Ofloxacin-SOLOfarm - instructions for use, dose, side effects, contraindications

The antimicrobial agent of a broad spectrum fluoroquinolone acts on the bacterial enzyme DNA gyrase, which provides supercoiling and thusthe stability of DNA bacteria (the destabilization of DNA chains leads to their death). Has a bactericidal effect. It is active against microorganisms producing beta-lactamase and fast-growing atypical mycobacteria. Sensitive: Staphylococcus aureus (including strains), Staphylococcus epidermidis, Streptococcus pneumoniae. Streptococcus pyogenes, Enterococcus faecalis, Corynebacterium spp.. Micrococcus spp., Bacillus spp., Enterobacteriaceae (Escherichia coli, Citrobacter, Enterobacter spp., Klebsiela spp., Proteus spp., Salmonella spp., Serratia spp., Shigella spp.), Pseudomonas aeruginosa and Pseudomonas species, Haemophilus influenza, Haemophilus ducreyi, Branhamella catarhalis, Neisseria gonorrhoeae, Neisseria menengitidis, Acinetobacter spp.. Campylobacter spp., Gardenerella vaginalis, Helicobacter pylori, Brucella spp. The drug is also active against Chlamydia trachomatis, Chlamydia pneumoniae. Mycoplasma pneumoniae and some other mycoplasmas.

Clostridium species, Bacteroides species and Peptococcus species have resistance. Resistance Pseudomonas aeruginosa fluctuates between 15-20 %, and resistance Staphylococcus aureus between 5-10 %.

Pharmacokinetics:

After 4 hours after topical administration, the average concentration of ofloxacin in the lacrimal fluid is greater than 2 μg / ml (the minimum concentration required to suppress growth in vitro by 90 % for the most common strains of infectious eye diseases - MIC₉₀).

Inhibition of ofloxacin in the ear in the case of an intact tympanic membrane is accompanied by a minimum absorption in the middle ear. However, the absorption of ofloxacin is enhanced by perforations of the tympanic membrane.After instillation of a 0.3% solution of ofloxacin to an adult with perforation of the tympanic membrane the maximum concentration in serum is 10 ng / ml.

The maximum concentration of ofloxacin in the serum after 10 days of regular topical application is 1000 times less than with the use of standard doses of ofloxacin inside.

Indications:

Ophthalmology

Bacterial infections of the anterior part of the eye caused by microorganisms sensitive to ofloxacin in adults and children aged 1 year and older: corneal ulcers, conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis, dacryocystitis, meibomite (barley), chlamydial infections of the eyes; prevention and treatment of bacterial infection after eye injuries and surgical interventions.

Ear infections

Ofloxacin - SOLOfarm is indicated for the treatment of bacterial infections caused by pathogenic microorganisms sensitive to ofloxacin in adults and children 12 years and older:

- external otitis, chronic suppurative otitis media, including perforation of the tympanic membrane;

- prevention of infectious complications in surgical interventions in adults;

- otitis externa and acute otitis media with an established tympanostomy tube in children from 1 to 11 years old.

Official recommendations on the use of antibacterial drugs should be taken into account.

Contraindications:

- Hypersensitivity to the components of the drug and other quinolone derivatives;

- non-bacterial diseases of the adnexa of the eye, anterior and posterior segment of the eye;

- non-bacterial otitis media;

- children's age (up to 1 year);

- pregnancy, the period of breastfeeding.

Carefully:

- Childhood.

Pregnancy and lactation:

Contraindicated use during pregnancy and during breastfeeding.

Dosing and Administration:

Locally.

Infectious Diseases of the Eyes

The drug is instilled 1 drop into the conjunctival sac of the diseased eye 2-4 times a day. It is not recommended to use the drug for more than 2 weeks.

Ear infections

Adults and children over 12 years of age

The frequency of the drug and the duration of treatment are set individually by the doctor.

As a rule, in the case of external otitis, 10 drops are dropped into the affected ear 2 times a day for 10 days.

In the treatment of chronic purulent otitis media with chronic perforation of the drummembrane recommended dose is 10 drops in the affected ear 2 times a day for 14 days.

Children from 1 to 11 years old

The frequency of the drug and the duration of treatment are set individually by the doctor.

For the treatment of external otitis and acute otitis media with a tympanostomy tube, the recommended dose is 5 drops per affected ear twice a day for 10 days.

Before instillation, you should warm the bottle in your hand for 1-2 minutes to avoid the development of dizziness (possibly with a cold solution). The instillation is performed in the patient's position lying on its side. After instillation, the patient should maintain this position for 5 minutes to facilitate passage of the solution through the external auditory meatus. If necessary, instillation in the other ear works in a similar way.

Side effects:

After the introduction into the conjunctival sac, there may be: transient burning or discomfort in the eye, conjunctival hyperemia, blurred vision, pain in the eye, itching sensation.

When used in the form of ear drops, itching and bitter taste in the mouth may occur.Very rarely possible: eczema, paresthesia, dizziness, earache, ringing in the ears, dry mouth.

Overdose:

After topical application of the excessive dose, the eyes should be washed with clean water at room temperature. There are no data on systemic manifestations of an overdose.

Interaction:

Magnesium, aluminum, iron and zinc reduce the absorption of ofloxacin.

Special instructions:

As with other antimicrobials, prolonged use of ofloxacin can lead to an increase in insensitive flora. Therefore, in the absence of clinical improvement during the standard treatment period or deterioration of the condition, it is necessary to cancel the drug and begin alternative therapy. Contact lenses should be removed before instillation of the drug and set again after 20 minutes after instillation. The drug should not be administered subconjunctivally or into the anterior chamber of the eye.

Effect on the ability to drive transp. cf. and fur:

Patients who, after applying the drug in the eyes, develop a short-term impairment of visual clarity, should not drive vehicles and mechanisms within 15 minutes after using the drug.

Form release / dosage:

Eye and ear drops 0,3%.

Packaging:

5 ml per bottle with a dropper of low-density polyethylene and a lid with a control of the first opening or a flask-dropper made of high-density polyethylene, complete with a cap screwed and stopper-dropper.

1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. After opening the bottle - 1 month.

Do not use after the expiration date!

Terms of leave from pharmacies:On prescription

Registration number:LP-004323

Date of registration:05.06.2017

Expiration Date:05.06.2022

The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia

Manufacturer: & nbsp

GROTEKS, LLC Russia

Information update date: & nbsp13.11.2017

Illustrated instructions

Instructions

Ofloxacin-SOLOfarm (Ofloxacin-SOLOpharm)