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

1 ml of the solution contains: active substance: ciprofloxacin hydrochloride (in terms of ciprofloxacin)	3 mg
Excipients: disodium edetate (Trilon B)	0.5mg
mannitol (mannitol)	46 mg
Sodium acetate	0.5 mg
acetic acid	0.0015 ml
benzalkonium chloride	-0.1 mg
water for injections	up to 1 ml

Description:

Transparent solution slightly yellowish or yellowish-greenish in color.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

The broad-spectrum antimicrobial agent, a derivative of fluoroquinolone, suppresses bacterial DNA-gyrase (topoisomerases II and IV, responsible for DNA untwisting, to ensure a further transcription process), disrupts DNA synthesis, growth and division of bacteria.

It acts bactericidal against Gram-negative organisms in the period of rest and division, on gram-positive microorganisms - only in the period of division.

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:

Ciprofloxacin, when applied topically, penetrates well into the tissues of the eye. After a single instillation, its concentration in the moisture of the anterior chamber of the eye after 10 minutes is 0.1 mg / ml.The maximum concentration, determined after 1 hour in the moisture of the anterior chamber, is 0.19 mg / ml.

After 2 hours, the concentration begins to decrease, but its antibacterial effect in the tissues of the cornea persists up to 6 hours, in the moisture of the anterior chamber up to 4 hours.

The half-life of serum from the local application is 4 to 5 hours. FROM_maxin plasma - less than 5 ng / ml. The average plasma concentration is below 2.5 ng / ml. The drug is excreted through the kidneys mainly (up to 50%) unchanged and up to 10% in the form of metabolites; about 15% is excreted through the intestine; in nursing mothers - partially excreted in breast milk.

After instillation, systemic absorption of the drug is possible. When treated for 7 days, on average, 4 times a day in both eyes, the average concentration is 2 ng / ml.

Indications:

Infectious and inflammatory diseases of the eyes (acute and subacute conjunctivitis, blepharitis, blepharoconjunctivitis, keratitis, keratoconjunctivitis, bacterial corneal ulcer, meibomite, acute dacryocystitis, infectious lesions after eye injury), pre- and postoperative prophylaxis of infectious complications in ophthalmic surgery.

Contraindications:

Hypersensitivity to the components of the drug, viral and fungal lesions of the eyes, pregnancy, the period of breastfeeding, children under 1 year.

Dosing and Administration:

Locally. The drug is instilled in 1-2 drops in a conjunctival sac. The frequency of instillation depends on the severity of the inflammatory process.

With acute bacterial conjunctivitis, simple, scaly and ulcerative blepharitis, meibomites, the drug is prescribed 4 to 8 times a day, depending on the severity of the disease. The course of treatment is from 5 to 14 days.

In keratitis, the drug is prescribed 1 drop at least 6 times a day, with a positive effect, the maximum course of treatment, depending on the severity of the lesion of the cornea, is about 2-4 weeks.

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

With acute dacryocystitis the drug is prescribed 6-12 times a day for 1 drop of treatment should not exceed 14 days.

In case of eye trauma, incl.ingress of foreign bodies for the prevention of infectious complications, the drug is prescribed for 1 to 2 weeks, 1 drop 4-8 times a day.

In the preoperative period: 1 drop 4 times a day for two days before the operation and 1 drop every 10 minutes 5 times immediately before the operation.

For the prevention of inflammatory diseases after surgery, the drug is prescribed 4-6 times a day for 1 drop for the entire period of the postoperative period, usually from 5 days to 1 month.

Side effects:

Allergic reactions, itching and burning in the eye, mild tenderness and congestion hyperemia, nausea, rarely - eyelid edema, photophobia, lacrimation, sensation of foreign body in the eyes, unpleasant aftertaste in the mouth, instability, white crystalline precipitate in patients with a corneal ulcer, keratitis, keratopathy, corneal infiltration, development of superinfection.

Overdose:

Data on drug overdose are absent. In case of accidental ingestion of the drug, no specific symptoms are present. There may be nausea, vomiting, diarrhea, headache, fainting, a sense of anxiety.

Treatment: standard measures of emergency care, sufficient supply of fluid in the body, the creation of an acidic urine reaction to prevent crystalluria.

Interaction:

There are reports that the systemic use of certain quinolones leads to an increase in the concentration of theophylline in the blood plasma, enhances the effect of indirect anticoagulants (incl. warfarin and its derivatives).

With the joint use of ciprofloxacin. and caffeine, there is a decrease in the metabolism of caffeine in the liver (slowing its elimination and increasing concentration in the blood).

There was reported a temporary increase in serum creatinine in patients who were prescribed ciclosporin together with systemic use of ciprofloxacin.

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 15 minutes.

During the treatment with the drug, contact lenses are not recommended.

After opening the vial, the drug should be used no more than 14 days.

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

Immediately after using the drug, blurred vision may occur, which can lead to difficulties in controlling vehicles and working with mechanisms; it is recommended to start work (driving) 15 minutes after using the drug.

Form release / dosage:

Eye drops 0.3%.

Packaging:

1 ml, 2 ml in a dropper with a valve or 5 ml, 10 ml ml in a tube-dropper with a screw neck of polyethylene.

Tube-dropper with a screw neck is capped with screw caps made of polymer materials.

5 tubes-droppers for 1 ml, 2 ml or 1 tube-dropper for 5 ml, 10 ml with instructions for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C.

Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LSR-002480/10

Date of registration:26.03.2010

The owner of the registration certificate:UPDATE OF PFC, CJSC UPDATE OF PFC, CJSC Russia

Manufacturer: & nbsp

UPDATE, PFC CJSC Russia

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Ciprofloxacin (Ciprofloxacin)