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Zylet Drop 5 Ml By Valeant Pharma

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Zylet Drop 5 Ml By Valeant Pharma

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Zylet Drop 5 Ml By Valeant Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3637816/RXB10032400
Size : 5 ML
Selling UoM : EA
NDC: 24208-0358-05
UPC Barcode : 324208358054
Supplier: 0050001428 VALEANT PHARMACEUTICALS INT'L
Supplier Material : 035805
Generic Code : 058620 TOBRAMYCIN/LOTEPRED ETAB OPHTHALMIC DROP
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

Drops , white
White to off-white

(loteprednol etabonate and tobramycin) Ophthalmic Suspension, 0.5%/0.3% Sterile

DRUG DESCRIPTION
Zylet (loteprednol etabonate and tobramycin ophthalmic suspension), is a sterile, multiple dose topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders.

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Each mL contains: Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.7-5.9. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsm/kg.

INDICATIONS

Zylet 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.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group Abeta-

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.

SIDE EFFECTS

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.
Zylet

In a 42 day safety study comparing Zylet to placebo, the incidence of ocular adverse events reported in greater than 10% of subjects included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Zylet) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation. Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.

The incidence of non-ocular adverse events reported in approximately 14% of subjects was headache all other non-ocular events had an incidence of less than 5%.