[Posted 12/20/2018]AUDIENCE: Health Professional, Infectious Disease, Cardiology, Patient ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection. BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years. They work by killing or stopping the growth of bacteria that can cause illness. Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones, available at RECOMMENDATION: Healthcare professionals should: Taking ciprofloxacin increases the risk that you will develop tendinitis (swelling of a fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of a fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. 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 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 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 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 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 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 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 disturbances, 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 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 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, Cr Cl 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 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 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 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.
Ciprofloxacin is the generic form of the brand-name antibiotic Cipro. Doctors prescribe ciprofloxacin to treat or prevent infections caused by various bacteria that are sensitive to ciprofloxacin. Ciprofloxacin should be taken for 3-14 days depending on your infection. Marked symptomatic relief in case of bladder infection is expected in 24-48 hours, although milder symptoms may persist for 5-7 days.