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LEVODEXA is a brand name for Dexamethasone, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LEVODEXA (Dexamethasone and levofloxacin ophthalmic solution) is indicated in adults for the prevention and treatment of inflammation, and the prevention of infection, associated with cataract surgery in adults, where adjunct topical therapy to reduce the risk of bacterial infection is appropriate. To reduce the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Re-evaluation of the patient to assess the need to continue the administration of corticosteroid eye drops as monotherapy is recommended after the completion of one week Product Monograph LEVODEXA, Dexamethasone and levofloxacin ophthalmic solution Page 5 of 30 of therapy with LEVODEXA eye drops.
The length of this treatment can depend on the patient’s risk factors and outcome of surgery and must be determined by the doctor according to slit- lamp microscopic findings and depending on the severity of the clinical picture. A follow-up treatment with steroid eye drops should not normally exceed 2 weeks.
However, care should be taken not to discontinue therapy prematurely. 2 Recommended Dose and Dosage Adjustment One drop instilled into the conjunctival sac after surgery every 6 hours. Duration of treatment is 7 days. Care should be taken not to discontinue therapy prematurely.
• Pediatric population: The safety and efficacy of LEVODEXA in children and adolescents below the age of 18 years have not been established. No data are available. LEVODEXA is not recommended for use in children and adolescents below the age of 18 years.
• Elderly patients: No dosage adjustment in elderly patients is necessary. • Use in renal/hepatic impairment LEVODEXA has not been studied in patients with renal/hepatic impairment and LEVODEXA should therefore be used with caution in such patients.
4 Administration For ocular use only. One drop should be administered in the lateral canthus while applying pressure at the medial canthus to prevent drainage of the drops. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures as this could cause injury to the eye.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Nasolacrimal occlusion by compression of lacrimal ducts may reduce systemic absorption. In case of concomitant treatment with other eye drops solutions, instillations should be spaced out by 15 minutes. 5 Missed Dose If one dose is missed, it should be takes as soon as possible.
1 Adverse Reaction Overview In clinical studies, 438 patients have been treated with LEVODEXA. No serious adverse reactions occurred. The most commonly reported non-serious adverse reactions are eye Product Monograph LEVODEXA, Dexamethasone and levofloxacin ophthalmic solution Page 10 of 30 irritation, ocular hypertension, and headache.
Increase of intraocular pressure Prolonged use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous IOP induced by steroids or with pre-existing high IOP or glaucoma). Children and elderly patients may be particularly susceptible to steroid-induced IOP rise.
Diabetics are also more prone to develop subcapsular cataracts following prolonged topical steroid administration. Possible adverse reactions related to cornea In diseases causing thinning of the cornea, topical use of steroids could lead to cornea perforation in some cases.
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas. Additional adverse reactions that have been observed with prolonged use of the active substance levofloxacin and may potentially occur also with LEVODEXA.
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.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
General LEVODEXA is for topical ocular use only. Not for injection into the eye. 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.
Delayed Wound Healing:
Topical ophthalmic corticosteroids may slow corneal wound healing. Nonsteroidal anti-inflammatory drugs (NSAIDs) are also known to slow or delay healing. Concomitant use of NSAIDs and topical steroids may increase the potential for healing problems.
5% (w/v) levofloxacin Benzalkonium chloride, sodium citrate, sodium hydroxide or hydrochloric acid (to adjust pH), sodium phosphate dibasic dodecahydrate, sodium phosphate monobasic monohydrate, water for injections Product Monograph LEVODEXA, Dexamethasone and levofloxacin ophthalmic solution Page 7 of 30 Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.
If blurred vision occurs after instillation, the patient must wait until the vision clears before driving or using machinery. Endocrine and Metabolism 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 9 DRUG INTERACTIONS). In these cases, treatment should not be discontinued abruptly, but progressively tapered. Immune Prolonged use of corticosteroids may suppress the host immune response and aid in the establishment of ocular bacterial, viral, fungal, or parasitic infections.
In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Corticosteroid therapy should be discontinued if fungal infection occurs.
LEVODEXA is contraindicated in patients with: • Hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Herpes simplex keratitis. • Vaccinia, varicella and other viral diseases of the cornea and conjunctiva. • Mycobacterial ocular infections, including tuberculosis of the eye. • Fungal diseases of ocular structures or untreated parasitic eye infections.
• Acute purulent untreated infections of the eye, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of dexamethasone.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dexamethasone in Canada.
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However, if it is close to your next regular dose, skip your missed dose and follow your regular schedule. Do not take a double dose to make up for a forgotten dose. Product Monograph LEVODEXA, Dexamethasone and levofloxacin ophthalmic solution Page 6 of 30
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following adverse reactions have been reported with LEVODEXA during clinical trials that enrolled patients after cataract surgery (within each frequency grouping, adverse reactions are presented in order of decreasing frequency).
g. corneal oedema, eye irritation, abnormal sensation in the eye, lacrimation increased, asthenopia, corneal disorder, dry eye, eye pain, ocular discomfort, uveitis, blurred vision, visual brightness, conjunctivitis) and nausea have been reported during clinical trials.
These reactions are usually mild and transient and are assessed to be related to the cataract surgery itself. 3 Less Common Clinical Trial Adverse Reactions Eye disorders: Abnormal sensation in eye, asthenopia, conjunctival haemorrhage, corneal disorder, dry eye, eyelid oedema, foreign body sensation in eyes, lacrimation increased, ocular discomfort, ocular hypertension, retinal detachment, uveitis, vision blurred, visual acuity reduced, visual brightness General disorders and administration site conditions: Pyrexia Infections and infestations: Conjunctivitis, rhinitis Investigations: Intraocular pressure increased Product Monograph LEVODEXA, Dexamethasone and levofloxacin ophthalmic solution Page 12 of 30 Nervous system disorders: Dysgeusia, headache
Monitoring and Laboratory Tests If dexamethasone is used for 10 days or longer, intraocular pressure (IOP) should be routinely and frequently monitored. Musculoskeletal Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including levofloxacin, particularly in older patients and those treated concurrently with corticosteroids.
Therefore, caution should be exercised and treatment with LEVODEXA should be discontinued at the first sign of tendon inflammation. The systemic administration of quinolones has led to lesions or erosions of the cartilage in weightbearing joints and other signs of arthropathy in immature animals of various species.
Consequently, levofloxacin should not be used in pre-pubertal patients. Ophthalmologic Increased risk of bleb formation, cataract, glaucoma, impaired healing, infection, IOP increase, perforation and central serous chorioretinopathy (CSCR) have been associated with the use of topical corticosteroids.
Product Monograph LEVODEXA, Dexamethasone and levofloxacin ophthalmic solution Page 8 of 30 Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
g. diabetes). Corticosteroids should not be used in the presence of glaucoma, ocular hypertension (IOP ≥ 24 mmHg) or a history of steroid-induced IOP elevation unless absolutely necessary and under close ophthalmologic monitoring. Caution should be exercised and duration of treatment with dexamethasone should be kept as short as possible.
In diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. After cataract surgery patients should not wear contact lenses for the whole duration of therapy with LEVODEXA.
The preservative in LEVODEXA, benzalkonium chloride, may cause eye irritation and is known to discolour soft contact lenses.
Reproductive Health:
Female and Male Potential • Fertility Systemically administered corticosteroids may impair male and female fertility by influencing hormonal secretion of the hypothalamus and pituitary gland as well as gametogenesis in testes and ovaries.
It is unknown if dexamethasone impairs human fertility after ocular use. Levofloxacin caused no impairment of fertility in rats at exposures considerably in excess of the maximum human exposure after ocular administration. • Teratogenic Risk Levofloxacin did not influence fertility and only impaired embryo-foetal development in animals at exposures, considerably in excess of those achievable at the recommended ocular therapeutic dose in humans.
Topical and systemic administration of dexamethasone impaired male and female fertility and induced teratogenic effects including formation of cleft palate, intra-uterine growth retardation and foetal mortality. Peri- and postnatal toxicity of dexamethasone was also observed.
Skin Moderate to severe phototoxicity reactions have been observed in patients exposed to direct sunlight or ultraviolet (UV) light while receiving fluoroquinolones. Excessive exposure to sunlight or UV light should be avoided. 1% of patients.
, skin eruption) occurs. 1 Pregnant Women There are no or limited amount of data from the use of dexamethasone and levofloxacin in pregnant women. Corticosteroids cross the placenta. Prolonged or repeated […]