Loteprednol

LOTEMAX

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Loteprednol ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Loteprednol ballicule

What it isRapidly inactivated ophthalmic glucocorticoid; ocular inflammation and dry-eye flares.

Why this oneIts ester design permits rapid local inactivation and tends to raise pressure less than ketone-based ocular steroids.

What limits itPressure elevation, cataract, and infection still require monitoring with prolonged use; severe inflammation may need a stronger steroid.

Loteprednol molecular structure (skeletal formula) — Molecular structure: Loteprednol

FDA-approved for

ocular inflammation
dry eye disease flares (2020)

FDA label

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FDA dosing	Population	Start	Target	Max
Steroid-responsive ocular inflammatory conditions	Adults	1 drop in affected eye(s) QID

Renal Undefined

Hepatic Undefined

Instructions

Shake vigorously before use
Instill 1 drop into the affected eye(s) four times daily

Available strengths

susp 0.2, 0.25, 0.5, 1 %
gel 0.38, 0.5 %
ointment 0.5 %

Contraindications

Most viral corneal/conjunctival diseases — epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella
Mycobacterial ocular infection
Fungal diseases of ocular structures

Cautions

Elevated intraocular pressure (may damage optic nerve, cause visual acuity/field defects)
Posterior subcapsular cataract formation
Secondary ocular infection (incl. herpes simplex)
Globe perforation where cornea/sclera is thinned
Delayed healing

Adverse reactions

Abnormal vision/blurring
Burning on instillation
Chemosis
Discharge
Dry eyes
Epiphora
Foreign body sensation
Itching
Injection
Photophobia
Elevated IOP

Pregnancy Embryotoxic and teratogenic in animals at high oral doses; no adequate human data

Lactation Undefined

Cost

Loteprednol (LOTEMAX)

Strength		#/mo	CostPlus
0.2 %	susp	per unit	not offered
0.25 %	susp	per unit	not offered
0.5 %	susp	per unit	not offered
1 %	susp	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Loteprednol is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2019

NO BOXED WARNINGS

Principal riskSteroid-induced pressure rise on prolonged use

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger0 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryC

Defining liabilityLocal tissue effects and irritation; systemic corticosteroid toxicity is uncommon at usual exposure.

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