Eye drops Ofloxacin-Stulln® UD



Where to buy
Eye drops Ofloxacin-Stulln® UD

Eye drops Ofloxacin-Stulln® UD



Where to buy

Ofloxacin-Stulln ®UD

 

INSTRUCTION

for medical use of the medicinal product

Composition

active substance: ofloxacin (1 ml of eye drops contains 3.0 mg of ofloxacin);

excipients: sodium chloride, hydrochloric acid, sodium hydroxide; water for injections.

Medicinal form: eye drops.

Physical and chemical properties: transparent colorless solution.

Pharmacotherapeutic group: products used in ophthalmology. Antimicrobial agents.

Code ATX S01A E01.

 

Pharmacological properties

Pharmacodynamics

Ofloxacin, a derivative of quinolinic acid, is a fluoroquinolone (gyrase inhibitor) — an antibiotic with a bactericidal effect.

Threshold values

Gentamicin tests were performed using a series of dilutions. The following minimum inhibitory concentrations were determined for sensitive and resistant bacteria.

 

Threshold values ​​according to EUCAST (European Committee for Antimicrobial Susceptibility Testing) recommendations

Pathogen

Sensitive

Resistant

Enterobacteriaceae

≤2 mg/l

>4 mg/l

Pseudomonas spp.

≤4 mg/l

>4 mg/l

Acinetobacter spp.

≤4 mg/l

>4 mg/l

Staphylococcus spp.

≤1 mg/l

>1 mg/l

Non-species-specific threshold values*

≤2 mg/l

>4 mg/l

 
 

*To a greater extent determined based on blood serum pharmacokinetics.

 

Antibacterial spectrum

The spectrum of action of ofloxacin includes obligate anaerobes, facultative anaerobes, aerobes, and other microorganisms such as Chlamydia. The prevalence of acquired resistance in individual species may vary by location and time. Therefore, obtaining local information about resistance is the main thing for prescribing adequate treatment for severe infections.

Microbiological detection of the type of pathogens and their sensitivity to ofloxacin must be carried out in case of severe infections or if the treatment did not give a therapeutic effect. Cross-resistance of ofloxacin to other fluoroquinolones is possible.

Resistance data refer to systemic use. When topically applied to the eye, significantly higher concentrations of the antibiotic were achieved, so clinical efficacy is observed even with pathogens that have been determined to be resistant in laboratory studies. Such an effect is observed, for example, with Enterococcus species.

Usually sensitive species

Gram-positive aerobes: Bacillus spp., Staphylococcus aureus sensitive to methicillin,

Gram-negative aerobes: Acinetobacter baumannii, Acinetobacter lwoffi, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Serratia marcescens.

Species that, due to acquired resistance, may be insensitive to the use of the drug

Gram-positive aerobes: Corynebacterium spp., Enterococcus faecalis, Staphylococcus aureus resistant to methicillin[1], Staphylococcus epidermidis, Streptococcus pneumoniae[2], Streptococci (except Streptococcus pneumoniae)2.

Gram-negative aerobes: Pseudomonas aeruginosa, Stenotrophomonas maltophilia.

Species with natural resistance to the drug

Gram-positive aerobes: Enterococcus spp.

 

Pharmacokinetics

Effectiveness largely depends on the ratio of the maximum concentration in the tissue and the minimum inhibitory concentration of the pathogen.

Animal testing has shown that after topical application ofloxacin can be detected in the cornea, conjunctiva, eye muscle, sclera, iris, ciliary body, and anterior chamber of the eyeball. With repeated use, the drug accumulates in therapeutic concentrations in the vitreous body.

Ofloxacin-Stulln ®UD eye drops, instilled 5 times a day at 5 minutes intervals, after 60–120 minutes, are detected in the intraocular fluid at a concentration of ofloxacin of 1.2–1.7 μg/ml. After 3 hours, this value decreases to 0.8 μg/ml. Depending on the frequency of instillation, after 5–6 hours the concentration of ofloxacin in the intraocular fluid drops to zero.

By analogy with the results of animal studies, it can be assumed that other eye tissues contain higher concentrations of the drug than the intraocular fluid. Since ofloxacin can bind to melanin-containing tissues, delayed excretion from these tissues should be expected. The half-life of ofloxacin from plasma with its systematic use is from 3.5 to 6.7 hours.

 

Clinical characteristics

Indication

Infections of the anterior part of the eye, caused by pathogenic microorganisms sensitive to the ofloxacin, such as bacterial inflammation of the conjunctiva, cornea, eyelid margin, and lacrimal gland; sty and corneal ulcer.

 

Contraindication

Hypersensitivity to any of the excipients of the drug, other quinolones.

 

Features of application

If an allergic reaction to the drug has developed, one should stop the use of this drug at once.

Before the first instillation of the medicinal product, it is recommended to make a microbiological test of swabs taken from the conjunctival sac to determine the sensitivity of bacterial strains to the drug.

With long-term use, the formation of bacterial resistance and microorganisms insensitive to the antibacterial agent are possible. If symptoms worsen or there is no clinical improvement, treatment should be stopped and alternative therapy should be considered.

Contact lenses should not be used during treatment. Therefore, it is recommended to remove the lenses before using the drug and put them back on no earlier than 20 minutes after the instillation of eye drops.

 

Interaction with other medicinal products and other types of interactions

Unknown

When using Ofloxacin-Stulln ®UD eye drops together with other eye drops/eye ointments, medicinal products should be used at an interval of at least 15 minutes. In any case, the eye ointment should be applied last.

With systemic use of fluoroquinolones, the drug should be used with caution in patients with a risk of prolonging the QT interval, namely: with a congenital syndrome of prolongation of the QT interval, with the simultaneous use of drugs that prolong the QT interval (such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics), with uncorrected electrolyte balance (for example, with hypokalemia, hypomagnesemia), elderly patients, patients with heart diseases (in particular, with heart failure, myocardial infarction, bradycardia).

 

Use during pregnancy or breastfeeding

Although there is no evidence of teratogenic effects, the use of the drug should be avoided during pregnancy and breastfeeding if possible.

 

The ability to influence the speed of reaction when driving a motor vehicle or working with other mechanisms

Immediately after the instillation of this medicinal product into the conjunctival sac of the eye, blurring of visual perception may appear for several minutes. That is why, during this time, one should refrain from working with mechanisms, avoid dangerous activities, and abstain from driving a car.

 

Method of instillation and dosage

The dose of the drug and the duration of treatment are always determined by the doctor depending on the severity of the disease and the age of the patient.

If not prescribed otherwise, adults, children, including newborns, should be instilled into the conjunctival sac of the affected eye 1 drop 4 times a day. The duration of treatment with eye drops should not exceed 14 days.

 

Instructions for use

Open the aluminum foil bag and take out the block of disposable vials. Separate one bottle from the block. Place the remaining single-use vials back in the bag and close it by wrapping the edge. Keep the package in the box.

Carefully pull the lower eyelid down and, slightly pressing the bottle, instill 1 drop into the conjunctival sac of the affected eye. The contents of a single-use bottle are enough for both eyes.

Throw away the bottle after use.

 

Children

The drug is used in pediatric practice.

 

Overdose

No case of overdose was registered.

 

Adverse reactions

Immediately after administration of the drug, blurred vision may occur for several minutes.

General manifestations

Serious reactions after systemic use of ofloxacin rarely occur, and most symptoms are reversible. Although a small amount of ofloxacin is absorbed into the systemic circulation when applied topically, the probability of side effects that have been reported cannot be excluded.

Immune system

Redness of the conjunctiva and/or a slight burning in the eye. In most cases, these symptoms are short-lived.

Hypersensitivity, including angioedema, shortness of breath, anaphylactic reactions/shock, swelling of the oropharynx and tongue, and itching of the eyes and eyelids.

Nervous system

Dizziness.

Organs of vision

Eye discomfort, eye irritation, keratitis, conjunctivitis, blurred vision, photophobia, eye swelling, eye redness, foreign body sensation, increased lacrimation, dry eyes, eye pain, itching, and eyelid swelling.

Corneal deposits may occur, especially if there is a history of corneal diseases.

There are reports that with local application, such reactions as toxic epidermal necrolysis, and Stevens-Johnson syndrome, have occurred very rarely. A cause-and-effect relationship with the use of Ofloxacin-Stulln ®UD eye drops concerning such manifestations has not been established.

Digestive system

Nausea.

Skin and subcutaneous tissue

Facial swelling, periorbital edema. 

Serious, sometimes fatal hypersensitivity reactions, sometimes after the first dose, have been observed with systemic use of quinolones.

 

Expiration date and shelf life: if the drug is stored in undamaged packaging, the shelf life is 3 years. Do not use the drug after the expiration date indicated on the package and the single-use vial.

Ofloxacin-Stulln ®UD does not contain preservatives. The opened single-use bottle is not for storage. Residues of the drug left in the disposable bottle after use must be disposed of.

 

Storage conditions: store in the original packaging at a temperature not exceeding 25 °C in a place inaccessible to children. Protect from light.

After opening, the contents of the single-use vial should be used immediately.

After opening the aluminum foil package, the medicine must be used within 4 weeks. If the single-use vials are stored in a cardboard box after opening the aluminum foil package, the medicine is stable for 3 months.

 

Packaging: 0.5 ml in a dropper tube containing one dose of Ofloxacin-Stulln ®UD eye drops. 5 dropper tubes connected in a block; 1 block (#5) or 2 blocks (#10) in an aluminum package or 6 blocks (#30, every 2 blocks in an aluminum package) of dropper tubes in a cardboard box.

 

For dispensing prescription only

 

Producer: Pharma Stuln GmbH, Germany.

The location of the manufacturer and the address of the place of its activity: Werksstrasse 3, 92551 Stulln, Germany /Werksstrasse 3, 92551 Stulln, Germany).



[1] The level of resistance exceeds 50% in at least one region.

[2] The natural sensitivity of most individual species lies in the middle range. However, in tear fluid after one instillation, a concentration of at least 4 mg/l is reached within 4 hours, which is enough to kill 100% of microorganisms.