Ciprofloxacin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Treatment and postexposure prophylaxis of inhalation anthrax 500 mg bid for 60 days from the confirmation of Bacillus anthracis exposure. Bone and joint infections 500-750 mg bid. Max treatment duration: 3 months. Lower respiratory tract infections; Upper respiratory tract infections; Skin and soft tissue infections 500-750 mg bid for 7-14 days. Malignant otitis externa 750 mg bid for 7-14 days up to 3 months. Prostatitis 500-750 mg bid. Treatment duration: 2-4 weeks (acute); 4-6 weeks (chronic). Uncomplicated pyelonephritis 500 mg bid for 7 days (immediate-release); 1,000 mg every 24 hours for 7-14 days (extended-release). Complicated pyelonephritis 500-750 mg bid for at least 10 or up to 21 days if required. Complicated cystitis 500 mg bid for 7 days (immediate-release); 1,000 mg every 24 hours for 7-14 days (extended-release). Uncomplicated cystitis 250-500 mg bid for 3 days (immediate-release); 500 mg every 24 hours for 3 days (extended-release). Typhoid fever 500 mg bid for 7 days. Gonococcal urethritis; Gonococcal cervicitis In patients with ciprofloxacin-susceptible N. gonorrhoeae infection: 500 mg as a single dose. Refer to local guidelines. Epididymo-orchitis; Pelvic inflammatory disease In patients with ciprofloxacin-susceptible N. gonorrhoeae infection: 500-750 mg bid for at least 14 days. Refer to local guidelines. Intra-abdominal infections 500-750 mg bid for 5-14 days. Diarrhoea 500 mg bid for 1-5 days depending on the severity and nature of infection. Prophylaxis against meningococcal meningitis 500 mg as a single dose. IV Treatment and postexposure prophylaxis of inhalation anthrax 400 mg bid for 60 days from the confirmation of Bacillus anthracis exposure. Bone and joint infections 400 mg bid to tid. Max treatment duration: 3 months. Lower respiratory tract infections; Upper respiratory tract infections; Skin and soft tissue infections 400 mg bid to tid for 7-14 days. Malignant otitis externa 400 mg tid for 28 days up to 3 months. Acute prostatitis 400 mg bid to tid for 2-4 weeks. Urinary tract infections; Pyelonephritis 400 mg bid to tid for 7-21 days or longer if needed. Epididymo-orchitis; Pelvic inflammatory disease In patients with ciprofloxacin-susceptible N. gonorrhoeae infection: 400 mg bid to tid for at least 14 days. Refer to local guidelines. Intra-abdominal infections 400 mg bid to tid for 5-14 days. Diarrhoea 400 mg bid for 1-5 days, depending on the severity and nature of infection. Typhoid fever 400 mg bid for 7 days. All doses are given via infusion over 60 minutes. Ophth Corneal ulcer As 0.3% solution: Initial: Instill 2 drops onto affected eye(s) every 15 minutes for the 1st 6 hours, then every 30 minutes thereafter on day 1. Then, instill 2 drops onto affected eye(s) hourly on day 2. Thereafter, instill 2 drops onto affected eye(s) 4 hourly on days 3-14. Max treatment duration: 21 days. Superficial ocular infections As 0.3% solution: Instill 1 or 2 drops onto affected eye(s) 4 times daily. Severe infections: Instill 1 or 2 drops 2 hourly for 2 days during waking hours, then 4 times daily thereafter. Max treatment duration: 21 days. As 0.3% ointment: Apply approx ½ inch ribbon into the conjunctival sac onto the affected eye(s) tid for 2 days, then bid for the next 5 days. Otic/Aural Acute otitis externa As 0.2% solution: Instill 0.25 mL into the affected ear(s) bid for 7 days. As 6% susp: Instill 0.2 mL into the affected ear(s) as a single dose.
Administration
May be taken with or without food. May be taken w/ meals to minimise GI discomfort. Do not take w/ antacids, Fe or dairy products.
Contraindications
Hypersensitivity to ciprofloxacin or other quinolones. History or risk of QT prolongation; known history of myasthenia gravis. Concomitant use with tizanidine.
Special Precautions
Patient with known or suspected CNS disorders, risk factors predisposing to seizures, or lower seizure threshold; history or risk factors for QT interval prolongation, torsades de pointes, uncorrected hypokalaemia/hypomagnesaemia, cardiac disease (e.g. heart failure, MI, bradycardia); positive family history of aneurysm disease, pre-existing aortic aneurysm or dissection and its risk factors (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, hypertension, peripheral atherosclerotic vascular disease); diabetes, previous tendon disorder (e.g. rheumatoid arthritis), G6PD deficiency. Renal and hepatic impairment. Elderly, children. Pregnancy and lactation. Immunocompromised febrile neutropenic patients. Not recommended for the treatment of streptococcal infections or as treatment option for gonococcal infections in some countries due to increase in quinolones-resistant N. gonorrhoeae globally. Not effective in the treatment of syphilis. Reserve use for the treatment of acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, or acute sinusitis in patients with no alternative treatment options. Patient Counselling This drug may cause dizziness and temporary loss of vision, if affected, do not drive or operate machinery. Avoid excessive exposure to sunlight or artificial UV light (e.g. tanning beds) and use protective measures (e.g. sunscreen, wear loose-fitting clothes) if staying outdoors during therapy. Remove contact lenses prior to administration and wait at least 15 minutes before reinsertion. Maintain adequate hydration during therapy. Monitoring Parameters Monitor transaminases, blood glucose levels, CBC, renal function, LFT periodically and during prolonged therapy. Monitor for signs and symptoms of hypersensitivity reactions, tendonitis, and altered mental status. Perform eye examinations regularly. Perform culture and susceptibility tests prior to treatment initiation; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Test patients for syphilis at the time of gonorrhoeal diagnosis and 3 months thereafter.
Adverse Reactions
Significant: Irreversible tendinitis, tendon rupture, peripheral neuropathy, CNS effects (e.g. seizures, increased intracranial pressure), QT interval prolongation, torsades de pointes, psychiatric reactions (e.g. depression, psychosis, suicidal ideation), aortic aneurysm ruptures or dissection (long-term use), photosensitivity reactions, haemolytic reactions (in G6PD deficiency patient), hyperglycaemia; delayed corneal healing (ophth). Rarely, crystalluria. Blood and lymphatic system disorders: Jaundice. Ear and labyrinth disorders: Ear pruritus, otitis media, pain at the application site. Eye disorders: Ophth: Corneal deposits, burning sensation, conjunctival hyperaemia, crusting of eyelid, eye pruritus. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia. General disorders and administration site conditions: Fever, irritability. Hepatobiliary disorders: Hepatitis. Injury, poisoning and procedural complications: Inj and infusion site reactions. Investigations: Increased transaminases. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia. Nervous system disorders: Increased intracranial pressure, dizziness, headache, restlessness, tremor. Psychiatric disorders: Insomnia, nervousness, somnolence. Respiratory, thoracic and mediastinal disorders: Rhinitis, nasopharyngitis. Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Hypoglycaemia, hepatic necrosis, severe hypersensitivity reactions [e.g. anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)], severe myasthenia gravis exacerbation, superinfection in prolonged use (e.g. C. difficile-associated diarrhoea, pseudomembranous colitis).
Drug Interactions
Increased risk of prolonged QT interval with Class IA (e.g. quinidine, procainamide) and Class III (e.g. amiodarone, sotalol) antiarrhythmics, TCA, macrolides (e.g. erythromycin), cisapride, antipsychotics. Increased serum concentration with probenecid. May increase serum concentration and toxicity of methotrexate; CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline); xanthine derivatives (e.g. caffeine, pentoxifylline). Increased risk of tendon disorders with corticosteroids. Increased serum creatinine with cyclosporin. Increased risk of convulsions with NSAIDs. May alter serum concentrations of phenytoin. Reduced oral absorption with products containing multivalent cations (e.g. Al, Ca, Mg, Fe). May increase anticoagulant effect of vitamin K, warfarin.
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
S01AE03 - ciprofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
S03AA07 - ciprofloxacin ; Belongs to the class of antiinfectives used in ophthalmologic and otologic preparations.
S02AA15 - ciprofloxacin ; Belongs to the class of antiinfectives used in the treatment of ear infections.
Disclaimer: This information is independently developed by CIMS based on ciprofloxacin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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