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medicalmeds.eu Medicines Antibacterial drug of group of ftorkhinolon for topical administration in ophthalmology. Ofloxacin

Ofloxacin

Препарат Офлоксацин. ОАО "Синтез" Россия


Producer: JSC Sintez Russia

Code of automatic telephone exchange: S01AX11

Release form: Soft dosage forms. Oculentum.

Indications to use: Keratitis. Helcoma. Blepharitis. Conjunctivitis. Blefarokonjyunktivit. Meibomitis. Dacryocystitis. Infectious diseases of eyes. Postoperative period.


General characteristics. Structure:

Active ingredient:  1 g ofloxacin  of 3 mg;

Excipients: methylparahydroxybenzoate - 0.8 mg, пропилпарагидроксибензоат - 0.2 mg, vaseline - to 1 g.

Description: an oculentum of 0.3% white, white with a yellowish shade or yellow color.




Pharmacological properties:

Antibacterial drug of a broad spectrum of activity from group of ftorkhinolon for topical administration in ophthalmology. Affects bacterial DNK-girazu enzyme, the providing superspiralling and, thus, stability of DNA of bacteria (destabilization of chains of DNA leads to their death). Has bactericidal effect.

It is highly active concerning 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.; anaerobe bacterias: Propionibacterium acnes.

 

Pharmacokinetics. In pilot studies it is established that after topical administration ofloxacin is found in a cornea (an eye cornea), a conjunctiva, eye muscles, a sclera, an iris of the eye, a ciliary body and in an anterior chamber of an eye.

Repeated use also leads to achievement of therapeutic concentration of an ofloksatsin in a vitreous. In tissues of an eye higher concentration of medicine, than in watery moisture of an eye is created.

After single use of a strip of ointment about 1 cm long (0.12 mg of an ofloksatsin are approximately equivalent) Cmax of an ofloksatsin in a conjunctiva and a sclera are reached in 5 min. then concentration of an ofloksatsin slowly decreases. Cmax of an ofloksatsin in watery moisture of an eye and a cornea is reached in 1 h.


Indications to use:

— bacterial diseases century, conjunctivas and corneas (bacterial keratitis and helcomas, blepharites, conjunctivitis, blefarokonjyunktivita);

meibomitis (barley), dacryocystitis;

— chlamydial infections of eyes;

— prevention of infectious complications in the postoperative period after surgical interventions concerning removal of a foreign body and an injury of an eye.


Route of administration and doses:

Locally. For a lower eyelid of the affected eye 2-3 put 1 cm of a strip of ointment (0.12 mg of an ofloksatsin). At chlamydial infections ointment is put by 5-6 times /

For administration of ointment it is necessary to delay carefully a lower eyelid down and, having slightly pressed a tube, to enter a strip of ointment 1 cm long into a conjunctival sac. Then to close an eyelid and to move an eyeglobe for ointment hypodispersion.

Duration of a course of treatment makes no more than 2 weeks (at chlamydial infections the course is extended up to 4-5 weeks).


Features of use:

It is not necessary to carry soft contact lenses during treatment by drug.

It is recommended to wear sunglasses (because of possible development of a photophobia), and also to avoid long influence of bright light.

It is not necessary to enter Ofloxacin subkonjyunktivalno or into an anterior chamber of an eye.

Influence on ability to driving of motor transport and to control of mechanisms

Right after use of drug the illegibility of visual perception is possible that it can entail difficulties when driving and during the work with mechanisms. Rekomennutsya to get to work (driving) in 15 min. after drug use.


Side effects:

Local reactions: a burning sensation and discomfort in eyes, a hyperemia, an itch and dryness of a conjunctiva, a photophobia, dacryagogue, allergic reactions. In most cases these symptoms short.


Interaction with other medicines:

At Ofloksatsin's appointment together with other eye drops / ointments drugs should be used with an interval, at least, 15 min., and Ofloxacin should be applied in the last turn.


Contraindications:

— chronic not bacterial conjunctivitis;

— pregnancy;

— lactation period;

— children's and teenage age up to 15 years;

— hypersensitivity to components of drug and other derivatives of a hinolon.

 

Use of the drug OFLOXACIN at pregnancy and feeding by a breast
Use of drug at pregnancy and during breastfeeding is contraindicated.

 

Use for children
Drug is contraindicated to use at children's and teenage age up to 15 years.


Overdose:

Data on overdose of drug are not provided.


Storage conditions:

List B. Drug should be stored in the place, unavailable to children, at a temperature from 15 to 25 °C. A period of validity - 3 years.


Issue conditions:

According to the recipe


Packaging:

5 g - aluminum (1) - packs cardboard.



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