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information about product

CIPRO-TECH
(Solution of ciprofloxacin 0.2 % for an intravenous injection)

The trading (patented) name of a preparation - CIPRO-TECH
The international name
SOLUTION OF CIPROFLOXACIN 0.2%
ATC-CODE - J01MA02

STRUCTURE AND THE FORM OF RELEASE
1 litre of a solution contains
Ciprofloxacin Hydrochloride hydrate....2g
Sodium Cloride....9g
Sodium Lactate.....0.6g
Other components: water for an injection.
100, 200 ml of solution in plastic PVC containers.

PHARMACOLOGICAL EFFECT
Cipro-Tech is bactericidal and acts by inhibiting the A subunit of DNA gyrase (topoisomerase) which is essential in the reproduction of bacterial DNA. It has a broader spectrum of activity and is more potent in vitro than the non-fluorinated quinolone nalidixic acid. Activity may be reduced in acid media.

SPECTRUM OF ACTIVITY
Among Gram-negative aerobic bacteria, ciprofloxacin is active in vitro against Enterobacteriaceae, including Escherichia coli and Citrobacter, Enterobacter, Klebsiella, Proteus, Providencia, Salmonella, Serratia, Shigella, and Yersinia spp. It is also active against Pseudomonas aeruginosa, but less so against other Pseudomonas spp. Haemophilus ducreyi, H. influenzae, Moraxella catarrhalis (Branhamella catarrhalis), and Neisseria gonorrhoeae are all very sensitive, including beta-lactamase-producing strains; N. meningitidis is also susceptible. Other Gram-negative aerobic bacteria reported to be sensitive to ciprofloxacin have included Acinetobacter spp., Campylobacter spp., Gardnerella vaginalis, Helicobacter pylori, Legionella spp., Pasteurella multocida, and Vibrio spp. Variable activity has been reported against Brucella melitensis.

Among Gram-positive aerobic bacteria, ciprofloxacin is active against staphylococci, including penicillinase-producing and penicillinase-nonproducing strains, and against some meticillin-resistant strains. Streptococci, in particular Streptococcus pneumoniae and enterococci, are less susceptible. Other Gram-positive bacteria sensitive to ciprofloxacin in vitro are Bacillus anthracis and Corynebacterium spp.

Most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile, are resistant to ciprofloxacin, although some other Clostridium spp. may be susceptible.

Ciprofloxacin has some activity against mycobacteria, mycoplasmas, rickettsias, and the protozoan Plasmodium falciparum. Chlamydia trachomatis is moderately susceptible, and Nocardia asteroides and Ureaplasma urealyticum are usually considered to be resistant. The spirochaete Treponema pallidum and fungi are also resistant.

Activity with other antimicrobials. There have been some reports of enhanced activity in vitro when ciprofloxacin has been used with other antimicrobials, such as aminoglycosides or azlocillin against Staphylococcus aureus and Pseudomonas aeruginosa, imipenem against Ps. aeruginosa, and cefotaxime or clindamycin against anaerobic bacteria.

INDICATIONS FOR ADMINISTRATION
Cipro-Tech it is applied during urological infections, complicated infections of respiratory system (at presence of gram-negative bacteria), infections of a skin and soft fabrics, bones and joints, a gastroenteric path, infections caused by salmonellas. The preparation is applied also during prostatitis, infections causing Pseudomonas, meningitis, sepsis and other pyoinflammatory processes.

DOSAGE
Cipro-Tech is intended for intravenous administration preferable as short-term infusion (about 30 minutes). The ready solution (in PVC containers) can be entered without cultivation or dissolving in solution of sodium chloride and 5 % glucose. Doses for intravenous introduction during non complicated infections of uric systems - 50 ml twice daily , in other cases - 100 ml twice daily.

SIDE-EFFECTS
Ciprofloxacin is generally well tolerated. The range of side-effects associated with ciprofloxacin and other fluoroquinolone antibacterials is broadly similar to that of earlier quinolones such as nalidixic acid. They most often involve the gastrointestinal tract, CNS, or skin.

Gastrointestinal disturbances include nausea, vomiting, diarrhoea, abdominal pain, and dyspepsia and are the most frequent adverse effects. Pseudomembranous colitis has been reported rarely.

Headache, dizziness, and restlessness are among the commonest effects on the CNS. Others include tremor, drowsiness, insomnia, nightmares, and visual and other sensory disturbances and, more rarely, hallucinations, psychotic reactions, depression, and convulsions. Paraesthesia and peripheral neuropathy have occurred occasionally.

In addition rash and pruritus, hypersensitivity-type reactions affecting the skin have included, rarely, vasculitis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Photosensitivity has occurred, although it may be more frequent with some newer fluoroquinolones such as lomefloxacin and sparfloxacin. Anaphylaxis has been associated with ciprofloxacin and some other quinolone antibacterials. As with other quinolone antibacterials, reversible arthralgia has sometimes occurred and joint erosions have been documented in immature animals. Tendon damage has been reported.

Other adverse effects reported with ciprofloxacin include transient increases in serum creatinine or blood urea nitrogen and, occasionally, acute renal failure secondary to interstitial nephritis; crystalluria; elevated liver enzyme values, jaundice, and hepatitis; haematological disturbances including eosinophilia, leucopenia, thrombocytopenia and, very rarely, pancytopenia, haemolytic anaemia or agranulocytosis; myalgia; gynaecomastia; and cardiovascular effects including tachycardia, oedema, syncope, hot flushes, and sweating.

As with other antibacterials, superinfection with organisms not very susceptible to ciprofloxacin is possible. Such organisms include Candida, Clostridium difficile, and Streptococcus pneumoniae. There is some evidence that ciprofloxacin usage may cause Staphylococcus aureus and vancomycin-resistant enterococci, be associated with an increased risk of colonisation by meticillin-resistant

Pain and irritation may occur at the site of injection accompanied rarely by phlebitis or thrombophlebitis.

General reviews of the adverse effects of fluoroquinolone antibacterials.

CONTRAINDICATION
Fluoroquinolones are known to inhibit hepatic drug metabolism and may interfere with the clearance of drugs, such as theophylline, that are metabolised by the liver. Cations such as aluminium, magnesium, or iron reduce the absorption of ciprofloxacin and related drugs when given concomitantly. Changes in the pharmacokinetics of fluoroquinolones have been reported when given with histamine H2 antagonists, possibly due to changes in gastric pH, but do not seem to be of much clinical significance.

PREGNANCY AND LACTATION
Contradicted during pregnancy and lactation. During experiments there was found evidence that it causes arthropady.

STORAGE CONDITIONS AND SHELF LIFE
The preparation should be stored in the dry place protected from light at temperature 5-20 oC. Expiry date - 2 years.

  Copyright © 2006 PharmaTech