Ciprofloxacin tablets are indicated for the treatment of the following infections. Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Adults: Treatment of infections caused by ciprofloxacin-sensitive pathogens such as: Lower respiratory tract infections due to Gram-negative bacteria. – exacerbations of chronic obstructive pulmonary disease. – broncho-pulmonary infections in cystic fibrosis or in bronchochiectasis. – pneumonia. – Upper respiratory tract infections: Chronic supportive otitis media. – Acute exacerbation of chronic sinusitis especially if theses are caused by Gram-negative bacteria. Malignant external otitis . – Urinary tract infections-, including a cute uncomplicated cystitis, complicated infections and pylenophritis. Genital organ infections, including Gonococcal uretritis and cervicitis. – Epididymo-orchitis including cases due to Neisseria gonorrhoeae. – Pelvic inflammatory diseases including cases due to Neisseria gonorrhoeae. In the above genital tract infectons when thought or known to be due to Neisseria gonorrhoeae is is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing. – Gsatro-intestinal infections ( severe gastroenteritis ). – Intra-abdominal infections. – Infections of the skin and soft tissue – Infections of the bones and joints. severe systemic infections: septica emia, peritonitis ( in -case of per itontiis, the ana erobic component should be covered by another antibacterial agent such as metronidazole , infections in immuno-suppressed patients. Treatment of infections in neutropenic patients. – Prophylaxis of infections in neutropenic patients. – Prophylaxis of invasive infections due to Neisseria meningitidis. – inhalation anthrax (post-exposure prophylaxis and curative treatment). Children and adolescents: – Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa. – Complicated urinary tract infections and pylonephritis. – inhalation anthrax (post-exposure prophylaxis and curative treatment)

DOSAGE OF CIPROFLOXACIN 500MG TAB

Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet

Ask your pharmacist or doctor for help if you do not understand the instructions on the box .

The recommended dose is : –

The dose of Ciprofloxacin tablets is determined by the indication, the sensetivity of the causative organism(s), the age , weight and renal function of the patient . The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course. treatment should be maintained for at least 3 days after body temperature has returned to normal , or clinical symptoms have resolved. The following dose recommendations are provided as a guidline and refer to oral dosing only. Treatment of infections due to certain bacteria ( e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci ) may require higher ciprofloxacin doses and co-administration with other-appropriate antibacterial agents. Treatment of some infections ( e.g. pelvic inflammatory disease , intra-abdominal infections, infections in neutropenic patients and infections of bones and joints ). may require co-administration with other appropriate antibacterial agents depending on the pathogens involved. In case of infections of the lower respiratory tract : daily dose is 500 mg twice daily to 750 mg twice daily (tab) for 7 to 14 days. In case of infections of the upper respiratory tract (Acute exacerbation of chronic sinusitis): daily dose is 500 mg twice daily to 750 mg twice daily (tab) for 7 to 14 days. In case of infections of the upper respiratory tract (chronic suportive otitis media): daily dose is 500 mg twice daily to 750 mg twice daily (tab) for 7 to 14 days. In case of infections of the upper respiratory tract (Malignant external otitis): daily dose is 750 mg twice daily (tab) for 28 days up to 3 months. In case of urinary tract infections (Uncomplicated cystitis) : daily dose is 250 mg twice daily to 500 mg twice daily for 3 days ( In-premenopausal women, 500 mg single dose may be used. In case of urinary tract infections (complicated cystitis, uncomplicated pyelonephritis) : daily dose is 500 mg twice daily for 7 to 21 days, it can continued for longer than 21 days in some specific circumatances such as abscesses. In case of urinary tract infections (complicated pyelonephritis) : daily dose is 500 mg twice daily to 750 mg twice daily (tab) for at least 10 days, it can continued for longer than 21 days in some specific circumatances such as abscesses. In case of urinary tract infections (prostatitis ) : daily dose is 500 mg twice daily to 750 mg twice daily (tab) for 2 to 4 weeks (acute) to 4 to 6 weeks (chronic). In case of Genital tract infections (acute uncomplicated gonorrhoea) : daily dose is 250-500 mg as a single dose for 1 day (single dose). In case of Genital tract infections (Gonococcal uretritis and cercicitis) : daily dose is 500 mg as a single dose for 1 day (single dose). In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( severe gastro enteritis) : daily dose is 500 mg twice daily for 3-7 day. In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dyseneriae type 1 and emptrical treatment of severe travellers’s diarrhoea) : daily dose is 500 mg twice daily for 1 day. In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( Diarrhoea caused by Shigella dyseneriae type 1 ) : daily dose is 500 mg twice daily for 5 days. In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( Diarrhoea caused by Shigella dyseneriae type 1 ) : daily dose is 500 mg twice daily for 5 days. In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( Diarrhoea caused Vibrio cholerae ) : daily dose is 500 mg twice daily for 3 days. In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( Typhoid fever ) : daily dose is 500 mg twice daily for 7 days. In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( Diarrhoea caused Vibrio cholerae ) : daily dose is 500 mg twice daily for 3 days. In case of Infections of the gastro-intestinal tract and Intra-abdominal infections ( Intra-abdominal infections due to Gram-negative bacteria ) : daily dose is 500 mg twice daily to 750 mg twice daily for 5 to 14 days. In case of Infections of the skin and soft tissue : daily dose is 500 mg twice daily to 750 mg twice daily for 7 to 14 days. In case of Bone and joint infections: daily dose is 500 mg twice daily for 7 to 14 days. In case of inhalation anthrax (post-exposure prophylaxis and curative treatment for persons able to recieve treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure: daily dose is 500 mg twice daily for 60 days from the confirmation of Bacillus anthracis exposure. Children and adolescents : In case of Cystic fibrosis: daily dose is 20 mg/kg body weight twice daily with a maximum of 750 mg per dose for 10 to 14 days. In case of Complicated urinary tract infections and pylonephritis: daily dose is 10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose for 10 to 21 days. In case of inhalation anthrax (post-exposure prophylaxis and curative treatment for persons able to recieve treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure: daily dose is 10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 500 mg per dose for 60 days from the confirmation of Bacillus anthracis exposure. Elderly patients: Elderly patients should recieve a dose selected according to the severity of the disorder and on creatinine clearance. Renal and hepatic impairment: Recommended starting and maintenance doses for patients with impaired renal function: In case of (creatinine clearance > 60 ml/min/1.73 m2): serum creatinine < 124 µmol/L : Dose is See usual dosage. In case of (creatinine clearance 30- 60 ml/min/1.73 m2): serum creatinine 124-168 µmol/L : Dose is 250-500 mg every 12 h. In case of (creatinine clearance < 30 ml/min/1.73 m2): serum creatinine > 169 µmol/L : Dose is 250-500 mg every 24 h (after dialysis). In case of patients on haemodialysis : serum creatinine > 169 µmol/L : Dose is 250-500 mg every 24 h (after dialysis) . In case of patients on peritoneal dialysis : serum creatinine > 169 µmol/L : Dose is 250-500 mg every 24 h . Impaired HEPATIC function : dose adjustment NOT NECESSARY. iMPAIRED RENAL AND HEPATIC FUNCTION: dOSE ADJUSTMENT as under 1, with monitoring of serum ciprofloxacin concentrations. Method of administration: Tablets are to be swallowed with liquid. They can be takenat any time regardless of meals . ingestion on an empty stomach accelerate the absorption of active substance. Dairy products with a high calcium content ( e.g. milk, yoghurt) or mineral-fortified fruit-juice ( e.g. calcium-fortified orange juice) may reduce ciprofloxacin absorption.

OVER-DOSAGE OF CIPROFLOXACIN 500MG TAB

An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure. Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures,hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crytalluria and haematuria. Reversible renal toxicity has been reported. Apart from routine emergency measures. It is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Only small of ciprofloxacin (< 10%) is eliminated by haemodialysis or peritoneal dialysis.

CONTRA-INDICATION OF CIPROFLOXACIN 500MG TAB

Hypersensitivity to ciprofloxacin, or any of the excipients contained in the tablets or other chemotherapeutic agents of the quinolone type. Concomitant administration of ciprofloxacin and tizanidine.

STORAGE OF CIPROFLOXACIN 500MG TAB

Store at room temperature not exceeding 30 °C, in a dry place.
PACK OF CIPROFLOXACIN 500MG TAB
Carton box containing 1 (transparent PVC/Al) strip of 10 film-coated tablets & an inner leaflet.
CIPROFLOXACIN 500MG TAB MANUFACTURED BY
EUROPEAN EGYPTIAN PHARMACEUTICAL INDUSTRIES ALEXANDRIA – EGYPT

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