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OFTOTSIPRO

Препарат ОФТОЦИПРО. ОАО "Татхимфармпрепараты" Россия


Producer: JSC Tatkhimfarmpreparaty Russia

Code of automatic telephone exchange: S03AA07

Release form: Soft dosage forms. Oculentum.

Indications to use: Infectious diseases of eyes. Blepharitis. Blefarokonjyunktivit. Keratitis. Keratoconjunctivitis. Purulent helcoma. Chronic dacryocystitis. Meibomitis. Foreign body in an eye.


General characteristics. Structure:

Active ingredient. Structure: in 100 g of ointment of active agent: hydrochloride ciprofloxacin in terms of ciprofloxacin 0,3g; excipients: нипагин (methylparahydroxybenzoate), vaseline medical, lanolin anhydrous.

Description. Ointment of white color or color, white with slightly yellowish, greenish or grayish shade.




Pharmacological properties:

Pharmacodynamics. The antimicrobic broad-spectrum agent derivative of a ftorkhinolon, suppresses bacterial DNK-girazu (the topoisomerases II and IV responsible for untwisting of DNA for ensuring further process of a transcription), breaks DNA synthesis, growth and division of bacteria. Affects bakteritsidno gram-negative organisms during a dormant period and divisions, on gram-positive microorganisms - only during division.

Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobakteriya (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.), other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.), some intracellular activators - Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Corynebacterium diphtheriae; gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). The majority of the stafilokokk steady against Methicillinum, rezistentna and to ciprofloxacin. Sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) - moderated (for their suppression high concentration are required).

To rezistentna drug: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. It is not effective concerning Treponema pallidum. Resistance develops extremely slowly as, on the one hand, after effect of ciprofloxacin there is practically no persistent microorganism left, and with another - bacterial cells have no enzymes inactivating it.

Pharmacokinetics. At topical administration system absorption low.


Indications to use:

The infectious and inflammatory diseases of eyes caused by sensitive microorganisms (acute and subacute conjunctivitis, a blepharitis, blefarokonjyunktivit, a keratitis, a keratoconjunctivitis, a bacterial helcoma, a chronic dacryocystitis, a meibomitis, infectious damages of eyes after injuries or hit of foreign bodys), before - and postoperative prevention of infectious complications in an ophthalmosurgery.


Route of administration and doses:

At adults and children 2 years are more senior.

The strip of ointment 1 - 1,5 cm long is put for a lower eyelid of the affected eye by 3 times a day within 2 days. Then within 5 days 2 times a day use drug. In case of development of heavy infectious process ointment is put each 3 - 4 hours, in process of reduction of the phenomena of an inflammation, reduce drug use frequency. The course of treatment should not exceed 14 days. For administration of ointment it is necessary to delay carefully a lower eyelid down and, having slightly pressed a tube, to enter an ointment strip into a conjunctival sac. Then slowly to release an eyelid and to press it by means of a wadding stick or a cotton plug within 1 - 2 minutes. After that it is necessary to close eyes within 1 - 2 minutes.


Features of use:

Right after use of an oculentum the illegibility of visual perception is possible that it can entail difficulty at control of vehicles and during the work with mechanisms; it is recommended to get to work (driving) in 15 minutes after drug use. During treatment drug does not recommend carrying contact lenses. When using other ophthalmologic medicines the interval between their introduction has to make not less than 5 minutes.


Side effects:

Allergic reactions, itch, burning, easy morbidity and hyperemia of a conjunctiva, nausea, it is rare - the century, a photophobia, dacryagogue, feeling of a foreign body in eyes, unpleasant smack in a mouth right after a mortgaging, decrease in visual acuity, emergence of white crystal precipitated calcium superphosphate in patients with a helcoma, a keratitis, a keratopathy, infiltration of a cornea, development of superinfection swelled.


Interaction with other medicines:

Oftotsipro's interaction an oculentum with other drugs at simultaneous use is not revealed. There are data that system use of some hinolon leads to increase in concentration of theophylline in a blood plasma, influences metabolism of caffeine and strengthens effect of peroral anticoagulants (including warfarin and its derivatives). It was reported about temporary increase in level of creatinine in blood serum at patients to whom appointed cyclosporine together with system use of ciprofloxacin.


Contraindications:

Hypersensitivity, pregnancy, the lactation period, children's age (to 2 - x years), virus and fungal infections of eyes.


Overdose:

Data on overdose of drug are absent. At accidental administration of drug inside specific symptoms are absent.

Symptoms. Developing of nausea, vomiting, diarrhea, headache, faint, feeling of alarm is possible.

Treatment: standard measures of acute management, sufficient intake of liquid in an organism, creation of acid reaction of urine for prevention of a crystalluria.


Storage conditions:

List B. At a temperature from 2 to 25 °C. To store in the place, unavailable to children.

Period of validity 2 years. Not to use after the expiry date specified on packaging. Storage duration after packaging opening no more than 5 weeks.


Issue conditions:

According to the recipe


Packaging:

Oculentum of 0,3%. On 3 g, 5 g in aluminum tubas. 1 tuba together with the application instruction is placed in a pack from a cardboard.



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