Classes
DEA Class; Rx
Common Brand Names; Cipro, Cipro XR, ProQuin XR
- Fluoroquinolones
ciprofloxacin otic (Rx)
- Classes: Antibiotics, Otic;
- Quinolones, Otic
ciprofloxacin ophthalmic (Rx)
- Classes: Quinolones, Ophthalmic
Description
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
Indications
- 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)
Contraindications
Documented hypersensitivity; concurrent tizanidine administration
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
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.
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.
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.
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.
How supplied
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%