Drug Catalog - Product Detail
LEVOFLOXACIN OPHTH. SOL. SOL 0.005 5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50383-0283-05 | HI-TECH | 5 | 0.5% | SOLUTION |
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Description
DESCRIPTION Levofloxacin Ophthalmic Solution, 0.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is the pure (-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin. Structural formula Chemical Name: (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo- 7H -pyrido[1,2,3- de ]-1,4 benzoxazine-6-carboxylic acid hemihydrate. Levofloxacin (hemihydrate) is a yellowish-white crystalline powder. Each mL of levofloxacin ophthalmic solution contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin. Contains: Active: Levofloxacin 0.5% (5 mg/mL); Preservative: benzalkonium chloride 0.005%; Inactives: purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Levofloxacin ophthalmic solution is isotonic and formulated at pH 6.5 with an osmolality of approximately 300 mOsm/kg. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Chemical Structure
How Supplied
HOW SUPPLIED Levofloxacin Ophthalmic Solution 0.5% (5 mL) is supplied in a white, low density polyethylene bottle with a controlled dropper tip and a tan, high density polyethylene cap (NDC 50383-283-05). Storage: Store at 20 - 25°C (68 - 77°F) [see USP Controlled Room Temperature]. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Made in U.S.A. Rev. 283:00 6/09
Indications & Usage
INDICATIONS AND USAGE Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: AEROBIC GRAM-POSITIVE MICROORGANISMS Corynebacterium species* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci AEROBIC GRAM-NEGATIVE MICROORGANISMS Acinetobacter Iwoffii* Haemophilus influenza Serratia marcescens* * Efficacy for this organism was studied in fewer than 10 infections.
Dosage and Administration
DOSAGE AND ADMINISTRATION Days 1 and 2: Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day. Days 3 through 7: Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.