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QUINOFREE 1,5 mg/0,5 ml Eye drops single-dose container 20Unit-dose/0,5ml
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QUINOFREE 1,5 mg/0,5 ml Eye drops single-dose container 20Unit-dose/0,5ml

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Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of the 19/03/2024

QUINOFREE®
ofloxacin


Forms and presentations

Eye drops at 1,5 mg/0,5 ml:  single-dose container of 0,5 ml, box of 20.


Composition

  single-dose p
Ofloxacin 
1,5 mg
Excipients: sodium chloride, hydrochloric acid, sodium hydroxide, water for injectable preparations.

Indications

Local antibacterial treatment of severe ocular infections (severe conjunctivitis, keratitis and corneal ulcers) due to germs sensitive to ofloxacin.
Official recommendations concerning the appropriate use of antibacterial agents should be taken into account.

Dosage and administration

Dosage

The usual dosage is 2 drops 4 times a day in the affected eye or eyes.

Treatment lasting more than 15 days should require a new ophthalmological consultation.


Method of administration:

Ophthalmic use.

For ocular instillation.


Contraindications

This medicine must never be used in case of:
  • Hypersensitivity to ofloxacin or to another medicine of the quinolone family.
  • Hypersensitivity to any of the excipients of this eye drops.
  • Breastfeeding (see Fertility/Pregnancy/Breastfeeding).

Warnings and precautions

The eye drops must not be injected or swallowed.

The eye drops must not be used for peri- or intraocular injection.

Data are insufficient to establish the efficacy and safety of ofloxacin eye drops at 0,3 % in the treatment of conjunctivitis in newborns.

In the absence of evaluation, the use of ofloxacin eye drops is not recommended in newborns with neonatal conjunctivitis due to Neisseria gonorrhoeae or due to Chlamydia trachomatis. These should receive appropriate treatment, such as systemic treatment of infections due to Neisseria gonorrhoeae or at Chlamydia trachomatis.

The use of this eye drop should take into account a risk of nasopharyngeal passage that may contribute to the emergence and spread of bacterial resistance. As with all antibiotic pharmaceutical forms, prolonged use may promote the emergence of resistant bacteria.

Non-clinical and clinical publications have reported the occurrence of corneal perforation in patients with corneal ulcer or corneal abscess after local antibiotic treatment based on fluoroquinolone. However, significant confounding factors have been identified in most of these cases, such as advanced age, the presence of multiple ulcers, associated ocular conditions (example: dry eye syndrome), systemic inflammatory diseases (example: rheumatoid arthritis) and concomitant use of ophthalmic steroids or non-steroidal anti-inflammatory drugs. Therefore, caution is recommended regarding the risk of corneal perforation when treating patients with corneal ulcer or corneal abscess with fluoroquinolone.

The patient should be advised to wash their hands thoroughly before and after instillation, and during instillation not to touch the eye, eyelids or other surfaces with the tip of the single-dose container.

Inflammation and tendon rupture may occur with systemic treatment with fluoroquinolones, including with ofloxacin, particularly in elderly patients and those concurrently treated with corticosteroids. Therefore, precautions must be taken and treatment with Quinofree 1,5 mg/0,5 ml, eye drops in single-dose container must be discontinued at the first signs of inflammation of a tendon (see Undesirable effects).


Interactions

The efficacy of an eye drop may be disrupted by the simultaneous instillation of another eye drop. In case of concomitant treatment with a second eye drop, it is advisable to wait 15 minutes before its instillation.


Fertility, pregnancy and breastfeeding

Pregnancy:

Although animal studies have not shown a teratogenic effect, clinical data on the use of systemic ofloxacin are still insufficient.

Joint damage has been described in children treated with quinolones, but to date, no case of arthropathy secondary to exposure in utero has been reported.

As a result, use of this medicine should only be considered during pregnancy if necessary.


Breastfeeding:

Administration of this medicine requires breastfeeding to be contraindicated, due to the passage of fluoroquinolones into breast milk and the risk of joint effects in the breastfed newborn.


Adverse effects

Eye disorders:
Local burning or stinging sensation.
In a tolerance study of 10 subjects over 15 days, no transient conjunctival hyperaemia was observed.
Frequency not determined: periorbital oedema (including eyelid oedema).
Skin and subcutaneous tissue disorders:
Frequency not determined: Stevens-Johnson syndrome, toxic epidermal necrolysis.

Ruptures of the tendon of the shoulder, hand, Achilles tendon or other tendons requiring surgical repair or resulting in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post-marketing experience with systemic quinolones indicate that the risk of such ruptures may be increased in patients receiving corticosteroids, particularly geriatric patients and where tendons are subjected to high stress, notably the Achilles tendon (see Warnings and Precautions for Use).

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.


Overdose

In case of excessive local administration, wash abundantly with sterile physiological saline.


Pharmacodynamics

Pharmacotherapeutic class: Ophthalmological drugs, other anti-infectives (ATC code: S01AE01).

Ofloxacin is a synthetic antibiotic belonging to the quinolone family, of the fluoroquinolone group. Its activity is strongly bactericidal through inhibition of bacterial DNA gyrase, preventing the synthesis of bacterial chromosomal DNA.

Spectrum of antibacterial activity:
Critical concentrations separate susceptible strains from strains of intermediate susceptibility and the latter from resistant ones: S ≤ 1 mg/l and R > 4 mg/l.
The prevalence of acquired resistance can vary according to geography and time for certain species. It is therefore useful to have information on local resistance prevalence, especially for the treatment of severe infections. These data can only provide guidance on the probabilities of the susceptibility of a bacterial strain to this antibiotic.
When the variability of resistance prevalence in France is known for a bacterial species, the frequency of acquired resistance in France (> 10 %; extreme values) is indicated in parentheses:
Susceptible species:
  • Aerobic Gram-positive: Bacillus anthracis*, Staphylococcus spp. methicillin-S.
  • Aerobic Gram-negative: Acinetobacter, essentially Acinetobacter baumannii (50-75 %), Branhamella catarrhalis, Bordetella pertussis, Campylobacter, Citrobacter freundii (15-25 %), Enterobacter cloacae (15-25 %), Escherichia coli (0-10 %), Haemophilus influenzae, Klebsiella oxytoca (0-11 %), Klebsiella pneumoniae (0-25 %), Legionella, Morganella morganii, Neisseria, Pasteurella, Proteus mirabilis (0-10 %), Proteus vulgaris, Providencia (45-70 %), Pseudomonas aeruginosa (45-85 %), Salmonella, Serratia (40-45 %), Shigella, Vibrio, Yersinia.
  • Anaerobes: Mobiluncus, Propionibacterium acnes.
  • Others: Mycoplasma hominis.
Moderately susceptible species (in vitro of intermediate susceptibility):
  • Gram-positive aerobes: corynebacteria, Streptococcus, Streptococcus pneumoniae.
  • Others: Chlamydiae, Mycoplasma pneumoniae, Ureaplasma urealyticum.
Resistant species:
  • Gram-positive aerobes: enterococci, Listeria monocytogenes, Nocardia asteroides, Staphylococcus spp. methicillin-R**.
  • Anaerobes: with the exception of Mobiluncus and Propionibacterium acnes.
*  Bacillus anthracis: no experimental animal infection studies in anthrax have been carried out.
**  The frequency of methicillin resistance is approximately 30 to 50 % of all staphylococci and is found mainly in hospital settings.

Atypical mycobacteria: ofloxacin has in vitro moderate activity against certain mycobacterial species (Mycobacterium tuberculosis, Mycobacterium fortuitum, lesser activity on Mycobacterium kansasii and even less so on Mycobacterium avium).
Note:
This spectrum corresponds to that of the systemic forms of ofloxacin. With the local pharmaceutical presentations, the concentrations obtained in situ are much higher than plasma concentrations. Some uncertainties remain regarding the kinetics of the concentrations in situ, on the local physicochemical conditions which may modify the activity of the antibiotic and on the stability of the product in situ.

Pharmacokinetics

Studies carried out in animals show that, one hour after the administration of one drop of this eye drop solution, the product concentrations are above the MICs of the main germs encountered in ocular infections, in tears, the cornea and the aqueous humor.

Studies carried out in humans have confirmed the favourable kinetics of ofloxacin in the aqueous humour and in tears.


Storage conditions

Shelf life
3 years.

Store protected from light.

Stability after opening:
After use, the single-dose container must be discarded.
Do not use, a single-dose container already opened.

HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.


Prescription, supply and reimbursement

LIST I
Marketing authorisation (AMM) 3400949952670 (2011, SmPC rev 19.09.2019).
   
Price: 2,93 euros (20 single-dose units).
Reimbursed by Social Security at 65 %. Collective.


THÉA PHARMA
37, rue Georges-Besse
63100 Clermont-Ferrand

http://www.theapharma.fr

Source: VIDAL · Updated on 11/11/2026. This information does not replace advice from a healthcare professional.