In patients receiving systemic quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of product. Serious acute hypersensitivity reactions require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
Prolonged use of ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently. This is especially important in pediatric patients, as the risk of corticosteroid-induced ocular hypertension may be greater in children and may occur earlier than in adults.
The risk of corticosteroid-induced raised intraocular pressure and/or cataract formation is increased in predisposed patients (e.g. diabetes).
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy. Therefore, treatment with Vigadexa should be discontinued at the first sign of tendon inflammation. (See Adverse Reactions.)
Cushing's syndrome and/or adrenal suppression associated with systemic absorption of ophthalmic dexamethasone may occur after intensive or long-term continuous therapy in predisposed patients, including children and patients treated with CYP3A4 inhibitors (including ritonavir and cobicistat) (see Interactions). In these cases, treatment should not be discontinued abruptly, but progressively tapered.
Corticosteroids may reduce resistance to and aid in the establishment of nonsusceptible bacterial, fungal, viral or parasitic infections and mask the clinical signs of infection.
Fungal infection should be suspected in patients with persistent corneal ulceration. Corticosteroids therapy should be discontinued if fungal infection occurs.
Topical ophthalmic corticosteroids may slow corneal wound healing. Topical NSAIDs are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems (see Interactions).
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
Prolonged use of antibiotics may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
General target population: Adults.
Special populations: Renal impairment: No studies have been conducted in subjects with renal impairment.
Hepatic impairment: No studies have been conducted in subjects with hepatic impairment.
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. Keep the bottle tightly closed when not in use. If using other eye drop or eye ointment medicines, leave at least 5 minutes between each medicine. Eye ointments should be administered last.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
Females and males of reproductive potential: There is limited clinical data to evaluate the effect of moxifloxacin or dexamethasone on male or female fertility. Moxifloxacin did not impair fertility in rats. No standard fertility studies are available with dexamethasone. (See Pharmacology: Toxicology under Actions.)
Use in Children: (below 18 years) Pediatric experience in clinical trials is limited; specific posology recommendations cannot be made.
Use in Elderly: There are limited data available on the use of Vigadexa in patients older than 65 years of age, but there is no evidence suggesting that a dosage regimen adjustment is required in geriatric patients.