TSiprolet - instructions for use, doses, side effects, contraindications

Excipients: disodium edetate 0.50 mg, sodium chloride 9.00 mg, benzalkonium chloride 50% solution 0.0002 ml, hydrochloric acid 0.000034 mg, water for injection up to 1.0 ml.

Description:

A clear, colorless or light yellow 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.It acts bactericidal on gram-negative organisms during rest and division (since it affects not only DNA-gyrase, but also causes lysis of the cell wall), Gram-positive microorganisms are effective only during the fission period. Low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them. Against the background of taking ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of DNA-gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to 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 Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) - moderate (to suppress them, high concentrations are required).

To the drug are resistant: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. He is effective 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:

The maximum concentration of the drug (C_max) in plasma with the use of eye drops - less than 5 ng / ml. The average concentration is below 2.5 ng / ml. After instillation, systemic absorption of the drug is possible. The drug is excreted through the kidneys mainly unchanged (50%) in the form of metabolites (up to 10%), about 15% is excreted through the intestine, in nursing mothers enters the breast milk.

Indications:

Local treatment of various infectious diseases of the eye and its appendages caused by bacteria sensitive to the drug: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers, bacterial keratitis and keratoconjunctivitis, chronic dacryocystitis and meibomites.

Preoperative prophylaxis in ophthalmic surgery. Treatment of postoperative infectious complications.

Treatment and prevention of infectious complications of the eyes after injuries or foreign bodies.

Contraindications:

Hypersensitivity to ciprofloxacin and other drugs of the quinolone group, viral keratitis, pregnancy, lactation (breastfeeding), children's age (up to 1 year).

Carefully:

Use with caution in patients with atherosclerosis of cerebral vessels, cerebral circulation disorder, convulsive syndrome.

Dosing and Administration:

Locally. With mild and moderately severe infection, 1-2 drops are injected into the conjunctival sac of the affected eye every 4 hours, with severe 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. If after 14 days of therapy epithelization has not occurred, the treatment can be continued.

Side effects:

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

Overdose:

There is no evidence of an overdose of the drug with topical application.

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 into the body, the creation of an acidic urine reaction to prevent crystalluria.

Interaction:

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole) synergy is usually observed; can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin, azlocillin, etc. beta-lactam antibiotics - with streptococcal infections; with isoxazole penicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.

The solution of ciprofloxacin is pharmaceutically incompatible with drugs with a pH value of 3-4 that are physically or chemically unstable.

Special instructions:

Eye drops can only be used topically, do not inject the drug subconjunctivally or into the anterior chamber of the eye.

When using eye drops Tsiprolet and other ophthalmic solutions, the interval between their administration should be at least 5 minutes.

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

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

Patients who temporarily lose visual clarity after application are not advised to drive a car or work with complicated equipment, or with any complicated equipment requiring clear vision, immediately after instillation of the drug.

Form release / dosage:Eye drops 3 mg / ml.

Packaging:

5 ml of the drug in a plastic vial-dropper with a screw cap.

1 bottle is placed in a pack of cardboard along with instructions for use.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Do not freeze. Keep out of the reach of children!

Shelf life:

2 years.

Use the drug for 1 month after opening the vial.

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

Terms of leave from pharmacies:On prescription

Registration number:П N012765 / 01

Date of registration:14.07.2008

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.

Information update date: & nbsp22.10.2015

Illustrated instructions

Instructions

Ciprolet® (Ciprolet®)