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Ciprofloxacin (Systemic)

Pronunciation

Pronunciation

(sip roe FLOKS a sin)

Index Terms

  • Ciprofloxacin HCl
  • Ciprofloxacin Hydrochloride
  • Proquin XR

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Cipro in D5W: 200 mg/100 mL (100 mL [DSC]) [latex free]

Generic: 200 mg/100 mL (100 mL); 400 mg/200 mL (200 mL); 200 mg/20 mL (20 mL [DSC]); 400 mg/40 mL (40 mL)

Solution, Intravenous [preservative free]:

Cipro in D5W: 200 mg/100 mL (100 mL [DSC]); 400 mg/200 mL (200 mL) [latex free]

Generic: 200 mg/100 mL (100 mL); 400 mg/200 mL (200 mL); 200 mg/20 mL (20 mL); 400 mg/40 mL (40 mL)

Suspension Reconstituted, Oral:

Cipro: 250 mg/5 mL (100 mL); 500 mg/5 mL (100 mL) [strawberry flavor]

Generic: 250 mg/5 mL (100 mL); 500 mg/5 mL (100 mL)

Tablet, Oral, as hydrochloride [strength expressed as base]:

Cipro: 250 mg, 500 mg

Generic: 100 mg, 250 mg, 500 mg, 750 mg

Tablet Extended Release 24 Hour, Oral, as base and hydrochloride [strength expressed as base]:

Cipro XR: 500 mg, 1000 mg

Generic: 500 mg, 1000 mg

Brand Names: U.S.

  • Cipro
  • Cipro in D5W
  • Cipro XR

Pharmacologic Category

  • Antibiotic, Fluoroquinolone

Pharmacology

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

Absorption

Oral: Well-absorbed; 500 mg orally every 12 hours produces an equivalent AUC to that produced by 400 mg IV over 60 minutes every 12 hours

Distribution

Vd: 2.1 to 2.7 L/kg; tissue concentrations often exceed serum concentrations especially in kidneys, gallbladder, liver, lungs, gynecological tissue, and prostatic tissue; CSF concentrations: 10% of serum concentrations (noninflamed meninges), 14% to 37% (inflamed meninges)

Metabolism

Partially hepatic; forms 4 metabolites (limited activity)

Excretion

Urine (30% to 50% as unchanged drug); feces (15% to 43%; <1% as unchanged drug)

Clearance: After IV:

CF children: 0.84 L/hour/kg

Adults: 0.5 to 0.6 L/hour/kg

Time to Peak

Oral:

Immediate release tablet: 0.5 to 2 hours

Extended release tablet: Cipro XR: 1 to 2.5 hours

Half-Life Elimination

Children: 4 to 5 hours; Adults: Normal renal function: 3 to 5 hours

Protein Binding

20% to 40%

Special Populations: Renal Function Impairment

The half-life is prolonged.

Special Populations: Elderly

Cmax increased 16% to 40%, AUC increased approximately 20% to 30%, and half-life increased approximately 20%.

Use: Labeled Indications

Children: Complicated urinary tract infections and pyelonephritis due to E. coli. Note: Although effective, ciprofloxacin is not the drug of first choice in children.

Children and Adults: To reduce incidence or progression of disease following exposure to aerosolized Bacillus anthracis; prophylaxis and treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis.

Adults: Treatment of the following infections when caused by susceptible bacteria: Urinary tract infections; acute uncomplicated cystitis in females; chronic bacterial prostatitis; lower respiratory tract infections (including acute exacerbations of chronic bronchitis); acute sinusitis; skin and skin structure infections; bone and joint infections; complicated intra-abdominal infections (in combination with metronidazole); infectious diarrhea; typhoid fever due to Salmonella typhi (eradication of chronic typhoid carrier state has not been proven); uncomplicated cervical and urethra gonorrhea (due to N. gonorrhoeae); nosocomial pneumonia; empirical therapy for febrile neutropenic patients (in combination with piperacillin)

Note: Fluoroquinolone-resistant gonorrhea is widespread in the United States. Centers for Disease Control and Prevention (CDC) guidelines do not recommend use of fluoroquinolones for the treatment of gonorrhea in the United States.

Use: Unlabeled

Acute pulmonary exacerbations in cystic fibrosis (children); cutaneous/gastrointestinal/oropharyngeal anthrax (treatment, children and adults); chancroid (adults); epididymitis (adults); prophylaxis to Neisseria meningitidis following close contact with an infected person; empirical therapy (oral) for febrile neutropenia in low-risk cancer patients; HACEK group endocarditis; infectious diarrhea (children); periodontitis; chronic oral antimicrobial suppression of prosthetic joint infection; surgical (preoperative) prophylaxis

Contraindications

Hypersensitivity to ciprofloxacin, any component of the formulation, or other quinolones; concurrent administration of tizanidine

Dosing: Adult

Note: Extended release tablets and immediate release formulations are not interchangeable. Unless otherwise specified, oral dosing reflects the use of immediate release formulations.

Anthrax:

Inhalational (postexposure prophylaxis):

Oral: 500 mg every 12 hours for 60 days

IV: 400 mg every 12 hours for 60 days

Cutaneous (treatment, CDC guidelines): Oral: Immediate release formulation: 500 mg every 12 hours for 60 days. Note: In the presence of systemic involvement, extensive edema, lesions on head/neck, refer to IV dosing for treatment of inhalational/gastrointestinal/oropharyngeal anthrax.

Inhalational/gastrointestinal/oropharyngeal (treatment, CDC guidelines): IV: 400 mg every 12 hours. Note: Initial treatment should include two or more agents predicted to be effective (per CDC recommendations). Continue combined therapy for 60 days.

Bacterial enteric infections in HIV-infected patients (empiric treatment) (off-label use; HHS [OI adult 2015]):

Oral: 500 to 750 mg every 12 hours

IV: 400 mg every 12 hours

Bite wounds (animal, human) (off-label use) (IDSA [Stevens 2014]): Note: Recommended as an alternative therapy for human bite wound in patients hypersensitive to beta-lactams.

Oral: 500 to 750 mg twice daily; in combination with metronidazole

IV: 400 mg every 12 hours; in combination with metronidazole

Bone/joint infections:

Oral: 500 to 750 mg twice daily for 4 to 8 weeks

IV:

Mild/moderate: 400 mg every 12 hours for 4 to 8 weeks

Severe/complicated: 400 mg every 8 hours for 4 to 8 weeks

Chancroid (off-label use): Oral: 500 mg twice daily for 3 days (CDC [Workowski 2015])

Cystitis, acute uncomplicated:

Oral, immediate release: 250 mg every 12 hours for 3 days

Oral, extended release (Cipro XR): 500 mg every 24 hours for 3 days

Endocarditis due to HACEK organisms (off-label use) (AHA [Baddour 2015]):

Oral: 500 mg every 12 hours for 4 weeks (native valve) or 6 weeks (prosthetic valve)

IV: 400 mg every 12 hours for 4 weeks (native valve) or 6 weeks (prosthetic valve)

Epididymitis, chlamydial (off-label use): Oral: 500 mg single dose (Canadian STI Guidelines 2008)

Febrile neutropenia: IV: 400 mg every 8 hours for 7 to 14 days (combination therapy with piperacillin generally recommended)

Gonococcal infections:

Urethral/cervical gonococcal infections: Oral: 250 to 500 mg as a single dose (CDC recommends concomitant doxycycline or azithromycin due to possible coinfection with Chlamydia); Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of uncomplicated gonococcal disease.

Granuloma inguinale (donovanosis) (alternative to preferred therapy) (off-label use): Oral: 750 mg twice daily for at least 3 weeks (and until lesions have healed )(CDC [Workowski 2015]). Note: If symptoms do not improve within the first few days of therapy, the addition of gentamicin may be considered (CDC [Workowski 2015]).

Infectious diarrhea: Oral:

Salmonella: 500 mg twice daily for 5 to 7 days

Shigella (including Shigella dysentery type 1) (off-label regimen): 500 mg twice daily for 3 days (IDSA 2001)

Traveler's diarrhea (off-label regimen): Mild: 750 mg as a single dose (CDC 2012; de la Cabada Bauch 2011); Severe: 500 mg twice daily for 3 days (IDSA 2001)

Vibrio cholerae (off-label regimen): 1 g as a single (CDC 2011)

Infectious diarrhea due to Salmonella, Shigella, or Campylobacter in HIV-infected patients (off-label use; HHS [OI adult 2015]): Note: Patients with bacteremia due to Campylobacter should receive additional therapy with an aminoglycoside

Oral: 500 to 750 mg every 12 hours

IV: 400 mg every 12 hours)

Duration of therapy: Oral, IV:

Salmonella: Without bacteremia: 7 to 14 days (CD4 count ≥200 cells/mm3) or 2 to 6 weeks (CD4 count <200 cells/mm3); With bacteremia: 14 days or longer based on clinical condition (CD4 count ≥200 cells/mm3) or 2 to 6 weeks (CD4 count <200 cells/mm3)

Shigella or Campylobacter: Gastroenteritis: 7 to 10 days; Bacteremia: ≥14 days; Recurrent infections: Campylobacter: 2 to 6 weeks; Shigella: ≤6 weeks

Intra-abdominal, complicated, community-acquired (in combination with metronidazole): Note: Avoid using in settings where E. coli susceptibility to fluoroquinolones is <90%:

Oral: 500 mg every 12 hours for 7 to 14 days

IV: 400 mg every 12 hours for 7 to 14 days; Note: 2010 IDSA guidelines recommend treatment duration of 4 to 7 days (provided source controlled)

Lower respiratory tract:

Oral: 500 to 750 mg twice daily for 7 to 14 days

IV: 400 mg every 8 to 12 hours for 7 to 14 days

Meningococcal meningitis prophylaxis (off-label use): Oral: 500 mg as a single dose (CDC 2005)

Nosocomial pneumonia: IV: 400 mg every 8 hours for 10 to 14 days

Plague:

Manufacturer's labeling:

Oral: 500 to 750 mg every 12 hours for 14 days

IV: 400 mg every 8 to 12 hours for 14 days

Alternate dosing:

Contained casualty management: IV: 400 mg twice daily for 10 days. Can switch to oral administration when clinically indicated (Bossi 2004; CDC [plague] 2012; Inglesby 2000).

Mass casualty management: Oral: 500 mg twice daily for 10 days (Inglesby 2000)

Mass casualty postexposure prophylaxis: Oral: 500 mg twice daily for 7 days (Bossi 2004; CDC [plague] 2012; Inglesby 2000).

Prostatitis (chronic, bacterial):

Oral: 500 mg every 12 hours for 28 days

IV: 400 mg every 12 hours for 28 days

Sinusitis (acute):

Oral: 500 mg every 12 hours for 10 days

IV: 400 mg every 12 hours for 10 days

Skin/skin structure infections:

Oral: 500 to 750 mg twice daily for 7 to 14 days

IV: Mild to moderate: 400 mg every 12 hours for 7 to 14 days; Severe/complicated: 400 mg every 8 hours for 7 to 14 days

Skin and soft tissue necrotizing infection due to Aeromonas hydrophila (off-label use): IV: 400 mg every 12 hours; in combination with doxycycline. Continue treatment until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Spontaneous bacterial peritonitis (prevention) (off-label use): Oral: Long-term prophylaxis: 500 mg once daily (preferred) (Terg 2008). Weekly dosing of 750 mg orally for long-term prophylaxis has been studied, but concerns regarding quinolone bacterial resistance limit use (AASLD [Runyon 2012]; Roulachon 1995). American Association for the Study of Liver Diseases (AASLD) guidelines note that intermittent dosing (ie, 5 days/week, weekly) of antibiotics, although shown to be effective in SBP prevention, may be inferior to daily dosing due to development of bacterial resistance. Daily dosing regimens are preferred (AASLD [Runyon 2012]).

Surgical (preoperative) prophylaxis (off-label use): IV: 400 mg within 120 minutes prior to surgical incision (Bratzler 2013)

Surgical site infection (intestinal or GU tract, perineum, or axilla) (off-label use) (IDSA [Stevens 2014]):

Oral: 750 mg every 12 hours, in combination with metronidazole

IV: 400 mg every 12 hours, in combination with metronidazole

Tularemia (off-label use):

Contained casualty management: IV: 400 mg twice daily for 10 days. Can switch to oral administration when clinically indicated (Dennis 2001).

Mass casualty management or postexposure prophylaxis: Oral: 500 or 750 mg twice daily for 14 days. At least 14 days of therapy is recommended in oral regimens (Bossi [tularemia] 2004; Dennis 2001; Stevens 2014).

Typhoid fever: Oral: 500 mg every 12 hours for 10 days

Urinary tract infection:

Oral, immediate release: 250 to 500 mg every 12 hours for 7 to 14 days

IV: 200 to 400 mg every 8 to 12 hours for 7 to 14 days

Urinary tract infection, complicated (including pyelonephritis): Oral , extended release (Cipro XR): 1000 mg every 24 hours for 7 to 14 days

Dosing: Geriatric

Refer to adult dosing. Adjust dose carefully based on renal function.

Dosing: Pediatric

See Warnings/Precautions. Note: Extended release tablets and immediate release formulations are not interchangeable. Unless otherwise specified, oral dosing reflects the use of immediate release formulations.

Anthrax:

Inhalational (postexposure prophylaxis):

Oral: 15 mg/kg/dose every 12 hours for 60 days; maximum: 500 mg/dose

IV: 10 mg/kg/dose every 12 hours for 60 days; do not exceed 400 mg/dose (800 mg/day)

Cutaneous (treatment, CDC guidelines): Oral: 10 to 15 mg/kg every 12 hours for 60 days (maximum: 1000 mg/day); amoxicillin 80 mg/kg/day divided every 8 hours is an option for completion of treatment after clinical improvement. Note: In the presence of systemic involvement, extensive edema, lesions on head/neck, refer to IV dosing for treatment of inhalational/gastrointestinal/oropharyngeal anthrax.

Inhalational/gastrointestinal/oropharyngeal (treatment, CDC guidelines): IV: Initial: 10 to 15 mg/kg every 12 hours for 60 days (maximum: 500 mg/dose); switch to oral therapy when clinically appropriate; refer to adult dosing for notes on combined therapy and duration

Bacterial enteric infections in HIV-infected patients (empiric treatment) (off-label use): Adolescents: Refer to adult dosing

Community-acquired pneumonia (CAP) (IDSA/PIDS 2011): H. influenzae, moderate-to-severe infection (alternative to ampicillin, ceftriaxone, or cefotaxime): Infants >3 months and Children: IV: 30 mg/kg/day divided every 12 hours

Cystic fibrosis (off-label use): Children 5 to 17 years:

Oral: 40 mg/kg/day divided every 12 hours administered following 1 week of IV therapy has been reported in a clinical trial; total duration of therapy: 10 to 21 days (Rubio 1997)

IV: 30 mg/kg/day divided every 8 hours for 1 week, followed by oral therapy, has been reported in a clinical trial (Rubio 1997)

Infectious diarrhea due to Salmonella, Shigella, or Campylobacter in HIV-infected patients (off-label dose): Adolescents: Refer to adult dosing.

Shigella dysentery type 1 (off-label use): Oral: 30 mg/kg/day in 2 divided doses for 3 days (WHO 2005)

Plague:

Manufacturer's labeling: Infants, Children, and Adolescents:

Oral: 15 mg/kg/dose every 8 to 12 hours for 10 to 21 days; maximum: 500 mg/dose

IV: 10 mg/kg/dose every 8 to 12 hours for 10 to 21 days; maximum: 400 mg/dose

Alternate dosing: Children and Adolescents:

Contained casualty management: IV: 15 mg/kg twice daily for 10 days (maximum: 1000 mg/day). Can switch to oral administration when clinically indicated (CDC [plague] 2014; Inglesby 2000).

Mass casualty management: Oral: 20 mg/kg twice daily for 10 days (maximum: 1000 mg/day) (Inglesby 2000)

Mass casualty postexposure prophylaxis: Oral: 20 mg/kg twice daily for 7 days (maximum: 1000 mg/day) (CDC [plague] 2014; Inglesby 2000)

Surgical (preoperative) prophylaxis (off-label use): Children ≥1 year: IV: 10 mg/kg within 120 minutes prior to surgical incision (maximum: 400 mg/dose) (Bratzler 2013)

Urinary tract infection (complicated) or pyelonephritis: Children 1 to 17 years:

Oral: 20 to 40 mg/kg/day in 2 divided doses (every 12 hours) for 10 to 21 days; maximum: 1,500 mg/day. Note: 30 to 40 mg/kg/day reserved for severe infections (Red Book 2012).

IV: 6 to 10 mg/kg every 8 hours for 10 to 21 days (maximum: 400 mg/dose)

Dosing: Renal Impairment

Adults:

Manufacturer's labeling:

Oral, immediate release:

CrCl >50 mL/minute: No dosage adjustment necessary.

CrCl 30 to 50 mL/minute: 250 to 500 mg every 12 hours

CrCl 5 to 29 mL/minute: 250 to 500 mg every 18 hours

ESRD on intermittent hemodialysis (IHD)/peritoneal dialysis (PD) (administer after dialysis on dialysis days): 250 to 500 mg every 24 hours

Oral, extended release:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: 500 mg every 24 hours

ESRD on intermittent hemodialysis (IHD)/peritoneal dialysis (PD) (administer after dialysis on dialysis days): 500 mg every 24 hours

IV:

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl 5 to 29 mL/minute: 200 to 400 mg every 18 to 24 hours

Alternate recommendations: Oral (immediate release), IV:

CrCl >50 mL/minute: No dosage adjustment necessary (Aronoff 2007).

CrCl 10 to 50 mL/minute: Administer 50% to 75% of usual dose every 12 hours (Aronoff 2007).

CrCl <10 mL/minute: Administer 50% of usual dose every 12 hours (Aronoff 2007).

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): Minimally dialyzable (<10%): Oral: 250 to 500 mg every 24 hours or IV: 200 to 400 mg every 24 hours (Heintz 2009). Note: Dosing dependent on the assumption of 3 times weekly, complete IHD sessions.

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH/CVVHD/CVVHDF: IV: 200 to 400 mg every 12 to 24 hours

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer’s labeling. Use with caution in severe impairment.

Reconstitution

Injection, vial: May be diluted with NS, D5W, SWFI, D10W, D51/4NS, D51/2NS, LR.

Extemporaneously Prepared

A 50 mg/mL oral suspension may be made using 2 different vehicles (a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Methylcellulose 1% and Simple Syrup, NF). Crush twenty 500 mg tablets and reduce to a fine powder. Add a small amount of vehicle and mix to a uniform paste; mix while adding the vehicle in geometric proportions to almost 200 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 200 mL. Label "shake well" and "refrigerate". Stable 91 days refrigerated and 70 days at room temperature. Note: Microcapsules for oral suspension available (50 mg/mL; 100 mg/mL); not for use in feeding tubes.

Nahata MC, Pai VB, and Hipple TF, Pediatric Drug Formulations, 5th ed, Cincinnati, OH: Harvey Whitney Books Co, 2004.

Administration

Oral: May administer with food to minimize GI upset; avoid antacid use; maintain proper hydration and urine output. Administer immediate release ciprofloxacin and Cipro XR at least 2 hours before or 6 hours after antacids or other products containing calcium, iron, or zinc (including dairy products or calcium-fortified juices). Separate oral administration from drugs which may impair absorption (see Drug Interactions).

Oral suspension: Should not be administered through feeding tubes (suspension is oil-based and adheres to the feeding tube). Patients should avoid chewing on the microcapsules.

Nasogastric/orogastric tube: Crush immediate-release tablet and mix with water. Flush feeding tube before and after administration. Hold tube feedings at least 1 hour before and 2 hours after administration.

Tablet, extended release: Do not crush, split, or chew. May be administered with meals containing dairy products (calcium content <800 mg), but not with dairy products alone.

Parenteral: Administer by slow IV infusion over 60 minutes into a large vein (reduces risk of venous irritation).

Dietary Considerations

Food: Drug may cause GI upset; take without regard to meals (manufacturer prefers that immediate release tablet is taken 2 hours after meals). Extended release tablet may be taken with meals that contain dairy products (calcium content <800 mg), but not with dairy products alone.

Dairy products, calcium-fortified juices, oral multivitamins, and mineral supplements: Absorption of ciprofloxacin is decreased by divalent and trivalent cations. The manufacturer states that the usual dietary intake of calcium (including meals which include dairy products) has not been shown to interfere with ciprofloxacin absorption. Immediate release ciprofloxacin and Cipro XR may be taken 2 hours before or 6 hours after any of these products.

Caffeine: Patients consuming regular large quantities of caffeinated beverages may need to restrict caffeine intake if excessive cardiac or CNS stimulation occurs.

Compatibility

Stable in D51/4NS, D51/2NS, D5W, D10W, LR, NS, SWFI; variable stability (consult detailed reference) in peritoneal dialysis solution.

Y-site administration: Incompatible with aminophylline, amphotericin B cholesteryl sulfate complex, ampicillin, ampicillin/sulbactam, azithromycin, cefepime, dexamethasone sodium phosphate, furosemide, hydrocortisone sodium succinate, methylprednisolone sodium succinate, pantoprazole, pemetrexed, phenytoin, potassium phosphate, propofol, vancomycin, warfarin.

Storage

Injection:

Premixed infusion: Store between 5°C to 25°C (41°F to 77°F); avoid freezing. Protect from light.

Vial: Store between 5°C to 30°C (41°F to 86°F); avoid freezing. Protect from light. Diluted solutions of 0.5 to 2 mg/mL in D51/4NS, D51/2NS, D5W, D10W, LR, NS are stable for up to 14 days refrigerated or at room temperature.

Microcapsules for oral suspension: Prior to reconstitution, store below 25°C (77°F). Protect from freezing. Following reconstitution, store below 30°C (86°F) for up to 14 days. Protect from freezing.

Tablet:

Immediate release: Store between 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Extended release: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

ACE Inhibitors: May enhance the arrhythmogenic effect of Ciprofloxacin (Systemic). Monitor therapy

Agomelatine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Agomelatine. Avoid combination

Aminolevulinic Acid: Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid. Monitor therapy

Angiotensin II Receptor Blockers: May enhance the arrhythmogenic effect of Ciprofloxacin (Systemic). Monitor therapy

Antacids: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Exceptions: Sodium Bicarbonate. Consider therapy modification

ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bendamustine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Bendamustine. Concentrations of the active metabolites of bendamustine may be decreased. Monitor therapy

Blood Glucose Lowering Agents: Quinolone Antibiotics may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Caffeine: Ciprofloxacin (Systemic) may increase the serum concentration of Caffeine. Monitor therapy

Calcium Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Exceptions: Calcium Chloride. Consider therapy modification

CarBAMazepine: Ciprofloxacin (Systemic) may increase the serum concentration of CarBAMazepine. Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

CloZAPine: Ciprofloxacin (Systemic) may enhance the QTc-prolonging effect of CloZAPine. Ciprofloxacin (Systemic) may increase the serum concentration of CloZAPine. Management: Avoid when possible. Reduce the clozapine dose by one-third when adding ciprofloxacin and monitor closely for evidence of excessive QTc prolongation and clozapine toxicity. Resume the previous clozapine dose following ciprofloxacin discontinuation. Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Quinolone Antibiotics. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy

CYP1A2 Substrates: CYP1A2 Inhibitors (Strong) may decrease the metabolism of CYP1A2 Substrates. Consider therapy modification

Didanosine: Quinolone Antibiotics may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Consider therapy modification

DULoxetine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of DULoxetine. Avoid combination

Erlotinib: Ciprofloxacin (Systemic) may increase the serum concentration of Erlotinib. Management: Avoid use of this combination when possible. When the combination must be used, monitor the patient closely for the development of severe adverse reactions, and if such severe reactions occur, reduce the erlotinib dose (in 50 mg decrements). Consider therapy modification

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Monitor therapy

Fosphenytoin: May enhance the QTc-prolonging effect of Ciprofloxacin (Systemic). Ciprofloxacin (Systemic) may diminish the therapeutic effect of Fosphenytoin. Ciprofloxacin (Systemic) may decrease the serum concentration of Fosphenytoin. Monitor therapy

Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

HYDROcodone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of HYDROcodone. Monitor therapy

Iron Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral iron salts. Exceptions: Ferric Carboxymaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Consider therapy modification

Ivabradine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Kola Nut: Ciprofloxacin (Systemic) may increase the serum concentration of Kola Nut. Specifically, ciprofloxacin may increase serum concentrations of caffeine, a major component of kola nut. Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Lanthanum: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolone antibiotics at least two hours before or after lanthanum. Consider therapy modification

Lomitapide: Ciprofloxacin (Systemic) may increase the serum concentration of Lomitapide. Avoid combination

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Magnesium Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Consider therapy modification

Methotrexate: Ciprofloxacin (Systemic) may increase the serum concentration of Methotrexate. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Moderate Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolone Antibiotics. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Quinolone Antibiotics. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Interactions can be minimized by administering the oral quinolone at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (i.e., calcium, iron, magnesium, selenium, zinc). Consider therapy modification

Mycophenolate: Quinolone Antibiotics may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Monitor therapy

Nadifloxacin: May enhance the adverse/toxic effect of Quinolone Antibiotics. Avoid combination

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolone Antibiotics. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolone Antibiotics. Monitor therapy

Pentoxifylline: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Pentoxifylline. Monitor therapy

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Phenytoin: Ciprofloxacin (Systemic) may diminish the therapeutic effect of Phenytoin. Ciprofloxacin (Systemic) may decrease the serum concentration of Phenytoin. Monitor therapy

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Avoid combination

Pirfenidone: Ciprofloxacin (Systemic) may increase the serum concentration of Pirfenidone. Management: With ciprofloxacin doses of 1,500 mg/day, the pirfenidone dose should be reduced to 1,602 mg daily (2 capsules, three times a day). With lower daily doses of ciprofloxacin, use pirfenidone with caution. Consider therapy modification

Pomalidomide: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Pomalidomide. Management: Avoid when possible. Monitor toxicity closely when combined. In patients also receiving a P-gp inhibitor and strong CYP3A4 inhibitor, reduce pomalidomide dose by 50% (Canadian labeling says to reduce dose with any use of a strong CYP1A2 inhibitor). Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Probenecid: May decrease the excretion of Quinolone Antibiotics. Specifically, probenecid may decreased the renal excretion of quinolone antibiotics. Probenecid may increase the serum concentration of Quinolone Antibiotics. Monitor therapy

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Quinapril: May decrease the serum concentration of Quinolone Antibiotics. Management: Separate doses of quinapril and oral quinolones by at least 2 hours in order to reduce the risk of interaction. Monitor for reduced efficacy of the quinolone if these products are used concomitantly. Consider therapy modification

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Rasagiline: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Rasagiline. Management: Limit rasagiline dose to 0.5 mg once daily in patients taking strong CYP1A2 inhibitors. Consider therapy modification

Roflumilast: Ciprofloxacin (Systemic) may increase the serum concentration of Roflumilast. Monitor therapy

ROPINIRole: Ciprofloxacin (Systemic) may increase the serum concentration of ROPINIRole. Monitor therapy

Ropivacaine: Ciprofloxacin (Systemic) may increase the serum concentration of Ropivacaine. Monitor therapy

Sevelamer: May decrease the absorption of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after sevelamer. Consider therapy modification

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Spironolactone: May enhance the arrhythmogenic effect of Ciprofloxacin (Systemic). Monitor therapy

Strontium Ranelate: May decrease the serum concentration of Quinolone Antibiotics. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Avoid combination

Sucralfate: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least 2 hours before or 6 hours after the sucralfate dose. Greater separation of doses may further lessen the risk for a significant interaction. Consider therapy modification

Tasimelteon: CYP1A2 Inhibitors (Strong) may increase the serum concentration of Tasimelteon. Avoid combination

Teriflunomide: May increase the serum concentration of OAT3 Substrates. Monitor therapy

Theophylline Derivatives: Quinolone Antibiotics may decrease the metabolism of Theophylline Derivatives. Ciprofloxacin and enoxacin are of greatest concern. Theophylline/quinolone therapy might augment the seizure-producing potential of each of the individual agents. Exceptions: Dyphylline. Consider therapy modification

Thyroid Products: Ciprofloxacin (Systemic) may decrease the serum concentration of Thyroid Products. Monitor therapy

TiZANidine: CYP1A2 Inhibitors (Strong) may increase the serum concentration of TiZANidine. Management: Tizanidine use with ciprofloxacin or fluvoxamine is contraindicated. If use with another strong inhibitor cannot be avoided, initiate tizanidine at an adult dose of 2 mg and increase in 2-4 mg increments based on response. Monitor closely. Avoid combination

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Varenicline: Quinolone Antibiotics may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concurrent use of levofloxacin or other quinolone antibiotics, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Vinflunine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination

Vitamin K Antagonists (eg, warfarin): Quinolone Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Zinc Salts: May decrease the serum concentration of Quinolone Antibiotics. Management: Administer oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral zinc salts. Exceptions: Zinc Chloride. Consider therapy modification

Zolpidem: Ciprofloxacin (Systemic) may increase the serum concentration of Zolpidem. Monitor therapy

Test Interactions

Some quinolones may produce a false-positive urine screening result for opioids using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opioid screens by more specific methods should be considered.

Adverse Reactions

1% to 10%:

Central nervous system: Neurological signs and symptoms (children 2%; includes dizziness, insomnia, nervousness, somnolence), headache (IV administration), restlessness (IV administration)

Dermatologic: Skin rash (children 2%, adults 1%)

Gastrointestinal: Diarrhea (children 5%; adults 2%), vomiting (children 5%; adults 1%), abdominal pain (children 3%; adults <1%), dyspepsia (children 3%; adults <1%), nausea (3%)

Hepatic: Increased serum AST (adults 1%), increased serum ALT

Local: Injection site reactions (IV administration)

Respiratory: Rhinitis (children 3%)

Miscellaneous: Fever (children 2%; adults <1%)

<1% (Limited to important or life-threatening): Abnormal gait, acute generalized exanthematous pustulosis, acute gout attack, acute renal failure, ageusia, agitation, agranulocytosis, albuminuria, anaphylactic shock, anaphylaxis, anemia, angina pectoris, angioedema, anorexia, anosmia, anxiety, arthralgia, ataxia, atrial flutter, bone marrow depression (life-threatening), bronchospasm, candidiasis, candiduria, cardiorespiratory arrest, casts in urine, cerebral thrombosis, chills, cholestatic jaundice, chromatopsia, Clostridium difficile-associated diarrhea, confusion, constipation, crystalluria (particularly in alkaline urine), decreased hematocrit, decreased hemoglobin, decreased prothrombin time, delirium, depersonalization, depression (including self-injurious behavior), dizziness, drowsiness, dyspepsia (adults), dysphagia, dysphasia, dyspnea, edema, eosinophilia, erythema multiforme, erythema nodosum, exacerbation of myasthenia gravis, exfoliative dermatitis, fixed drug eruption, flatulence, gastrointestinal hemorrhage, hallucination, headache (oral), hematuria, hemolytic anemia, hepatic failure, hepatic necrosis, hepatotoxicity (idiosyncratic) (Chalasani, 2014), hyperesthesia, hyperglycemia, hyperpigmentation, hypersensitivity reaction, hypertension, hypertonia, hypoglycemia, hypotension, increased blood urea nitrogen, increased creatine phosphokinase, increased INR (in patients treated with vitamin K antagonists), increased intracranial pressure, increased lactate dehydrogenase, increased serum alkaline phosphatase, increased serum bilirubin, increased serum cholesterol, increased serum creatinine, increased serum glucose, increased serum lipase, increased serum triglycerides, increased uric acid, insomnia, interstitial nephritis, intestinal perforation, irritability, jaundice, laryngeal edema, lethargy, lymphadenopathy, malaise, manic behavior, mastalgia, methemoglobinemia, migraine, myalgia, myocardial infarction, myoclonus, nephritis, nephrolithiasis, nightmares, nystagmus, orthostatic hypotension, palpitations, pancreatitis, pancytopenia (life-threatening), paranoia, paresthesia, peripheral neuropathy, petechia, phobia, phototoxicity, pneumonitis, polyneuropathy, prolonged prothrombin time (in patients treated with vitamin K antagonists), pseudotumor cerebri, pulmonary edema, rupture of tendon, seizure (including grand mal), serum sickness-like reaction, skin photosensitivity, status epilepticus, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, syncope, tachycardia, tendonitis, thrombocythemia, thrombocytopenia, thrombophlebitis, tinnitus, torsades de pointes, toxic epidermal necrolysis, toxic psychosis, tremor, twitching, unresponsive to stimuli, urethral bleeding, vaginitis, vasculitis, ventricular arrhythmia, ventricular ectopy, visual disturbance, vulvovaginal candidiasis, weakness

ALERT: U.S. Boxed Warning

Serious adverse reactions:

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 ciprofloxacin immediately and avoid the use of fluoroquinolones in patients who experience any of these serious adverse reactions. Because fluoroquinolones have been associated with serious adverse reactions, reserve ciprofloxacin for use in patients who have no alternative treatment options for the following indications: acute exacerbation of chronic bronchitis, acute sinusitis, and acute uncomplicated cystitis.

Exacerbation of myasthenia gravis:

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis.

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with a history of or at risk for QTc prolongation, torsade de pointes, uncorrected hypokalemia, hypomagnesemia, cardiac disease (heart failure, myocardial infarction, bradycardia) or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).

• Crystalluria: Rarely, crystalluria has occurred; urine alkalinity may increase the risk. Ensure adequate hydration during therapy.

• Glucose regulation: Fluoroquinolones have been associated with the development of serious, and sometimes fatal, hypoglycemia. These events have occurred most often in elderly patients with diabetes, but have also been reported in patients without a prior history of diabetes. Prompt identification and treatment of hypoglycemia is essential. Individual quinolones may differ in their potential to cause this effect. It was most evident with gatifloxacin (no longer marketed as a systemic formulation). Hyperglycemia has also been associated with the use of fluoroquinolones. Patients should be monitored closely for signs/symptoms of disordered glucose regulation.

• Hepatotoxicity: Hepatocellular, cholestatic, or mixed liver injury has been reported, including hepatic necrosis, life-threatening hepatic events, and fatalities. Acute liver injury can be rapid onset (range: 1-39 days), often associated with hypersensitivity. Most fatalities occurred in patients >55 years of age. Discontinue immediately if signs/symptoms of hepatitis (abdominal tenderness, dark urine, jaundice, pruritus) occur. Additionally, temporary increases in transaminases or alkaline phosphatase, or cholestatic jaundice may occur (highest risk in patients with previous liver damage).

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatitis, jaundice, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Photosensitivity/phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may cause moderate-to-severe phototoxicity reactions which may appear as exaggerated sunburn reactions. Discontinue use if phototoxicity occurs.

• Serious adverse reactions:[US Boxed Warning]: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue ciprofloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Patients of any age or without preexisting risk factors have experienced these reactions; may occur within hours to weeks after initiation.

- CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects including seizures, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis; may also cause nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or actions. May occur following the first dose; discontinue immediately and avoid further use of fluoroquinolones in patients who experience these reactions. Use with caution in patients with known or suspected CNS disorder, or risk factors that may predispose to seizures or lower the seizure threshold.

- Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of peripheral neuropathy; may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur. Avoid use in patients who have previously experienced peripheral neuropathy.

- Tendinitis/tendon rupture: Fluoroquinolones have been associated with an increased risk of tendonitis and tendon rupture in all ages; risk may be increased with concurrent corticosteroids, solid organ transplant recipients, and in patients >60 years of age, but has also occurred in patients without these risk factors. Rupture of the Achilles tendon has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps, hand) have also been reported. Inflammation and rupture may occur bilaterally. Cases have been reported within hours or days of initiation, and up to several months after discontinuation of therapy. Strenuous physical activity, renal failure, and previous tendon disorders may be independent risk factor for tendon rupture. Discontinue at first sign of tendon pain, swelling, inflammation or rupture. Avoid use in patients with a history of tendon disorders or who have experienced tendinitis or tendon rupture.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with a known history of myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support and deaths have been reported.

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required. May increase risk of tendon rupture.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.

• Syphilis: Since ciprofloxacin is ineffective in the treatment of syphilis and may mask symptoms, all patients should be tested for syphilis at the time of gonorrheal diagnosis and 3 months later.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Theophylline: Serious and fatal reactions including seizures, status epilepticus, cardiac arrest, and respiratory failure have been reported with concomitant administration of theophylline. If concurrent use is unavoidable, monitor serum theophylline levels and adjust theophylline dose as warranted.

Special populations:

• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in elderly patients.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients with latent or actual G6PD deficiency.

• Pediatric: Adverse effects, including those related to joints and/or surrounding tissues, are increased in pediatric patients and therefore, ciprofloxacin should not be considered as drug of choice in children (exception is anthrax treatment).

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: Reserve use of ciprofloxacin for treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or acute uncomplicated cystitis for patients who have no alternative treatment options because of the risk of disabling and potentially serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects).

Monitoring Parameters

CBC, renal and hepatic function during prolonged therapy

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Ciprofloxacin crosses the placenta and produces measurable concentrations in the amniotic fluid and cord serum (Ludlam 1997). Based on available data, an increased risk of teratogenic effects has not been observed following ciprofloxacin use during pregnancy (Bar-Oz 2009; Padberg 2014). Ciprofloxacin is recommended for prophylaxis and treatment of pregnant women exposed to anthrax (Meaney-Delman 2014). Serum concentrations of ciprofloxacin may be lower during pregnancy than in nonpregnant patients (Giamarellou 1989).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, vomiting, or nausea. Have patient report immediately to prescriber signs of tendon inflammation or rupture (pain, bruising, or swelling in the back of the ankle, shoulder, hand, or other joints), signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of nerve problems (sensitivity to heat or cold; decreased sense of touch; burning, numbness, or tingling; pain, or weakness in the arms, hands, legs, or feet), angina, tachycardia, abnormal heartbeat, severe dizziness, thrush, passing out, severe headache, severe loss of strength and energy, vision changes, hallucinations, seizures, insomnia, nightmares, shortness of breath, bruising, bleeding, tremors, abnormal gait, sunburn, chills, tinnitus, pharyngitis, vaginitis, muscle pain, muscle weakness, injection site irritation, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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