Ofloxacin

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Available since: 2019-09-19

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Clinical Pharmacology

Pharmacotherapeutic group:

Antimicrobial agent - fluoroquinolone

ATH:

S.01.A.E.01 Ofloxacin

J.01.M.A.01 Ofloxacin

Pharmacodynamics:

An antimicrobial agent of broad-spectrum from the group of fluoroquinolones, acts on the bacterial enzyme DNA-girazu, which provides supercoiling and, thus, the stability of DNA-bacteria (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., Creat a, syr. Cit., Citrobacter spp., Klebsiela spp., Proteus spp., Salmonella spp., Syr. Cit., Citrobacter spp., Klebsiela spp., Proteus spp., Salmonella spp., Creatrocter, smon., Klebsiela spp., Proteus spp., Salmonella spp., Creatro, Sre. Pseudomonas aeruginosa and Pseudomonas species, Haemophilus influenza, Haemophilus ducreyi, Branhamella catarhalis, Neisseria gonorrhoeae, Neisseria menengitidis, Acinetobacter spp. Campylobacter spp., Gardenerella vaginalis, hectarchters, Helicenthester stif. The drug is also active against Chlamydia trachomatis, Chlamydia pneumoniae. Mycoplasma pneumoniae and some other mycoplasmas.

Clostridium species, Bacteroides species and Peptococcus species are resistant. Resistance of Pseudomonas aeruginosa varies between 15–20%, and resistance of Staphylococcus aureus between 5–10%.

Pharmacokinetics:

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

Insolation of ofloxacin in the ear in the case of an intact eardrum is accompanied by minimal absorption in the middle ear. However, the absorption of ofloxacin is enhanced by perforations of the eardrum. After instillation of a 0.3% solution of ofloxacin in an adult with perforation of the eardrum, 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 when using standard doses of ofloxacin inside.

Indications

Ophthalmology

Bacterial infections of the anterior segment 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, meybomitis, blepharitis, blepharoconjunctivitis, dacryocystitis, meybomitis, blepharitis, blepharitis, blepharitis, blepharitis, dacryocystitis, meybomitis, blepharitis, blepharitis, blepharitis, dacryocystitis, meybomitis prevention and treatment of bacterial infections 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 aged 12 years and older:

- external otitis, chronic purulent otitis media, including those with perforation of the eardrum;

- prevention of infectious complications during surgical interventions in adults;

- external otitis and acute otitis media with an installed tympanostomy tube in children from 1 to 11 years.

You should consider the official recommendations for the use of antibacterial drugs.

Composition

1 ml of the preparation contains:

Active substance:

Ofloxacin 3.0 mg

Excipients:

Sodium dihydrogen phosphate dihydrate 13.22 mg
Sodium hydrophosphate dihydrate 8.01 mg
Benzalkonium chloride 0.05 mg
Water for injection up to 1.0 ml.

Ofloxacin is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
			eye drops
Ofloxacin	Zentiva KS	Czech	pills
Ofloxacin-Teva	Teva	Israel	pills
Ofloxacin	Kraspharma	Russia	vials
Dancil	Sentiss Pharma	India	eye drops
Uniflox	Unimed	Slovakia	eye drops
Floxal®	Valeant	Germany	eye drops
Floxal®	Valeant	Russia	ointment

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Dosage and Administration

Locally.

Infectious eye diseases

The drug is instilled in 1 drop in the conjunctival sac of the sore 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 old

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

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

In the treatment of chronic suppurative otitis media with chronic perforation of the eardrum, the recommended dose is 10 drops to the affected ear 2 times a day for 14 days.

Children from 1 to 11 years old

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

For the treatment of otitis externa and acute otitis media with an installed tympanostomy tube, the recommended dose is 5 drops to the affected ear 2 times a day for 10 days.

Before instillation, warm the vial in your hand for 1-2 minutes to avoid dizziness (possibly with a cold solution). Instillation is performed in the position of the patient lying on its side. After instillation, the patient must maintain this position for 5 minutes to facilitate the passage of the solution through the external auditory canal. If necessary, instillations in the other ear act in a similar way.

Adverse reactions

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

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

Contraindications

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

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

- nonbacterial otitis;

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

- pregnancy, breastfeeding period.

Carefully:

Childhood.

Drug interactions

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

Pregnancy and Lactation

Contraindicated use during pregnancy and during breastfeeding.

Special instructions

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

Impact on the ability to drive trans. Wed and fur .:

Patients who, after applying the drug, appear in the eyes of a short-term violation of the clarity of visual perception, should not drive vehicles and mechanisms for 15 minutes after applying the drug.

Overdosage

After topical application of an overdose of the drug, the eyes should be washed with clean water at room temperature. Data on systemic manifestations of overdose is not.