Dexagen L Eye Drops

Dexagen L Eye Drops is used for: Prevention and treatment of inflammation, prevention of infection associated with cataract surgery

Adult Eye Drop The recommended dose is 1 drop in the affected eye every 6 hours. The maximum dose is 4 drops per day. The usual total treatment course is 7 days

Children and adolescents: This is not recommended for children and adolescents below 18 years due to a lack of data on safety and efficacy in this age group.

Read these instructions with you before applying the drops. Wash carefully your hands. Open the bottle. Remove the loose collar from the cap when the bottle is first opened. Take special care that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers. Twist off the bottle cap. Hold the bottle pointing down, between your thumb and fingers. Pull down your lower eyelid with a finger, until there is a ‘pocket’ between the eyelid and your eye. The drop will go in here. Tilt your head back and bring the bottle tip close to the eye and squeeze the bottle gently in the middle and let a drop fall into your eye. Please note that there might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard. After using this eye drop press a finger into the corner of your eye by the nose. This helps to stop the medicine from getting into the rest of the body.

Hypersensitivity to active substance levofloxacin or to other quinolones, to dexamethasone, or to other steroids, or to any of the excipients; Herpes simplex keratitis, varicella and other viral disease of the cornea and conjunctiva; Mycobacterial infections of the eye are caused by, but not limited to, acid-fast bacilli such as Mycobacterium tuberculosis, Mycobacterium leprae, or Mycobacterium avium; Fungal diseases of ocular structures; Untreated purulent infection of the eye.

Ocular effects: Levofloxacin + Dexamethasone eye drops solution is for ocular use only. It must not be injected sub-conjunctively. The solution should not be introduced directly into the anterior chamber of the eye. Prolonged use may induce antibiotic resistance with result of overgrowth of non-susceptible organisms, including fungi. If infection develops, the treatment should be discontinued and alternative therapy used. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. Prolonged use of topical ophthalmic corticosteroids may result in ocular hypertension/glaucoma but this is unlikely when Levofloxacin + Dexamethasone eye drops solution is used for the recommended treatment period (7 days). In any case, it is advisable that the intraocular pressure be checked frequently. The risk of corticosteroid-induced increase in the intraocular pressure is increased in predisposed patients (e.g. diabetes). Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may be related to complications to cataract surgery, development of glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Topical ophthalmic corticosteroids may slow corneal wound healing. Topical ocular NSAIDs are also known to slow or delay healing. Concomitant use of topical ocular NSAIDs and steroids may increase the potential for healing problems. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. Systemic effects: Fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction to levofloxacin occurs, discontinue the medication. 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 Levofloxacin + Dexamethasone eye drops solution should be discontinued at the first sign of tendon inflammation. Cushing's syndrome and/or adrenal suppression associated with systemic absorption of ocular 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). In these cases, treatment should be progressively discontinued. Effects on Immune System: Prolonged use (generally observed within 2 weeks of treatment) may also result in secondary ocular infections (bacterial, viral, or fungal) due to suppression of host response or to the delay of their healing. In addition, topical ocular corticosteroids may promote, aggravate or mask signs and symptoms of eye infections caused by opportunistic microorganisms. Occurrence of these conditions is limited in case of short-term corticosteroid treatment such as the one suggested for Levofloxacin + Dexamethasone eye drops solution. Excipients: Benzalkonium chloride: Benzalkonium chloride has been reported to cause eye irritation, and symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use. After cataract surgery patients should not wear contact lenses for the whole duration of therapy with Levofloxacin + Dexamethasone eye drops solution. Effects on the ability to drive and use machines: As with any eye drops, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs, the patient must wait until the vision is clear before driving or using machines.

Pregnancy: 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 corticosteroid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation, lower birth weight and risk for high blood pressure, vascular disorders and insulin resistance in the adulthood. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. Studies in animals with corticosteroids have shown reproductive toxicity and teratogenic effects (including cleft palate). Since a relevant systemic corticosteroid exposure cannot be excluded after ocular administration, treatment with Levofloxacin + Dexamethasone eye drops solution is not recommended during pregnancy, and especially during the first three months, should only take place after a careful benefit-risk assessment. Breastfeeding: Systemic corticosteroids and levofloxacin are excreted into human milk. No data are available, to indicate whether relevant amounts of dexamethasone are transferred into human breast milk and which are capable of producing clinical effects in the infant. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Levofloxacin + Dexamethasone eye drops solution therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. 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.

No interaction studies have been performed. Since maximum plasma concentrations of levofloxacin and dexamethasone after ocular administration are at least 1000 times lower than those reported after standard oral doses, interactions with other products for systemic use are unlikely to be clinically relevant. The concomitant use of probenecid, cimetidine, or ciclosporin with levofloxacin altered some pharmacokinetic parameters of levofloxacin, but not to a clinically significant extent. Concomitant use of topical steroids and topical NSAIDs may increase the potential for corneal healing problems. CYP3A4 inhibitors (including ritonavir and cobicistat) may decrease dexamethasone clearance resulting in increased effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid effects.

Side effects of Dexamethasone + Levofloxacin eye prep : Increase of intraocular pressure: Increase of the intra-ocular pressure (IOP) and glaucoma may occur. Prolonged use of corticosteroid treatment may result in ocular hypertension/glaucoma (especially for patients with previous high 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. Post-procedural adverse reactions: Ocular disorders (e.g. corneal edema, 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. 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.

Levofloxacin: Mechanism of action: Levofloxacin, the active L-isomer of ofloxacin, is a fluoroquinolone antibacterial agent, that inhibits bacterial type II topoisomerases - DNA gyrase and topoisomerase IV. Levofloxacin preferentially targets DNA gyrase in Gram negative bacteria and topoisomerase IV in Gram positive bacteria. The spectrum of activity against ocular pathogens includes aerobic Gram-positive microorganisms (e.g. S. aureus MSSA, S. pyogenes, S. pneumoniae, viridans group streptococci), aerobic Gram-negative bacteria (e.g. E. coli, H. influenzae, M. catarrhalis, P. aeruginosa community isolates), other organisms (e.g. Chlamydia trachomatis). Dexamethasone: Mechanism of action: Corticosteroids like dexamethasone suppress vascular endothelial cell adhesion molecules, cyclooxygenase I or II, and cytokine expression. This action culminates in a reduced expression of proinflammatory mediators and the suppression of adhesion of circulating leukocytes to the vascular endothelium, thereby preventing their migration into inflamed ocular tissue. Dexamethasone has marked anti-inflammatory activity with reduced mineralocorticoid activity compared with some other steroids and is one of the most potent anti-inflammatory agents.

Dexagen L 0.1% + 0.5% Eye Drops manufactured by General Pharmaceuticals Ltd.. Its generic name is Dexamethasone + Levofloxacin eye prep. Dexagen L is availble in Bangladesh. Farmaco BD drug index information on Dexagen L Eye Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.