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Contraindications

Documented hypersensitivity; concurrent tizanidine administration

Cautions

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

No longer recommended for gonorrhea in United States, because of widespread resistance

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

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 drug of first 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)

Fluoroquinolones are associated with increased risk of tendinitis and tendon rupture in all ages; this risk is further increased in older patients (usually >60 years); in patients taking corticosteroids; and in kidney, heart, or lung transplant recipients; 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

Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis are reported with fluoroquinolones; psychotic reactions have progressed to suicidal ideations or thoughts and self-injurious behavior

Avoid IV administration in patients who have known QT prolongation, carry risk factors for prolonged QT, or are taking class 1A or class III antiarrhythmic drugs

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

Serious and sometimes fatal hypoglycemia reported with fluoroquinolone use; hyperglycemia also reported; monitor patients closely for signs/symptoms of abnormal glucose levels

Co-administration of CIPRO IV and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine, and zolpidem) results in increased plasma concentrations of co-administered drug and could lead to clinically significant pharmacodynamic adverse reactions of the co-administered drug

Moderate-to-severe phototoxicity reactions reported; avoid excessive sunlight and take precautions to limit exposure; discontinue use if phototoxicity occurs

Use with caution in patients with history of seizures taking concurrent therapy that lowers seizure threshold; risk increases rarely when administered concomitantly with NSAIDs

Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190

Serious and fatal reactions have reported in patients receiving concurrent administration of ciprofloxacin and theophylline; if concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate

Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria


Source: http://reference.medscape.com/drug/cipro-xr-ciprofloxacin-342530


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