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Normon S.A. - Sapin

ANASTROZOLE NORMON
BISOPROLOL NORMON
DESLORATIDINE NORMON
ESCITALOPRAM NORMON
ESOMEPRAZOLE NORMON
ESTECINA Inj.
ESTECINA Tablets
FIXIM
GASTRIMUT
LAMOTRIGINE NORMON
LETROZOLE NORMON
LEVOFLOXACIN NORMON
LIDOCAINE 2% EPINEPHRINE NORMON
NORMOCEF
NORMOPRIL
PARACETAMOL NORMON
SIMVASTATIN NORMON
TOPAGAN

Forms and presentation
Injectable solution: IV infusion: Bottle of 100 ml and 50 bags of 100 ml.

Composition
100 ml contains: Ciprofloxacin lactate: 200 mg.

Properties
Ciprofloxacin is a 4-quinolone chemotherapic agent with bactericidal activity. It acts by the inhibition of the bacterial DNA-gyrase, interfering replication DNA. It is effective in vitro against a wide spectrum of Gram+ and Gram- organisms. The effectiveness curves show a quick bactericidal effect and it has been often found that minimum bactericidal concentrations are in the same range that MIC. It has not been observed a cross-resistance with penicillin, cephalosporin, aminoglycoside and tetracyclin. The resistant organisms to these antibiotics are generally sensitive to Ciprofloxacin. The concomitant administration with other antibacterial agents produces an additive effect.
Ciprofloxacin is effective against the following bacterias:
Gram+ organisms: Staph. aureus (including meticillin susceptible and meticillin resistant), Staph. pyogenes and Str. pneumoniae. Str. faecalis, M. tuberculosis and C. trachomatis are moderately sensitives.
Gram- organisms: E. coli, Klebsiellae, including K. pneumoniae and K. oxytoca, Enterobacter, Citrobacter, Edwardsiella tarda, Salmonella, Shigella, P. mirabilis, P. vulgaris, Pr. rettgeri, Pr. stuaartii, M. morganii, Serratia (including S. marcescens), Y. enterocolitica, P. aeruginosa, Acinetobacter, H. influenzae, H. parainfluenzae, H. ducreyi, N. gonorrhoeae, N. meningitidis, B. catarrhalis. Campylobacter, Aeromonas, Vibrio (including V. cholerae), Brucella melitensis, P. multocida and Legionella.
S. marcenses, Str. faecalis, Str. faecium, Str. pneumoniae, M. hominis, Micobacterium and anaerobios, are sensitive germs to ciprofloxacin but their sensitivity must be checked before the treatment is instaured.
P. aeruginosa may develop resistance during treatment with Ciprofloxacin, so, controls will be carried out to detect this possibility.
U. urealyticum, C. difficile and N. asteroides are generally resistant.
There is not available information about efficacy of Ciprofloxacin against T. pallidum.

Indications
Respiratory tract infections: Bronchopneumoniae and lobar pneumoniae, acute bronchitis, chronical bronchitis, cystic fibrosis, bronchiectasia, empyema, caused by E. coli, K. pneumoniae, E. cloacae, P. mirabilis, P. aeruginosa, H. influenzae, H. parainfluenzae and Str. pneumoniae.
Genito-urinary tract infections: Complicated and no complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis, gonorrhea, caused by E. coli, K. pneumoniae, E. cloacae, P. mirabilis, Pr. rettgeri, M. morganii, C. diversus, C. freundii, P. aeruginosa, Staph. epidermidis, N. gonorrhoeae, S. marcenses and Staph. faecalis.
Gastrointestinal infections: Enteric fever, infectious diarrhea caused by E. coli, C. jejuni, Shigella flexneri and Shigella sonnai, Klebsiella sp, P. mirabilis, Staph. aureus, Staph. epidermidis, E. coli.
Osteoarticular infections: Osteomyelitis, septic arthritis caused by E. cloacae, P. aeruginosa and S. marcenses.
Skin and soft-tissue infections: Ulcers and infected burns caused by E. coli, K. pneumoniae, E. cloacae, P. mirabilis, P. vulgaris, Pr. stuartii, M. morganii, C. freundii, P. aeruginosa, Staph. aureus, Staph. epidermidis and Str. pyogenes.
Severe systemic infections: Septicemia, bacteriemia, peritonitis, infections in immunocompromised patients with hematologic or solid tumors and in patients receiving intensive care with specific problems, such as infected burns.
Biliar tract infections: Cholangitis, chotecystitis, empyema of biliar vesicle.
Intra-abdominal infections: Peritonitis, intra-abdominal abcess.
Pelvic infections: Salpingitis, endometritis, pelvic inflammatory disease.
Otorrhinolaryngologic infections: Otitis media, sinusitis, mastoiditis.

Contraindications
History of hypersensitivity to Ciprofloxacin and other quinolones. It should not be used in children unless if it is considered essential.

Precautions
Due to the eventual side effects related with CNS, Ciprofloxacin will be only used if is considered essential, when the benefits are considered superior to possible risks. Therefore Ciprofloxacin must be used with caution in patients with history of epileptic crisis or CNS disorders (such as low convulsive threshold, clinical history of convulsive disorders, reduced circulation of the cerebral blood, cerebral organic distrubance or cerebral vascular accident).
Rarely, it has been reported crystalluria related with Ciprofloxacin treatment. An adequate hydration should be maintained during treatment and excessive alcalinity of the urine avoid in patients receiving Ciprofloxacin.

Drug interactions
Increase in theophylline serum concentrations has been observed when Ciprofloxacin is simultaneously administered with other quinolones. Caution is recommended when Ciprofloxacin and theophylline are simultaneously administered. A reduction in theophylline dosage may be required.
Temporary increase in creatinine serum concentrations has been observed when Ciprofloxacin and cyclosporine are simultaneously administered. Therefore, control of this parameter (twice/week) will be carried out frequently.

Ability to drive and use machine
The ability to drive or operate machinery may be impaired by Ciprofloxacin, specially when alcohol is taken.

Pregnancy and lactation
Pregnancy: Reproduction toxicological studies in mice, rats and rabbits receiving Ciprofloxacin orally and parenterally, reported no teratogenicity adverse effects in fertility, peri and post-natal development. However, like other quinolones, Ciprofloxacin has shown to cause arthropathy in immature animals so, its use is not recommended in pregnancy.
Lactation: Studies in rats have shown Ciprofloxacin is excreted in human breast milk so, its use is not recommended during lactation.

Side effects
Gastrointestinal disturbances: Nausea, vomiting, diarrhea, dyspepsia, abdominal pain. If severe and persistant diarrheas appeared may dissimulate an intestinal illness (pseudomembranous colitis), which must be immediately treated. Treatment with Ciprofloxacin will be stopped and an adequate therapy established.
CNS disturbances: Vertigo, headache, tiredness, insomnia, agitation, very rarely peripheral paralgesia, sudation, unstable gait, convulsion, anxiety state, nightmare, confusion, depression, hallucination, taste and smell alteration, visual disturbances (double vision, color). Sometimes these reactions appear just with the first administration, therefore treatment will be stopped and a doctor will be informed immediately.
Hypersensitivity reactions: Rash and more rarely; pruritus, medicamentous fever, anaphylactic reactions (facial, vascular and larigneal oedema, anaphylactic shock in these cases treatment will be stopped and an adequate therapy established), petechias, ampoules, vasculitis, Stevens-Johnson syndrome, interstitial nephritis; less frequently, hepatic disturbances including hepatic necrosis.
Temporary increases in hepatic enzymes values may appear, specially in patients with previous hepatic damage.
Blood formula: Very rarely: eosinophilia, leucocytopenia, leucocytosis, anemia, thrombocytopenia, thrombocytosis, altered prothrombin levels.
Various: Very rarely: muscular and articular pain, tenosynovitis, moderate photosensitivity, temporary alteration in audition, specially at hight frequencies.

Dosage and administration
Dosage of Ciprofloxacin is determined depending on the severity and the kind of infection, sensitivity of the germ, age, weight and renal function of the patient.
Usual adult IV daily dose: Dosage is in the range of 200-400 mg twice daily depending on the infection, severity of the sickness and the clinical status of the patient.
Duration of the treatment depends on the severity of the infection, clinical response and bacteriological results.
The usual period of treatment for acute infections is of 5-10 days. Generally, treatment should be continued 3 days after the symptoms have dissapeared.
IV dosage in patients with cystic fibrosis will be determined considering their low corporal weight.
Old people: No dosage adjustment in aged patients is needed, although Ciprofloxacin serum levels are high.
Adolescent and children: Like other quinolones, Ciprofloxacin may cause arthiopaty in immature animals. Therefore its use is not recommended in children and adolescents growing, although any relation with humans has been reported. However, if it is considered essential (e.g. cystic fibrosis), IV doses of 5-10 mg/kg every 12 hrs have been suggested depending on the severity of the infection and the weight of the patient.
Impaired renal function: Usually it is not necessary to adjust the dosage, independly of the administration route, except in patients with severe renal impairment (Clcr < 20 ml/min). If a dosage adjustment is needed, it may be calculated by a reduction to the middle of the daily dose.
Correct administration: Initial IV administration may be followed by an oral treatment with Ciprofloxacin. IV Ciprofloxacin will be infused during a period of time of 30-60 minutes. Ciprofloxacin is compatible with physiological saline solution, Ringer solution, 5% or 10% dextrose solution, 10% glucose solution and 10% fructose solution. Any aqueous solution must be used within 24 hrs since is prepared.
Warning: 0.2% Ciprofloxacin solution contains 0.9% w/v of sodium chloride, that is approximately equivalent to sodium 154 mmol per liter.

Overdosage
There is no available information about overdosage. In case of intoxication, routine measures will be carried out as soon as possible. Dialysis decreases Ciprofloxacin serum levels.

Storage conditions
As Ciprofloxacin is sensitive to light, the bottles should be protected from light.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Registration Number: 
Vial: 261405/1997
Bags: 127414/2014