SILAFOX [Ciprofloxacin] 3 mg Eye drops
instructions for the medical use of
the medicinal product
SILAFOX
Tradename: Silafox, Силафокс
International non-proprietary name
or generic name: ciprofloxacin, ципрофлоксацин
Dosage form: eye ointment.
1 g of the
medicine contains:
active substance: ciprofloxacin hydrochloride monohydrate equiv.
ciprofloxacin 3 mg;
excipients: anhydrous lanolin, chlorobutanol, soft
yellow paraffin.
Pharmacotherapeutic
group: Antimicrobial
agent - fluoroquinolone.
Pharmacological properties
A broad-spectrum antimicrobial agent, a
fluoroquinolone derivative.
It inhibits bacterial DNA gyrase (topoisomerases II
and IV, responsible for the supercoiling of chromosomal DNA around nuclear RNA,
which is necessary for the reading of genetic information), disrupts DNA
synthesis, growth, and division of bacteria, and causes pronounced
morphological changes (including cell wall and membrane changes) and rapid cell
death.
It has a bactericidal effect on gram-negative
organisms during dormancy and cell division (as it affects not only DNA gyrase
but also causes cell wall lysis), and on gram-positive microorganisms only
during cell division.
Its low toxicity to host cells is explained by the
absence of DNA gyrase. Ciprofloxacin does not lead to the development of
resistance to other antibiotics that are not gyrase inhibitors, making it
highly effective against bacteria that are resistant to, for example,
aminoglycosides, penicillins, cephalosporins, tetracyclines, and many other
antibiotics.
Gram-negative aerobic bacteria are sensitive to ciprofloxacin:
enterobacteria (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 pathogens (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).
Most methicillin-resistant staphylococci are also
resistant to ciprofloxacin. The sensitivity of Streptococcus pneumoniae,
Enterococcus faecalis, and Mycobacterium avium (located intracellularly) is
moderate (high concentrations are required for their suppression). The
following organisms are resistant to the drug: Bacteroides fragilis,
Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum,
Clostridium difficile, and Nocardia asteroides. It is ineffective against
Treponema pallidum.
Resistance develops extremely slowly because, on the
one hand, virtually no persistent microorganisms remain after ciprofloxacin
exposure, and on the other hand, bacterial cells lack the enzymes that
inactivate it.
With topical application, systemic absorption is low.
Indications for use
In ophthalmology: treatment of corneal ulcers and
infections of the anterior segment of the eyeball and its appendages caused by
bacteria sensitive to ciprofloxacin.
Contraindications
• Hypersensitivity,
• pregnancy,
• lactation,
• children under 2 years of age,
• viral and fungal eye infections.
Use with caution in patients with cerebral
atherosclerosis, cerebrovascular accident, or seizure disorder.
Method of administration and dosage
Topical.
For adults and children over 2 years of age
Apply a 1-1.5 cm strip of ointment behind the lower eyelid of the affected
eye 3 times daily for 2 days. Then, apply the ointment twice daily for 5 days.
In case of severe infection, apply the ointment every 3-4 hours; as
inflammation subsides, reduce the frequency of application.
The course of treatment should not exceed 14 days.
Instructions for use
Wash your hands thoroughly before applying the ointment. To apply the
ointment, gently pull the lower eyelid down and, gently pressing the tube,
insert a strip of ointment into the conjunctival sac. Then slowly release the
eyelid and apply pressure with a cotton swab or cotton ball for 1-2 minutes.
Close your eyes for 1-2 minutes.
Special instructions and precautions
Consult a physician before using this medication.
Discontinue use if any signs of hypersensitivity
occur. Patients should be advised that if conjunctival hyperemia persists or
worsens after using the ointment, discontinue use and consult a physician.
When using other ophthalmic medications, the
interval between administrations should be at least 15 minutes.
Contact lenses are not recommended during
treatment with this medication.
Influence on the ability to drive vehicles and
mechanisms
After using eye drops, visual acuity may be
reduced. Therefore, driving or engaging in activities requiring increased
alertness and rapid psychomotor reactions is not recommended immediately after
instillation.
Side effect
Eye
disorders: Common: corneal precipitates, ocular
discomfort, conjunctival injection; Uncommon: keratopathy, punctate keratitis,
corneal infiltrates, photophobia, decreased visual acuity, eyelid edema,
blurred vision, eye pain, dry eye sensation, conjunctival and eyelid edema,
lacrimation, eye discharge, eyelid margin crusting, eyelid skin peeling, eyelid
hyperemia; Rare: eye toxicity, keratitis, conjunctivitis, corneal epithelial
defect, diplopia, decreased corneal sensitivity, asthenopia, styes.
Other:
hypersensitivity reactions, unpleasant taste in the
mouth immediately after instillation, dysgeusia, nausea.
If
any of the side effects listed in the instructions get worse, or you notice any
other side effects not listed in the instructions, tell your doctor.
Interaction with other medicinal products
Given the low systemic plasma concentration of
ciprofloxacin after application of the ointment to the conjunctiva,
interactions between drugs co-administered with ciprofloxacin are unlikely.
When co-administered with other topical ophthalmic
medications, the interval between their administrations should be at least 5 minutes,
with ophthalmic ointments being the last to be applied.
There
are no data on drug overdose.
Storage conditions
Store at temperatures
below 30°C.
Keep out of reach of
children!
Shelf life
2 years. Do not use
after the expiration date printed on the package.
Vacation conditions
By prescription.
Release form
5 g of the drug in a tube together with instructions for use are packed in a cardboard box.