Ciprofloxacin-Solofarm, eye and ear drops 0.3% 5 ml

A broad spectrum antibacterial drug of fluoroquinolone group for local use in ophthalmology and ENT practice. Inhibits bacterial DNA-Gyrase (topoisomerases II and IV, responsible for the process of superspiralization of chromosomal DNA around the nuclear RNA, which is necessary for reading genetic information), disrupts DNA synthesis, growth and division of bacteria. Causes pronounced morphological changes (including cell wall and membranes) and rapid death of the bacterial cell.

It acts bactericidally on Gram-negative organisms during resting and dividing (as it affects not only DNA-giase, but also causes lysis of cell wall), on Gram-positive microorganisms – only during dividing.

The low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them. Against the background of ciprofloxacin use there is no parallel development of resistance to other antibiotics which do not belong to gyrase inhibitors group and this fact makes it highly effective against bacteria which are resistant to, for example, aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics.

Active against Gram-negative aerobic bacteria: 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., Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp, Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.; Gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae); some intracellular pathogens: Legionella pneumophila, Brucella spp, Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Corynebacterium diphtheriae.

The Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) are moderately sensitive to ciprofloxacin (high concentrations are required for their suppression).

Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to ciprofloxacin. Most methicillin-resistant staphylococci are also resistant to ciprofloxacin.

It is not effective against Treponema pallidum.

Resistance develops very slowly: on the one hand there are almost no persistent microorganisms after the action of ciprofloxacin and on the other hand the bacterial cells have no enzymes that inactivate it.

Indications

In ophthalmology

– acute and subacute conjunctivitis;

– blepharitis;

p> – blepharoconjunctivitis;

Keratitis;

Keratoconjunctivitis;

Bacterial corneal ulcer;

– chronic dacryocystitis;

– meibomitis (barley);

– infectious eye lesions after trauma or foreign bodies;

– preoperative and postoperative prevention of infectious complications in ophthalmic surgery.

In otorhinolaryngology

– external otitis media;

– treatment of postoperative infectious complications.

Active ingredient

Composition

1 ml of ciprofloxacin (in the form of monohydrate hydrochloride) 3 mg

Associates:

Sodium acetate trihydrate,

Mannitol,

Dinatrium edetate dihydrate,

benzalkonium chloride,

glacial acetic acid,

purified water.

How to take, the dosage

In ophthalmology

In mild to moderate infections, ciprofloxacin is instilled into the conjunctival sac of the affected eye every 4 hours; in severe infections, 2 drops/h. After the condition improves, the dose and frequency of instillation are reduced.

In case of bacterial corneal ulcer the drug is instilled in 1 drop in every 15 minutes for 6 hours, then 1 drop in every 30 minutes during waking hours. On day 2, 1 drop per hour during the waking hours. From day 3 to day 14, 1 drop every 4 hours during the waking hours.

In otorhinolaryngology

The external auditory canal should be cleaned gently before using the drug. The solution should be at room temperature (or body temperature) when used to avoid vestibular stimulation. The drug is injected into the external auditory canal in 3-4 drops 2-4 times/day or more frequently as needed. After instillation, the patient should lie on the opposite side of the ear for 5-10 minutes.

In isolated cases, after local cleansing, a cotton swab moistened with ciprofloxacin solution may be placed in the ear, in the external auditory canal. The swab may remain in the external auditory canal until the next treatment.

The duration of treatment should not exceed 5-10 days. In some cases, treatment may be prolonged if the local flora is sensitive.

Interaction

The interaction of Ciprofloxacin drops with other drugs during concomitant use has not been identified.

There is information that systemic use of some quinolones leads to increased plasma concentrations of theophylline, affects caffeine metabolism and enhances the effect of oral anticoagulants (including warfarin and its derivatives).

Transient increases in serum creatinine levels have been reported in patients treated with cyclosporine combined with systemic administration of ciprofloxacin.

Ciprofloxacin is incompatible with alkaline solutions.

Special Instructions

The solution in the form of eye drops is not intended for intraocular injections.

If other ophthalmic drugs are used, the interval between injections should be at least 5 minutes.

The use of the drug should be discontinued if any signs of hypersensitivity occur.

The patient should be informed that if conjunctival hyperemia persists or increases for a prolonged period of time after using the drops, the product should be discontinued and the patient should see a physician.

Wearing of soft contact lenses is not recommended during treatment with the drug. If rigid contact lenses are used, they should be removed before insertion and inserted again 15-20 min after instillation of the drug.

Contraindications

– viral keratitis;

– childhood under 1 year (for eye drops);

– hypersensitivity to the components of the drug.

Side effects

Sensory organs: Itching, burning, mild soreness and hyperemia of the conjunctiva or in the area of the external auditory canal and tympanic membrane; rarely – eyelid edema, photophobia, lacrimation, foreign body feeling in the eyes, unpleasant taste in the mouth immediately after injection, reduced visual acuity, appearance of white crystalline precipitate in patients with corneal ulceration, keratitis, keratopathy, appearance of corneal stains or corneal infiltration.

Others: nausea, allergic reactions, development of superinfection.

Overdose

There are no data on overdose of Ciprofloxacin when used in the form of eye drops.

In case of accidental oral administration of the drug the occurrence of overdose symptoms is unlikely as the content of the drug in one bottle of drops is extremely low (15 mg), the maximum daily dose for an adult is 1 g (500 mg for children).

Consult a physician if you accidentally use orally.

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