TobraDex

TobraDex

tobramycin + dexamethasone

Manufacturer:

Novartis

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Ophth susp Tobramycin 0.3%, dexamethasone 0.1%. Ophth oint Tobramycin 0.3%, dexamethasone 0.1%
Indications/Uses
Ocular steroid-responsive inflammatory conditions for which a corticosteroid is indicated & where bacterial ocular infection, or a risk of bacterial ocular infection exists, due to tobramycin-responsive microorganisms resistant to most of the other antibiotics, especially Pseudomonas aeruginosa, in adults & childn ≥2 yr. Inflammatory conditions of the palpebral & bulbar conjunctiva, cornea & anterior segment of the eye where inherent risk of steroid use in certain infective conjunctivitis is accepted to obtain a decrease in oedema & inflammation. Chronic anterior uveitis & corneal injury from chemical agents, radiation, thermal burns, or penetration of foreign bodies.
Dosage/Direction for Use
Ophth susp 1-2 drops into the conjunctival sac every 4 hr. During initial 24-48 hr, dosage may be increased to 1-2 drops every 2 hr. Severe disease 1-2 drops every hr until inflammation is controlled, decrease to 1-2 drops every 2 hr during 3 days, then 1-2 drops every 4 hr during 5-8 days, & finally 1-2 drops every day during the last 5-8 days, if necessary. Ophth oint Apply small amount (1-1.5 cm) into the conjunctival sac tds-qds, or use adjunctively w/ eye drops during the day & eye oint at bedtime.
Contraindications
Hypersensitivity to tobramycin, dexamethasone, & aminoglycosides. Herpes simplex keratitis. Vaccinia, varicella, & other viral corneal & conjunctival infections (except herpes zoster keratitis). Fungal diseases of ocular structures or untreated parasitic eye infections. Mycobacterial ocular infections. Infections or injuries limited to the superficial corneal epithelium. Should not be used following uncomplicated removal of a foreign body from the cornea.
Special Precautions
Not for inj or ingestion. Discontinue treatment if hypersensitivity develops. Cross-hypersensitivity to other aminoglycosides. Risk of neurotoxicity, ototoxicity & nephrotoxicity w/ systemic aminoglycoside therapy. Caution in patients w/ known or suspected neuromuscular disorders eg, myasthenia gravis or Parkinson's disease. Excessive &/or prolonged use may increase risk of ocular complications & systemic side effects; cause hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, & decreased growth rate in childn; ocular HTN &/or glaucoma, w/ damage to the optic nerve, reduced visual acuity & visual field defects, & posterior subcapsular cataract formation; reduce resistance to & aid in establishment of bacterial, viral, fungal, or parasitic infections & mask clinical signs of infection. Routinely & frequently check IOP in patients receiving ophth corticosteroid therapy for ≥10 days. Visual disturbance. Should only be used in acute purulent eye infections when treatment w/ steroid/anti-infective combination product is necessary. May result in overgrowth of non-susceptible organisms, including fungi. Use w/ caution when treating herpes simplex other than epithelial herpes simplex keratitis. Perforations may occur in diseases causing thinning of the cornea or sclera. Topical ophth corticosteroid may slow corneal wound healing. Concomitant use w/ topical NSAIDs & topical steroids. Do not discontinue treatment prematurely. Risk of corticosteroid-induced raised IOP &/or cataract formation in predisposed patients (eg, diabetes). Contact lens wear is not recommended. May affect the ability to drive & use machines. Not recommended during pregnancy. Lactation. Paed patients. Ophth susp: Contains benzalkonium Cl.
Adverse Reactions
Eye pain, increased IOP, eye irritation, & eye pruritus.
Drug Interactions
Additional IOP elevation w/ pupil-dilating eye drops (atropine & other anticholinergic substances). If >1 topical ophth prep is being used, products must be administered at least 5 min apart; eye oint should be administered last. Dexamethasone: Increased plasma conc w/ strong CYP3A4 inhibitors (eg, ritonavir).
MIMS Class
Eye Antiseptics with Corticosteroids
ATC Classification
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Presentation/Packing
Form
TobraDex ophthalmic susp
Packing/Price
5 mL x 1's
Form
TobraDex ophthalmic oint
Packing/Price
3.5 g x 1's
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