May mask and exacerbate existing ocular infection. Re-evaluate patients if symptoms do not improve after 2 days. Glaucoma; may delay healing after cataract surgery. Monitor intraocular pressure (prolonged use).
Indication
Postoperative ocular inflammation and pain, Allergic conjunctivitis, Ocular inflammation
Contra Indication
Contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids. Viral infections of the cornea and conjunctiva; mycobacterial eye infection; fungal infections of ocular structures.
Contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Dose
N/A
Side Effect
>10%
(0.5% ointment only)
Anterior chamber inflammation (~25%)
5-15%
(0.5% suspension only)
Abnormal vision/blurring
Burning on instillation
Chemosis
Discharge
Dry eyes
Epiphora
Foreign body sensation
Itching
Photophobia
<5%
(0.5% gel only)
Anterior chamber inflammation (5%)
Eye pain (2%)
Foreign body sensation (2%)
(0.5% suspension only)
Conjunctivitis
Corneal abnormalities
Eyelid erythema
Keratoconjunctivitis
Ocular irritation/pain/discomfort
Papillae
Uveitis
(0.5% ointment only)
Conjunctival hyperemia (4-5%)
Corneal edema (4-5%)
Eye pain (4-5%)
Headache (1.5%)
Frequency Not Defined
(0.1% only)
Infrequent optic nerve damage
Visual acuity and field defects
Posterior subcapsular cataract formation
Delayed wound healing
Secondary ocular infection from pathogens (eg, herpes simplex)
Perforation of the globe where there is thinning of the cornea or sclera
Pregnancy Category
Name :
Not Classified
Description
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Loteprednol is a synthetic nonfluorinated glucocorticoid. It stimulates the production of lipicortins, proteins that modulate the activity of prostaglandins and leukotrienes.
Interaction
N/A
Pregnancy Category Note
Pregnancy
(0.1% preparation)
Drug is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to drug
(0.5% preparation)
There are no adequate and well controlled studies in pregnant women; use during pregnancy only if the potential benefit justifies the potential risk to the fetus
Lactation
(0.1% preparation)
Drug is not absorbed systemically by the mother following topical ophthalmic administration, and breastfeeding is not expected to result in exposure of the child
(0.5% and 0.2% preparation)
There are no data on presence of loteprednol etabonate in human milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered, along with mother?s clinical need for therapy and any potential adverse effects on breastfed infant
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk
Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
Adult Dose
Ophthalmic
Postoperative ocular inflammation and pain
Indicated for treatment of postoperative inflammation and pain following ocular surgery
(1% preparation)
Instill 1-2 drops into affected eye(s) BID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively
(0.5% preparation)
Gel or suspension: Apply 1-2 drops into conjunctival sac of affected eye(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively
Ointment: Apply ~0.5 inch ribbon into conjunctival sac(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively
Seasonal Allergic Conjunctivitis
Indicated for temporary relief of signs and symptoms of seasonal allergic conjunctivitis
(0.2% preparation)
Instill 1 drop into affected eye(s) QID
Steroid Responsive Inflammatory Conditions
Indicated for steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides) when steroid use is accepted to obtain an advisable diminution in edema and inflammation
(0.5% preparation)
Suspension only
Apply 1-2 drops into the conjunctival sac of affected eye(s) QID
During initial treatment within the first week, may increase dose up to 1 drop q1hr, if necessary
Do not to discontinue therapy prematurely; if signs and symptoms fail to improve after 2 days, re-evaluate patient
Child Dose
Postoperative Inflammation
Indicated for treatment of postoperative inflammation and pain following ocular surgery
(0.5% preparation)
Gel or suspension: Apply 1-2 drops into conjunctival sac of affected eye(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively
Ointment: Apply ~0.5 inch ribbon into conjunctival sac(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively
Steroid Responsive Inflammatory Conditions
Indicated for steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides) when steroid use is accepted to obtain an advisable diminution in edema and inflammation
(0.5% preparation)
Suspension only
Apply 1-2 drops into the conjunctival sac of affected eye(s) QID
During initial treatment within the first week, may increase dose up to 1 drop q1hr, if necessary
Do not to discontinue therapy prematurely; if signs and symptoms fail to improve after 2 days, re-evaluate patient
Renal Dose
N/A
Administration
N/A
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.