Moxidrop. 5 mg/1 ml Ophthalmic Solution

MOXIDROP 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 have been observed between elderly and other adult patients.

Use in children: Moxifloxacin as in MOXIDROP 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 moxifloxacin as in MOXIDROP has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

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 the low systemic exposure by the topical route of administration, no dosage adjustment of MOXIDROP 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 moxifloxacin as in MOXIDROP is necessary in patients with renal impairment.

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.

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

Prescribers should adhere to the principles of antibiotic stewardship. 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 MOXIDROP occurs, discontinue the use of MOXIDROP. 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. 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, particularly in older patients and those treated concurrently with corticosteroids. Following ophthalmic administration of MOXIDROP 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 MOXIDROP should be discontinued at the first sign of tendon inflammation (see section 4.8). MOXIDROP 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. MOXIDROP 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.

No specific drug-drug interaction studies have been performed with MOXIDROP drops, they have been performed with the oral product at much higher systemic exposures than are achieved by the topical ocular route. Unlike some other fluoroquinolones, no clinically significant drug-drug 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 is unlikely to alter the pharmacokinetics of drugs metabolised by these cytochrome P450 isozymes. 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 adequate and well-controlled studies of the use of moxifloxacin as in MOXIDROP in pregnant women. MOXIDROP should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Breastfeeding

Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin. Moxifloxacin has not been measured in human milk although it can be presumed to be excreted in human milk. Caution should be exercised when MOXIDROP is administered to a nursing mother.

Fertility

No studies have been performed to evaluate the effect of ocular administration of moxifloxacin as in MOXIDROP on fertility.

MOXIDROP, as with any eye drops, 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.

Summary of the safety profile

No serious ophthalmic or systemic undesirable effects related to the medicine were reported in clinical studies. The most frequently reported treatment-related undesirable effects with the medicine were eye irritation and eye pain.

Tabulated summary of adverse reactions

System Organ Classification Frequency Adverse reactions Blood and lymphatic system disorders Less frequent Decreased haemoglobin Immune system disorders Frequency unknown Hypersensitivity Nervous system disorders Less frequent Headache, paraesthesia Frequency unknown Dizziness Eye disorders Frequent Eye pain, eye irritation, ocular discomfort (burning or stinging upon instillation) Less frequent Punctate keratitis, dry eye, conjunctival haemorrhage, ocular hyperaemia, eye pruritus, eyelid oedema, corneal epithelium defect, corneal disorder, conjunctivitis, blepharitis, eye swelling, conjunctival oedema, blurred vision, reduced visual acuity, asthenopia, erythema of eyelid Frequency unknown Endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, increased intraocular pressure, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, increased lacrimation, eye discharge, foreign body sensation in eyes Cardiac disorders Frequency unknown Palpitations Respiratory, thoracic and mediastinal disorders Less frequent Nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat) Frequency unknown Dyspnoea Gastrointestinal disorders Less frequent Dysgeusia, vomiting Frequency unknown Nausea Hepato-biliary disorders Less frequent Increased alanine aminotransferase, increased gamma glutamyl transferase Skin and subcutaneous tissue disorders Frequency unknown Erythema, rash, pruritus, urticaria

Paediatric population

Reports from clinical trials have shown that moxifloxacin as in MOXIDROP is safe in paediatric patients, including neonates. In patients under 18 years old, the two most frequent adverse reactions were eye irritation and eye pain. 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 providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://sahpra.org.za/wpcontent/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pd.

The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of MOXIDROP. The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.