CIPROFLOXACIN/DEXAMETHASONE

Posology Adults and elderly population Instil four drops in the affected ear(s) twice a day for 7 days according to the different instillation instructions for patients with acute otitis media with typanostomy tubes and patients with acute otitis externa.

No overall differences in safety and effectiveness have been observed between elderly and other adult patients. 4 for use in children younger than 6 months for AOMT and in children younger than 1 year for AOE). 2). Patients with hepatic and renal impairment Hepatic or renal impairment (mild to moderate) does not alter the pharmacokinetics of ciprofloxacin or dexamethasone following systemic administration.

Following topical otic administration of Ciprofloxacin/Dexamethasone ear drops, small increases in ciprofloxacin and dexamethasone plasma concentrations may be observed in patients with severe renal or hepatic impairment. However, since systemic exposure to ciprofloxacin or dexamethasone is low after topical otic administration, any increase in systemic concentrations due to renal or hepatic dysfunction would still be well below plasma concentrations that are well tolerated in children or adults following oral or intravenous recommended doses.

Dose adjustment of this medication in patients with renal or hepatic dysfunction is not necessary. Method of administration For otic use only. Instruct the patients to shake the bottle well before use. The suspension should be warmed by holding the bottle in the hand for several minutes 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 pulling several times on the aurical. For patients with acute otitis media with tympanostomy tubes, the tragus should be pumped 5 times by pushing inward to facilitate penetration of the drops into the middle ear.

This position should be maintained for around 5 minutes to facilitate penetration of the drops in the ear. Repeat, if necessary, for the opposite ear. To prevent contamination of the dropper tip in order to limit bacterial risks, 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.

Keep the bottle tightly closed when not in use. Keep the bottle until the completion of the treatment.

Summary of the safety profile In 5 clinical studies involving 976 patients, Ciprofloxacin/Dexamethasone was administered twice daily. This included 439 patients participating in 3 clinical studies with acute otitis media with tympanostomy tubes and 537 patients participating in 2 clinical studies with acute otitis externa.

No serious otic or systemic undesirable effects related to Ciprofloxacin/Dexamethasone were reported in any of the clinical studies. 5% patients. Tabulated summary of adverse events The following adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience.

They are ranked according to system organ class and classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 1%). Of these events, only 1 patient discontinued therapy with that being due to an occurrence of ear discomfort. 5%). No patient discontinued therapy due to an occurrence of ear pruritus.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching.

The development of secondary infections has occurred after the use of combinations containing corticosteroids or antimicrobials. Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones.

Studies and post marketing experience with systemic fluoroquinolones indicate that the risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including the Achilles tendon.

To date, clinical and post marketing data have not demonstrated a clear association between otic administration of ciprofloxacin and these musculoskeletal and connective tissue adverse reactions. Paediatric population Ciprofloxacin/Dexamethasone has been shown to be safe in paediatric patients 6 months of age or older for the treatment of AOMT and 1 year of age or older for the treatment of AOE.

The frequency, type and severity of adverse reactions in paediatric patients are expected to be the same as in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

This medicinal product is for otic use only, not for ophthalmic use, inhalation or injection. If otorrhea 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.

As with other antibacterial preparations, prolonged use of this product may result in overgrowth of non-susceptible organisms, including bacterial strains, yeast and fungi. If superinfection occurs, discontinue use and appropriate therapy should be initiated.

If after one week of therapy some signs and symptoms persist, further evaluation is recommended to reassess the disease and the treatment. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. This product should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin, particularly in elderly patients and in those treated currently with corticosteroids.

Therefore treatment with Ciprofloxacin/Dexamethasone should be discontinued at the first sign of tendon inflammation. 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 the product.

Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist 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.

Benzalkonium chloride may irritate the skin. Paediatric population Safety and efficacy of Ciprofloxacin/Dexamethasone have not been established in children younger than 6 months in acute otitis media in patients with tympanostomy tubes and in children younger than 1 year in acute otitis externa.

Under exceptional circumstances, Ciprofloxacin/Dexamethasone treatment could be used in this sub-paediatric population after a very careful benefit-risk evaluation by the prescribing physician taking into account that although there are no known safety concerns or differences in disease process to preclude use in these children, clinical experience is insufficient in these specific subgroups of paediatric population.

1. , varicella, herpes simplex) and fungal otic infections.