Lotenol T0.5%+0.3%

Loteprednol etabonate and tobramycin ophthalmic suspension is a combination corticosteroid-antibiotic eye drop used for steroid-responsive inflammatory ocular conditions where a corticosteroid is indicated and where a superficial bacterial ocular infection, or a risk of one, exists. It is commonly used after eye surgery, and for other conditions where the inherent risk of steroid use in the presence of certain infective conjunctival conditions is accepted in order to reduce oedema (swelling) and inflammation.

Contains loteprednol etabonate 0.5% (5 mg/mL, a corticosteroid) and tobramycin 0.3% (3 mg/mL, an aminoglycoside antibiotic) as active ingredients in a sterile ophthalmic suspension, preserved with benzalkonium chloride.

Loteprednol etabonate and tobramycin is a combination eye drop that pairs a corticosteroid designed to be broken down quickly by the eye's own tissue enzymes (which is associated with a lower tendency to raise eye pressure compared to some older, more traditional ophthalmic steroids) with tobramycin, a broad-spectrum antibiotic effective against many bacteria that cause eye infections. It is used when there is eye inflammation together with a bacterial infection or meaningful infection risk, commonly following eye surgery, combining anti-inflammatory control with antibiotic coverage in a single product.

Therapeutic Class: Ophthalmic Corticosteroid-Antibiotic Combination

Loteprednol etabonate belongs to a class of corticosteroids specifically designed to be rapidly metabolized to inactive compounds once they have exerted their anti-inflammatory effect in ocular tissue, which is associated with a comparatively lower incidence of raised intraocular pressure than some older ophthalmic steroids, though this risk is not eliminated and monitoring is still required with extended use. Tobramycin is a broad-spectrum aminoglycoside active against many gram-positive and gram-negative bacteria commonly causing external eye infections, working by inhibiting bacterial protein synthesis at the ribosome.

• Shake the suspension well before each use
• Wash hands before use
• Tilt the head back, gently pull down the lower eyelid to form a pocket, and instill the prescribed number of drops
• Avoid touching the dropper tip to the eye or any surface, to prevent contaminating the suspension
• Remove soft contact lenses before instillation, given the benzalkonium chloride preservative, which can be absorbed by soft contact lenses; do not reinsert until advised by your doctor

Systemic absorption from topical ophthalmic use is generally limited, so significant systemic drug interactions are uncommon with normal use. If other eye medicines are used at the same time, doses should be spaced apart, and any concerns should be discussed with a doctor or pharmacist.

Common side effects

• Eye stinging, burning, or discomfort on instillation
• Superficial punctate keratitis (mild surface irritation of the cornea)
• Increased intraocular pressure
• Itching or a foreign body sensation

Serious side effects with prolonged use

• Raised intraocular pressure progressing to glaucoma with optic nerve damage and visual field defects, particularly with courses of 10 days or longer
• Posterior subcapsular cataract formation
• Delayed wound healing, particularly relevant following cataract surgery, where steroid use may delay healing and increase the incidence of bleb-related complications
• Secondary ocular infection, including fungal infection, due to prolonged suppression of the local immune response

Pregnancy

There are no adequate, well-controlled studies with loteprednol etabonate or tobramycin in pregnant women. This medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as advised by a doctor.

Breastfeeding

It is not known whether topical ophthalmic administration results in sufficient systemic absorption to produce detectable amounts of either component in human milk. Caution is advised, and use should be discussed with a healthcare professional.

• Prolonged use may result in raised intraocular pressure and glaucoma with optic nerve damage; intraocular pressure should be monitored if this product is used for 10 days or longer.
• Prolonged use may also increase the risk of posterior subcapsular cataract formation.
• Use of ocular corticosteroids may prolong the course and worsen the severity of many viral eye infections, including herpes simplex keratitis; avoid use in this setting.
• Corticosteroids can suppress the host immune response, increasing the risk of secondary ocular infection, including fungal infection, particularly with extended use.
• Corticosteroid use following cataract surgery may delay healing and increase the incidence of bleb formation; use with appropriate postoperative monitoring.
• Do not allow the dropper tip to contact any surface, to avoid contaminating the suspension.
• Not more than the initial prescribed quantity should be used without further examination by a physician.

Topical ophthalmic overdose is uncommon with normal use, but excessive or prolonged use increases the risk of the steroid-related eye effects described above. If the product is accidentally swallowed, or a large amount is applied, seek medical advice. Stop use and consult a doctor if irritation or symptoms worsen.

Store upright at 15-25°C (59-77°F), protected from freezing, as directed on the product label. Do not use after the labeled expiry date; discard any unused portion after the manufacturer's specified in-use period once opened.

• Elderly: No overall differences in safety or effectiveness have been observed between elderly and younger adult patients.
• Children (0-6 years): Has been studied for lid inflammation and blepharoconjunctivitis in this age group; efficacy for these specific indications was not clearly demonstrated over vehicle in clinical trials, so use should follow an ophthalmologist's specific assessment of the individual case.

Treatment duration depends on clinical response and is determined by the prescribing doctor. Because prolonged corticosteroid use increases the risk of raised eye pressure and cataract, intraocular pressure should be checked if treatment continues for 10 days or longer, and the prescription should not be refilled without further evaluation.

Drug Class: Site-specific ('soft') corticosteroid (loteprednol etabonate) combined with an aminoglycoside antibiotic (tobramycin)

Loteprednol etabonate suppresses local inflammation in ocular tissue by binding to glucocorticoid receptors, reducing swelling, redness, and cellular inflammatory activity, and is metabolized to inactive compounds relatively quickly once it has acted. Tobramycin works by binding to the bacterial ribosome, blocking bacterial protein synthesis, which kills susceptible bacteria. Together, the combination addresses both the inflammatory component and the infection (or infection risk) present in the treated eye.

This combination has been studied in children aged 0-6 years for lid inflammation and blepharoconjunctivitis, though clinical trials did not clearly demonstrate efficacy over the vehicle alone for these specific indications in this age group. Use in children should be guided by an ophthalmologist based on the specific condition being treated.