Version May 2024
Ocular inflammatory conditions: Ophthalmic:
Ointment: Apply ~1/2-inch ribbon in the conjunctival sac of the affected eye(s) up to 3 to 4 times daily
Suspension:
TobraDex: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) every 4 to 6 hours; may be increased to 1 to 2 drops every 2 hours for the first 24 to 48 hours, then reduce to less frequent intervals as signs and symptoms improve
TobraDex ST: Instill 1 drop into the conjunctival sac of the affected eye(s) every 4 to 6 hours; may be increased to 1 drop every 2 hours for the first 24 to 48 hours, then reduce to less frequent intervals as signs and symptoms improve
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
Ocular inflammatory conditions: Children ≥2 years and Adolescents: Refer to adult dosing.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
1% to 10%:
Cardiovascular: Increased blood pressure (≤1%)
Hypersensitivity: Hypersensitivity reaction (<4%)
Nervous system: Headache (≤1%)
Ophthalmic: Blepharitis (<4%), conjunctival erythema (<4%), eyelid pruritus (<4%)
Postmarketing:
Dermatologic: Erythema multiforme
Hypersensitivity: Anaphylaxis
Hypersensitivity to tobramycin, dexamethasone, or any component of the formulation; viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial infection of the eye; fungal diseases of ocular structure.
Canadian labeling: Additional contraindications (not in US labeling): Patients with known or suspected hypersensitivity to other aminoglycosides; after uncomplicated removal of a corneal foreign body; untreated parasitic or untreated acute purulent infections of the eye.
Concerns related to adverse effects:
• Hypersensitivity reactions: Sensitivity varying from local to generalized effects (eg, erythema, pruritus, urticaria, skin rash, anaphylaxis, anaphylactoid reaction, bullous reaction) to topically applied aminoglycosides may occur; discontinue if sensitivity reaction occurs. Cross-sensitivity to other aminoglycoside antibiotics may occur.
• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary ocular infections (including fungal infections). Acute purulent or parasitic ocular infections may be masked or exacerbated with use. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
• Ocular effects: Prolonged use may result in glaucoma, injury to the optic nerve, visual defects in acuity and field of vision, and formation of posterior subcapsular cataracts. Use with caution in presence of glaucoma (steroids increase intraocular pressure). Perforation may occur with topical steroids in diseases which thin the cornea or sclera. Steroid use after cataract surgery may delay healing and increase the incidence of bleb formation. Intraocular pressure should be monitored if this product is used >10 days.
Disease-related concerns:
• Ocular herpes simplex: Use with extreme caution in patients with a history of ocular herpes simplex; use of corticosteroids may prolong the course and exacerbate severity of infection.
Special populations:
• Contact lens wearers: May contain benzalkonium chloride (ophthalmic suspension) which may be adsorbed by contact lenses; contact lenses should not be worn during treatment of ophthalmic infections.
Other warnings/precautions:
• Appropriate use: For topical ophthalmic use only. A maximum of 8 g of ointment or 20 mL of suspension should be prescribed initially; patients should be evaluated prior to additional refills. Patients should be re-evaluated if symptoms do not improve after 2 days. Monitor intraocular pressure if this product is used >10 days. Initial prescription and renewal of medication should be made by health care provider only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate). Inadvertent contamination of multiple-dose ophthalmic bottle dropper and tips has caused bacterial keratitis.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, Ophthalmic:
TobraDex: Tobramycin 0.3% and dexamethasone 0.1% (3.5 g) [contains chlorobutanol]
Suspension, Ophthalmic:
TobraDex: Tobramycin 0.3% and dexamethasone 0.1% (2.5 mL [DSC], 5 mL [DSC], 10 mL [DSC]) [contains benzalkonium chloride]
TobraDex ST: Tobramycin 0.3% and dexamethasone 0.05% (5 mL) [contains benzalkonium chloride]
Generic: Tobramycin 0.3% and dexamethasone 0.1% (2.5 mL, 5 mL, 10 mL)
Yes: Suspension (0.3%/0.1%)
Ointment (TobraDex Ophthalmic)
0.3-0.1% (per gram): $93.00
Suspension (TobraDex ST Ophthalmic)
0.3-0.05% (per mL): $57.10
Suspension (Tobramycin-dexAMETHasone Ophthalmic)
0.3-0.1% (per mL): $18.25 - $29.09
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, ophthalmic:
Tobradex: Tobramycin 0.3% and dexamethasone 0.1% (3.5 g) [contains chlorobutanol]
Suspension, ophthalmic:
Tobradex: Tobramycin 0.3% and dexamethasone 0.1% (5 mL) [contains benzalkonium chloride]
Ophthalmic: Contact lenses should not be worn during therapy. Per the manufacturer, for topical ophthalmic use only; to avoid contamination, do not touch container tip to eyelids or other surfaces when placing drops or ointment in eyes.
Ointment: Apply ointment into pocket between eyeball and lower lid; patient should look downward before closing eye.
Suspension: Shake well before using. Tilt head back, instill suspension in conjunctival sac and close eye(s). Apply light finger pressure on lacrimal sac for 1 minute following instillation.
Otic (off-label route):
Suspension: Shake well before using. Thoroughly cleanse external auditory canal and dry with a sterile cotton applicator. Lie down with affected ear upward and medication instilled. Maintain this position for 3 to 5 minutes to facilitate penetration of the drops. Repeat, if necessary, for the opposite ear. Alternatively, insert a cotton wick impregnated with tobramycin 0.3%/dexamethasone 1% drops (or a dry wick subsequently saturated with the suspension) into the ear canal. This wick should be kept moist by adding further suspension 3 to 4 times daily. The wick is unnecessary after ear canal edema subsides, typically in 24 to 48 hours. The otic route should not be used when the integrity of the tympanic membrane is in question (Ref).
Ophthalmic: For topical ophthalmic use only; not for injection into the eye. To avoid contamination, do not touch container tip to eyelids or other surfaces when placing drops or ointment in eyes. Contact lenses should not be worn during therapy.
Ointment: Tilt head back and apply ointment into pocket between eyeball and lower lid (conjunctival sac); patient should look downward before closing eye.
Suspension: Shake well before using. Tilt head back, instill suspension in conjunctival sac, and close eye(s).
Ocular inflammatory conditions: Treatment of steroid-responsive ocular inflammatory conditions (where either a superficial bacterial ocular infection or the risk of a bacterial ocular infection exists) of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe; chronic anterior uveitis; corneal injury from chemical, radiation or thermal burns; penetration of foreign bodies.
Otitis externa, acute
TobraDex may be confused with Tobrex
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
CYP3A4 Inhibitors (Strong): May increase the serum concentration of DexAMETHasone (Ophthalmic). Risk C: Monitor therapy
Nirmatrelvir and Ritonavir: May increase the serum concentration of Corticosteroids (Ophthalmic). Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Adverse events have been observed with topical corticosteroids in animal reproduction studies. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988). See individual agents.
It is not known if systemic absorption following topical administration results in detectable quantities in human milk. The manufacturer recommends that caution be exercised when administering tobramycin/dexamethasone to breast-feeding women. See individual agents.
Monitor intraocular pressure with use >10 days and in patients with glaucoma; signs/symptoms of secondary infection; re-evaluate if signs and symptoms persist beyond 2 days.
Tobramycin: Interferes with bacterial protein synthesis by binding to 30S ribosomal subunit resulting in a defective bacterial cell membrane.
Dexamethasone: Decreases inflammation by suppression of neutrophil migration, decreased production of inflammatory mediators, and reversal of increased capillary permeability; suppresses normal immune response.
See individual agents.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
