Uniflox - instructions for use, dose, side effects, contraindications

Excipients: sodium phosphate dodecahydrate 80.6 mg, sodium dihydrogen phosphate dihydrate 66.10 mg, benzalkonium chloride 0.25 mg, purified water up to 5 ml.

Description:

Transparent with a yellowish shade solution.

Pharmacotherapeutic group:antimicrobial agent-fluoroquinolone

ATX: & nbsp

S.01.A.E.01 Ofloxacin

J.01.M.A.01 Ofloxacin

Pharmacodynamics:

A broad-spectrum antimicrobial agent from the group of fluoroquinolones,acts on the bacterial DNA-gyrase enzyme, providing super-convolution and, thus, the 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 influenzae, Haemophilus ducreyi, Branhamella

catarhalis, Neisseria gonorrhoeae ,. Neisseria meningitidis, Acinetobacter spp.,

Campylobacter spp., Gardenerella vaginalis, Helicobacter pylori, Brucella spp. A drug also is showing activity at respect Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae and some other Mycoplasma.

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

Pharmacokinetics:

4 hours after topical application the average concentration of ofloxacin in

lacrimal fluid exceeds 2 μg / ml (the minimum concentration required for growth inhibition in vitro by 90% for most common strains of infectious eye diseases - MIFROM₉₀).

Inhibition of ofloxacin in the ear in the case of an intact tympanic membrane

accompanied by a minimum absorption in the middle ear. However, the absorption of ofloxacin is enhanced by perforations, the tympanic membrane. After instillation of a 0.3% solution of ofloxacin in adults 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 sensitive ofloxacin by microorganisms in adults and children aged 1 year and older: corneal ulcers, conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis, dacryocystitis, meibomite (barley), chlamydial infections eye.

Prevention of infections in ophthalmic surgery.

Ear infections

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

- prevention of infectious complications during surgical interventions in adults;

- external otitis and acute otitis media with established tympanostomic

tube for children from 1 to 11 years.

Contraindications:

Hypersensitivity to components (including other

derivative of quinolones), non-bacterial diseases of the adnexa of the eye, anterior and posterior segment of the eye, non-bacterial otitis, children's age

(up to 1 year).

Pregnancy and lactation:

Sufficient experience in the use of the drug during pregnancy and during lactation there. The use of Uniflox during pregnancy and during breastfeeding is possible only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus or infant. It has not been established whether local use of ofloxacin can cause it to occur in breast milk, so the question of stopping breastfeeding should be addressed.

Dosing and Administration:

Locally.

Infectious Diseases of the Eyes

Adults:

The doctor determines the exact dose and duration of treatment. As a rule, in the first 2 days, 1-2 drops are prescribed to the affected eye (or both eyes) every hour,in the subsequent - 1-2 drops regularly 6-8 times a day for 7 days, but not less than 3 days after the termination of the purulent department. The course of treatment is not more than 2 weeks. Petit above 1 year old:

The doctor should specifically prescribe the use of the drug, dosage. All treatment should be carried out under his outpatient supervision. As a rule, appoint to

1 Drop into the affected eye (or both eyes) 5 times a day for 7 days.

Ear infections Adults and children over 12 years of age:

The doctor determines the exact dose and duration of treatment. 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 tympanic membrane, the recommended dose is 10 drops per affected ear twice a day for 14 days.

Children from 1 to 11 years:

The doctor should specifically prescribe the use of the drug and determine the dosage. All treatment should be carried out under his outpatient supervision.

For the treatment of external otitis and acute otitis media with an established 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. When need instillation in another the ear act 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, sensation of itching.

When applied in the form of ear drops, itching and bitter

taste in the mouth. Very rarely possible: eczema, paresthesia, dizziness, pain

in the ear, a ringing in the ears, dry mouth.

Overdose:

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

Interaction:

During the use of the drug Uniflox should be taken into account that magnesium, aluminum, iron and zinc reduce the absorption of ofloxacin.

Special instructions:

As with other antimicrobials, prolonged

The use of ofloxacin can lead to an increase insensitive to it

flora. Therefore, in the absence of clinical improvement during the standard term of treatment or deterioration, it is necessary to cancel the drug and begin

alternative therapy.

It is necessary to remove contact lenses before instillation of the drug and install again 20 minutes after instillation. The drug should not be administered subconjunctivally or into the anterior chamber of the eye.

The bottle must be closed after each use.

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

After application of the Uniflox preparation (after insertion into the conjunctival sac), blurred vision is possible, therefore, it is allowed to drive vehicles and perform works requiring high speed of psychomotor reactions not earlier than 15 minutes.

Form release / dosage:

Eye and ear drops 3 mg / ml.

Packaging:Plastic bottle-dropper for 5 ml with screwed plastic stopper, which has a control ring for the first opening in a cardboard box, along with the instructions for use.

Storage conditions:

List B.

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

2 of the year.

The bottle after opening is suitable for 1 month. After instillation, the vial must be closed immediately and tightly. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N016044 / 01

Date of registration:23.12.2009

The owner of the registration certificate:Unimed Pharma s.r.o.Unimed Pharma s.r.o. The Slovak Republic

Representation: & nbspUNIMED PHARMA SROUNIMED PHARMA SRORussia

Information update date: & nbsp14.10.2011

Illustrated instructions

Instructions

Uniflox (Uniflox)