CIPROMAX TAB Quinolone Topical Antibiotic     COMPOSITION Two tablet presentations of Cipromax are available : - Cipromax 250 : Each film-coated tablet contains ciprofloxacin HCl monohydrate equivalent to 250mg ciprofloxacin. - Cipromax 500 : Each film-coated tablet contains ciprofloxacin HCl monohydrate equivalent to 500mg ciprofloxa     INDICATIONS Complicated and uncomplicated infections caused by organisms sensitive to ciprofloxacin. Infections of the: Respiratory tract: Cipromax is indicated if so-called problem organisms (eg. Klebsiella, Enterobacter, Proteus, Pseudomonas, Legionella, staphylococcus, Escherichia Coli) are found to be responsible. - In pneumococcal lung inflammations (pneumonia) treated by a GP. Cipromax is not the drug of first choice. The use of Cipromax may, however, be indicated if so-called problem organisms are found to be responsible (e.g. Klebsiella, Enterobacter, proteus, Pseudomonas, Legionella, Staphylococcus, Escherichia coli). - Middle ear (otitis media) and paranasal sinuses (sinusitis), particularly where these are caused by gram-negative organisms including Pseudomonas or Staphylococcus. Cipromax therefore must not be used in acute tonsillitis (angina tonsillaris). - Eyes - Kidneys and/or the efferent urinary tract - Genital organs, including inflammation of the ovaries fallopian tubes (adnexitis), of the urethra (gonorrhoea), and of the prostate (prostatitis) - Abdominal cavity (e.g. infections of the gastrointestinal tract or of the biliary tract, peritonitis) - Skin and soft tissues - Bones and joints Blood poisoning (sepsis) Infections or imminent risk of infection (prophylaxis) in patients with a weakened immune system, e.g. patients receiving treatment with drugs which inhibit the immune system (immunosuppressants) or patients with a reduced white blood cell count (neutropenia). Administration for selective intestinal decontamination in immunosuppressed patients. According to investigations outside the living organism (in vitro), the following organisms can be regarded as sensitive: E. coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus (indole-positive and indole-negative), Providencia, Morganella, Yersinia; Vibrio, Aeromonas, Plesiomonas, Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria, Moraxella, Branhamella, Acinetobacter, Brucella; Staphylococcus, Listeria, Corynebacterium, Chlamydia. The following organisms show varying degrees of sensitivity: Gardnerella, Flavobacterium, Alcaligenes, Streptococcus agalactiae, Streptococcus faecalis, Streptococcus pyogenes, Sterptococcus pneumoniae, Streptococcus viridans, Mycoplasma hominis, Mycobacterium tuberculosis, and Mycobacterium fortuitum. The following organisms are generally resistant: Streptococcus faecium, Ureaplasma urealyticum, Nocardia asteroides. With a few exceptions, anaerobes are moderately sensitive (e.g.Peptococcus, Peptostreptococcus) to resistant (e.g. Bacteroides). Cipromax is ineffective against Treponema Pallidum.     DOSAGE Unless otherwise prescribed, the following guideline doses are recommended: Uncomplicated infections of the upper and lower urinary tract 1/2 Tablet Cipromax 250 Twice daily. Complicated infections of the urinary tract (according to severity ) One Tablet Cipromax 250 or 500 Twice daily. Infections of the respiratory tract (e.g. bronchitis ) One Tablet Cipromax 250 or 500 Twice daily. Other infections (cf. Indications) One Tablet Cipromax 500 Twice daily. In particularly serious infections (e.g. recurrent infective episodes in patients with cystic fibrosis, pneumonia, or infections of the abdominal cavity, bones, and joints) caused by Pseudomonas or staphylococci and in acute pneumonias due to Streptococcus pneumoniae, the daily dose must be increased to one and half Cipromax 500 film-coated tablet if treatment is not administered parenterally. In chlamydial infections of the urogenital tract, the dose should be increased to one and half tablet Cipromax 500 twice daily if necessary. Up to 500 mg (2 film-coated tablets) can also be administered as a single daily dose in uncomplicated urinary tract infections and gastrointestinal infections. Acute uncomplicated gonorrhoea in men and women and acute uncomplicated cystitis in women can be treated with a single dose of one tablet Cipromax 250. Older patients should receive as low a dose as possible, depending on the severity of the infection and creatinineexcretion(clearance). If because of the severity of the illness or for other reasons, the patient is unable to take the film-coated tablets,it is recommended to begin treatment with the intravenous form of ciprofloxacin.     ADMINISTRATION The film-coated tablets are to be swallowed whole with a little liquid. They can be taken independently of meal-times. The active substance is absorbed more quickly if the film-coated tablets are taken on an empty stomach. Duration of use The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course. The treatment should in principle be continued systematically for at least 3 days after disappearance of the fever or of the clinical symptoms. Average durations of treatment: 1 day for acute uncomplicated gonorrhoea and cystitis, up to 7 days for infections of the kidneys, urinary tract, and abdominal cavity, over the entire period of the neutropenic phase (period with a reduced white blood cell count) in patients with weakened body defences, a maximum of 2 months in bone infections, and 7-14 days in all other infections. In streptococcal infections the treatment must last at least 10 days because of the risk of late complications. Treatment of chlamydial infections should also last at least 10 days.     CONTRAINDICATIONS Cipromax must not be used in cases of hypersensitivity to ciprofloxacin or to other drugs from the same class of substances (quinolone, gyrase inhibitors). Cipromax must be not prescribed to growing children or adolescents, to pregnant women, or to nursing mothers, since there is no experience with the drug's safety in these patients groups and since animal studies indicate that damage to articular cartilage in the immature organism cannot be fully excluded. Animal studies have not yeilded any evidence of teratogenic effects (malformations). Note: In patients who suffer from seizures (epileptics) and patients with other existing damage to the central nervous system (e.g. reduced convulsion threshold, history of convulsions, reduced cerebral blood flow, changes in brain structure, or stroke) Cipromax should only be used after a careful consideration of the risks and the benefits, as these patients may be at risk from central-nervous side effects.     SIDE EFFECTS Effects on the gastrointestinal tract Nausea, diarrhoea, vomiting, digestive disturbances, abdominal pain, flatulence, loss of appetite. If severe and persistent diarrhoea occurs during or after treatment the doctor must be consulted, since this can mask a serious underlying intestinal disorder (pseudomembranous colitis) which requires immediate treatment. In such cases Cipromax must be discontinued and suitable therapy initiated (e.g. 4 x 250 mg vancomycin/day p.o.). Drugs which inhibit peristalsis must not be administered . Effects on the nervous system : Dizziness, headache, tiredness, agitation, tremor very rarely, sleeplessness, sensory disturbances in the arms and the legs (peripheral), sweating, unsteady gait, convulsions, increase in intracranial pressure, anxiety states, nightmares, confusion, depression, hallucinations, in isolated cases psychotic reactions(right up to self-aggression). These reactions sometimes occurred after only one dose. In such cases Cipromax must be discontinued immediately and the treating physician must be informed. EFFECTS ON THE SENSE ORGANS: Very rarely taste and smell disturbances, visual disturbances (e.g. double vision, seeing colours), tinnitus,temporary hearing difficulties, particularly at high frequencies. Hypersensitivity reactions The following reactions sometimes occurred after only one dose. In such cases Cipromax must be discontinued immediately and the treating physician must be informed. Skin reactions such as rashes pruritus, drug fever. VERY RARELY: - severe skin reactions, which may be life-threatening, which may be associated with disturbances of general health, fever and inflamed reddening or vesicular lifting of the skin, lips and mucosa (petechiae, haemorrhagic bullae, papules, vasculitis, Stevens-Johnson syndrome, Lyell's syndrome). -Kidney and liver damage (interstitial nephritis, liver-cell necrosis right through to life-threatening liver failure). - immediate severe allergic reactions right through to shock (anaphylactic/anaphylactoid reactions), sometimes after only one dose. In such cases Cipromax must be discontinued immediately and medical treatment (e.g. shock therapy) initiated. The signs of shock include for example facial, vascular and laryngeal oedema, cold sweats, dyspnoea, dizziness and drowsiness, fast pulse rate, and a fall in blood pressure. Effects on the cardiovascular system Tachycardia; very rarely hot flushes, migraine, syncope. Others Articular complaints; very rarely a general feeling of weakness, muscle pains, tendosynovitis, light-sensitivity with reddening of the skin (photosensitivity), transient impairment of kidney function right through to temporary kidney failure. Inflammation of the Achilles tendon has been observed in isolated cases during treatment with Cipromax. Since this may lead to tendon rupture, if there is any evidence of inflammation of the Achilles tendon (e.g. painfull swelling Cipromax must be discontinued immediately and the doctor informed. Repeated and long-term use of an antibiotic can lead to a renewed infection with the same pathogen, if the strain has developed resistance to the antibiotic. Superinfection with blastomycetes is also possible. Effects on blood and constituents Changes in blood cells or blood coagulation may occur (eosinophilia, leucocytopenia, granulocytopenia, anaemia thrombocytopenia; very rarely leucocytosis, thrombocytosis, haemolytic anaemia, altered prothrombin values. Influence on laboratory and urinary parameters Liver function may be affected (increase in transaminases and alkaline phosphatase, right through to cholestatic jaundice) particularly in patients with existing liver damage. There may be an increase in metabolic products in the blood (urea, creatinine, bilirubin, and glucose). In isolated cases crystals or red blood cells have been observed in the urine (crystalluria and haematuria). Note for drivers Even when used in accordance with the instructions, this product may affect the speed of reaction to such a degree that the ability to drive or to operate machinery is impaired. The effect is intensified by combination with alcohol.     INTERACTIONS Simultaneous administration of Cipromax and iron, sucralfate or antacids containing magnesium, aluminium, or calcium reduces the absorption of Cipromax. Cipromax should therefore be taken either 1-2 h before or at least 4 h after these products. This restriction does not apply to antacids of the H2- receptor blocker type.     PRESENTATIONS 250 mg & 500 mg tablet in blister pack.