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tobramycin/loteprednol ophthalmic (Zylet)

 

Classes: Antibiotics/Corticosteroids, Ophthalmic

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