Vigamox 1 ml Solution

VIGAMOX is indicated for

• the topical treatment of bacterial conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer) caused by susceptible organisms. (See section 5.1)
• preoperative and postoperative sterilization for ophthalmic surgery

Changes in the international and local antimicrobial resistance patterns should also be a consideration.

Posology

Use in adults including the elderly

For conjunctivitis, blepharitis, dacryocystitis, hordeolum, tarsadenitis, keratitis (including corneal ulcer): instill one drop in the affected eye(s) 3 times a day for 7 days. Increase or decrease of frequency of instillation can be adjusted according to the symptoms.

For preoperative and postoperative sterilization: The recommended dose is one drop of VIGAMOX in the affected eye(s) 5 times per day for 2 days before ophthalmic surgery, and 3 times per day for 14 days after ophthalmic surgery.

Special populations

Paediatric population

VIGAMOX has been shown to be safe and effective for bacterial infection treatment in paediatric patients including neonates and can be used at the same dose as in adults. Use of VIGAMOX for surgical sterilization in paediatric patients has not been studied. There is no evidence that the ophthalmic administration of VIGAMOX has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.

Elderly population

No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

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 VIGAMOX 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 VIGAMOX is necessary in patients with renal impairment.

Method of administration

• For ocular use. Not for injection. VIGAMOX should not be injected sub-conjunctivally or introduced directly into the anterior chamber of the eye.
• 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.
• After cap is removed, if tamper evident snap collar is loose, remove before using product.
• Patients should be instructed to take at least 5 minutes between administrations if using VIGAMOX concurrently with other ophthalmic solutions.

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

Principles of antibiotics stewardship should be adhered to. For ocular use only. Not for injection. VIGAMOX should not be injected sub-conjunctivally or introduced directly into the anterior chamber of the eye (see section 4.2).

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

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

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

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including moxifloxacin as contained in VIGAMOX, particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore, treatment with VIGAMOX should be discontinued at the first sign of tendon inflammation (see section 4.8).

While drug-drug interaction studies have not been conducted with VIGAMOX, 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, probenicid, 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.

Women of childbearing potential/ Contraception in males and females

No information available.

Pregnancy

Since there are no adequate and well-controlled studies in pregnant women, VIGAMOX should be used during pregnancy with caution. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin as contained in VIGAMOX from topical ocular application 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 VIGAMOX is administered to a nursing mother. However, at therapeutic doses of VIGAMOX no effects on the suckling child are anticipated.

Fertility

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

Temporary blurred vision or other visual disturbances may affect mental and/or physical abilities to perform or execute tasks or activities requiring mental alertness, judgment and/or sound coordination and vision. 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

In clinical studies involving 1060 subjects, VIGAMOX was administered twice or three times daily. No serious ophthalmic or systemic undesirable effects related to VIGAMOX were reported in clinical studies. The most frequently reported treatment-related undesirable effect was ocular discomfort (4.1 %), which was mild in 95.3 % of those subjects who experienced it. The discontinuation rate due to ocular discomfort was 0.1 %.

The following adverse reactions have been reported during clinical trials with VIGAMOX and are classified according to the following convention:

very common (u2265 1/10), common (u2265 1/100 to <1/10), uncommon (u22651/1,000 to <1/100), rare (u22651/10,000 to <1/1,000), very rare (<1/10,000). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness.

Tabulated list of adverse reactions

Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.

System organ classification Adverse reactions

Immune system disorders Hypersensitivity

Nervous system disorders Dizziness

Eye disorders ulcerative keratitis, keratitis, increased lacrimation, photophobia, eye discharge

Cardiac disorders Palpitations

Respiratory, thoracic and mediastinal disorders Dyspnoea

Gastrointestinal disorders Nausea

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

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).

Paediatric population

In clinical trials, VIGAMOX 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, 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 u201cReport Drug Reaction Processu201d, found online under SAHPRAu2019s safety publications: https://www.sahpra.org.za/

In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8). The limited holding capacity of the conjunctival sac for ophthalmic products practically precludes any overdosing of VIGAMOX. Intoxication after inadvertent oral ingestion can also be ruled out.