Ciprobay 750

Ciprobay  750

Ciprobay 750 mg Film Coated Tablet
Ciprofloxacin
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CiproUay 750 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 750 mg cipronoxaan (as hydrochloride).
For the tull list of excipients, see section 6M _
3. PHARMACEUTICAL FORM
Film-coated tablet
Oblong, nearly white to slightly yenowish tabWs marked with •CIP 750" on one side and •BAYER* on the reverse side,
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Cgyobay 750 mg film-coated tablets are hdicated for the treatment of fie following infections (see sections 4 A and 91 Special attention should Oe paid to available information on
resistance to ciprofloxacin before commencing therapy
Consideration should given to official guidance on appropriate use of antibacterial agents
• Lower resWatryy tract infections due to Gram-negative bacteria
- exacerbations Of chron•c obstructive puirncmary disease
- bronctw'-puinunary infections in cystic or
- pneumonia
• Chronic suppurative otitis media
• Acute exacerbatm of chronic sinusitis especially it these are caused by Gram-negative bacteria
• urinary tract infections
• Genital tract infections
• gonococcal uretritis and cervicRis due to susceptible Neisseria gonorrhoeae
• epidk'ynw—orchitis including cases due to susceptible Neissena gonorrhoeae
pelvic innammatory disease including cases due to susceptible Neisseria gonorrhoeae
• Intecü»ns of the gastro-intesbnai tract (e_y travelers' diarrhea)
• Intra-abdominal infections
• Intectms of the skin and son tissue caused by Gram-negative bacteria
• Malignant external otitis
• Infections of the tnnes and joints
• Prophylaxis 01 invasive infections due to Neisseria meningitidis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may be in the management Of patients With fever that is suspected to be due to a bacterial infectiory
• Broncho-pulmonary infectons in cystic fibrosis caused by Pseudomonas aen.oinosa
• Complicated urinary tract infections and pyelonephritis
• anthrax (post-exMjsure prophylaxis and curative treatment)
Ciprofloxacin may also be used to treat severe infections in children and adolescents When this is considered to be necessary
Trearnent should be init'ated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 44 and 5, 1 J,
4.2 Posology and method Of administration
The dosage is determined by the indication. the severity and the site of the infection. the susceptibility to ciprofloxacili•
e causative organism(s), the renal function Ot the patient and,
in children and adolescents me body weight
The duration of treatrnent depends on the severity of the illness and on the clinical and bacteriological course.
Treatment Of infections due to certain bacteria (e Pseudomonas a-emOir*sa, Actnetobacter 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 hfections. infections in neutropenic patients and infections of bones and joints) may require
co-administration with Other appropriate antibacterial agents depending on the pathogens involved
prophylaxis Of invasive infections
due to Neisseha menin9it'dis
Inhalation anthrax post-exposure prophylaxis and curative
treatment for persons able to receive treatment
clinically appropnate
as soon as possible aner
suspected or confirmed exposure
Indications
Cystic fibrosis
Cornplicated urinary tract and pyelonephritis
Inhalation anthrax post-exposure prophylaxis andcurative
treatment for persons able to receive treatment by route
when clinically appropriate. Drug administration should be•øn
as scnn as possible aner suspected or confirrned exposure.
Other severe infections
500 mg as a single dose
500 mg twice daily
Daily dose In mg
20 mg/kg body weight twice daily
with a maxirnum Ot 750 mg per dose,
I O mg/kg body weight twice daily
to 20 mg/kg body weight twice daliy
with a maximum of 750 mg dose
I a rWkg body weight-twice dab' to 1 5
mgy*g body weight twice daily with
maximum Of 500 mg per dose.
20 mg/kg body weight twice daily with a
maximurn Of 750 mg per do*.
I day (single dose)
60 days front the confirmation Of Bacillus anthracis
Total duration Of treatment (potentially
initial parent.ral treatment With ciprofloxacin)
10 to 14 days
10 to 21 days
60 days from the confirmation Of Bacillus anthracis exposure
According to the type of fifections
Elderly patients should receive a dose selected according to the severity of the infection and the ptient's creatinine clearance
Recommended starting and maiMenance doses patE'ts With impaired renal function:
Oral Dose
See Usual
Creatinine Clearance
ImUmin/1.73m')
60
30-60
30
Patients on haemodialysis
Patients on peritoneal dialysis
Serum Creatinine
€124
124 to 168
169
250 -
250
250 -
250 -
500 mg every 12 h
500 mg every 24 h
mg every 24 h (after dialysis)
500 mg every 24 h
in patients with Impaired liver function no dose adjustment is required.
Oosing in children with impaired renal and/or hepatic function has not been studied.
Tablets are to be swallowed unchewed With fluid. They can be taken independent Of meal time. It taken on an empty stomach, the active substance is absorbed more rapidly
Ciprofloxacin tablets should not be taken With dairy products milk, yoghurt) or mineral-fortified fruit-juice (e.g. calcium-fortified orange juice) (see section
In severe cases or if the patient is unable to take tablets (e.g. patients on entera nutrition). it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral
administration is
4.3 Contraindications
• Hypersensitivity to the active substance. to other quinolones Or to any Of the excipients listed in section 6.1.
• Concomitant administration of ciprofloxacin and tizanidine (see section 4.5).
4.4 Special warnings and precautions for use
Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such ü-lfections ciprofloxacin
must With Other appropriate antibacterial agents.
Ciprofloxacin is not recommended for the treatrnent Of streptococcal infectimS due to inadequate 'mcacy.
Gonococcai uretritis. cervicitis. epididymo-orchitis and pelvic Inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates
Therefore, ciprofloxacin should be administered for the treatment of gonococcai uretritis or cervicitis only if ciprofoxacin-res.stant Neisseria gonorrhoeae can be excludecr
For $didymo—orchitis and petvic inflammatory diseases. empirical ciprofloxacin should only considered in combination With another appropriate antibacteriai agent a
cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded, If chniæi improvement is not achieved after 3 days Of treatment, the tierapy should be
reconsidered.
Resistance to fluoroquinolones Of Escherichia coli — the most common pathogen involved in urinæ-y tract infections — varies across the European Union, Prescribers are advised to take
into account the prevalence resistance in Escherichia coli to fluoroquinclones,
The single dose of ciprofloxacin. that may be used in uncomplicated cystitis in pre-menopausal women, is expected to be associated with lower emcacy than the longer treatment
duration. This is all the rnore to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones_
There are limited data on the emcacy of ciprofloxacin in the treatment of post-surgical intra-abdorninai infections.
The choice of ciprofloxacin should take into account infcymation resistance to ciprofloxacin in relevant pathogens in the countries visited,
Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation
use in humans is based on in-vitro susceptibility data and on animal experimental data together limited human data. Treating physicians should refer to national and'or international
consensus documents regarding treatment Of anthrax
The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are expenenced in the
treatment Of cystic fibrosis and/or severe infections in children and adolescents
Caprofloxacin has been shown to cause arthropathy weight-bearing joints of immature animals. Safety data from a randomised double-blind study on use in children
(ciprofloxacin: n:33S. mean age 64 years: comparators: n--34g. mean age 62 years; age range | to 17 years) revealed an incidence of suspected drug-realed arthropathy
(discerned from joint-related Signs and symptoms) by Day 442 of 7 and 4.60K Respectively an incidence Ot drug-related arthropathy by I •year foIow-up was '3 and
The increase Of suspected drug-related arthropathy cases over time was not statistically significant between groups. Treatment shcpa'd be initiated only after a careful benefiVnsk
evaluation, due to possible adverse events related to and/or surrounding tissue.
Clin.cai trials have induded children and adolescents aged 5-17 years More hmited experience is available in treating children between 1 and 5 years of age.
Como/jG4ted urinary tract fifections and av.e(Qnwhritis
Ciprofloxacin treatment ot urinary tract infections should be cnnsidered when other treatments be used, and be based the results of tile microbido" documentation.
Clinical trials have included children and adolescents aged 1-17 years,
Other severe infections in accordance with official guidance. or aner careful benefit-risk evaluation when other treatments cannot be used. or after failure to conventional therapy and
when the microbiological documentat'or, can justify a ciprofloxacin use
The use ot ciprofloxacin tor specific sovere infections Other than those mentioned above has not been in clinical trials and the clinical experience is lirMed Consequently,
caution is advised when treating patients with these infections.
Hypersensitivity and allergic reactions. including anaphylaxis and anaphylactoid reactions. may occur following a single dose (see section 4.8) and may be life-eveateniny If such
reaction occurs. ciprofloxacin sh0'Nd be discontinued and an adequate medical treatrnent is reqWed
Musculoskeleta_Sxstem
Ciprofloxadn should generally not be used in patients with a history Of tendon disease/disorder related to quinolone treatment. Nevertheless. in very rare instances, aner microbiological
documentation of the causative organism and evaluation of the risk'benefit balance. ciprofloxacin may he prescribed to these patients for the treatment ot certain severe infections,
partrcularly In the event of failure of the standard therapy or bacterial resistance, where the rnicrobiological data may justify the use of
Tendinitis and tendon rupture (especiai'y Achilles tendon), sometimes bilateral. may occur WIth ciprofloxacin, even within the first 4B hours ot treatment Infarnrnatbn and ruptures of
tendon may occur even up to several months after discontinuation Of ciprofloxacin therapy. The risk of tendinopathy may be increased in elderly patents or in patients Concomitantly
treated with corticosteroids (see section
At any sign of tendinitis (e. painfui swelling. inflammation). ciprofloxacin treatment should be discontinued Care should be taken to keep the affected limb at rest.
Ciprofloxacin should be used with caution in patients with myasthenia gravis. because symptorns can be exacerbated (see section 48),
Total duration of treatment (potentially including initial
parenteral treatment with ciprofloxacin)
7 to 14 days
7 to 14 days
7 to 14 days
2B days up to 3 months
3 days
Infections Of the bwer respiratory tract
Daily dose In mg
500 twice daily to 750 mg twice daily
500 mg twice dairy to 750 mg twice daily
500 mg twice daily to 750 mg twice daily
750 twice daily
500 mg twice daily to 750 mg twice daily
Infections Of
the upper
urinary tract
(see section 4.4)
Genital tract
Infections of the
tract and
fitra-abdominal
Acute exacerbation
Of chrmic sinusitis
suppurative
Otitis media
external
Uncomplicated cystitis
Uncomplicated
Cornpücated pyelonephritis
Gonococcal urethtis and cervicitis
Epididymc-orchitis and pelvic
inflammatory diseases
Diarrhoea caused by bacterial
In pre-menc»ausal women, 500 mg single dose may be used
500 mg twEe daily
500 rng twice daily to 750 mg twice daily
500 mg twice daily to 750 mg twice daily
500 mg as a single dose
500 rng twice dany to mg twice daily
7 days
at least 10 days it can be continued for longer than 21
days in some specific circumstances (such as abscesses)
2 to 4 weeks (acute) to 4 to 6 weeks (chronic)
1 day (single 'fiseb
at least 14 days
i day
3 days
7 days
5 to 14 days
7 to 14 days
max of 3 rnonths
Therapy should be continued over the entire period Of neutropenia
pathogens including Shigella spsx other
500 mg twice dady
than Shigeua dysenteriae type' and
empirical treatment of severe
traveners diarrhoea
Diarrhoea caused by Shigella
dysenteriae type 1
500 mg twice daily
Diarrhoea caused by Vibrio cholerae
T yph0k$ fever
Intra-abdominal infections due to Gram
negabve bacteria
Infections of twe skin and soft tissue
Bone and joint infections
Neutro$y.nic patients with fever that is suscæcted to be due
to a bacterial intecticn.
Ciprofloxacin should be co-administered with appropriate
antibacterial agent(s) in accordance to official guklance_
500 mg twice daily
500 mg Wice daily to 750 rng twice daily
500 mg twice daily to 750 mg twice daily
mg twice daily to 750 rog twice daily
500 mg twice daily to 750 mg twice daily