Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE HANDLING Levofloxacin Ophthalmic Solution, 0.5% is a clear light yellow solution supplied in a white LDPE bottle with translucent LDPE nozzle and tan coloured HDPE cap in the following size: 5 mL filled in 5 mL bottle – NDC 72888-142-22 Storage: Store at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature].; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Carton Label Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Container Label Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Carton Label Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Container Label
- 16 HOW SUPPLIED/STORAGE HANDLING Levofloxacin Ophthalmic Solution, 0.5% is a clear light yellow solution supplied in a white LDPE bottle with translucent LDPE nozzle and tan coloured HDPE cap in the following size: 5 mL filled in 5 mL bottle – NDC 72888-142-22 Storage: Store at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature].
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Carton Label Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Container Label Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Carton Label Levofloxacin Ophthalmic Solution, 0.5% Sterile Ophthalmic Solution - NDC 72888-142-22 - 5 mL Container Label
Overview
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 a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Levofloxacin is the pure (-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin. 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 light yellow powder. Each mL of levofloxacin ophthalmic solution, 0.5% contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg levofloxacin. Contains Levofloxacin 5 mg equivalent to 5.12 mg levofloxacin hemihydrate with benzalkonium chloride 0.005%, sodium chloride, water for injection, hydrochloric acid and/or sodium hydroxide (to adjust pH). Levofloxacin ophthalmic solution, 0.5% is isotonic and formulated at pH 6.0-6.8 with an osmolality between 285-315 mOsm/kg. 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 ocul
Indications & Usage
Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci* Gram-negative bacteria Acinetobacter lwoffii * Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria: Corynebacterium species * Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumonia Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci* Gram-negative bacteria: Acinetobacter lwoffii * Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections ( 1 )
Dosage & 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. Day s 1 and 2: Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day. Day s 3 through 7: Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day. ( 2 )
Warnings & Precautions
Hypersensitivity and anaphylaxis have been reported with systemic use of levofloxacin as well as topical use of other fluoroquinolones, including levofloxacin ophthalmic solution. ( 5.1 ) Prolonged use may result in the overgrowth of non- susceptible organisms, including fungi. ( 5.2 ) Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. ( 5.3 ) 5.1 Hypersensitivity Reactions In patients receiving systemically administered quinolones, including levofloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema, (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. If allergic reaction to levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated. 5.2 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and where appropriate, fluorescein staining. 5.3 Avoidance of Contact Lens Wear Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Contraindications
Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. Levofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication. ( 4 )
Adverse Reactions
The most frequently reported adverse reactions in the overall study population were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. These reactions occurred in approximately 1-3% of patients. Other reported reactions occurring in less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching. The most frequently reported adverse reactions in the overall study population were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. These reactions occurred in approximately 1 to 3% of patients. Other reported reactions occurring in less than 1% of patients included allergic reactions, lid edema, ocular dryness, and ocular itching. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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