CIPROBAY 500MG TABLET
Ciprobay: Each 250- and 500-mg tablet contains ciprofloxacin HCl 250 mg and 500 mg, respectively.
Each 50-, 100- and 200-mL vial of infusion solution contains ciprofloxacin lactate 100 mg, 200 mg and 400 mg, respectively.
Ciprobay tablet also contains microcrystalline cellulose, maize starch, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 4000 and titanium dioxide (E171) while the infusion solution also contains lactic acid, sodium chloride, concentrated hydrochloric acid and water for injections.
Ciprobay XR: Each 500 mg tablet contains ciprofloxacin HCl monohydrate 334.8 mg and ciprofloxacin hydrous 253 mg, corresponding to ciprofloxacin 500 mg. Each 1 g tablet contains ciprofloxacin HCl monohydrate 669.4 mg and ciprofloxacin hydrate 506 mg, corresponding to ciprofloxacin 1000 mg.
Ciprobay XR also contains the following excipients: Crospovidone, magnesium stearate, anhydrous colloidal silica, succinic acid, hypromellose, macrogol 3350, titanium dioxide and purified water in bulk.
Indications / Uses :
Ciprobay: Uncomplicated and complicated infections caused by ciprofloxacin-sensitive pathogens: Infections of the respiratory tract. In the treatment of outpatients with pneumonia due to Pneumococcus, ciprofloxacin should not be used as a drug of first choice. Ciprofloxacin can be regarded as an advisable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, E. coli, Pseudomonas, Haemophilus, Branhamella, Legionella and Staphylococcus.
Infections of the middle ear (otitis media), of the paranasal sinuses (sinusitis), especially if these are caused by gram-negative organisms including Pseudomonas or by Staphylococcus; eyes; kidneys and/or the efferent urinary tract; genital organs, including adnexitis, gonorrhea, prostatitis; abdominal cavity (eg, infections of the gastrointestinal tract or of the biliary tract, peritonitis); skin and soft tissue; bones and joints.
Sepsis: Infections or imminent risk of infection (prophylaxis) in patients whose immune system have been weakened (eg, patients on immunosuppressants or have neutropenia). Selective intestinal decontamination in immunosuppressed patients.
Prophylaxis of invasive infections due to Neisseria meningitidis.
Consideration should be given to applicable official guidances on the appropriate use of antibacterial agents.
Ciprobay XR: 500 mg: Acute uncomplicated urinary tract infections (acute cystitis) caused by ciprofloxacin susceptible organisms.
1 g: Complicated urinary tract infections including acute uncomplicated pyelonephritis caused by ciprofloxacin susceptible organisms.
May be taken with or without food: Do not take w/ antacids, Fe or dairy products. XR tab: Swallow whole, do not chew/crush.
Ciprobay must not be used in cases of hypersensitivity to ciprofloxacin or other quinolone chemotherapeutics or to any excipients of Ciprobay/Ciprobay XR.
Concurrent administration of ciprofloxacin and tizanidine is contraindicated since an undesirable increase in the serum tizanidine concentrations associated with clinically relevant tizanidine-induced side effects (hypotension, somnolence, drowsiness) can occur.
Special Precautions :
Severe Infections and/or Infections due to Gram-Positive or Anaerobic Bacteria: For the treatment of severe infections, staphylococcal infections and infections involving anaerobic bacteria, ciprofloxacin should be used in combination with an appropriate antibacterial agent.
Streptococcus pneumoniae Infections: Ciprofloxacin is not recommended for treatment of pneumococcal infections due to inadequate efficacy against Streptococcus pneumoniae.
Genital Tract Infections: Genital tract infections may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates. In genital tract infections thought or known to be due to N. gonorrhoeae, it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.
Cardiac Disorders: Ciprofloxacin is associated with cases of QT prolongation (see Adverse Reactions). In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation with the QT interval (eg, class IA or III antiarrhythmics) or in patients with risk factors for Torsades de pointes (eg, known QT prolongation, uncorrected hypokalemia).
Cytochrome P-450: Ciprofloxacin is known to be a moderate inhibitor of the CYP450 1A2 enzymes. Care should be taken when other medicinal products which are metabolized via the same enzymatic pathway (eg, theophylline, methylxanthines, caffeine, duloxetine, clozapine) are administered concomitantly. Increased plasma concentrations associated with drug-specific side effects may be observed due to inhibition of their metabolic clearance by ciprofloxacin.
Gastrointestinal System: In the event of severe and persistent diarrhea during or after treatment, a doctor must be consulted since this symptom can hide a serious intestinal disease (life-threatening pseudomembranous colitis with possible fatal outcome), requiring immediate treatment. In such cases, ciprofloxacin must be discontinued and appropriate therapy initiated (eg, vancomycin orally, 4 x 250 mg/day). Drugs that inhibit peristalsis are contraindicated.
There can be a temporary increase in transaminases, alkaline phosphatase or cholestatic jaundice, especially in patients with previous liver damage.
Nervous System: In epileptics and in patients who have suffered from previous CNS disorders (eg, lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke), ciprofloxacin should only be used where the benefits of treatment exceed the risks, since these patients are endangered because of possible central nervous side effects.
In some instances, the CNS reactions occurred after the first administration of ciprofloxacin already. In rare cases, depression or psychosis can progress to self-endangering behavior. In these cases, ciprofloxacin has to be discontinued and the doctor should be informed immediately.
Hypersensitivity: In some instances, hypersensitivity and allergic reactions already occurred after the first administration and the doctor should be informed immediately.
Anaphylactic/anaphylactoid reactions in very rare instances can progress to a life-threatening shock, in some instances after the first administration. In these cases, ciprofloxacin has to be discontinued, medical treatment (eg, treatment for shock) is required.
Injection Site Reaction: Local IV site reactions have been reported with the IV administration of ciprofloxacin. These reactions are more frequent if the infusion time is =30 min. These may appear as local skin reactions which resolve rapidly upon completion of the infusion. Subsequent IV administration is not contraindicated unless the reactions recur or worsen.
Musculoskeletal System: At any sign of tendinitis (eg, painful swelling, inflammation) a physician should be consulted and the antibiotic treatment be discontinued. Care should be taken to keep the affected extremity at rest and avoid any inappropriate physical exercise (as the risk for tendon rupture might increase otherwise). Tendon rupture (predominantly Achilles tendon) has been reported predominantly in the elderly on prior treatment with glucocorticoids. Ciprofloxacin should be used with caution in patients with a history of tendon disorders related to quinolone treatment.
Skin and Appendages: Ciprofloxacin has been shown to produce photosensitivity reactions. Patients taking ciprofloxacin should avoid direct exposure to excessive sunlight or UV light. Therapy should be discontinued if photosensitization (ie, sunburn-like skin reactions) occur.
Interaction with Tests: Ciprofloxacin in vitro potency may interfere with the Mycobacterium spp culture test by suppression of mycobacterial growth, causing false negative results in specimens from patients currently taking ciprofloxacin.
Renal Impairment: Patients with severe renal impairment (creatinine clearance =30 mL/min/1.73 m2 or the serum creatinine concentration =2 mg/100 mL) should receive Ciprobay XR 500 mg tablet/day and should not receive Ciprobay XR 1 g tablet.
Effects on the Ability to Drive or Operate Machinery: Fluoroquinolones including ciprofloxacin may result in an impairment of the patient’s ability to drive or operate machinery due to CNS reactions. This applies particularly in combination with alcohol.
Use in pregnancy: Since the safety of ciprofloxacin in pregnant women has not been established and since, on the basis of animal studies, it is not entirely improbable that the drug could cause damage to articular cartilage in the immature fetal organism, ciprofloxacin must not be prescribed to pregnant women.
Animal studies have not shown any evidence of teratogenic effects (malformations).
Use in lactation: Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breastfeeding.
Use in children and adolescents: As with medicinal products in its class, ciprofloxacin has been shown to cause arthropathy in weight bearing joints of immature animals. The analysis of available safety data from ciprofloxacin use in patients <18 years, the majority of whom had cystic fibrosis, did not disclose any evidence of drug-related cartilage or articular damage. The use of ciprofloxacin for indications other than the treatment of acute pulmonary exacerbation of cystic fibrosis caused by Pseudomonas aeruginosa infection (children 5-17 years), complicated urinary tract infections and pyelonephritis due to Escherichia coli (children 1-17 years), and for the use in inhalational anthrax (post-exposure) was not studied. For other indications clinical experience is limited.
Caution for Usage
Ciprobay: Incompatibilities: Infusion Solution: When Ciprobay infusion solutions are mixed with compatible infusion solutions, for microbiological reasons and light sensitivity, these solutions should be administered shortly after admixture.
Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are precipitation, clouding and discoloration. Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (eg, penicillins, heparin solutions), especially on combination with solutions adjusted to an alkaline pH (pH of the Ciprobay infusion solutions: 3.9-4.5). Protect from light. Do not refrigerate or freeze.
For ease of use, the infusion vial stopper should be penetrated in the central ring. Penetration of the outer ring may result in damage to the vial stopper.