Loading…
NETILDEX is a brand name for Netilmicin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PrNETILDEX® (netilmicin and dexamethasone ophthalmic solution) is indicated in adult patients (including the elderly) for the treatment of inflammatory ocular conditions of the anterior segment of the eye following cataract surgery where adjunct topical therapy to reduce the risk of bacterial infection is appropriate.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations For topical ophthalmic use only. Not for injection into the eye. Not for otic use. Not for nasal use. 2 Recommended Dose and Dosage Adjustment Instill one drop of NETILDEX into the conjunctival sac of the affected eye, four times daily for 7 days.
PrNETILDEX (netilmicin sulphate and dexamethasone sodium phosphate) – Product Monograph Page 5 of 32 Health Canada has not authorized an indication for pediatric use (<18 years of age). 3 Administration NETILDEX ophthalmic solution with preservative Ensure that the tip of the container does not touch the eye or any other surface.
Close the container immediately after use. Discard the container and any unused content 28 days after first opening. NETILDEX preservative-free ophthalmic solution Ensure the preservative-free container is not damaged before use. Use immediately after opening.
After administration, discard the container and any unused content. If concurrent use of NETILDEX and soft contact lenses is necessary, it is advised to use NETILDEX preservative-free ophthalmic solution. Remove contact lenses prior to administration and wait at least 15 minutes after administration before re-insertion.
(see WARNINGS AND PRECAUTIONS). If more than one topical ophthalmic product is being used by the patient, the administrations should be at least ten minutes apart. 4 Missed Dose If a dose of this medication is missed, it should be taken as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and return to the regular dosing schedule. Do not use a double dose to make up for the missed dose.
1 Adverse Reaction Overview Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component or the combination. 5% (4/751) of clinical trial subjects treated with NETILDEX (or concurrent single actives), following cataract surgery: bacterial conjunctivitis, corneal oedema, endophthalmitis and uveitis.
Symptoms of ocular discomfort (pain, photophobia, tearing, burning, stinging, itching, blurred vision) were common on the day following cataract surgery, and most resolved within 7 days PrNETILDEX (netilmicin sulphate and dexamethasone sodium phosphate) – Product Monograph Page 10 of 32 treatment.
3% (8/395), symptoms worsened to severe. 6% (4/638) of patients. Cases of corneal deposits or corneal opacity have been reported in association with the use of phosphate containing eye drops. Aminoglycosides Serious adverse reactions which have been reported in patients receiving systemic aminoglycoside therapy, some with netilmicin, include: ototoxicity, nephrotoxicity, eighth cranial nerve toxicity, neuromuscular blockade, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Risk factors include: pre-existing renal, vestibular or auditory impairment; concurrent or sequential therapy with nephrotoxic or ototoxic agents; prolonged therapy; high dose; drug interactions. Corticosteroids Other reactions which have been reported after use of systemic and topical corticosteroids include: altered vision (visual disturbances, defects in visual acuity and visual fields, loss of accommodation), cataract (posterior subcapsular), central serous chorioretinopathy (CSCR), corneal perforation, Cushing’s syndrome/ adrenal suppression, dysregulation (glucose, potassium), impaired healing, infections (secondary, fungal, viral, worsening Herpes simplex infection), mydriasis, and decreased response to somatotropin.
General FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. NOT FOR OTIC USE. NOT FOR NASAL USE. NOT FOR ORAL INGESTION. The safety and efficacy of NETILDEX therapy for a duration beyond 7 days have not been established. Drug interactions are known to occur with topical ophthalmic and/or systemic exposure to corticosteroids and aminoglycosides.
Serious adverse reactions, and increased risk of adverse reactions, may occur with sequential or concurrent use of interacting drugs, including additional corticosteroids and/or aminoglycosides (see DRUG INTERACTIONS). Carcinogenesis and Mutagenesis Refer to Non-Clinical Toxicology section.
Driving and Operating Machinery Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after NETILDEX administration, the patient must wait until 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 and patients treated with inhibitors of cytochrome P450 3A4 such as ritonavir (see DRUG INTERACTIONS).
In these cases, treatment should not be discontinued abruptly, but progressively tapered. Immune Sensitivity to topically applied aminoglycosides or corticosteroids may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions, such as PrNETILDEX (netilmicin sulphate and dexamethasone sodium phosphate) – Product Monograph Page 7 of 32 erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions or bulbous reactions.
If hypersensitivity develops during use of NETILDEX, treatment should be discontinued. Cross-hypersensitivity to other aminoglycosides and to other corticosteroids can occur. Patients who become sensitized to topical netilmicin or to topical dexamethasone may also be sensitive to other topical and/or systemic aminoglycosides or corticosteroids.
NETILDEX is contraindicated in: • Known or suspected hypersensitivity to netilmicin or other aminoglycosides, dexamethasone or other corticosteroids, or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
• Herpes simplex keratitis or other Herpes simplex eye infections. • Vaccinia, varicella, and other viral diseases of the cornea and conjunctiva. • Fungal diseases of the eye or untreated parasitic eye infections. • Mycobacterial ocular infections, including tuberculosis of the eye.
• Acute purulent untreated infections of the eye which may be masked or enhanced by the presence of a corticosteroid. • After uncomplicated removal of a corneal foreign body.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Risk factors include prolonged or intensive corticosteroid use; diabetes; corneal or scleral thinning; concurrent use of topical nonsteroidal anti-inflammatory drugs (NSAIDs); pediatrics; hepatic impairment, hypoprothrombinemia, or hypothyroidism.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of NETILDEX and netilmicin sulfate (with or without concurrent dexamethasone sodium phosphate), formulated as topical eye solution, eye gel or eye ointment was evaluated across 13 prospective, randomized trials for a treatment period of 6 to 14 days, and followed post-treatment up to study day 14 and 30, respectively, in a total of 1228 adult subjects.
1% dexamethasone (as dexamethasone sodium phosphate). Among these trials were 751 unique patients from 4 trials in a post- phacoemulsification cataract surgery / intraocular lens implantation setting (580 treated with NETILDEX solution; 171 treated with concurrent single actives); 50 patients from 1 trial in a post- vitreoretinal surgery setting treated with NETILDEX solution; 334 patients from 6 trials in a non- surgical, conjunctivitis setting (71 treated with NETILDEX solution; 150 treated with netilmicin solution and netilmicin ointment; 122 treated with netilmicin solution) and 84 healthy subjects from 2 trials (21 treated with NETILDEX solution; 21 treated with NETILDEX gel; 21 treated with netilmicin solution; 21 treated with netilmicin gel).
Subjects were treated with one drop/eye four times per day, except for 42 healthy subjects who were treated six times per day. Subjects treated with netilmicin ointment received it at bedtime as one of the four daily treatments. The safety PrNETILDEX (netilmicin sulphate and dexamethasone sodium phosphate) – Product Monograph Page 11 of 32 analyses were conducted on available data from the safety population, which included all randomized subjects who received at least 1 dose of investigational treatment.
In these trials, 425 adult subjects were treated with active comparators. U. 3% gentamicin ointment). Post-operative inflammation following cataract surgery Table 2 summarizes treatment-emergent adverse events from four trials of patients treated for post-operative inflammation following uncomplicated phacoemulsification / intraocular lens implantation cataract surgery.
Trial subjects were Caucasian male and female adults (age range 40 to 94 years, evenly distributed to age […]
Monitoring and Laboratory Tests Ophthalmic evaluation and intraocular pressure (IOP) should be routinely and frequently monitored according to current clinical practice recommendations. Ophthalmic examinations are recommended during prolonged therapy.
In predisposed patients, consideration should be given to assessment of auditory function, hypothalamic-pituitary-adrenal (HPA) axis function, or renal function, as appropriate. 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.
Prolonged or intensive 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.
This risk is higher in patients with diabetes. In patients with diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical corticosteroids. 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 should be kept as short as possible. If a patient presents with symptoms such as blurred vision or other visual disturbances, consider referral to an ophthalmologist for evaluation.
Impaired Healing Topical ophthalmic corticosteroids may slow corneal wound healing. Concurrent use of topical ophthalmic corticosteroids and topical NSAIDs may increase the potential for, and severity of, healing problems (see DRUG INTERACTIONS).
Bleb Formation Topical ophthalmic corticosteroids may increase the incidence of bleb formation after cataract surgery. Infections Prolonged use of corticosteroids may suppress the host response, and aid in the establishment of secondary ocular bacterial, viral, fungal or parasitic infections and mask the clinical signs of infection.
In patients with a history of herpetic infection of the cornea, reactivation of the disease may occur with use of topical ophthalmic corticosteroids. PrNETILDEX (netilmicin sulphate and dexamethasone sodium phosphate) – Product Monograph Page 8 of 32 Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
If fungal infection occurs, corticosteroid therapy, including NETILDEX, should be discontinued and appropriate therapy initiated. NETILDEX, if handled incorrectly, can become contaminated, which may lead to eye infections. Serious ocular damage and subsequent loss of vision may result from using contaminated eye drops.
Advise patients not to touch the tip of the container to any surface including the eye to avoid possible contamination. Corneal Deposits NETILDEX contains phosphates which may lead to corneal deposits or corneal opacity when topically administered.
Risk factors include pre-existing corneal damage. NETILDEX should be used with caution in patients presenting with compromised cornea and in instances where the patient is receiving other phosphate containing eye medications. If significant clinical improvement does not occur within a few days, or if any irritation or sensitization phenomena occur, discontinue NETILDEX and initiate appropriate therapy.
Benzalkonium Chloride NETILDEX ophthalmic solution with preservative contains the preservative benzalkonium chloride, which may cause eye irritation and is known to bind to, and discolour, soft contact lenses. Use of Contact Lenses Contact lens wear is not recommended during treatment with NETILDEX due to the increased […]