility

South African recommendations

• No animal studies have been performed to evaluate the effect on fertility of ciprofloxacin/fluocinolone acetonide

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

Infections and Infestations

Less frequent

• Candidiasis
• Fungal ear infection
• Contralateral otitis media

Nervous System Disorders

Frequent

• Dysgeusia

Less frequent

• Paraesthesia (tingling in ears)
• Dizziness
• Headache
• Crying

Eye Disorders

Frequency unknown (cannot be estimated from the available data)

• Blurred vision

Ear and Labyrinth Disorders

Frequent

• Ear pain
• Ear discomfort
• Ear pruritus

Less frequent

• Hypoacusis
• Tinnitus
• Otorrhoea
• Ear congestion
• Tympanic membrane disorder
• Auricular swelling

Vascular Disorders

Less frequent

• Flushing

Gastrointestinal Disorders

Less frequent

• Vomiting

Skin and Subcutaneous Tissue Disorders

Less frequent

• Skin exfoliation
• Rash erythematous
• Rash
• Granulation tissue

General Disorders and Administrative Site Conditions

Less frequent

• Irritability
• Fatigue

Investigations

Less frequent

• Medicine residue

Injury, Poisoning and Procedural Complications

Frequent

• Device occlusion (tympanostomy tube obstruction)

No significant interactions

None routine

Ciprofloxacin
As a fluoroquinolone antibacterial medicine, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair and recombination.

Fluocinolone Acetonide
Fluocinolone acetonide is a synthetic fluorinated corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties and reduces the formation of granulation tissue. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids.

Spectrum of activity: Staphylococcus aureus, Pseudomonas aeruginosa, Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis