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Ciprofloxacin

    Brands

    DEA Class; Rx

    Common Brand Names; Cipro, Cipro XR, ProQuin XR

    • Fluoroquinolones

    ciprofloxacin otic (Rx)

    Brand and Other Names: Cetraxal, Otiprio
    • Classes: Antibiotics, Otic; 
    • Quinolones, Otic

    ciprofloxacin ophthalmic (Rx)

    Brand and Other Names: Ciloxan
    • Classes: Quinolones, Ophthalmic

    Oral, intravenous, ophthalmic, otic broad-spectrum fluoroquinolone anti-infective
    Used for urinary tract infections, respiratory tract infections, skin and skin structure infections, infectious diarrhea, anthrax, plague, corneal ulcers, bacterial conjunctivitis, acute otitis externa, and bilateral otitis media with effusion in patients undergoing tympanostomy tube placement
    Associated with disabling and potentially irreversible adverse events, including tendonitis, tendon rupture, and peripheral neuropathy

    Indicated for
    • Acute Sinusitis
    • Bone & Joint Infections
    • Infectious Diarrhea
    • Empirical Therapy in Febrile Neutropenic Patients
    • Intra-abdominal Infections
    • Lower Respiratory Tract Infections
    • Nosocomial Pneumonia
    • Skin/Skin Structure Infections
    • Urinary Tract Infections (Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections)
    • Urethral & Cervical Gonococcal Infections
    • Anthrax Infection

    Indication for treatment and prophylaxis of plague due to Yersinia pestis

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

    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

    Infection caused by susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus

    Also Indicated for

    • Bacterial Conjunctivitis
    • Corneal Ulcers (Keratitis)

    Documented hypersensitivity; concurrent tizanidine administration

    • 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%)
    • 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

    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

    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 (see Black Box Warnings)

    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 first drug of 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)

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

    Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

    Published literature reports that ciprofloxacin is present in human milk following intravenous and oral administration; there is no information regarding effects on milk production or breastfed infant; because of potential risk of serious adverse reactions in breastfed infants, including arthropathy shown in juvenile animal studies

    Adults

    1.5 g/day PO regular release products; 1 g/day PO Cipro XR; 1.2 g/day IV; 1 mg/ear/day otic solution; 12 mg/ear for otic suspension; 120 drops/eye/day of ophthalmic solution; maximum dosage not available for ophthalmic ointment.

    Geriatric

    1.5 g/day PO regular release products; 1 g/day PO Cipro XR; 1.2 g/day IV; 1 mg/ear/day otic solution; 12 mg/ear for otic suspension; 120 drops/eye/day of ophthalmic solution; maximum dosage not available for ophthalmic ointment.

    Adolescents

    45 mg/kg/day PO (Max: 1.5 g/day) or 30 mg/kg/day IV (Max: 1.2 g/day); for pulmonary exacerbations of cystic fibrosis, up to 2 g/day PO has been studied off label; safety and efficacy of extended-release oral products have not been established; 1 mg/ear/day otic solution; 12 mg/ear for otic suspension; 120 drops/eye/day of ophthalmic solution; maximum dosage not available for ophthalmic ointment.

    Children

    2 to 12 years: 45 mg/kg/day PO (Max: 1.5 g/day) or 30 mg/kg/day IV (Max: 1.2 g/day); for pulmonary exacerbations of cystic fibrosis, up to 2 g/day PO has been studied off label; safety and efficacy of extended-release oral products have not been established; 1 mg/ear/day otic solution; 12 mg/ear for otic suspension; 120 drops/eye/day of ophthalmic solution; maximum dosage not available for ophthalmic ointment.
    1 year: 45 mg/kg/day PO or 30 mg/kg/day IV; safety and efficacy of extended-release oral products have not been established; 1 mg/ear/day otic solution; 12 mg/ear for otic suspension; 120 drops/eye/day of ophthalmic solution; safety and efficacy not established for ophthalmic ointment.

    Infants

    6 to 11 months: 45 mg/kg/day PO or 30 mg/kg/day IV; 120 drops/eye/day of ophthalmic solution; 12 mg/ear for otic suspension. Safety and efficacy of other formulations have not been established.
    1 to 5 months: 45 mg/kg/day PO or 30 mg/kg/day IV; 120 drops/eye/day of ophthalmic solution. Safety and efficacy of other formulations have not been established.

    Neonates

    45 mg/kg/day PO or 30 mg/kg/day IV; 120 drops/eye/day of ophthalmic solution. Safety and efficacy of other formulations have not been established.

    Ciprofloxacin hydrochloride

    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

    otic solution (Cetraxal)

    • 0.5mg/0.25mL (0.2%)/dropper

    otic suspension (Otiprio)

    • 60mg/mL (6%)/vial

    ophthalmic solution

    • 0.3%

    ophthalmic ointment

    • 0.3%