Ciprofloxacin (Systemic)

(sip roe FLOKS a sin)

• Cipro
• Cipro in D5W
• Cipro XR

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

Refer to adult dosing.

Note: In pediatric patients, ciprofloxacin is not routinely first-line therapy, but after assessment of risks and benefits, can be considered a reasonable alternative for some situations [eg, anthrax, resistance (cystic fibrosis)] or in situations where the only alternative is parenteral therapy and ciprofloxacin offers an oral therapy option (Bradley 2011b).

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

Usual dosage range (Red Book [AAP 2015]): Infants, Children, and Adolescents:

Mild to moderate infections: Oral: 10 mg/kg/dose twice daily (maximum dose: 500 mg/dose)

Severe infections:

Oral: 15 to 20 mg/kg/dose twice daily (maximum dose: 750 mg/dose)

IV: 10 mg/kg/dose every 8 to 12 hours (maximum dose: 400 mg/dose)

Anthrax: Infants, Children, and Adolescents: Note: Consult public health officials for event-specific recommendations:

Inhalational exposure (postexposure prophylaxis):

Oral: 15 mg/kg/dose every 12 hours for 60 days (maximum dose: 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 (without systemic involvement) (off-label use) (AAP [Bradley 2014]): Oral: 15 mg/kg/dose every 12 hours (maximum dose: 500 mg/dose). Duration: 7 to 10 days for naturally acquired infection, up to 60 days for biological weapon-related event.

Systemic, treatment (including meningitis) (off-label use) (AAP [Bradley 2014]): IV: Initial: 10 mg/kg/dose every 8 hours (maximum dose: 400 mg/dose) as part of combination therapy; continue until clinical criteria for stability are met, then may switch to oral therapy (15 mg/kg/dose orally twice daily) to complete a 60-day course

Chancroid (off-label use): Adolescents: Oral: 500 mg twice daily for 3 days (Red Book [AAP 2015])

Endocarditis, culture negative, empiric therapy (off-label use): Note: Administer in combination with other antibiotics: Children and Adolescents (AHA [Baltimore 2015]):

Oral: 10 to 15 mg/kg/dose twice daily for 4 to 6 weeks; maximum dose: 750 mg/dose

IV: 10 to 15 mg/kg/dose twice daily for 4 to 6 weeks; maximum dose: 400 mg/dose

Intra-abdominal infection, complicated (off-label use): Infants, Children, and Adolescents: IV: 10 to 15 mg/kg/dose every 12 hours; maximum dose: 400 mg/dose (IDSA [Solomkin 2010])

Meningococcal invasive disease prophylaxis, high-risk contacts (off-label use): Infants, Children, and Adolescents: Oral: 20 mg/kg as a single dose; maximum dose: 500 mg/dose (Red Book [AAP 2015])

Mycobacterium avium complex, severe or disseminated disease, HIV-exposed/-infected (off-label use): Infants and Children: Oral: 10 to 15 mg/kg/dose twice daily in addition to other antibiotics; maximum dose: 750 mg/dose (HHS [pediatric] 2013)

Peritoneal dialysis catheter, exit site or tunnel infection (off-label use): Infants, Children, and Adolescents: 10 to15 mg/kg/dose once daily (maximum dose: 500 mg/dose) (Warady [ISPD 2012])

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 (CDC [plague] 2015): Children and Adolescents:

Treatment:

Initial treatment: IV: 15 mg/kg/dose every 12 hours; maximum dose: 400 mg/dose; continue until 2 days after fever subsides, then may change to oral therapy.

Oral step down to complete a 10 to 14 day course: Oral: 20 mg/kg/dose twice daily; maximum dose: 500 mg/dose.

Postexposure prophylaxis: Oral: 20 mg/kg/dose twice daily for 7 days; maximum dose: 500 mg/dose)

Pneumonia, community-acquired (H. influenzae) (off-label use): Infants >3 months and Children: IV: 15 mg/kg/dose every 12 hours (IDSA/PIDS [Bradley 2011a])

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

Urinary tract infection:

Cystitis, acute uncomplicated: Adolescents ≥18 years: Oral, extended release: Refer to adult dosing

Complicated, including pyelonephritis:

Oral, immediate release: Children and Adolescents ≤17 years: 10 to 20 mg/kg/dose every 12 hours for 10 to 21 days; maximum dose: 750 mg/dose.

Oral, extended release: Adolescents ≥18 years: Refer to adult dosing

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

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

CBC, renal and hepatic function during prolonged therapy, altered mental status, signs and symptoms of tendonitis

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).