Tobramycin/loteprednol ophthalmic

Dosage Forms & 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

Dosage Forms & 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

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 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.