Ciprobay 200 mg. 100 ml.

Drug, ciprofloxacin (ciprofloxacin)
1 vial of 100 ml contains 254,4 mg ciprofloxacin lactate, corresponding to 200 mg of ciprofloxacin.
Excipients are: lactic acid, sodium chloride, hydrochloric acid, water for injections.
CIPROBAY 200 is available in packages of 5 bottles (N2), each containing 100 ml of infusion solution.


Manufacturer:
Bayer AG, Leverkusen.

1. What CIPROBAY 200 what is it used?
Ciprofloxacin, the active substance of CIPROBAY 200 belongs to the group of quinolones. The main site of action of the quinolones is the bacterial enzyme (gyrase), which plays a vital role in bacterial metabolism and reproduction. By blocking this enzyme with ciprofloxacin, the drug has a bactericidal effect on germs (ie kills microorganisms).

indications
adults
For the treatment of uncomplicated and complicated infections caused by pathogenic micro-organisms sensitive to ciprofloxacin:

infections
the respiratory system. Most of microorganisms known as "problematic organisms" (eg. Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella, Staphylococcus, Escherichia coli) are very sensitive to CIPROBAY. Most cases of pneumonia, which does not require hospitalization are caused by Streptococcus pneumoniae. In these cases CIPROBAY 200 mg is not a drug of first choice;
middle ear (otitis media) and paranasal sinuses (sinuitis), especially when caused by pathogens such as Pseudomonas or Staphylococus. Other antibiotic shall be used for the treatment of acute tonsillitis (angina):
Eye;
kidney and / or urinary tract;
the sexual organs, including inflammation of the ovaries and fallopian tubes (adnexitis), gonorrhea, and infections of the prostate (prostatitis). CIPROBAY 200 is not effective against Treponema pallidum (the causative agent of syphilis);
Celiac e. the gastrointestinal tract, biliary tract, and the peritoneum (peritonitis);
Skin and soft tissue;
bones and joints;
Blood poisoning (sepsis);
Infection or risk for infection (prophylaxis), in patients with an impaired immune system, e. persons who are treated with drugs that suppress the natural immune defenses (immunosuppressants) or whose blood contains a reduced number of certain white blood cells (neutropenia).
For children and adolescents between the ages of 5 and 17 years:
For oral treatment of acute infections in cystic fibrosis (CF congenital metabolic disease with increased production and increased viscosity of the secretions of the glands in the bronchi, and the gastrointestinal tract) caused by P. aeruginosa treatment sufficient parenteral treatment is more effective, but is difficult to implement. CIPROBAY 200 is not recommended for other indications.

anthrax:
For immediate treatment for the treatment of anthrax after inhaling anthrax bacilli (Bacillus anthracis). The efficacy of Ciprobay Anthrax has been demonstrated in studies.

2. What you should know before using CIPROBAY 200?
CIPROBAY 200 should not be used:
if you are hypersensitive (allergic) to ciprofloxacin, other drugs of the same pharmacological group (group quinolone, gyrase inhibitors);
if you are pregnant or breast-feeding.
Particular attention is necessary when used CIPROBAY 200:
If you suffer from seizures (epilepsy) or other forms of pre-existing central nervous system (CNS) (eg. Low threshold for seizures, a history of seizures, decreased cerebral blood flow, brain injury or stroke in the past). Patients in this group are at risk of adverse reactions from the CNS. In isolated cases appear psychotic reactions (mental disability affected by perception, by level of attempted suicide), in some cases, after the first use. In such cases, immediately stop using the CIPROBAY and inform the physician;
If a severe and persistent diarrhea during or after treatment. You should consult a doctor as this could be a sign of serious, possibly life-threatening intestinal condition (pseudomembranous colitis), which requires immediate treatment. Using CIPROBAY should be discontinued in these cases and appropriate therapy (eg. Vancomycin orally 4 x 250 mg daily). Do not take medicines that suppress gastric motility.
In isolated cases were observed inflammation of the tendons (tendinitis) and tendon rupture (eg. Achilles tendon) after treatment with fluoroquinolones (pharmacological class to which it belongs CIPROBAY 200). These findings were observed mainly in elderly patients who have been previously treated with corticosteroids. If it is assumed tendinitis, treatment with 200 CIPROBAY should be stopped immediately to avoid physical exertion and appropriate treatment.
Although photosensitivity occurs very rarely following treatment with ciprofloxacin, -treated patients CIPROBAY 200 should not be exposed to sunlight without the need to avoid and stay under UV light (high mountain sun, tanning beds). Treatment should be discontinued if there is a light-sensitive reactions (eg. Skin reactions similar to sunburn).
In isolated cases a severe rapid allergic reactions including facial swelling (edema), blood vessels and larynx, and shortness of breath (dyspnea), extending to life-threatening shock (anaphylaxis / anaphylactoid) reactions, in some cases after the first use of the product . In such cases, stop using CIPROBAY 200 immediately and notify the physician.

Children and adolescents
As with other gyrase inhibitors, known to ciprofloxacin,  drug CIPROBAY of 200 can cause bearing joints of young animals. Evaluation of safety data in patients under 18 years who suffered from cystic fibrosis mainly (CF) does not reveal evidence of harm to joints / cartilage.
Current data support the use of CIPROBAY to treat episodes of acute infections in cystic fibrosis caused by P. aeruginosa in children and adolescents between 5 and 17 years; currently there is insufficient experience with its use in children and adolescents with other infections, and children under 5 years. Consequently, ciprofloxacin should not be used in other infections in children under 5 years.

pregnancy
CIPROBAY 200 should not be used during pregnancy, as there is no data on its safety in pregnant women. Animal studies do not provide evidence of fetal malformations (teratogenic effects), but it is not entirely ruled out that the cartilage damage is caused to organisms that have not reached maturity.

breastfeeding
It is generally recommended CIPROBAY 200 should not be used while breast-feeding.

Driving and using machines
Do not drive or operate machinery while taking this medicine; even when used properly, this drug may impair the speed of the reaction and thus the ability to drive, use machines or work without safe support, or patients can not perform these activities at all. This is especially true for the beginning of treatment, when the dose is increased in case of the drug in conjunction with alcohol.

Interactions with other drugs:
Ciprobay 200 must be applied separately, unless it is confirmed compatibility with other infusion solutions / drugs. Visible signs of incompatibility are pritsipitatsii, cloudiness and discoloration of the solution.
Incompatibility is manifested in all the infusion fluids / drugs that are physically or chemically unstable at pH CIPROBAY 200 (eg. Penicillins, heparin solutions), especially when combined with a solution of an alkaline pH (pH of CIPROBAY 200 infusion solution: 3.9 - 4.5).

Ciprobay / xanthine
Co-administration of 200 CIPROBAY and theophylline (asthma) may lead to an undesirable increase in the concentration of theophylline in the blood and thus increase the incidence of adverse effects caused by theophylline, which in isolated cases can be life threatening or fatal. If necessary the use of both drugs at the same time, the concentration of theophylline in the blood should be monitored, and dosage should be reduced. There are reports of increasing concentrations of the xanthine derivatives pentoxifylline and caffeine (a drug which improves blood circulation) in the blood, where such substances are applied simultaneously CIPROBAY 200.

Ciprobay / non-steroidal anti-inflammatory drugs
Animal studies have shown that using a combination of very high doses of quinolones (gyrase inhibitors) and certain drugs that inhibit inflammation (non-steroidal anti-inflammatory drugs) can cause seizures. This does not apply to medicines containing acetylsalicylic acid.

Ciprobay / cyclosporine
Temporary impairment of renal function associated with an increase in the concentration of creatinine in the blood was observed in isolated cases where CIPROBAY 200 was administered at the same time with ciclosporin (a medicine that suppresses the body's defense mechanisms). If you take both drugs at the same time should be carefully monitored (twice a week) your creatinine concentration.

Ciprobay / warfarin
Simultaneous use of CIPROBAY 200 and warfarin (a drug that inhibits blood clotting) may increase the effects of warfarin.

Ciprobay / glibenclamide
In isolated cases, the simultaneous use of CIPROBAY 200 and glibenclamide (diabetes) may potentiate the effect of glibenclamide to the extent hypoglycaemia.

Ciprobay / probenecid
Probenecid (gout) affect the excretion of ciprofloxacin in the urine (renal secretion). Concomitant use of CIPROBAY 200 and probenecid increases the concentration of ciprofloxacin in the blood (serum).

Ciprobay / metoclopramide
Metoclopramide (gastrointestinal drug) accelerates the absorption of ciprofloxacin in the blood and increases the maximum concentration in blood (plasma) more quickly than usual. It is not known influence on the bioavailability of Ciprobay in the human body.

Ciprobay / mexiletine
The concomitant use of these two drugs can lead to increased concentration of mexiletine in the body.

Ciprobay / phenytoin
Increased or decreased phenytoin serum concentrations have been reported after concomitant use of these two drugs.

Ciprobay / diazepam
There are reports that the simultaneous use of CIPROBAY and diazepam diazepam slows down the body (reduced clearance, a prolonged half-life). It is therefore recommended careful monitoring of treatment with diazepam.

Ciprobay / methotrexate
The simultaneous use of these two substances can lead to delayed excretion of methotrexate, and thus to increased plasma levels of methotrexate. These patients should be carefully monitored, since this may lead to an increased risk of toxic effects induced by methotrexate.

Ciprobay / omeprazole
The concomitant use of ciprofloxacin and omeprazole may lead to a slight increase in peak plasma concentrations (Cmax) and bioavailability (AUK) of ciprofloxacin.

Please tell your doctor or pharmacist if you are taking other medicines or have taken any other medicines currently, even if they are medicines obtained without a prescription.

3. How should I use CIPROBAY 200 mg?
Unless otherwise prescribed by your doctor recommends the following doses (Table 1):
adults:
Indications single / daily dose for adults
  Single dose Total daily dose
  Number of bottles Ciprobay 200 Quantity drug (mg ciprofloxacin) 200 Number of bottles Ciprobay Quantity drug (mg ciprofloxacin)
Infections of the respiratory system * (depending on the severity and causative) 1-2 ** 2-4 bottles bottles 200-400 400-800
Urinary tract infections
complicated
1 bottle 2 bottles 200 400
Diarrhea 1 bottle 2 bottles 200 400
* Other infections (indications) 1-2 2-4 bottles bottles 200-400 400-800
Tab. 1 Recommended daily dose for adults
* The recommended dose in patients with particularly severe, life-threatening infections (especially those caused by Pseudomonas, Staphylococcus Streptococcus), for example. pneumonia caused by Streptococcus, recurrence of infection in patients with cystic fibrosis (CF congenital metabolic disease with increased production and increased viscosity of secretions from glands in the bronchi and digestive system), infections of bones and joints, blood poisoning (sepsis) and infections the peritoneum (peritonitis), a 3x2 bottles, each containing 200 mg of ciprofloxacin per day.
** This product is available with a content of active substance of 400 mg of this dosage form.

anthrax:
Adults: 2 bottles Ciprobay 200, each containing 100 ml of infusion solution (400 mg ciprofloxacin), 2 times a day.
Children: 10 mg / kg bw 2 times a day. The maximum daily dose should not exceed 400 mg.
Treatment should be initiated immediately after suspected or confirmed inhalation anthrax bacilli.