Ciproxin施博善

Ciproxin

ciprofloxacin

Manufacturer:

Bayer

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Ciprofloxacin
Indications/Uses
Adult patients: Lower resp tract infections due to gm -ve bacteria (exacerbation of COPD; broncho-pulmonary infections in cystic fibrosis or in bronchiectasis; pneumonia); chronic suppurative otitis media; acute exacerbation of chronic sinusitis especially if caused by gm -ve bacteria; UTI (uncomplicated acute cystitis (tab only); acute pyelonephritis; complicated UTI; bacterial prostatitis); genital tract infections (gonococcal urethritis & cervicitis due to susceptible Neisseria gonorrhoeae (tab only), epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae; pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae); infections of the GI tract (eg, travellers’ diarrhoea); intra-abdominal infections; infections of the skin & soft tissue caused by gm -ve bacteria; malignant external otitis; infections of the bones & joints; prophylaxis of invasive infections due to Neisseria meningitidis (tab only); inhalation anthrax (post-exposure prophylaxis & curative treatment). May be used in the management of neutropenic patients w/ fever that is suspected to be due to a bacterial infection. Childn & adolescents: Broncho-pulmonary infections in patients w/ cystic fibrosis caused by Pseudomonas aeruginosa; complicated UTI & acute pyelonephritis; inhalation anthrax (post-exposure prophylaxis & curative treatment). May also be used to treat severe infections in childn & adolescents when considered necessary.
Dosage/Direction for Use
Adult Lower resp tract infection; acute exacerbation of chronic sinusitis; chronic suppurative otitis media 500-750 mg bd PO or 400 mg bd-tds IV for 7-14 days. Malignant external otitis 750 mg bd PO or 400 mg tds IV for 28 days up to 3 mth. Bacterial prostatitis 500-750 mg bd PO for 2-4 wk (acute) to 4-6 wk (chronic); or 400 bd-tds IV for 2-4 wk (acute). Epididymo-orchitis & pelvic inflammatory diseases due to susceptible Neisseria gonorrhoeae 500-750 mg bd PO or 400 mg bd-tds IV 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 mg bd PO or 400 mg bd IV for 1 day. Diarrhoea caused by Shigella dysenteriae type 1 500 mg bd PO or 400 mg bd IV for 5 days. Diarrhoea caused by Vibrio cholerae 500 mg bd PO or 400 mg bd IV for 3 days. Typhoid fever 500 mg bd PO or 400 mg bd IV for 7 days. Intra-abdominal infections due to gm -ve bacteria 500-750 mg bd PO or 400 mg bd-tds IV for 5-14 days. Infections of the skin & soft tissue caused by gm -ve bacteria 500-750 mg bd PO or 400 mg bd-tds IV for 7-14 days. Bone & joint infections 500-750 mg bd PO or 400 mg bd-tds IV for max 3 mth. Neutropenic patients w/ fever that is suspected to be due to a bacterial infection 500-750 mg bd PO or 400 mg bd-tds IV continued over the entire period of neutropenia. Inhalation anthrax post-exposure prophylaxis & curative treatment 500 mg bd PO or 400 mg bd IV for 60 days from the confirmation of Bacillus anthracis exposure. Childn Cystic fibrosis 20 mg/kg bd PO w/ a max of 750 mg per dose or 10 mg/kg tds IV w/ a max of 400 mg per dose, for 10-14 days. Complicated UTI & acute pyelonephritis 10-20 mg/kg bd PO w/ a max of 750 mg per dose or 6 mg/kg tds IV w/ a max of 400 mg per dose, for 10-21 days. Inhalation anthrax post-exposure prophylaxis & curative treatment 10-15 mg/kg bd PO w/ a max of 500 mg per dose or 10-15 mg/kg bd IV w/ a max of 400 mg per dose, for 60 days from the confirmation of Bacillus anthracis exposure. Other severe infections 20 mg/kg bd PO w/ a max of 750 mg per dose or 10 mg/kg tds IV w/ a max of 400 mg per dose. Tab Acute uncomplicated cystitis 250-500 mg bd PO for 3 days. 500 mg single dose PO may be used in pre-menopausal women. Complicated cystitis, acute pyelonephritis 500 mg bd PO for 7 days. Complicated pyelonephritis 500-750 mg bd PO for at least 10 days, can be continued for >21 days in some specific circumstances (eg, abscesses). Gonococcal urethritis & cervicitis due to susceptible Neisseria gonorrhoeae 500 mg single dose PO for 1 day. Prophylaxis of invasive infections due to Neisseria meningitidis 500 mg single dose PO for 1 day. IV Adult Acute & complicated pyelonephritis 400 mg bd-tds IV for 7-21 days, can be continued for >21 days in some specific circumstances (eg, abscesses).
Administration
May be taken with or without food: Do not take w/ antacids, Fe or dairy products.
Contraindications
Hypersensitivity to ciprofloxacin or other quinolones. Concomitant use w/ tizanidine.
Special Precautions
Ciprofloxacin monotherapy is not suited for treatment of severe infections & infections that might be due to gm +ve or anaerobic pathogens. Not recommended for streptococcal infections. Exclude resistance prior to treatment initiation. Risk of prolonged, disabling & potentially irreversible serious adverse reactions; discontinue immediately at 1st signs or symptoms of any serious adverse reaction. Risk of hypersensitivity & allergic reactions; tendinitis & tendon rupture especially in older patients, patients w/ renal impairment, patients w/ solid organ transplants, & those treated concurrently w/ corticosteroids; photosensitivity reactions; sensory or sensorimotor polyneuropathy; psychiatric reactions; disturbances in blood glucose usually in elderly DM patients receiving concomitant treatment w/ oral hypoglycaemic agent or insulin; antibiotic-associated colitis; crystalluria; hepatic necrosis & life-threatening hepatic failure; haemolytic reactions in patients w/ G6PD deficiency; aortic aneurysm & dissection particularly in the elderly. May exacerbate muscle weakness in patients w/ myasthenia gravis. Consult an eye specialist in case of vision disorders. Known to trigger seizures or lower the seizure threshold. In-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin. Patients w/ known risk factors for QT prolongation. Patients w/ renal impairment. Concomitant use w/ CYP1A2 substrates. Not recommended w/ methotrexate. May impair ability to drive or operate machinery. Preferable to avoid use during pregnancy. Should not be used during breast-feeding. Childn & adolescents. Elderly. IV: Local IV site reactions. Patients for whom Na intake is of medical concern.
Adverse Reactions
Nausea, diarrhoea; inj & infusion site reactions (IV administration only). IV or sequential (IV to oral) treatment: Vomiting, transient increase in transaminases, rash.
Drug Interactions
Caution w/ drugs known to prolong QT interval eg, class IA & III anti-arrhythmics, TCAs, macrolides, antipsychotics. Reduced absorption w/ dairy products or mineral-fortified drinks (eg, milk, yoghurt, Ca-fortified orange juice). Increased serum conc w/ probenecid. Slight Cmax & AUC reduction w/ omeprazole. Increased serum conc of tizanidine; theophylline; other xanthine derivatives (eg, caffeine or pentoxifylline); clozapine & N-desmethylclozapine. Altered serum levels of phenytoin. Increased plasma levels of methotrexate. Transient rise in serum creatinine conc w/ cyclosporin. Augmented anticoagulant effects of vit K antagonists. Hypoglycemia w/ oral antidiabetics, mainly sulfonylureas (eg, glibenclamide, glimepiride). Increased AUC & Cmax of duloxetine; ropinirole; sildenafil. Reduced clearance of IV lidocaine. Potential increase in agomelatine exposure. Increased 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. Accelerated absorption w/ metoclopramide.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Ciproxin FC tab 250 mg
Packing/Price
100's
Form
Ciproxin infusion 200 mg/100 mL
Packing/Price
1's
Form
Ciproxin infusion 400 mg/200 mL
Packing/Price
1's
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