Ciprolone - instructions for use, dose, side effects, contraindications

Active substance: ciprofloxacin hydrochloride in terms of ciprofloxacin 3.0 mg. Excipients: disodium edetate (Trilon B), sodium chloride, benzalkonium chloride, sodium hydroxide, water for injection - up to 1 ml.

Description:Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

A broad-spectrum antimicrobial agent, a derivative of fluoroquinolone, inhibits bacterial DNA-gyrase, breaks down the synthesis of DNA, growth and division of bacteria; causes significant morphological changes (including the cell wall and membranes) and the rapid death of the bacterial cell. It acts bactericidal on gram-negative organisms during rest and division (because it affects not only the DNA-gyrase, but also causes lysis of the cell wall), gram-positive microorganisms - only during the fission period.

Ciprofloxacin acts on gram-negative microorganisms: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp.,(indolpositive and indolotricative), Morganella morganii, Citrobacter spp., Klebsiella spp., Enterobacter spp., Yersinia spp., Vibrio spp., Campylobacter spp., Hafnia alvei, Providencia stuartii, Haemophilus influenzae, Pasteurella multocida, Pseudomonas spp., Gardnerella spp., Legionella pneumophila, Neisseria spp., Moraxella catarrhalis, Acinetobacter spp., Brucella spp., Chlamydia spp., Aeromonas spp., Serratia marcescens, Edwardsiella tarda.

Ciprofloxacin is also sensitive to gram-positive microorganisms: Staphylococcus spp., Streptococcus spp., Corynebacterium diphtheriae, Listeria monocytogenes.

Ciprofloxacin is resistant Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides.

Pharmacokinetics:

After a single instillation, the concentration of ciprofloxacin in the moisture of the anterior chamber of the eye is reached after 10 minutes and is 100 μg / ml. The maximum concentration (C_max) in the moisture of the anterior chamber after 1 hour is 190 μg / ml. After 2 hours the concentration of the drug begins to decrease, while its antibacterial action in the tissues of the cornea is maintained up to 6 hours, in the moisture of the anterior chamber - up to 4 hours.

After instillation, systemic absorption of the drug is possible. With topical application of eye drops of ciprofloxacin 4 times a day in both eyes for 7 days, the average concentration of ciprofloxacin in the blood plasma is less than 2-2.5 ng / ml, the maximum concentration is less than 5 ng / ml.

With local application of T1 / 2 plasma is 4-5 hours. The drug is excreted by the kidneys in unchanged form - up to 50%, and in the form of metabolites - up to 10 %; through the intestine - about 15%.Some part of the drug is excreted in breast milk.

Indications:

Infectious-inflammatory diseases of the eyes caused by microorganisms sensitive to the preparation:

acute and subacute conjunctivitis;
blepharitis;
blepharoconjunctivitis;
keratitis;
keratoconjunctivating,
bacterial corneal ulcer;
chronic dacryocystitis;

Infectious lesions of the eyes after injuries or foreign bodies;

Pre- and postoperative prophylaxis of infectious complications in ophthalmic surgery.

Contraindications:

Increased individual sensitivity to the components of the drug, viral and fungal lesions of the eyes, children under 1 year, pregnancy, lactation.

Pregnancy and lactation:

Ciprofloxacin penetrates the placenta. In connection with the fact that with topical application possible systemic absorption of ciprofloxacin, the use during pregnancy is contraindicated. Do not use in the period of breastfeeding, tk. even with topical application, some of the drug penetrates into breast milk.

Dosing and Administration:

The duration of treatment is determined by the doctor.

Locally.In mild and moderately severe infectious and inflammatory diseases instilled 1-2 drops in the affected eye (or both eyes) every 4 hours.

In severe conditions - 2 drops every hour. After the condition is improved, the dose and frequency of instillations are reduced.

With a bacterial ulcer of the cornea: 1 drop every 15 minutes for 6 hours, then 1 drop every 30 minutes during waking hours; on day 2 - 1 drop every hour during waking hours; from 3 to 14 days - 1 drop every 4 hours during waking hours. If after 14 days of therapy epithelization has not occurred, treatment can be continued for 1 week.

For the prevention of secondary infection in case of trauma to the eye and its appendages - 1 drop 4-8 times a day for 1-2 weeks.

For prophylaxis of inflammation after surgical interventions with perforation eyeball - 1 by dropwise for 1 hour before surgery, immediately after surgery and then 4-6 times a day during the postoperative period (usually from 5 days to 1 month).

Side effects:

Allergic reactions, itching, burning, conjunctival hyperemia, nausea, edema of the eyelids, photophobia, lacrimation, foreign body sensation in eyes, an unpleasant taste in the mouth immediately after instillation,blurred vision, the appearance of a precipitate in patients with corneal ulcer, keratitis, keratopathy, corneal infiltration, development of superinfection.

Overdose:

There is no evidence of an overdose of Ciprolon®.

When receiving ciprofloxacin orally or intravenously administered in overdose develop acute renal failure, seizures. The specific antidote is unknown. It is necessary to wash the stomach and other measures of emergency, carefully monitor the patient's condition, ensure sufficient fluid intake. With the help of hemo- or peritoneal dialysis, only a small amount (less than 10%) of the drug can be excreted.

Interaction:

A solution Tsiprolona® incompatible with drug solution having values of pH 3-4, which is physically or chemically unstable.

Special instructions:

With simultaneous use of the drug with other eye drops, the interval between instillations should be at least 5-10 minutes.

During the treatment with the drug, it is not recommended to wear soft contact lenses. When using hard lenses, they should be removed before instillation and re-put in 15-20 minutes after the instillation of the drug.

Effect on the ability to drive transp. cf. and fur:

Patients who, after instillation of droplets, temporarily have reduced vision, it is not recommended to drive or work with complex equipment until it is restored.

Form release / dosage:

Eye drops 0,3%.

Packaging:

For 10 ml in bottles made of light-protective neutral glass, sealed with stoppers made of rubber, with the capping of aluminum caps. For 10 ml in bottles of polymer droppers with a screw mouth, a stopper-dropper and a screw cap with the control of the first autopsy.

1 bottle complete with a lid-dropper polyethylene or 1 bottle-dropper polymer together with instructions for use will prevent in packs of cardboard.

Storage conditions:

In the dark place at a temperature of 0 ° to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration of the period indicated on the package.

After opening, the bottle should not be stored for more than 1 month.

Terms of leave from pharmacies:On prescription

Registration number:PN001679 / 01

Date of registration:06.10.2010

The owner of the registration certificate:FARM STANDART, OJSC FARM STANDART, OJSC Russia

Manufacturer: & nbsp

Pharmaceutical firm LEKKO, ZAO Russia

Information update date: & nbsp19.10.2015

Illustrated instructions

Instructions

Ciprolone® (Ciprolone®)