PRODUCTS

Regulatory Class: Rx
Generic Name: Ciprofloxacin HCl
Formulation/s: 500 mg Film-coated tablet

Indications or Use: Adult: Lower respiratory tract infections due to gram negative bacteria (exacerbations of COPD, broncho-pulmonary infections in cystic fibrosis or bronchiectasis, pneumonia); chronic suppurative otitis media; acute exacerbation of chronic sinusitis caused by gram-negative bacteria; UTI; genital tract infections; gonococcal urethritis & cervicitis due to susceptible Neisseria gonorrhoeae; epididymo-orchitis & pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae; GI tract infections (e.g., travellers’ diarrhoea); intra-abdominal, bone & joint infections; skin & soft tissue infections caused by gram negative bacteria; malignant external otitis; prophylaxis & treatment of infections in neutropenic patients; prophylaxis of invasive infections due to Neisseria meningitides. Post-exposure prophylaxis & treatment of inhalational anthrax. Pedia: Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa; complicated UTI & pyelonephritis; post-exposure prophylaxis & treatment of inhalational anthrax; cystic fibrosis &/or severe infections in children & adolescents.

Dosage and Directions for Use: Adult: Lower respiratory tract; acute exacerbation of chronic sinusitis; chronic suppurative otitis; skin & soft tissue infections 500-750 mg twice a day for 7-14 days. Malignant external otitis 750 mg twice a day for 7-14 days. Uncomplicated cystitis 250-500 mg twice a day for 3 days, in pre-menopausal women 500 mg as single dose. Complicated cystitis, uncomplicated pyelonephritis; typhoid fever 500 mg twice a day for 7 days. Complicated pyelonephritis 500-750 mg twice a day for at least 10 days, can be continued for longer than 21 days in some specific circumstances (e.g., abscesses). Prostatitis 500-750 twice a day for 2-4 weeks (acute) to 4-6 weeks (chronic). Gonococcal urethritis & cervicitis; prophylaxis of invasive infections due to Neisseria meningitidis 500 mg as single dose. Epididymo-orchitis & pelvic inflammatory diseases 500-750 mg twice a day for at least 14 days. Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 & empirical treatment of severe travellers’ diarrhoea 500 twice a day for 1 day. Diarrhoea caused by Shigella dysenteriae type 1 500 mg twice a day for 5 days. Pedia:  Cystic fibrosis 20mg/kg body weight twice a day  w/ a max of 750 mg/dose for 10-14 days. Complicated UTI & pyelonephritis 10-20 mg/kg body weight twice a day   w/ a max of 750 mg/dose for 10-21 days. Inhalation anthrax post-exposure prophylaxis & curative treatment 10-15 mg/kg body weight twice a day  w/ a max of 500 mg/dose for 60 days from the confirmation of Bacillus anthracis exposure. Other severe infections 20 mg/kg body weight twice a day w/ a max of 750 mg/dose (total duration of treatment: according to the type of infections). CrCl >60 mL/min/1.73 m² (<124 μmol/L) see usual dosage. CrCl 30-60 mL/min/1.73 m² (124-168 μmol/L) 250-500 mg every 12 hr. CrCl <30 mL/min/1.73 m² (>169 μmol/L) 250-500 mg every 24 hr. Patient on haemodialysis (>169 μmol/L) 250-500 mg every 24 hr (after dialysis). Patient on peritoneal dialysis (>169 μmol/L) 250-500 mg every 24 hr.

Administration: Take with or without food. Swallow unchewed with fluid. Do not take with dairy products (e.g., milk, yoghurt) or mineral-fortified fruit juice (e.g., Calcium-fortified orange juice).

Contraindication: Hypersensitivity to active substance, other quinolones or any of the excipients. Concomitant administration with tizanidine.

Special Precaution: Discontinue & adequate medical treatment is required if hypersensitivity & allergic reactions, including anaphylaxis & anaphylactoid reactions occur; seizures; depression or psychosis progressed to suicidal ideations/thought; patients experiencing symptoms of neuropathy; occurrence of severe and persistent diarrhoea during or after treatment. Not suited for treatment that might be due to gram positive or anaerobic pathogens. Not recommended for the treatment of streptococcal infections. Not to be used in patients w/ a history of tendon disease/disorder related to quinolone treatment. Should be administered for the treatment of gonococcal urethritis or cervicitis only if ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. For epididymo-orchitis & pelvic inflammatory diseases, empirical ciprofloxacin should be considered in combination w/ another appropriate antibacterial agent (e.g., cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered. Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones. Single dose of ciprofloxacin that may be used in uncomplicated cystitis in pre-menopausal women is expected to be associated w/ lower efficacy than the longer treatment duration.

Adverse Reaction:  Nausea, diarrhoea. Children: Arthropathy.

Interactions: Caution in drugs known to prolong QT interval (e.g., class IA & III anti-arrhythmics, TCAs, macrolides, antipsychotics). Reduced absorption of multivalent cation-containing drugs (e.g., Ca, Mg, Al, Fe), polymeric phosphate binders (e.g., sevelamer), sucralfate or antacids, & highly buffered drugs (e.g., didanosine tab). Avoid concurrent administration of dairy products or mineral-fortified drinks alone (e.g., milk, yoghurt, Ca-fortified orange juice). Increased serum conc w/ probenecid, theophylline, caffeine, pentoxifylline (oxpentifylline) & clozapine. Accelerates absorption w/ metoclopramide. Slight reduction of C_max & AUC w/ omeprazole. Increased plasma levels of MTX & risk of MTX-associated toxic reactions. Increased or reduced serum levels of phenytoin. Transient rise in serum creatinine conc of ciclosporin.

Presentation/ Packaging: Film-coated 500 mg x 100’s

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