Genfloc 5 mg/ml Ophthalmic Solution

GENFLOC is indicated for the topical treatment of bacterial conjunctivitis caused by susceptible organisms. (see section 5.1 for susceptibility to moxifloxacin).

Posology

Use in adults including the elderly

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

Special populations

Use in hepatic 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 the low systemic exposure by the topical route administration, no dosage adjustment of GENFLOC is needed in patients with hepatic impairment.

Use in renal impairment

The pharmacokinetic parameters of oral moxifloxacin are not significantly altered by mild, moderate or severe renal impairment. No dosage adjustment of GENFLOC is necessary in patients with renal impairment.

Paediatric population

GENFLOC has been shown to be safe and effective in paediatric patients including neonates and can be used at the same dose as in adults. There is no evidence that the ophthalmic administration of GENFLOC 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.

GENFLOC is contraindicated in patients with a history of hypersensitivity to the active substance moxifloxacin, to other quinolones or to any of the excipients of GENFLOC listed in section 6.1.

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 GENFLOC occurs, discontinue use of the medicine. Serious acute hypersensitivity reactions to moxifloxacin or any other ingredient may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated.

Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin as in GENFLOC, particularly in older patients and those treated concurrently with corticosteroids. Following ophthalmic administration, 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 GENFLOC should be discontinued at the first sign of tendon inflammation (see section 4.8).

GENFLOC 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.

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

Paediatric population

Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomatis or Neisseria gonorrhoeae. GENFLOC 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 trachomatis should receive appropriate systemic treatment.

While interaction studies have not been conducted with moxifloxacin ophthalmic solution, they have been performed with the oral dosage form at much higher systemic exposures than are achieved by the topical ocular route. No clinically significant interactions between systemically administered moxifloxacin and itraconazole, theophylline, warfarin, digoxin, oral contraceptives, probenecid, ranitidine or glyburide have been observed.

In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19 or CYP1A2 indicating that moxifloxacin as in GENFLOC is unlikely to alter the pharmacokinetics of medicines metabolised by these cytochrome P450 isozymes. Given the low systemic concentration of moxifloxacin following topical ocular administration (see Section 5.2), interactions are unlikely to occur.

Pregnancy

Since there are no adequate and well-controlled studies in pregnant women, GENFLOC should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

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 GENFLOC is administered to a nursing mother.

Fertility

Studies have not been performed to evaluate the effect of ocular administration of moxifloxacin on fertility.

Temporary blurred vision or other visual disturbances may occur with GENFLOC. Patients should be advised to wait until their vision clears before driving or using machinery if they experience blurred vision at instillation.

Tabulated summary of adverse reactions

System Organ Class GENFLOC Side Effects

Blood and lymphatic system disorders

• Less frequent: haemoglobin decreased

Immune system disorders

• Less frequent: hypersensitivity

Nervous system disorders

• Less frequent: headache, paraesthesia , dizziness

Eye disorders

• Frequent: eye pain, eye irritation
• Less frequent: 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, blurred vision, reduced visual acuity, asthenopia, erythema of eyelid endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, increased intraocular pressure, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, increased lacrimation, eye discharge, foreign body sensation in eyes

Cardiac disorders

• Less frequent: palpitations

Respiratory, thoracic and mediastinal disorders

• Less frequent: nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat), dyspnoea

Gastrointestinal disorders

• Less frequent: Dysgeusia, vomiting, nausea

Hepatobiliary disorders

• Less frequent: increased alanine aminotransferase, increased gamma- glutamyltransferase

Skin and subcutaneous tissue disorders

• Less frequent: erythema, rash, pruritus, urticaria

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 providers 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. In addition suspected adverse reactions can be reported to Gen-Eye (Pty) Ltd via email: [email protected] or telephonically on 011 312 3812.

The limited holding capacity of the conjunctival sac for ophthalmic medicines practically precludes any overdosing of GENFLOC. Intoxication after inadvertent oral ingestion can also be ruled out. The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.