Levofloxacin
5 mg/mL · Solution
- Prescription only
- Active substance
- Levofloxacin
- Made by
- Advagen Pharma Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-03-10
- Acinetobacter lwoffii * Haemophilus influenzae Serratia marcescens* *Efficacy for this organism was studied in fewer than 10 infections ( 1 )
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.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
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 )
From the official label · 2025-03-10 · DailyMed
How it works
From this product’s own US prescribing label.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Levofloxacin is a member of the fluoroquinolone class of anti-infective drugs.
(See 12.4 Microbiology ) 12.2 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.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-03-10
Do not take it if
- 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 )
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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 )
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects Levofloxacin at oral doses of 810 mg/kg/day in rats 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, at which systemic exposure was approximately 2,250 times that observed at the maximum recommended human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, at which systemic exposure was approximately 1000 times that observed at the maximum recommended human ophthalmic dose.
- There are, however, no adequate and well-controlled studies in pregnant women.
- Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- 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.
- IN SPECIFIC POPULATIONS
- 8.1 Pregnancy Teratogenic Effects Levofloxacin at oral doses of 810 mg/kg/day in rats 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, at which systemic exposure was approximately 2,250 times that observed at the maximum recommended human ophthalmic dose, or when dosed intravenously as high as 25 mg/kg/day, at which systemic exposure was approximately 1000 times that observed at the maximum recommended human ophthalmic dose.
- There are, however, no adequate and well-controlled studies in pregnant women.
- Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- 8.3 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.
- 8.4 Pediatric Use Safety and effectiveness in children below the age of six years have not been established.
- Oral administration of systemic 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.
- 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Use in children
- Safety and effectiveness in children below the age of six years have not been established.
- Oral administration of systemic 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.
Quoted from the official label, section “Pediatric Use”.
Use in older people
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Quoted from the official label, section “Geriatric Use”.
Side effects
- 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
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- 17.1
- Avoid Contamination of the Product Advise patients to
- avoid contaminating the applicator tip with material from the eye, finger, or other source.
- 17.2
- Avoid Contact Lens Wear Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
- 17.3 Hypersensitivity Reactions Systemically administered quinolones, including levofloxacin, have been associated with hypersensitivity reactions, even following a single dose.
- Advise patients to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.
- Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA Rev. 02/2025
Quoted from the official label, section “Patient Counseling Information”.
Strengths and forms
FORMS AND STRENGTHS 5 mL white LDPE bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 0.5%. 5 mL white LDPE bottle filled with 5 mL sterile ophthalmic solution of levofloxacin, 0.5% ( 3 )
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- /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].
Quoted from the official label, section “How Supplied”.
What is in it
- 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
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Details
| Made by | Advagen Pharma Limited |
|---|---|
| Active substance | Levofloxacin |
| Strength | 5 mg/mL |
| Form | Solution |
| Route | Ophthalmic |
| Packs | 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE |
| NDC | 72888-142 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
98 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet, Film Coated72 products
- Injection, Solution16 products
5 mg/mL2
5 mg/mL · 2 companies
25 mg/mL2
25 mg/mL · 2 companies
250 mg/50mL4
250 mg/50mL · 4 companies
500 mg/100mL4
500 mg/100mL · 4 companies
750 mg/150mL4
750 mg/150mL · 4 companies
- Solution3 products
- 5 mg/mL
25 mg/mL2
25 mg/mL · 2 companies
- Tablet3 products
Show all forms · 7 forms
- Injection, Solution, Concentrate2 products
- Solution/ Drops1 products
- Injection1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.