Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 16571-150 | ||||
|---|---|---|---|---|---|
| Drug Name | Levofloxacin |
||||
| Type | Generic | ||||
| Active Ingredients |
|
||||
| Route | TOPICAL | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 314080 | ||||
| Application Number | ANDA077700 | ||||
| Labeler Name | Rising Pharma Holdings, Inc. | ||||
| Packages |
|
||||
| Check if available Online | Get Medication Prices online with Discount |
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS The most frequently reported adverse events in the overall study populations were transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. These events 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. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
LEVOFLOXACIN Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions: Specific drug interaction studies have not been conducted with Levofloxacin Ophthalmic Solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Pharmacokinetics: Levofloxacin concentration in plasma was measured in 15 healthy adult volunteers at various time points during a 15 day course of treatment with Levofloxacin Ophthalmic Solution. The mean levofloxacin concentration in plasma 1 hour postdose, ranged from 0.86 ng/mL on Day 1 to 2.05 ng/mL on Day 15. The highest maximum mean levofloxacin concentration of 2.5 ng/mL was measured on Day 4 following 2 days of dosing every 2 hours for a total of 8 doses per day. Maximum mean levofloxacin concentrations increased from 0.94 ng/mL on Day 1 to 2.15 ng/mL on Day 15, which is more than 1,000 times lower than those reported after standard oral doses of levofloxacin. Levofloxacin concentration in tears was measured in 30 healthy adult volunteers at various time points following instillation of a single drop of Levofloxacin Ophthalmic Solution. Mean levofloxacin concentrations in tears ranged from 34.9 to 221.1 μg/mL during the 60-minute period following the single dose. The mean tear concentrations measured 4 and 6 hours postdose were 17.0 and 6.6 μg/mL. The clinical significance of these concentrations is unknown. Microbiology: Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves the inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoismerases), enzymes required for DNA replication, transcription, repair, and recombination. Levofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive microorganisms and is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Fluoroquinolones, including levofloxacin, differ in chemical structure and mode of action from β-lactam antibiotics and aminoglycosides, and therefore may be active against bacteria resistant to β-lactam antibiotics and aminoglycosides. Additionally, β-lactam antibiotics and aminoglycosides may be active against bacteria resistant to levofloxacin. Resistance to levofloxacin due to spontaneous mutation in vitro is a rare occurrence (range: 10 -9 to 10 -10 ). Levofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: AEROBIC GRAM-POSITIVE MICROORGANISMS Corynebacterium species* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci AEROBIC GRAM-NEGATIVE MICROORGANISMS Acinetobacter lwoffii* Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections. The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of levofloxacin in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials. These organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Levofloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2μg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following ocular pathogens: Aerobic gram-positive microorganisms Enterococcus faecalis Streptococcus agalactiae Staphylococcus saprophyticus Streptococcus pyogenes Aerobic gram-negative microorganisms Acinetobacter anitratus Legionella pneumophila Acinetobacter baumannii Moraxella catarrhalis Citrobacter diversusi Morganella morgqanii Citrobacter freudii Neisseria gonorrhoeae Enterobacter aerogenes Proteus mirabilis Enterobacter agglomerans Proteus vulgaris Enteroacter cloacae Providencia rettgeri Escherichia coli Providencia stuartii Haemophilus arainfluenzae Pseudomonas aeruginosa Klebsiella oxytoca Pseudomonas fluorescens Klebsiella pneumoniae Clinical Studies: In randomized, double-masked, multicenter controlled clinical trial where patients were dosed for 5 days, Levofloxacin Ophthalmic Solution demonstrated clinical cures in 79% of patients treated for bacterial conjunctivitis on the final study visit day (day 6-10). Microbial outcome for the same clinical trials demonstrated an eradication rate for presumed pathogens of 90%.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmacokinetics: Levofloxacin concentration in plasma was measured in 15 healthy adult volunteers at various time points during a 15 day course of treatment with Levofloxacin Ophthalmic Solution. The mean levofloxacin concentration in plasma 1 hour postdose, ranged from 0.86 ng/mL on Day 1 to 2.05 ng/mL on Day 15. The highest maximum mean levofloxacin concentration of 2.5 ng/mL was measured on Day 4 following 2 days of dosing every 2 hours for a total of 8 doses per day. Maximum mean levofloxacin concentrations increased from 0.94 ng/mL on Day 1 to 2.15 ng/mL on Day 15, which is more than 1,000 times lower than those reported after standard oral doses of levofloxacin. Levofloxacin concentration in tears was measured in 30 healthy adult volunteers at various time points following instillation of a single drop of Levofloxacin Ophthalmic Solution. Mean levofloxacin concentrations in tears ranged from 34.9 to 221.1 μg/mL during the 60-minute period following the single dose. The mean tear concentrations measured 4 and 6 hours postdose were 17.0 and 6.6 μg/mL. The clinical significance of these concentrations is unknown.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Levofloxacin Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components of this medication.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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 neutral pH than ofloxacin. Structural formula: Levofloxacin Hemihydrate C 18 H 20 FN 3 O 4 · ½ H 2 O Mol Wt. 370.38 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% ( mg/mL); Preservative: benzalkonium chloride 0.005%; Inactives: sodium chloride and water for injection. 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. structural-formula
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 pneumoniae Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci AEROBIC GRAM-NEGATIVE MICROORGANISMS Acinetobacter lwoffii* Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections.
Spl product data elements
Usually a list of ingredients in a drug product.LEVOFLOXACIN LEVOFLOXACIN LEVOFLOXACIN LEVOFLOXACIN ANHYDROUS BENZALKONIUM CHLORIDE SODIUM CHLORIDE WATER SODIUM HYDROXIDE HYDROCHLORIC ACID
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility: In a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or tumorigenic potential following daily dietary administration; the highest dose (100 mg/kg/day) was 875 times the highest recommended human ophthalmic dose. Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli), CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the in vivo mouse sister chromatid exchange assay. It was positive in the in vitro chromosomal aberration (CHL cell line) and in vitro sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, corresponding to 3,150 times the highest recommended human ophthalmic dose.
Microbiology
MicrobiologyMicrobiology: Levofloxacin is the L-isomer of the racemate, ofloxacin, a quinolone antimicrobial agent. The antibacterial activity of ofloxacin resides primarily in the L-isomer. The mechanism of action of levofloxacin and other fluoroquinolone antimicrobials involves the inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoismerases), enzymes required for DNA replication, transcription, repair, and recombination. Levofloxacin has in vitro activity against a wide range of Gram-negative and Gram-positive microorganisms and is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations. Fluoroquinolones, including levofloxacin, differ in chemical structure and mode of action from β-lactam antibiotics and aminoglycosides, and therefore may be active against bacteria resistant to β-lactam antibiotics and aminoglycosides. Additionally, β-lactam antibiotics and aminoglycosides may be active against bacteria resistant to levofloxacin. Resistance to levofloxacin due to spontaneous mutation in vitro is a rare occurrence (range: 10 -9 to 10 -10 ). Levofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section: AEROBIC GRAM-POSITIVE MICROORGANISMS Corynebacterium species* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Groups C/F) Streptococcus (Group G) Viridans group streptococci AEROBIC GRAM-NEGATIVE MICROORGANISMS Acinetobacter lwoffii* Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections. The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of levofloxacin in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials. These organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Levofloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2μg/mL or less (systemic susceptible breakpoint) against most (≥90%) strains of the following ocular pathogens: Aerobic gram-positive microorganisms Enterococcus faecalis Streptococcus agalactiae Staphylococcus saprophyticus Streptococcus pyogenes Aerobic gram-negative microorganisms Acinetobacter anitratus Legionella pneumophila Acinetobacter baumannii Moraxella catarrhalis Citrobacter diversusi Morganella morgqanii Citrobacter freudii Neisseria gonorrhoeae Enterobacter aerogenes Proteus mirabilis Enterobacter agglomerans Proteus vulgaris Enteroacter cloacae Providencia rettgeri Escherichia coli Providencia stuartii Haemophilus arainfluenzae Pseudomonas aeruginosa Klebsiella oxytoca Pseudomonas fluorescens Klebsiella pneumoniae
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.———PRINCIPAL DISPLAY PANEL——— NDC 16571-150-50 PACK Pharmaceuticals, LLC LEVOFLOXACIN OPHTHALMIC SOLUTION 0.5% FOR TOPICAL APPLICATION IN THE EYE Rx only (5 mL) Sterile product-label
LEVOFLOXACIN: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for Patients Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemic quinolones have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reactions.
Clinical studies
This field may contain references to clinical studies in place of detailed discussion in other sections of the labeling.Clinical Studies: In randomized, double-masked, multicenter controlled clinical trial where patients were dosed for 5 days, Levofloxacin Ophthalmic Solution demonstrated clinical cures in 79% of patients treated for bacterial conjunctivitis on the final study visit day (day 6-10). Microbial outcome for the same clinical trials demonstrated an eradication rate for presumed pathogens of 90%.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers: Levofloxacin has not been measured in human milk. Based upon data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when Levofloxacin Ophthalmic Solution is administered to a nursing mother.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established. Oral administration of quinolones has been shown to cause arthropathy in immature animals. There is no evidence that the ophthalmic administration of levofloxacin has any effect on weight bearing joints.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy: Teratogenic Effects. Pregnancy Category C Levofloxacin at oral doses of 810 mg/kg/day in rats, which corresponds to approximately 7,000 times the highest recommended human ophthalmic dose, caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, which corresponds to approximately 400 times the highest recommended maximum human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, corresponding to approximately 200 times the highest recommended human ophthalmic dose. There are, however, no adequate and well-controlled studies in pregnant woman. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Levofloxacin Ophthalmic Solution 0.5% is supplied in a natural, low density polyethylene bottle with a controlled dropper tip and a tan, high density polyethylene cap in the following size: Bottles of 5 mL NDC 16571-150-50 Store at 20°-25°C (68°-77°F) Rx Only Manufactured in India for: Rising Pharmaceuticals Inc. Allendale, NJ 07401 Distributed by: Pack Pharmaceuticals, LLC Allendale, NJ 07401
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General 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 slitlamp biomicroscopy, and where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General 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 slitlamp biomicroscopy, and where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Information for Patients Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemic quinolones have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reactions. Drug Interactions: Specific drug interaction studies have not been conducted with Levofloxacin Ophthalmic Solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly. Carcinogenesis, Mutagenesis, Impairment of Fertility: In a long term carcinogenicity study in rats, levofloxacin exhibited no carcinogenic or tumorigenic potential following daily dietary administration; the highest dose (100 mg/kg/day) was 875 times the highest recommended human ophthalmic dose. Levofloxacin was not mutagenic in the following assays: Ames bacterial mutation assay (S. typhimurium and E. coli), CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal test, rat unscheduled DNA synthesis assay, and the in vivo mouse sister chromatid exchange assay. It was positive in the in vitro chromosomal aberration (CHL cell line) and in vitro sister chromatid exchange (CHL/IU cell line) assays. Levofloxacin caused no impairment of fertility or reproduction in rats at oral doses as high as 360 mg/kg/day, corresponding to 3,150 times the highest recommended human ophthalmic dose. Pregnancy: Teratogenic Effects. Pregnancy Category C Levofloxacin at oral doses of 810 mg/kg/day in rats, which corresponds to approximately 7,000 times the highest recommended human ophthalmic dose, caused decreased fetal body weight and increased fetal mortality. No teratogenic effect was observed when rabbits were dosed orally as high as 50 mg/kg/day, which corresponds to approximately 400 times the highest recommended maximum human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, corresponding to approximately 200 times the highest recommended human ophthalmic dose. There are, however, no adequate and well-controlled studies in pregnant woman. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Levofloxacin has not been measured in human milk. Based upon data from ofloxacin, it can be presumed that levofloxacin is excreted in human milk. Caution should be exercised when Levofloxacin Ophthalmic Solution is administered to a nursing mother. Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established. Oral administration of quinolones has been shown to cause arthropathy in immature animals. There is no evidence that the ophthalmic administration of levofloxacin has any effect on weight bearing joints. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS NOT FOR INJECTION. Levofloxacin Ophthalmic Solution should not be injected subconjunctially, nor should it be introduced directly into the anterior chamber of the eye. In patients receiving systemic quinolones, 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 an 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API