Dosing and uses of TobraDex Suspension, TobraDex ST (dexamethasone-tobramycin)
Adult dosage forms and strengths
dexamethasone/tobramycin
ophthalmic ointment
- 0.1%/0.3%
ophthalmic suspension
- 0.05%/0.3%
- 0.1%/0.3%
Ocular Inflammation & Bacterial Infection
Ophthalmic suspension: 1-2 gtt to affected eye(s) q4-6hr; if needed, may increase frequency to q2hr during the first 24-48 hr; then taper to less frequent intervals
Ophthalmic ointment: Apply small amount (ie, ~0.5-in ribbon) to conjunctival sac(s) q6-8hr
Pediatric dosage forms and strengths
dexamethasone/tobramycin
ophthalmic ointment
- (0.1%/0.3%)
(ophthalmic suspension)
- (0.05%/0.3%)
- (0.1%/0.3%)
Ocular Inflammation & Bacterial Infection
<2 years
- Safety and efficacy not established
>2 years
- Ophthalmic suspension: 1-2 gtt to affected eye(s) q4-6hr; if needed, may increase frequency to q2hr during the first 24-48 hr; then taper to less frequent intervals
- Ophthalmic ointment: Apply small amount (ie, ~0.5-in ribbon) to conjunctival sac(s) q6-8hr
TobraDex Suspension, TobraDex ST (dexamethasone-tobramycin) adverse (side) effects
Frequency not defined
Ocular lid itching and swelling
Conjunctival erythema
Elevation of intraocular pressure (IOP) with possible development of glaucoma
Infrequent optic nerve damage
Cataract formation
Posterior subcapsular cataract formation
Delayed wound healing
Secondary infections
Keratitis
Warnings
Contraindications
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva
Mycobacterial infection of the eye
Fungal diseases of ocular structures
Hypersensitivity to a component of the medication
Cautions
Bacterial keratitis reported from inadvertent contamination of multiple dose ophthalmic solution
Immunosuppression resulting from prolonged use of steroid use may result in secondary bacterial and fungal infections; steroids may also mask symptoms of infections and enhance existing ocular infections
Ocular hypertension and/or glaucoma reported with prolonged corticosteroid use
Discontinue use if sensitivity reaction to tobramycin develops
Corticosteroid use following cataract surgery may delay healing
Pregnancy and lactation
Pregnancy category: C
Lactation: Excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of TobraDex Suspension, TobraDex ST (dexamethasone-tobramycin)
Mechanism of action
Dexamethasone prevents/reduces irritation & swelling by suppressing normal immune response, decreasing inflammatory mediators and reverses capillary permeability
Tobramycin: Alters bacterial cell membrane integrity by binding to 30S and 50S ribosomal subunits, which in turn interferes with bacterial protein synthesis
