Sunways India Pvt Ltd. More Than 60 Years of Dedicated & Commited Effort in the Field of OPTHAMOLOGY
NEBRACIN LP - Loteprednol Etabonate 0.5% and Tobramycin 0.3%
Nebracin  
Composition  
Loteprednol Etabonate 0.5% w/v
Tobramycin 0.3% w/v
(As Sulphate)  
Benzalkonium Chloride Solution I.P. 0.02% v/v
(As Preservative)  
Sterile Aqueous Buffered Vehicle q.s.
Dosage form
Ophthalmic Supension
Category
Antibiotic + Steroid
 Description

Corticosteroids inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and   leukotrienes by inhibiting the release of their common precursor arachidonic acid.

In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:  Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and  coagulase- negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some  Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella  pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most  Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata,  Acinetobacter calcoaceticus and some Neisseria species.
Indications
Nebracin LP is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. (to treat ocular infection & inflammation)
Dosage and Administration
Shake vigorously before using.

Apply one or two drops of Nebracin LP into the conjunctival sac of the affected eye(s) 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.

Contraindications
Loteprednol –Tobramycin combination as with other steroid anti-infective ophthalmic  combination drugs is contraindicated in most viral diseases of the cornea and  conjunctiva Loteprednol –Tobramycin combination is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Precautions
Pregnancy Teratogenic effects
Pregnancy Category C
There are no adequate and well controlled studies in pregnant women. Nebracin LP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation
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 Nebracin LP is administered to a nursing woman.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

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

Storage
Store in a cool & dark place
Presentation
Nebracin LP Eye Drops is available in a pack of 5 ml.