Advertisement
Advertisement
Cirok

Cirok

ciprofloxacin

Manufacturer:

Ratnatris Pharma

Distributor:

One Pharma
Concise Prescribing Info
Contents
Ciprofloxacin HCl
Indications/Uses
Adult: Lower resp tract infections due to gram -ve bacteria (exacerbations of COPD, broncho-pulmonary infections in cystic fibrosis or bronchiectasis, pneumonia); chronic suppurative otitis media; acute exacerbation of chronic sinusitis caused by gm -ve 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 (eg, travellers' diarrhoea); intra-abdominal, bone & joint infections; skin & soft tissue infections caused by gram -ve 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. Ped: 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 childn & adolescents.
Dosage/Direction for Use
Adult Lower resp tract; acute exacerbation of chronic sinusitis; chronic suppurative otitis; skin & soft tissue infections 500-750 mg bid for 7-14 days. Malignant external otitis 750 mg bid for 7-14 days. Uncomplicated cystitis 250-500 ng bid for 3 days, in pre-menopausal women 500 mg as single dose. Complicated cystitis, uncomplicated pyelonephritis; typhoid fever 500 mg bid for 7 days. Complicated pyelonephritis 500-750 mg bid for at least 10 days, can be continued for longer than 21 days in some specific circumstances (eg, abscesses). Prostatitis 500-750 bid for 2-4 wk (acute) to 4-6 wk (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 bid 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 bid for 1 day. Diarrhoea caused by Shigella dysenteriae type 1 500 mg bid for 5 days. Diarrhoea caused by Vibrio cholerae 500 mg bid for 3 days. Intra-abdominal infections due to Gram -ve bacteria 500-750 mg bid for 5-14 days. Bone & joint infections 500-750 mg bid max of 3 mth. Treatment or prophylaxis of infections in neutropenic patients 500-750 mg bid (total duration of treatment: therapy should be continued over the entire period of neutropenia). Ped Cystic fibrosis 20mg/kg body wt bid w/ a max of 750 mg/dose for 10-14 days. Complicated UTI & pyelonephritis 10-20 mg/kg body wt bid w/ a max of 750 mg/dose for 10-21 days. Inhalation anthrax post-exposure prophylaxis & curative treatment 10-15 mg/kg body wt bid w/ a max of 500 mg/dose for 60 days from the confirmation of Bacillus anthracis exposure. Other severe infections 20 mg/kg body wt bid 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
May be taken with or without food: Swallow unchewed w/ fluid. Do not take w/ dairy products (eg, milk, yoghurt) or mineral-fortified fruit juice (eg, Ca-fortified orange juice).
Contraindications
Hypersensitivity to active substance, other quinolones or any of the excipients. Concomitant administration w/ tizanidine.
Special Precautions
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 +ve 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 (eg, 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. Should be used in combination w/ other antimicrobial agents depending on the results of the microbiological documentation in infections of the bones & joints. Treatment of cystic fibrosis &/or severe infections in childn & adolescents should be initiated only after a careful benefit-risk evaluation, due to possible adverse events related to joints &/or surrounding tissue. Caution when treating patients w/ other specific severe infections. Tendinitis & tendon rupture (especially Achilles tendon) may occur w/ ciprofloxacin, as soon as the 1st 48 hr of treatment. Risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated w/ corticosteroids. Any signs of tendinitis (eg, painful swelling, inflammation) should be discontinued. Use w/ caution in patients w/ myasthenia gravis. Impaired vision. Avoid direct exposure to extensive sunlight or UV irradiation during treatment. Known to trigger seizures or lower the seizure threshold. Reports of status epilepticus; polyneuropathy, hypoglycaemia; hepatic necrosis & life-threatening hepatic failure. Caution in patients w/ CNS disorders; patients w/ known risk factor for prolongation of the QT interval; crystalluria. Psychiatric reactions may occur even after the 1st administration. Patient should be well hydrated & excessive alkalinity of the urine should be avoided. Dose adjustment is needed in patients w/ impaired renal function. Avoid in patients w/ G6PD deficiency. Monitor potential occurrence of haemolysis. Concomitant administration of theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine. Closely monitor for clinical signs of overdose, & determination of serum conc may be necessary. False -ve bacteriological test results against Mycobacterium tuberculosis. May impair ability to drive or operate machinery. Avoid use during pregnancy & lactation. Elderly.
Adverse Reactions
Nausea, diarrhoea. Childn: Arthropathy.
Drug Interactions
Caution in drugs known to prolong QT interval (eg, class IA & III anti-arrhythmics, TCAs, macrolides, antipsychotics). Reduced absorption of multivalent cation-containing drugs (eg, Ca, Mg, Al, Fe), polymeric phosphate binders (eg, sevelamer), sucralfate or antacids, & highly buffered drugs (eg, didanosine tab). Avoid concurrent administration of dairy products or mineral-fortified drinks alone (eg, milk, yoghurt, Ca-fortified orange juice). Increased serum conc w/ probenecid, theophylline, caffeine, pentoxifylline (oxpentifylline) & clozapine. Accelerates absorption w/ metoclopramide. Slight reduction of Cmax & 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. May augment anti-coagulant effects of vitamin K antagonists (eg, warfarin, acenocoumarol, phenprocoumon or fluindione). Increased AUC & Cmax of duloxetine, ropinirole & sildenafil. Reduced clearance of IV lidocaine. Increased agomelatine exposure. Increased blood levels of zolpidem.
MIMS Class
Quinolones
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cirok FC tab 500 mg
Packing/Price
100's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement