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 pathogen. 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 pathogen. 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 1/2 inch ribbon into the conjunctival sac onto the affected eye(s) tid for 2 days, then bid for the next 5 days. Otic 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.
Dosage Details
Intravenous
Lower respiratory tract infections, Skin and soft tissue infections, Upper respiratory tract infections
Adult: 400 mg bid to tid via infusion over 60 minutes for 7-14 days.

Intravenous
Malignant otitis externa
Adult: 400 mg tid via infusion over 60 minutes for 28 days up to 3 months.

Intravenous
Bone and joint infections
Adult: 400 mg bid to tid via infusion over 60 minutes. Max treatment duration: 3 months.

Intravenous
Treatment and postexposure prophylaxis of inhalation anthrax
Adult: 400 mg bid via infusion over 60 minutes for 60 days from the confirmation of Bacillus anthracis exposure.
Child: 10-15 mg/kg bid via infusion over 60 minutes for 60 days from the confirmation of Bacillus anthracis exposure. Max dose: 400 mg/dose.

Intravenous
Pyelonephritis, Urinary tract infection
Adult: 400 mg bid to tid via infusion over 60 minutes for 7-21 days or longer if needed.
Child: 6-10 mg/kg tid via infusion over 60 minutes for 10-21 days. Max: 400 mg/dose.

Intravenous
Acute prostatitis
Adult: 400 mg bid to tid via infusion over 60 minutes for 2-4 weeks.

Intravenous
Intra-abdominal infections
Adult: 400 mg bid to tid via infusion over 60 minutes for 5-14 days.

Intravenous
Epididymo-orchitis, Pelvic inflammatory disease
Adult: In patients with ciprofloxacin-susceptible N. gonorrhoeae infection: 400 mg bid to tid via infusion over 60 minutes for at least 14 days.

Intravenous
Typhoid fever
Adult: 400 mg bid via infusion over 60 minutes for 7 days.

Intravenous
Diarrhoea
Adult: 400 mg bid for 1-5 days depending on the severity and nature of infection, given via infusion over 60 minutes. Refer to detailed product guideline.

Intravenous
Cystic fibrosis
Child: 10 mg/kg tid for 10-14 days. Max: 400 mg/dose.

Ophthalmic
Superficial ocular infections
Adult: As 0.3% ophth 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% ophth ointment: Apply approx 1/2 inch ribbon into the conjunctival sac onto the affected eye(s) tid for 2 days, then bid for the next 5 days.
Child: ≥1 year As 0.3% ophth solution: Same as adult dose. ≥2 years As 0.3% ophth oint: Same as adult dose.

Ophthalmic
Corneal ulcer
Adult: As 0.3% ophth solution: Initially, 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.
Child: ≥1 year Same as adult dose.

Oral
Treatment and postexposure prophylaxis of inhalation anthrax
Adult: 500 mg bid for 60 days from the confirmation of Bacillus anthracis exposure.
Child: 10-15 mg/kg bid. Max: 500 mg/dose for 60 days from the confirmation of Bacillus anthracis exposure.

Oral
Lower respiratory tract infections, Skin and soft tissue infections, Upper respiratory tract infections
Adult: 500-750 mg bid for 7-14 days.

Oral
Malignant otitis externa
Adult: 750 mg bid for 7-14 days up to 3 months.

Oral
Typhoid fever
Adult: 500 mg bid for 7 days.

Oral
Prostatitis
Adult: 500-750 mg bid. Treatment duration: 2-4 weeks (acute); 4-6 weeks (chronic).

Oral
Pyelonephritis
Adult: Patients with uncomplicated cases: 500 mg bid for 7 days (immediate-release); 1,000 mg every 24 hours for 7-14 days (extended-release). Patients with complicated cases: 500-750 mg bid for at least 10 or up to 21 days if required.
Child: Patients with complicated cases: 10-20 mg/kg bid for 10-21 days. Max: 750 mg/dose.

Oral
Uncomplicated cystitis
Adult: 250-500 mg bid for 3 days (immediate-release); 500 mg every 24 hours for 3 days (extended-release).

Oral
Cystic fibrosis
Child: 20 mg/kg bid for 10-14 days. Max: 750 mg/dose.

Oral
Complicated cystitis
Adult: 500 mg bid for 7 days (immediate-release); 1,000 mg every 24 hours for 7-14 days (extended-release).
Child: 10-20 mg/kg bid for 10-21 days. Max: 750 mg/dose.

Oral
Bone and joint infections
Adult: 500-750 mg bid. Max treatment duration: 3 months.

Oral
Epididymo-orchitis, Pelvic inflammatory disease
Adult: In patients with ciprofloxacin-susceptible N. gonorrhoeae infection: 500-750 mg bid for at least 14 days.

Oral
Diarrhoea
Adult: 500 mg bid for 1-5 days depending on the severity and nature of infection. Refer to detailed product guideline.

Oral
Intra-abdominal infections
Adult: 500-750 mg bid for 5-14 days.

Oral
Gonococcal cervicitis, Gonococcal urethritis
Adult: In patients with ciprofloxacin-susceptible N. gonorrhoeae infection: 500 mg as a single dose. Refer to local guidelines.

Oral
Prophylaxis of meningococcal meningitis
Adult: 500 mg as a single dose.

Otic/Aural
Acute otitis externa
Adult: As 0.2% otic solution: Instill 0.25 mL into the affected ear(s) bid for 7 days. As 6% otic susp: Instill 0.2 mL into the affected ear(s) as a single dose.
Child: ≥1 year As 0.2% solution: Same as adult dose. ≥6 months As 6% otic susp: Same as adult dose.

Otic/Aural
Bilateral otitis media with effusion
Child: In patient undergoing tympanostomy tube placement: ≥6 months As 6% otic susp: Instill 0.1 mL intratympanically into the affected ear(s) as a single dose following suctioning of middle ear.
Special Patient Group
Oral
Immunocompromised neutropenic febrile patients with infection: In combination with other antibacterials: 500-750 mg bid, continued over the entire period of neutropenia.

Intravenous
Immunocompromised neutropenic febrile patients with infection: In combination with other antibacterials: 40 mg bid to tid via infusion over 60 minutes, continued over the entire period of neutropenia.
Renal Impairment
Oral:
CrCl (mL/min)  Dosage
 <30, patients on haemodialysis or peritoneal dialysis  250-500 mg once daily
 30-60  250-500 mg bid.
 >60  Same as adult dose.

Intravenous:
CrCl (mL/min) Dosage
<30, patients on haemodialysis or peritoneal dialysis 200-400 mg once daily.
30-60 200-400 mg bid.
>60 Same as adult 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.
Reconstitution
IV concentrate solution: Dilute with appropriate volume of either NaCl 0.9%, Lactated Ringer’s, 5 or 10% Dextrose inj, sterile water for inj to a final concentration of 1-2 mg/mL.
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 a 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.
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).
IV/Ophth/Otic/Parenteral/PO: C
Patient Counseling Information
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.
MonitoringParameters
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.
Overdosage
Symptoms: Dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, crystalluria, haematuria, acute renal and hepatic impairment. Management: Symptomatic treatment. Empty stomach by inducing emesis or by gastric lavage. Maintain adequate hydration. May administer antacids containing Mg, Al, or Ca to reduce oral absorption. Monitor ECG, renal function, urinary pH, and acidify urine if required to prevent crystalluria.
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.
Potentially Fatal: May increase serum concentration and potentiate hypotensive and sedative effects of tizanidine. Rarely, serious and fatal seizures, status epilepticus, cardiac arrest, respiratory failure with theophylline.
Food Interaction
Reduced oral absorption with dairy products or calcium-containing beverages.
Lab Interference
May produce a false-positive urine test result with opioids.
Action
Description: Ciprofloxacin, a fluoroquinolone anti-infective agent, acts by inhibiting DNA gyrase and topoisomerase IV, both essential in bacterial DNA replication, transcription, repair and recombination.
Pharmacokinetics:
Absorption: Rapid and well absorbed from the gastrointestinal tract. Bioavailability: Approx 70-80% . Time to peak plasma concentration: 0.5-2 hours (conventional tab); 1-2.5 hours (extended-release tab).
Distribution: Widely distributed in the tissues. Crosses placenta, enters breast milk, bile (high concentrations), and CSF (10% noninflamed meninges; 14-37% inflamed meninges). Volume of distribution: 2.1-2.7 L/kg. Plasma protein binding: 20-40%.
Metabolism: Partially metabolised in the liver to desthyleneciprofloxacin (M1), sulphociprofloxacin (M2), oxociprofloxacin (M3), and formylciprofloxacin (M4) in low concentrations.
Excretion: Via urine [approx 40-50% as unchanged drug, approx 15%, as metabolites (oral); 70% as unchanged drug, 10% as metabolites (parenteral)]; faeces [20-35% (oral), 15% (IV)]. Elimination half-life: Approx 3-5 hours.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Premixed solution: Store between 5-25°C. Do not freeze. Protect from light. IV solution: Store between 5-30°C. Do not freeze. Protect from light. Tab: Store between 20-25°C. Otic solution: Store below 30°C. Protect from light. Ophth solution: Store below 25°C. Do not refrigerate or freeze.
ATC Classification
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.
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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