Universal reference book for medicines
Name of the drug: OFLOXACIN (OFLOXACIN)

Active substance: ofloxacin

Type: Antibacterial drug of the group of fluoroquinolones for topical application in ophthalmology

Manufacturer: SYNTHESIS (Russia)
Composition, form of production and packaging
Eye ointment 0.3%
white, white with a yellowish tinge or yellow.

1 g

ofloxacin 3 mg

Excipients: methylparahydroxybenzoate - 0.8 mg, propyl parahydroxybenzoate - 0.2 mg, vaseline - up to 1 g.

5 g - aluminum tubes (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Antibacterial preparation of a wide spectrum of action from the group of fluoroquinolones for topical application in ophthalmology.
It acts on the bacterial DNA DNA enzyme, which ensures super-shrinkage and, thus, the stability of bacterial DNA (the destabilization of DNA chains leads to their death). Has a bactericidal effect.
Highly active against Gram-positive microorganisms: Staphylococcus spp.
(including Staphylococcus aureus, Staphylococcus epidermidis), Streptococcus spp.(including Streptococcus pneumoniae); Gram-negative microorganisms: Pseudomonas aeruginosa, Escherichia coli, Salmonella spp., Proteus spp. (including Proteus mirabilis), Morganella morganii, Shigella spp., Klebsiella spp. (including Klebsiella cloacae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Acinetobacter spp .; intracellular microorganisms: Chlamydia spp.(including Chlamydia trachomatis), Legionella spp., Mycoplasma spp .; anaerobes: Propionibacterium acnes.
PHARMACOKINETICS

In experimental studies , it has been found that ofloksatsin is found in the cornea (cornea of ​​the eye), conjunctiva, ocular muscles, sclera, iris, ciliary body and in the anterior chamber of the eye after topical application.

Multiple application also leads to the achievement of therapeutic concentrations of ofloxacin in the vitreous.
In the tissues of the eye, a higher concentration of the drug is created than in the aqueous humor of the eye.
After a single application of an ointment strip approximately 1 cm long (approximately equivalent to 0.12 mg ofloxacin), Cmax ofloxacin in the conjunctiva and sclera is reached after 5 minutes, after which the concentration of ofloxacin slowly decreases.
C max ofloxacin in the aqueous humor of the eye and the cornea is achieved after 1 hour.
INDICATIONS

- bacterial diseases of the eyelids, conjunctiva and cornea (bacterial keratitis and corneal ulcers, blepharitis, conjunctivitis, blepharoconjunctivitis);

- meibomite (barley), dacryocystitis;

- chlamydial infections of the eyes;

- prevention of infectious complications in the postoperative period after surgical interventions for the removal of a foreign body and eye trauma.

DOSING MODE

Locally.
For the lower eyelid of the affected eye, 2-3 times / day, 1 cm of ointment strip (0.12 mg ofloxacin) is placed. With chlamydial infections ointment is poured 5-6 times / day.
For the introduction of the ointment, gently pull the lower eyelid down and, lightly pressing on the tube, insert into the conjunctival bag a strip of ointment 1 cm long. Then close the eyelid and move the eyeball to distribute the ointment evenly.

The duration of treatment is no more than 2 weeks (with chlamydial infections, the course is extended to 4-5 weeks).

SIDE EFFECT

Local reactions: a burning sensation and discomfort in the eyes, hyperemia, pruritus and dryness of the conjunctiva, photophobia, lacrimation, allergic reactions.
In most cases, these symptoms are short.
CONTRAINDICATIONS

- chronic non-bacterial conjunctivitis;

- Pregnancy;

- lactation period;

- children and adolescence up to 15 years;

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

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy and during breastfeeding.

APPLICATION FOR CHILDREN

The drug is contraindicated for use in children and adolescents under 15 years.

SPECIAL INSTRUCTIONS

Do not wear soft contact lenses during treatment with the drug.

It is recommended to wear sunglasses (due to the possible development of photophobia), and avoid prolonged exposure to bright light.

Do not inject either orally into the anterior chamber of the eye.

Impact on the ability to drive vehicles and manage mechanisms

Immediately after using the drug, blurred vision may occur, which can lead to difficulties in driving and handling machinery.
It is recommended to start work (driving) 15 minutes after applying the drug.
OVERDOSE

Data on drug overdose are not provided.

DRUG INTERACTION

When prescribing of Ofloxacin together with other eye drops / ointments, the drugs should be applied at intervals of at least 15 minutes, with Ofloxacin should be used last.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at a temperature of 15 ° to 25 ° C.
Shelf life - 3 years.
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