Health Vidya

Ciprofloxacin tablets are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin­susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes. Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis. Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii † , Shigella dysenteriae, Shigella flexneri or Shigella sonnei † when antibacterial therapy is indicated. † Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. Ciprofloxacin tablets are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated. Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see Warnings and Precautions (5.17) ]. Ciprofloxacin tablets are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [ s ee Clinical Studies (14.2) ] . Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.3) ]. Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Esc h er i ch i a co l i or P ro t eus m i ra b i l i s. Ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by Esche r i c h i a co l i , Kl eb s i e l l a pneu m o n i ae, E n t e roba c t er c l oa c ae, P r o t e us mi ra b i l i s, Pseudo m on a s aeru g i nos a , H ae m op h il u s i n fl u enz a e, H ae m op h i l us p a ra i n fl u enz a e, or S t re p t oc oc cus p n eu m on i a e. Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to S t re p t o c occ u s pn e u m on i a e. Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by M or a xe l l a ca t a rrh a l i s. Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see W arn i ngs and P r eca u t i ons ( 5.1 to 5.16 ) ] and for some patients AECB is self-limiting, reserve ciprofloxacin tablets for treatment of AECB in patients who have no alternative treatment options. U r i na r y Tr a ct I n f ec t i o n s i n Adu l t s Ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by Esche r i c h i a c o l i, K l eb s i e ll a p neu m o n i ae, E n t eroba c t e r c l oac a e, S e rr a ti a m arce s cen s, Pr o t eus m i r a b i l i s, P ro v i de n c i a re t t ge r i, M or g an e ll a m o rg a n ii, C i t roba c t e r ko s e r i, Ci t r obac t er f re u nd i i, P s eudo m o nas a e rug i nosa, methicillin-susceptible S t a p hy l o c occ u s e p i d e r m i d i s, S t aphy l o co c cus s apro p hy t i c u s, or E n t e roco c cus f aec a l i s. Acu t e U n co m p l i c a t ed C ys ti ti s Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Esche r i c h i a co l i or S t a ph y l ococc u s sa p rop h y t i cu s . Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [ see Wa r n i n g s and P r e ca u ti o n s ( 5.1 to 5.16 ) ] and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options. C o m p li c a t e d U r i n ary T ra c t I n f ec t i on a nd P y e l o n eph r i t i s i n Pe d i a t r i c Pa t i e n t s Ciprofloxacin tablets are indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to E s ch e r i c h i a c o l i [ s ee U s e i n Spe c i f i c Pop u l a ti o ns (8.4) ]. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see W arn i ngs and P rec a u t i ons (5.13) , Adverse Rea c t i ons (6.1) , U se i n S pe c i f i c P o pu l a ti o ns (8.4) and N on c l i n i c a l To x i c o l ogy (13.2) ] . Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by H a e m oph i l us i n f l ue n zae, S t re p t o c occ u s pn e u m on i a e, or M ora x e l l a c a t a rrh a l i s. Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 to 5.16)] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute sinusitis in patients who have no alternative treatment options. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin tablets may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing p