Ciprobay

Ciprobay

ciprofloxacin

Manufacturer:

Bayer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ciprofloxacin (tab: HCl; IV: lactate)
Indications/Uses
Uncomplicated & complicated infections caused by susceptible pathogens. Infections of the resp tract (pneumonias caused by Klebsiella spp., Enterobacter spp., Proteus spp., E. coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp., & staphylococci); middle ear (otitis media) or paranasal sinuses (sinusitis), especially if caused by gm -ve organisms including Pseudomonas aeruginosa or by staphylococci; eyes; kidneys &/or the efferent urinary tract; genital organs including adnexitis, gonorrhea, prostatitis; abdominal cavity (eg, infections of the GI or biliary tract, peritonitis); skin & soft tissue; bones & joints. Sepsis. Infections or imminent risk of infection (prophylaxis) in patients whose immune system has been weakened (eg, patients on immunosuppressants or have neutropenia). Selective intestinal decontamination in immunosuppressed patients. Prophylaxis of invasive infections due to Neisseria meningitidis. 2nd & 3rd-line treatment of complicated UTI & pyelonephritis due to E. coli in childn 1-17 yr & for acute pulmonary exacerbation of cystic fibrosis associated w/ Pseudomonas aeruginosa in childn 5-17 years. Reduced incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults & childn.
Dosage/Direction for Use
Tab Adult Resp tract infection 500-750 mg bid for 7-14 days. Acute uncomplicated UTI 250-500 mg bid up to 7 days. Complicated UTI 500-750 mg bid up to 7 days. Cystitis in women (before menopause) 500 mg single dose. Uncomplicated gonorrhea (including extra-genital sites of infection) 500 mg single dose. Adnexitis, prostatitis, epididymo-orchitis 500-750 mg bid for 7-14 days. Diarrhea 500 mg bid for 7 days. Other infections 500 mg bid for 7-14 days. Recurrent infections in cystic fibrosis, bone & joint infections, septicemia, peritonitis 750 mg bid for 10 days. Prophylaxis of invasive infections due to N. meningitidis 500 mg single dose. Childn & adolescent Infections in cystic fibrosis 20 mg/kg bid for 10-14 days. Max: 750 mg. Complicated UTI & pyelonephritis 10-20 mg/kg bid for 10-21 days. Max: 750 mg. Adult Renal impairment & on hemodialysis CrCl 30-60 mL/min/1.73 m2 Max: 1,000 mg; <30 mL/min/1.73 m2 Max: 500 mg. Continuous ambulatory peritoneal dialysis Max: 250 mg bid or 500 mg once daily. IV infusion Administered over a period of 60 min. Resp tract infections 400 mg bid-tid for 7-14 days. Acute uncomplicated UTI 200-400 mg bid up to 7 days. Complicated UTI 400 mg bid-tid up to 7 days. Adnexitis, prostatitis, epididymo-orchitis 400 mg bid-tid for 7-14 days. Diarrhea 400 mg bid for 7 days. Other infections 400 mg bid for 7-14 days. Recurrent infections in cystic fibrosis, bone & joint infections, septicemia, peritonitis 400 mg tid for 10 days. Childn & adolescent Infections in cystic fibrosis 10 mg/kg tid for 10-14 days. Max: 400 mg/dose. Complicated UTI & pyelonephritis 6-10 mg/kg tid for 10-21 days. Max: 400 mg/dose. Adult Renal impairment & on hemodialysis CrCl 30-60 mL/min/1.73 m2 Max: 800 mg; <30 mL/min/1.73 m2 Max: 400 mg. Continuous ambulatory peritoneal dialysis 50 mg/L qid.
Administration
May be taken with or without food: Do not take w/ antacids, Fe or dairy products.
Contraindications
Hypersensitivity to ciprofloxacin or other fluoroquinolones. Concurrent administration w/ tizanidine.
Special Precautions
Hypersensitivity & allergic reactions. Should be used in combination w/ an appropriate antibacterial agent for severe infections, staphylococcal infections & infections involving anaerobic bacteria. Not recommended for pneumococcal infections. Confirm susceptibility based on laboratory testing in genital tract infections due to Neisseria gonorrhoeae. Concomitant use w/ drugs that can prolong QT interval (eg, class IA or III antiarrhythmics, TCAs, macrolides, antipsychotics) or in patients w/ risk factors for QT prolongation or torsade de pointes [eg, congenital long QT syndrome, uncorrected electrolyte imbalance (eg, hypokalemia or hypomagnesemia) & cardiac disease (eg, heart failure, MI, or bradycardia)]. Discontinue in the event of severe & persistent diarrhea during or after treatment; any signs & symptoms of hepatic disease (eg, anorexia, jaundice, dark urine, pruritus, or tendon abdomen); patient develops depression or psychotic reaction progressing to suicidal ideations/thoughts & self-injurious behavior eg, attempted or completed suicide. Temporary increase in transaminases, alkaline phosphatase, or cholestatic jaundice, especially in patients w/ previous liver damage. May exacerbate symptoms of myasthenia gravis. Tendinitis & tendon rupture (predominantly Achilles tendon); history of tendon disorders related to fluoroquinolone treatment. Known to trigger seizures or lower the seizure threshold; discontinue if seizure occurs. Sensory or sensorimotor polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, or weakness. Avoid direct exposure to excessive sunlight or UV light; discontinue if photosensitization (ie, sunburn-like skin reactions) occurs. Careful monitoring of blood glucose in diabetic patients is recommended. Careful benefit-risk assessment in patients w/ +ve family history of aneurysm disease, or diagnosed w/ preexisting aortic aneurysm &/or dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm & dissection (eg, Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, HTN, known atherosclerosis). Concomitant use w/ theophylline, methylxanthines, caffeine, duloxetine, ropinirole, clozapine, olanzapine, agomelatine. False -ve result w/ Mycobacterium tuberculosis culture test. May impair ability to drive or operate machinery. Not recommended during pregnancy & lactation. Elderly. IV infusion: Local IV site reactions.
Adverse Reactions
Nausea, diarrhea, vomiting, transient increase in transminases, rash. IV infusion: Inj site reaction.
Drug Interactions
Drugs known to prolong the QT interval (eg, class IA & III anti-arrhythmics, TCAs, macrolides, antipsychotics). Increased serum conc w/ probenecid. Increased serum conc of tizanidine, theophylline, caffeine or pentoxifylline (oxpentifylline) containing products, clozapine & N-desmethylclozapine. Altered (decreased or increased) serum levels of phenytoin. May inhibit renal tubular transport of methotrexate. Can provoke convulsions w/ NSAIDs (but not acetylsalicylic acid). Transient rise in serum creatinine conc w/ cyclosporin. May augment anticoagulant effects of vit K antagonist. Increased AUC & Cmax of duloxetine, ropinirole, sildenafil. Reduced clearance of lidocaine IV. Markedly inhibits the metabolism of agomelatine. May increase blood levels of zolpidem. Tab: Reduced absorption w/ multivalent cation-containing medicinal products & mineral supplements (eg, Ca, Mg, Al, Fe), polymeric phosphate binders (eg, sevelamer, lanthanum carbonate), sucralfate or antacids, & highly buffered drugs (eg, didanosine tab) containing Mg, Al, or Ca; dairy products or mineral-fortified drinks alone (eg, milk, yoghurt, Ca-fortified orange juice). Accelerates absorption w/ metoclopramide. Slight reduction of Cmax & AUC w/ omeprazole.
MIMS Class
Quinolones
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Ciprobay IV infusion 200 mg/100 mL
Packing/Price
1's
Form
Ciprobay IV infusion 400 mg/200 mL
Packing/Price
1's
Form
Ciprobay tab 500 mg
Packing/Price
50's
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