Instruction for medical use
of FLOKSIMED medicine
name Ciprofloxacin Dosage Form
oculentum of 0.3% 5 g.
of 1 g of drug contains
active agent – ciprofloxacin (in the form of hydrochloride ciprofloxacin) 3.0 mg
excipients: chlorbutanol, lanolin anhydrous, paraffin yellow soft.
Homogeneous ointment of yellow-white color
Drugs for treatment of diseases of eyes. Antimicrobial drugs. Ciprofloxacin.
The ATX S01AX13 code
Pharmacokinetics At properties of instillation of drug in both eyes every 2-4 hour the maximum concentration of ciprofloxacin in blood does not exceed 5 mg/ml. Now it is not established whether ciprofloxacin gets into breast milk at instillation in eyes, however it is known that at introduction of per os of a single dose of 500 mg it is found in breast milk.
Floksimed has antibacterial (bactericidal) effect: blocks a DNA-giraza and interferes with DNA replication, breaks growth and division of bacteria, causes the significant morphological changes (including a cell wall and membranes) and fast death of a cell: affects microorganisms in the period of growth and rest. Floksimed possesses a wide range of antimicrobial action, is most active concerning gram-negative bacteria, influence on anaerobe bacterias is less significant. Has effect on Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Campilobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloaceae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Salmonella typhi, Serratia marcescens, Shigella flexneri, Shigella sonnei, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophycus, Acinetobacter spp., Aeromonas caviae, Aeromonas hydrophilia, Brucella melitensis, Campylobacter coli, Edwardsiella tarda, Enterodacter aerogenes, Haemophilus ducreyi, Klebsiella oxytoca, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Neisseria meningitides, Pasteurella multicoda, Salmonella enteridis, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica, Chlamydia trachomatis, Vibrio vulnificus, Yersinia enterocolitica, Chlamydia trachomatic (moderate sensitivity), Mycobacterium tuberculosis (moderate sensitivity).
The majority of strains of Pseudomonas cepacia and some strains of Rseudomonas matolphilia and also the majority of anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile are insensitive to a floksimed.
– topical treatment of various infectious diseases of an eye and its appendages caused by bacteria, sensitive to drug: acute and subacute conjunctivitis, blefakonjyunktivit, blefarit, bacterial helcomas with without hypopyon, a bacterial keratitis and keratoconjunctivites, chronic dacryocystites and meybomiit
– preoperative prevention in an ophthalmosurgery
– treatment of postoperative infectious complications
– treatment and prevention of infectious complications after injuries (with or without foreign bodys) an eyeball and its adnexal device.
A route of administration and doses
Before appointment it is desirable for patient of drug to define sensitivity to it of the microflora which caused a disease in this patient.
Floksimed oculentum of 0.3% put in a conjunctival sac (a cavity between a back surface a century and the front surface of an eyeball).
At severe forms of infections oculentum is used 3-4 times a day, in process of weakening of symptoms of a disease the number of receptions can be reduced.
At easy forms of an infection drug is usually appointed by 2 times a day.
At night in addition to eye drops it is possible to apply oculentum to ensuring longer contact with drug.
– allergic reactions, an itching, burning, light morbidity and hyperaemia of a conjunctiva, nausea, discomfort of an eye, formation of crusts on an edge of the lid
It is rare:
– the 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 swelled.
– hypersensitivity to ciprofloxacin or to other drugs of group of ftorkhinolon
– deficit glyukozo-6-fosfatdegidrogenazy
– children’s and teenage age up to 18 years
– pregnancy and the period of a lactation.
the Activity of a floksimed increases at a combination its beta laktamnymi antibiotics, aminoglycosides, Vancomycinum, clindamycin, metronidazole.
instructions Floksimed can be applied only locally. The patient should be informed that if after use of eye drops or oculentum the long time proceeds or conjunctival hyperaemia accrues, then it is necessary to stop use of drug and to see a doctor.
During drug treatment the carrying soft contact lenses is not recommended. When using rigid contact lenses it is necessary to remove them before burying and again to dress in 15-20 min. after drug instillation.
Pregnancy and a lactation
Adequate and well controlled clinical trials of use of drug for pregnant women were not conducted. Drug during pregnancy is not recommended.
In order to avoid potential adverse influences on the newborn the breastfeeding for drug treatment should be stopped.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
To patients at whom is after use of eye drops or Floksimed oculentum sight clearness is temporarily lost, it is not recommended to drive or work with a difficult technique, machines or any other difficult equipment demanding sight clearness.
Data on overdose of the drug Floksimed is absent.
The form of release and packing
On 5 g of drug place in tubas aluminum with the screw-on cover.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a box of cardboard.
To Store storage conditions at a temperature not above 30 °C.
To store out of children’s reach!
The use period after opening of a tuba within no more than one month.
not to apply a period of storage after an expiration date.
According to the prescription
the Owner of a trademark and the registration certificate is the UORLD of OFTALMIKS MEDICINE company, Great Britain
Producer E.I.P.I. To., Egypt, Tens ov City Ramadan, the First B1 industrial zone, and I 149 Tens
(E.I.P.I.Co. Egypt, Tenth of Ramadan City, First Industrial Area B1, P.O. box: 149 Tenth)
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of RIN Pharm LLP, Almaty, Turksibsky district, Suyunbaya Ave., 222
Ph. / fax: 8 972720 529090