The instruction for medical use
of FLOKSIMED medicine
the Trade name
Mezhdunarodnoye the unlicensed
name Ciprofloxacin Dosage Form
of the Drop eye 0.3% 5 ml
of 1 ml of drug contains
active agent – ciprofloxacin a hydrochloride of 3.5 mg (it is equivalent to ciprofloxacin) – 3.0 mg,
excipients: a benzalkoniya chloride, dinatrium edetat, Mannitolum, ice acetic acid, sodium acetate anhydrous, 5M acid chlorohydrogen or 5M hydroxide sodium solution, water for injections.
Transparent liquid from colourless till light yellow color.
Drug group for treatment of diseases of eyes. Other antimicrobial drugs.
The code of automatic telephone exchange S01AX13
Drop Pharmacokinetics properties eye at topical administration well get into eye tissues. After single instillation its concentration in moisture of an anterior chamber of an eye in 10 min. makes 0.1% of mg/ml. The maximum concentration defined in 1 hour in moisture of an anterior chamber makes 0.19 mg/ml. After 2 hours the concentration begins to decrease, but antibacterial action in fabrics of a cornea remains till 6 o’clock, in moisture of an anterior chamber – till 4 o’clock. Т½ at topical administration of eye drops makes 4-5 hours of blood serum. Drug is removed through kidneys, mainly (up to 50%) in an invariable look, and up to 10% in the form of metabolites, about 15% are removed through intestines, at the nursing mothers – is partially removed with breast milk.
Floksimed is antimicrobial means from group of ftorkhinolon and possesses a broad spectrum of activity. Has bactericidal effect on the activator by means of inhibition bacterial DNK-girazy, DNA, necessary for synthesis, causing a growth disorder and divisions of bacteria and their fast death.
Floksimed is highly active concerning the majority of gram-negative bacteria: Aeromonas spp., Campylobacter jejuni, Citrobacter spp., Edwardsiella tarda, Escherichia coli, Enterobacter spp., Haemophilus spp., Hafnia alvei, Klebsiella spp., Legionella pneumophila, Moraxella catarrhalis, Morganella morganii, Neisseria spp., Pasteurella multocida, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeruginosa, Salmonella spp., Shigella spp., Serratia marcescens, Vibrio spp., Yersinia spp.
Gram-positive aerobic bacteria are sensitive to drug: Corynebacterium diphtheriae, Staphylococcus spp., Streptococcus agalactiae, Streptococcus pyogenes.
Floksimed is also active concerning such intracellular activators as Brucella spp., Listeria monocytogenes, Mycobacterium kansasii.
Are moderately sensitive to drug: Chlamydia trachomatis, Mycobacterium tuberculosis Streptococcus pneumoniae, Enterococcus faecalis, Mycoplasma hominis, Gardnerella spp., Mycobacterium aviumintracellulare.
Rezistentna to drug: Bacteroides fragilis, Clostridium difficile, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Nocardiaasteroides.
The microorganisms resistant to a beta laktamnym to antibiotics, aminoglycosides, can be sensitive to Floksimed.
Bacterial inflammatory diseases of an eye and its appendages
– acute and subacute conjunctivitis
– a keratitis
– a front uveitis
– blepharitis and other inflammatory diseases a century
– the dacryocystitis and a canaliculitis
– a helcoma
– prevention and treatment of infectious complications after wounds of an eye and its appendages and at eyeball surgeries
the Route of administration and doses
Locally. Drug is dug in on 1-2 drops in a conjunctival sac. Frequency of instillations and duration of treatment depends on weight of infectious defeat, a clinical course and results of a bacteriological research.
Just before use of drug it is recommended to warm a bottle, having taken it in a hand, in order to avoid unpleasant cold feelings and slightly to stir up bottle contents.
In bacterial conjunctivitis, simple and scaly and ulcer blefarita appoint from 4th to 8 times a day depending on disease severity. Course of treatment from 5 to 14 days.
In a keratitis drug is appointed on 1 drop not less than 6 times a day, with positive effect the maximum course of treatment depending on weight of defeat of a cornea and makes 2-4 weeks.
At defeat of a cornea a pyocyanic stick drug is appointed as often as possible – not less than 8-12 times a day on 1 drop. The course of treatment depends on the course of the disease and usually makes about 2-3 weeks.
In front uveites drug is dug in by 8-12 times a day on 1 drop.
In acute and subacute dacryocystites and canaliculites drug is appointed by 6-12 times a day, at chronic – 4-8 times a day on 1 drop.
In wounds of an eye and its appendages for prevention of consecutive infection and meybolita drug is appointed within 1-2 weeks on 1 drop of 4-8 times a day.
For prevention of inflammatory diseases after surgical interventions with perforation of an eyeball drug is appointed by 4-6 times a day on 1 drop to all term of the postoperative period, usually from 5 days to 1 month.
In a helcoma on 2 drops of solution in the affected eye each 15 minutes within the first 6 hours and then – on 2 drops each 30 minutes until the end of day. Next day – on 2 drops each hour. From the 3rd day – on 2 drops each 4 hours. Duration of treatment depends on disease severity, a clinical course and results of a bacteriological research.
Technology of burying.
To carefully wash up hands before drug use. To slightly incline the head back and to delay a lower eyelid down so that the pocket turned out, and to dig in it 1-2 drops of drug. To close eyes and to rotate eyeballs within 1-2 minutes. To repeat actions with other eye if it is offered the doctor. To wash up hands.
– the itching, burning
– allergic reactions, light morbidity and hyperaemia of a conjunctiva, nausea
– swelled a century
– a photophobia, dacryagogue
– feeling of a foreign body in eyes
– unpleasant smack in a mouth right after burying
– decrease in visual acuity
– emergence of white crystal precipitated calcium superphosphate in patients with a helcoma
– a keratitis, a keratopathy
– emergence of spots or infiltration of a cornea
– development of superinfection
of the Contraindication
– hypersensitivity to ciprofloxacin and other drugs of a hinolonovy row and also to any other component of drug
– children’s age up to 18 years
– pregnancy and the period of a lactation
Pharmaceutical interaction: solution of ciprofloxacin is incompatible with the solutions of medicines having values rn 3-4 which physically or are chemically unstable.
At a simultaneous combination to other germicides the sinergidny interaction is usually observed (beta laktamnye antibiotics, aminoglycosides, clindamycin, metronidazole).
Should be remembered that the chloride which is a part of drug a benzalkoniya can be absorbed by soft contact lenses. Therefore it is necessary to take lenses just before Floksimed’s burying and to dress in 15 minutes after instillation.
For prevention of microbic pollution of contents of a bottle dropper it is necessary to avoid contact of a tip of a bottle with any surfaces, including, eyes. Between uses the bottle needs to be held densely closed.
It is necessary to observe 5-10 minute interval between Floksimed’s introductions and other ophthalmologic solutions.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
to Patients at whom after use of eye drops the sight is temporarily broken is not recommended to drive or work with a difficult technique, machines or any other difficult equipment demanding sight clearness.
Symptoms: at accidental administration of drug inside specific symptoms are absent. Nausea, vomiting, diarrhea, headache, faint, feeling of alarm are possible.
Treatment: symptomatic, sufficient intake of liquid in an organism, creation of acid reaction of urine for prevention of a crystalluria.
The form of release and packing
On 5 ml of drug place in a plastic bottle with a stopper – a dropper with the screwing-up protective cap supplied with a safety ring.
On 1 bottle together with the instruction for medical use put in a cardboard box.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
After opening of a bottle to use drug within 1 month!
not to apply a period of storage after an expiration date.
According to the prescription
the Owner of a trademark and the certificate of registration of a yavlyaetsyakompaniye “UORLD MEDITSIN”, Great Britain (‘WORLD MEDICINE’, Great Britain).
E.I.P.I. is made. To., Egypt, Tens ov City Ramadan, the First B1 Industrial Zone, p.o. box 149 Tens
(“E.I.P.I.CO.” Egypt, Tenth of Ramadan City, First Industrial Area B1, P.O. box: 149 Tenth)
the Owner of the registration certificate are “UORLD MEDITSIN”, Great Britain
“The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of RK, Almaty, Turksibsky district, Suyunbaya Ave., 222
Ph. / fax: 8 (7272) 529090