Avoxa Eye Drops

AVOXA EYE DROPS is indicated for the topical treatment of bacterial conjunctivitis caused by susceptible organisms. (See section 5.1).

Posology

Dosage

Adults and the elderly

Instill one drop in the affected eye(s) 3 times a day for 4 days. No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Special population

Use in hepatic and renal impairment

Pharmacokinetic parameters of oral moxifloxacin were not significantly altered in patients with mild to moderate hepatic insufficiency (Child Pugh Classes A and B). Studies were not performed in patients with severe hepatic impairment (Child Pugh Class C). Because of low systemic exposure by the topical route of administration, no dosage adjustment of AVOXA EYE DROPS is needed in patients with hepatic impairment. The pharmacokinetic parameters of oral moxifloxacin are not significantly altered by mild, moderate or severe renal impairment. No dosage adjustment of AVOXA EYE DROPS is necessary in patients with renal impairment.

Paediatric population

AVOXA EYE DROPS has been shown to be safe and effective in paediatric patients including neonates and can be used at the same dose as adults. There is no evidence that the ophthalmic administration of AVOXA EYE DROPS has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

Method of administration

For ocular use only. 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. For new-born babies or children, in order to prevent the drops from being absorbed via the nasal mucosa, the nasolacrimal ducts should be held closed for 2 to 3 minutes with the fingers after administering the drops.

• Hypersensitivity to the moxifloxacin, to other quinolones, or to any of the excipients of AVOXA EYE DROPS listed in section 6.1.

Hypersensitivity reactions

In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria, and itching (see section 4.8). If an allergic reaction to AVOXA EYE DROPS occurs, discontinue use of the medicine. Serious acute hypersensitivity reactions to moxifloxacin or any other product ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated.

As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

Tendon inflammation

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin, particularly in older patients and those treated concurrently with corticosteroids. Following ophthalmic administration of AVOXA EYE DROPS plasma concentrations of moxifloxacin are much lower than after therapeutic oral doses of moxifloxacin (see section 4.5 and 5.2), however, caution should be exercised and treatment with AVOXA EYE DROPS should be discontinued at the first sign of tendon inflammation (see section 4.8).

AVOXA EYE DROPS should not be used for Neisseria gonorrhoeae eye infections. AVOXA EYE DROPS should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.

AVOXA EYE DROPS and contact lenses

Patients should be advised not to wear contact lenses if they have signs and symptoms of a bacterial ocular infection.

Paediatric population

Data are very limited to establish efficacy and safety of AVOXA EYE DROPS in the treatment of conjunctivitis in neonates. Therefore, use of this medicine to treat conjunctivitis in neonates is not recommended. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomitis or Neisseria gonorrhoeae.

AVOXA EYE DROPS is not recommended for the treatment of Chlamydia trachomatis in patients less than 2 years of age as it has not been evaluated in such patients. Patients older than 2 years of age with eye infections caused by Chlamydia trachomitis should receive appropriate systemic treatment.

No specific interaction studies have been performed with AVOXA EYE DROPS, solution. Given the low systemic concentration of moxifloxacin following topical ocular administration of the medicine (see section 5.2), medicine interactions are unlikely to occur.

Pregnancy

Since there are no or limited amount of data from the use of AVOXA EYE DROPS in pregnant women, it should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible.

Breastfeeding

Moxifloxacin has not been measured in human milk although it can be presumed to be excreted in human milk. Caution should be exercised when AVOXA EYE DROPS is administered during breast feeding.

Fertility

Studies have not been performed to evaluate the effect of ocular administration of AVOXA EYE DROPS on fertility.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient should wait until their vision clears before driving or using machinery.

a) Summary of the safety profile

The most frequently reported treatment-related undesirable effects were eye irritation and eye pain, occurring at an overall incidence of 1 to 2 %. These reactions were mild in 96 % of those patients who experienced them, with only 1 patient discontinuing therapy as a result.

b) Tabulated list of adverse reactions

The table below shows all adverse drug reactions (ADRs) observed during clinical trials and postmarket spontaneous reports with moxifloxacin. Frequency estimate: Frequent (u2265 1/100) Less frequent (< 1/100) Not known (cannot be estimated from the available data)

System Organ Class Frequency Frequent Less Frequent Not known

Blood and lymphatic system disorders Haemoglobin decreased

Nervous system disorders Headache, paraesthesia Dizziness

Eye disorders Ocular pain, eye irritation Punctate keratitis, dry eye, conjunctival haemorrhage, ocular hyperaemia, eye pruritus, eyelid oedema, ocular discomfort, corneal epithelium defect, corneal disorder, conjunctivitis, blepharitis, eye swelling, conjunctival oedema, vision blurred, visual acuity reduced, asthenopia, erythema of eyelid Endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, lacrimation increased, eye discharge, foreign body sensation in eyes

Cardiac disorders Palpitations

Respiratory, thoracic and mediastinal disorders Nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat) Dyspnoea

Gastrointestinal disorders Dysgeusia, vomiting Nausea

Hepatobiliary disorders Alanine aminotransferase increased, gammaglutamyltransferase increased

Skin and subcutaneous tissue disorders Erythema, rash, pruritus, urticaria

c) Description of selected adverse reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following 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 (see section 4.4).

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 quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon (see section 4.4).

d. Paediatric population

In clinical trials, AVOXA EYE DROPS has shown to be safe in paediatric patients, including neonates. In patients under 18 years old, the two most frequent adverse reactions were eye irritation and eye pain, both occurring at an incidence rate of 0,9 %. Based on data from clinical trials involving paediatric patients, including neonates (see section 5.1), the type and severity of adverse reactions in the paediatric population are similar to those in adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of AVOXA EYE DROPS. Intoxication after inadvertent oral ingestion can also be ruled out.