Dosing and uses of Zylet (tobramycin-loteprednol-ophthalmic)
Adult dosage forms and strengths
tobramycin/loteprednoL
ophthalmic suspension
- 0.3/0.5%
Ocular Inflammation
Indicated for steroid-responsive ocular inflammations with risk of superficial bacterial infections
Shake vigorously before use
Instill 1-2 gtts in affected eye(s) q4-6hr; may use as frequently as q1-2hr during first 24-48 hr
Decrease frequency of administration as signs and symptoms improve; if use exceeds >20 mL evaluate therapy further
Pediatric dosage forms and strengths
tobramycin/loteprednoL
ophthalmic suspension
- 0.3/0.5%
Ocular Inflammation
Indicated for steroid-responsive ocular inflammations with risk of superficial bacterial infections
Shake vigorously before use
Instill 1-2 gtts in affected eye(s) q4-6hr; may use as frequently as q1-2hr during first 24-48 hr
Decrease frequency of administration as signs and symptoms improve; if use exceeds >20 mL evaluate therapy further
Warnings
Contraindications
Hypersensitivity to any component of the formulation or to other corticosteroids
Viral, mycobacterial & fungal eye infections
Cautions
History of herpes simplex infections
May exacerbate infections by nonsusceptible organisms
Monitor IOP if used >10 d
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 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 Zylet (tobramycin-loteprednol-ophthalmic)
Mechanism of action
Loteprednol: 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