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

Per 1 ml of the preparation: active ingredient: ciprofloxacin hydrochloride monohydrate in terms of ciprofloxacin 3.0 mg; auxiliary components: sodium acetate trihydrate 0.68 mg, mannitol 46.00 mg, disodium edetate dihydrate 0.50 mg, benzalkonium chloride 0.10 mg, acetic glacial acid to pH 4.5-5, water purified to 1.0 ml.

Description:

Transparent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

A broad-spectrum antimicrobial agent, a derivative of fluoroquinolone, suppresses bacterial DNA-gyrase (topoisomerases II and IV, responsible for the process of supercoiling the chromosomal DNA around the nuclear RNA, which is necessary for reading out genetic information), disrupts DNA synthesis, growth and division of bacteria; causes significant morphological changes (including the cell wall and membranes) and the rapid death of the bacterial cell.

Bactericidal effect on gram-negative organisms in the dormant period and dividing (since not only affects DNA gyrase, but also causes lysis of the cell wall) for gram-positive microorganisms - only during division.

The low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them. While receiving ciprofloxacin occurs parallel generating resistance to other antibiotics, does not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria which are resistant, such as 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).

The majority of staphylococci, resistant to methicillin, are resistant to ciprofloxacin.Sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) - moderate (high concentrations are required to repress).

For drug resistant: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. Ineffective against Treponema pallidum.

Resistance develops very slowly, because on the one hand, after the action of ciprofloxacin are left with persistent microorganisms, and on the other - the bacterial cells do not have the enzymes that inactivate it.

Pharmacokinetics:

C max in plasma with the use of eye drops is less than 5 ng / ml. The average concentration is below 2.5 ng / ml.

Indications:

In ophthalmology: infectious and inflammatory diseases of the eyes (acute and subacute conjunctivitis, blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, bacterial corneal ulcer, chronic dacryocystitis, meibomite (barley), infectious lesions of the eyes after injuries or foreign bodies), pre- and postoperative prophylaxis infectious complications in ophthalmic surgery.

In otorhinolaryngology: otitis externa, treatment of postoperative infectious complications.

Contraindications:

Hypersensitivity, viral keratitis, children's age (up to 1 year - for eye drops).

Pregnancy and lactation:

During pregnancy and lactation Ciprofloxacin should be used only when the possible benefits for the mother justifies the potential risk to the fetus (child).

Dosing and Administration:

Locally.

In ophthalmology: with mild and moderately severe infection, 1-2 drops are injected into the conjunctival sac of the affected eye every 4 hours, with a serious infection - 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,

In otorhinolaryngology: Carefully cleared external auditory meatus. It is recommended that when used, the solution should have room temperature or body to avoid vestibular stimulation. The drug is instilled into the external ear canal. The recommended dose is 3-4 drops 2-4 times a day or more often, depending on the need. The patient should lie on the opposite patient's ear to the side within 5-10 minutes after instillation. In isolated cases, after a local cleansing, you can put in the ear,in the external auditory meatus a cotton swab moistened with a solution of ciprofloxacin; The tampon can be located in the external ear canal until the next procedure. In general, the duration of treatment should not exceed 5-10 days. In some cases, treatment can be prolonged if the local flora is sensitive.

Side effects:Allergic reactions, itching, burning, mild soreness and congestion hyperemia or in the area of the external auditory meatus and tympanic membrane, nausea, rarely - eyelid edema, photophobia, lacrimation, sensation of foreign body in the eyes, unpleasant aftertaste in the mouth, , the appearance of white crystalline precipitate in patients with corneal ulcer, keratitis, keratopathy, the appearance of corneal spots or corneal infiltration, the development of superinfection.

Overdose:

Data on the overdose of ciprofloxacin when used in the form of eye drops are absent. In case of accidental administration of the drug, the appearance of overdose symptoms is unlikely, since the drug content in one drop of drops is extremely small (15 mg), with a maximum daily dose for an adult of 1 g (500 mg for children).In case of accidental use of the drug inside - consult a doctor.

The interaction of drops of Ciprofloxacin with other drugs with simultaneous application is not revealed.

Interaction:

There are reports that the systemic use of certain quinolones leads to an increase in the concentration of theophylline in the blood plasma, affects the metabolism of caffeine and enhances the effect of oral anticoagulants such as warfarin and its derivatives. There was reported a temporary increase in serum creatinine in patients who were prescribed ciclosporin together with systemic use of ciprofloxacin.

Ciprofloxacin is incompatible with alkaline solutions.

Special instructions:

Solution in the form of eye drops is not intended for intraocular injections. When using other ophthalmic drugs, the interval between their administration should be at least 5 minutes. The drug should be discontinued if any signs of hypersensitivity occur. The patient should be informed that if after the application of drops for a long time continues or conjunctival hyperemia increases, then stop using the drug and consult a doctor.During the treatment with the drug, it is not recommended to wear soft contact lenses. When using hard contact lenses should be removed before instillation and re-dress 15-20 minutes after instillation drug.

Form release / dosage:

Eye and ear drops 0.30%.

Packaging:To 5 ml of solution in a white polymer bottle-dropper closed with a polymer lid with a safety ring. One bottle-dropper along with instructions for use in a cardboard pack.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C. In a place inaccessible to children.

Shelf life:

3 years.

After opening the vial, store it for no more than 4 weeks.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001296/08

Date of registration:28.02.2008

The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania

Manufacturer: & nbsp

S.C. ROMPHARM Company, S.R.L. Romania

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp23.10.2015

Illustrated instructions

Instructions

Ciprofloxacin (Ciprofloxacin)