ciprofloxacin (Rx)

Brand and Other Names:Cipro, Cipro XR, more...ProQuin XR
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

infusion solution

  • 200mg/100mL
  • 200mg/20mL
  • 400mg/40mL
  • 400mg/200mL

oral suspension

  • 250mg/5mL
  • 500mg/5mL

tablet

  • 100mg
  • 250mg
  • 500mg
  • 750mg

tablet, extended release

  • 500mg
  • 1000mg
more...

Acute Sinusitis

Mild/moderate: 500 mg PO q12hr or 400 mg IV q12hr for 10 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis

Bone & Joint Infections

Mild/moderate: 500 mg PO q12hr or 400 mg IV q12hr for ≥4-6 weeks

Severe/complicated: 750 mg PO q12hr or 400 mg IV q8hr for ≥4-6 weeks

Chronic Bacterial Prostatitis

Indicated for chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis

Mild/moderate: 500 mg PO q12hr or 400 mg IV q12hr for 28 days

Infectious Diarrhea

Mild/moderate/severe: 500 mg PO q12hr for 5-7 days

Empirical Therapy in Febrile Neutropenic Patients

Severe: 400 mg IV q8hr for 7-14 days

Intra-abdominal Infections

Complicated: 500 mg PO q12hr or 400 mg IV q12hr for 7-14 days

Lower Respiratory Tract Infections

Mild/moderate: 500 mg PO q12hr or 400 mg IV q12hr for 7-14 days

Severe/complicated: 750 mg PO q12hr or 400 mg IV q8hr for 7-14 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis

Nosocomial Pneumonia

Mild/moderate/severe: 400 mg IV q8hr for 10-14 days

Skin/Skin Structure Infections

Mild/moderate: 500 mg PO q12hr or 400 mg IV q12hr for 7-14 days

Severe/complicated: 750 mg PO q12hr or 400 mg IV q8hr for 7-14 days

Urinary Tract Infections

Acute uncomplicated: Immediate-release, 250 mg PO q12hr for 3 days; extended-release, 500 mg PO q24hr for 3 days

Mild/moderate: 250 mg PO q12hr or 200 mg IV q12hr for 7-14 days

Severe/complicated: 500 mg PO q12hr or 400 mg IV q12hr for 7-14 days

Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections

Urethral & Cervical Gonococcal Infections

Uncomplicated: 250-500 mg PO once

Anthrax Infection

Postexposure therapy

Inhalation (prophylaxis/postexposure): 500 mg PO q12hr or 400 mg IV q12hr for 60 days

Cutaneous: 500 mg PO q12hr or 400 mg IV q12hr for 60 days

Plague

Indication for treatment and prophylaxis of plague due to Yersinia pestis

500-750 mg PO q12hr x14 days, OR

400 mg IV q8-12hr x 14 days

Bronchiectasis (Orphan)

Orphan indication sponsor

  • Aradigm Corporation, 3929 Point Eden Way, Hayward, CA 94545

Noncystic Fibrosis Bronchiectasis (Orphan)

Dry powder for inhalation: Orphan designation for patients with NCFB who suffer from frequent severe acute pulmonary bacterial exacerbations which lead to further inflammation, airway, and lung parenchyma damage

Sponsor

  • Bayer HealthCare

Dosage Modifications

Renal impairment

  • CrCl >50 mL/min: Dose adjustment not necessary
  • CrCl 30-50 mL/min: 250-500 mg PO q12hr
  • CrCl <30 mL/min: Extended-release, 500 mg PO q24hr
  • CrCl 5-29 mL/min: 250-500 mg PO q18hr or 200-400 mg IV q18-24hr
  • Some clinicians suggest decreasing dose but not frequency of administration
  • Hemodialysis: 0.25-0.5 g PO q12hr or 0.2-0.4 g IV q24hr
  • Peritoneal dialysis: 0.25-0.5 g PO q8hr or 0.2-0.4 g IV q24hr

Dosing Considerations

ProQuin XR should be taken with a main meal, preferably evening meal

Cipro XR may be taken with or without meal; drink fluids liberally

Susceptible organisms

  • Aeromonas hydrophila, Bacillus anthracis, Bacteroides fragilis, Campylobacter jejuni, Citrobacter freundii, Citrobacter diversus, Enterobacter cloacae, Enterococcus faecalis, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, certain mycobacteria, Neisseria gonorrhoeae, Proteus mirabilis, Providencia spp, Pseudomonas aeruginosa, Salmonella typhi, Serratia spp, Shigella spp, methicillin-sensitive Staphylococcus aureus (MSSA), Staphylococcus epidermis, Staphylococcus saprophyticus, Streptococcus pneumoniae, Vibrio cholerae, Yersinia enterocolitica
  • First-line therapy: B anthracis, C freundii, C jejuni, Enterobacter spp, Hafnia alvei, S typhi, Salmonella spp, Shigella spp; no unanimity on others (eg, K pneumoniae, M morganii, V cholerae, Y enterocolitica )

Dosage Forms & Strengths

infusion solution

  • 200mg/100mL
  • 200mg/20mL
  • 400mg/40mL
  • 400mg/200mL

oral suspension

  • 250mg/5mL
  • 500mg/5mL

tablet

  • 250mg
  • 500mg
  • 750mg

tablet, extended release

  • 500mg
  • 1000mg
more...

Complicated Urinary Tract Infections or Pyelonephritis

<1 year: Safety and efficacy not established

≥1 year (IV): 6-10 mg/kg q8hr; individual dose not to exceed 400 mg for 10-21 days 

≥1 year (PO): 10-20 mg/kg q12hr; individual dose not to exceed 750 mg q12hr for 10-21 days

Cholera

Single dose: 30 mg/kg PO 

Multiple doses: 30 mg/kg/day PO divided q12hr for 3 days

Plague

Indication for treatment and prophylaxis of plague due to Yersinia pestis in pediatric patients from birth to 17 years of age

15 mg/kg PO q8-12hr x10-21 days; not to exceed 500 mg/dose, OR 

10 mg/kg IV q8-12hr x 10-21 days; not to exceed 400 mg/dose

Inhalational Anthrax (Off-label)

Postexposure therapy

IV: 10 mg/kg q12hr for 60 days; individual dose not to exceed 400 mg 

PO: 15 mg/kg q12hr for 60 days; individual dose not to exceed 500 mg

Change antibiotic to amoxicillin as soon as penicillin susceptibility confirmed

Cystic Fibrosis (Off-label)

PO: 40 mg/kg/day divided q12hr; not to exceed 2 g/day 

IV: 20-30 mg/kg/day divided q8-12hr; not to exceed 1.2 g/day

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Interactions

Interaction Checker

and ciprofloxacin

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            1-10%

            Nausea (3%)

            Abdominal pain (2%)

            Diarrhea (2% adults; 5% children)

            Increased aminotransferase levels (2%)

            Vomiting (1% adults; 5% children)

            Headache (1%)

            Increased serum creatinine (1%)

            Rash (2%)

            Restlessness (1%)

            <1%

            Acidosis

            Allergic reaction

            Angina pectoris

            Anorexia

            Arthralgia

            Ataxia

            Back pain

            Bad taste

            Blurred vision

            Breast pain

            Bronchospasm

            Diplopia

            Dizziness

            Drowsiness

            Dysphagia

            Dyspnea

            Flushing

            Foot pain

            Hallucinations

            Hiccups

            Hypertension

            Hypotension

            Insomnia

            Irritability

            Joint stiffness

            Lethargy

            Migraine

            Nephritis

            Nightmares

            Oral candidiasis

            Palpitation

            Photosensitivity

            Polyuria

            Syncope

            Tachycardia

            Tinnitus

            Tremor

            Urinary retention

            Vaginitis

            Postmarketing Reports

            Acute generalized exanthematous pustulosis (AGEP), erythema multiforme, exfoliative dermatitis, fixed eruption, photosensitivity/phototoxicity reaction

            Agitation, confusion, delirium

            Agranulocytosis, albuminuria, serum cholesterol and TG elevations, blood glucose elevation, hemolytic anemia, marrow depression (life threatening), pancytopenia (life threatening or fatal outcome), potassium elevation (serum)

            Anaphylactic reactions (including life-threatening anaphylactic shock), serum sickness like reaction, Stevens-Johnson syndrome

            Anosmia, hypesthesia

            Constipation, dyspepsia, dysphagia, flatulence, hepatic failure (including fatal cases), hepatic necrosis, jaundice, pancreatitis

            Hypertonia, hypotension (postural), increased INR (in patients treated with Vitamin K antagonists), QT prolongation, torsade de pointes, ventricular arrhythmia

            Methemoglobinemia

            Myasthenia, exacerbation of myasthenia gravis, myoclonus, nystagmus, peripheral neuropathy that may be irreversible, phenytoin alteration (serum), polyneuropathy, psychosis

            Myalgia, tendinitis, tendon rupture, toxic epidermal necrolysis (Lyell’s Syndrome), twitching

            Infections: Candiduria, vaginal candidiasis, moniliasis (oral, gastrointestinal, vaginal), pseudomembranous colitis

            Renal calculi

            Vasculitis

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            Warnings

            Black Box Warnings

            Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects

            Discontinue the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions

            May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis

            Serious adverse effects and limitations-of-use

            • Both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system
            • These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
            • Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
            • For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option

            Contraindications

            Documented hypersensitivity; concurrent tizanidine administration

            Cautions

            Use in pregnancy, though generally contraindicated for all quinolones, is allowed for life-threatening situations; limited data from use of ciprofloxacin in pregnancy show no higher rate of birth defects than background

            Do not use oral suspension in nasogastric tube; to prepare, add microcapsules to diluent

            No longer recommended for gonorrhea in United States, because of widespread resistance

            Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); these reactions can occur within hours to weeks after starting therapy, including in patients of any age or without pre-existing risk factors; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones

            Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent

            In prolonged therapy, perform periodic evaluations of organ system functions (eg, renal, hepatic, hematopoietic); adjust dose in renal impairment; superinfections may occur with prolonged or repeated antibiotic therapy; discontinue use immediately if signs and symptoms of hepatitis occur

            Not drug of first choice in pediatrics (except in anthrax), because of increased incidence of adverse events in comparison with control subjects, including arthropathy; no data exist on dosing for pediatric patients with renal impairment (ie, CrCl <50 mL/min)

            Fluoroquinolones are associated with increased risk of tendinitis and tendon rupture in all ages; this risk is further increased in older patients (usually >60 years); in patients taking corticosteroids; and in kidney, heart, or lung transplant recipients; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones

            Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis are reported with fluoroquinolones; psychotic reactions have progressed to suicidal ideations or thoughts and self-injurious behavior

            Avoid IV administration in patients who have known QT prolongation, carry risk factors for prolonged QT, or are taking class 1A or class III antiarrhythmic drugs

            Crystalluria may occur; urine alkalinity may increase risk; ensure adequate hydration during therapy

            Serious and sometimes fatal hypoglycemia reported with fluoroquinolone use; hyperglycemia also reported; monitor patients closely for signs/symptoms of abnormal glucose levels

            Co-administration of CIPRO IV and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine, and zolpidem) results in increased plasma concentrations of co-administered drug and could lead to clinically significant pharmacodynamic adverse reactions of the co-administered drug

            Moderate-to-severe phototoxicity reactions reported; avoid excessive sunlight and take precautions to limit exposure; discontinue use if phototoxicity occurs

            Use with caution in patients with history of seizures taking concurrent therapy that lowers seizure threshold; risk increases rarely when administered concomitantly with NSAIDs

            Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190

            Serious and fatal reactions have reported in patients receiving concurrent administration of ciprofloxacin and theophylline; if concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate

            Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

            Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug enters breast milk; use not recommended (American Academy of Pediatrics Committee states that drug is compatible with nursing)

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits relaxation of DNA; inhibits DNA gyrase in susceptible organisms; promotes breakage of double-stranded DNA

            Absorption

            Bioavailability (PO): ~50-85%

            Peak plasma time (PO): Immediate-release, 0.5-2 hr; extended-release, 1-2.5 hr

            Distribution

            Distributed widely throughout body; tissue concentrations often exceed serum concentrations, especially in kidneys, gallbladder, liver, lungs, gynecologic tissue, and prostatic tissue; cerebrospinal fluid (CSF) concentration is 10% in noninflamed meninges and 14-37% in inflamed meninges; crosses placenta; enters breast milk

            Protein bound: 20-40%

            Vd: 2.1-2.7 L/kg

            Metabolism

            Metabolized in liver

            Enzyme inhibitor: CYP1A2

            Elimination

            Half-life: 2-5 hr (children); 3-5 hr (adults)

            Excretion: Urine (30-50%), feces (15-43%)

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            Administration

            IV Incompatibilities

            Additive: Aminophylline, amoxicillin, amoxicillin-clavulanate, amphotericin, ampicillin-sulbactam, ceftazidime, cefuroxime, clindamycin, floxacillin, heparin, piperacillin, sodium bicarbonate, ticarcillin

            Y-site: Aminophylline, ampicillin-sulbactam, azithromycin, cefepime, dexamethasone sodium phosphate, furosemide, heparin, hydrocortisone sodium succinate, magnesium sulfate(?), methylprednisolone sodium succinate, phenytoin, potassium phosphates, propofol, sodium bicarbonate(?), sodium phosphates, total parenteral nutrition formulations, warfarin

            IV Compatibilities

            Solution: Compatible with most IV fluids

            Additive: Amikacin, aztreonam, dobutamine, dopamine, fluconazole, gentamicin, lidocaine, linezolid, metronidazole (ready-to-use form is compatible; hydrochloride form in vial is incompatible), midazolam, potassium chloride, tobramycin

            Y-site: Amiodarone, calcium gluconate, clarithromycin, digoxin, diphenhydramine, dobutamine, dopamine, linezolid, lorazepam, midazolam, promethazine, quinupristin/dalfopristin, tacrolimus

            IV Administration

            Infuse 1-2 mg/mL (diluted in D5W or NS) into large vein over 60 minutes

            When administering intermittently through Y-site, temporarily discontinue primary solution

            Stability

            Stable at concentration of 0.5-2 mg/mL in D5W or NS for 14 days at room temperature or refrigerated

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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