Tobrawin-LP

Loteprednol Etabonate & Tobramycin Ophthalmic Suspension

Loteprednol Etabonate & Tobramycin Ophthalmic Suspension is used to treat inflammation or swelling in the eye that is caused by a bacterial infection.

Pharmaceutical Information Chemistry:

Drug Substance: Tobramycin Sulfate & Loteprednol Etabonate

Composition:

Tobramycin Sulfate USP
Equivalent to Tobramycin 0.3% w/v
Loteprednol Etabonate 0.5% w/v
Stabilized Oxychloro Complex (As preservative) 0.005% w/v
Sterile Aqueous Base q.s.

Indications:

Loteprednol Etabonate & Tobramycin Ophthalmic Suspension is used to treat inflammation or swelling in the eye that is caused by a bacterial infection.

Contraindications:

Loteprednol Etabonate & Tobramycin Ophthalmic Suspension, as with other steroid anti-infective ophthalmic combination drugs, is 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.
It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Storage:

Store below 30°C. Protect from light & moisture. Do not freeze.

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior sub-capsular cataract formation.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Pregnancy:

There are no adequate and well controlled studies in pregnant women. Loteprednol Etabonate & Tobramycin Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

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. Caution should be exercised when Loteprednol Etabonate & Tobramycin Ophthalmic Suspension is administered by nursing woman.

Pediatric Use:

It is in a trial to evaluate the safety and efficacy of Loteprednol Etabonate & Tobramycin Ophthalmic Suspension for pediatric patients (age zero to six years) with lid inflammation.

Geriatric Use:

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Symptoms and Treatment of Overdosage:

No information provided.

Dosage and Administration:

Apply one or two drops of Loteprednol Etabonate & Tobramycin Ophthalmic Suspension into the conjunctival sac of the affected eye every four to six hours. During the initial 24 to 48 hours, the dosing may be increased to every one to two hours.
Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Not more than 20 ml should be prescribed initially and the prescription should not be refilled without further evaluation.

Special Instructions:

Patients should be advised to avoid contamination of the dispensing tip.

Presentation:

Tobrawin-LP Eye Drops is available in 5ml sterile plastic bottles.