CIPROFLOXACIN HCL (ciprofloxacin hcl)

There are 10 contraindications. Absolute contraindication.

Contraindication List
Aortic aneurysm
Congenital long QT syndrome
Congenital myasthenic syndrome
Dissection of aorta
Ehlers-danlos syndrome
History of aortic aneurysm
Loeys-dietz syndrome
Marfan syndrome
Myasthenia gravis
Torsades de pointes

There are 20 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Bradycardia
Cardiac transplantation
Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
Chronic kidney disease stage 5 (failure) GFr<15 ml/min
Clostridioides difficile infection
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Hemolytic anemia from pyruvate kinase and g6PD deficiencies
Hepatic failure
Hypokalemia
Hypomagnesemia
Idiopathic intracranial hypertension
Intracranial hypertension
Lung transplantation
Prolonged QT interval
Renal transplant
Sjogren's syndrome
Tendon rupture
Tendonitis

There are 11 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Cerebral ischemia
Dehydration
Diabetes mellitus
Disease of liver
Hypoglycemic disorder
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Lower seizure threshold
Peripheral neuropathy
Seizure disorder
Severe hepatic disease
Toxic psychosis

There are 77 severe adverse reactions.

More Frequent	Less Frequent
None.	Abnormal hepatic function tests

Rare/Very Rare

Acute hepatic failure Acute renal failure Agranulocytosis Allergic dermatitis Anaphylaxis Anemia Angina Angioedema Aortic aneurysm Aplastic anemia Arterial dissection Asthma Atrial fibrillation Cardiac arrhythmia Cerebral thrombosis Clostridioides difficile infection Colitis Depersonalization Dissection of aorta DRESS syndrome Drug-induced hepatitis Drug-induced psychosis Dysglycemia Dyspnea Eosinophilia Erythema nodosum Facial edema Hallucinations Hematuria Hemolytic anemia Hyperbilirubinemia Hyperglycemia Hypersensitivity drug reaction Hypersensitivity pneumonitis Hypertension Hypertonia Hypertriglyceridemia Hyperuricemia Hypoglycemic disorder Hypotension Increased alanine transaminase Increased aspartate transaminase Interstitial nephritis Intracranial hypertension Jaundice Leukopenia Maculopapular rash Methemoglobinemia Myocardial ischemia Neuromuscular blockade Non-traumatic rupture of achilles tendon Pancreatitis Pancytopenia Paroxysmal supraventricular tachycardia Prolonged QT interval Pulmonary edema Rhabdomyolysis Rotator cuff tendon rupture Seizure disorder Serum sickness Severe diarrhea Stevens-johnson syndrome Suicidal ideation Syncope Tendon rupture Tendon rupture extensor of hand and wrist Tendon rupture flexor of hand and wrist Tendonitis Thrombocytopenic disorder Thrombocytosis Thrombotic thrombocytopenic purpura Tonic clonic seizure Torsades de pointes Toxic epidermal necrolysis Valvular regurgitation Vasculitis

There are 75 less severe adverse reactions.

More Frequent	Less Frequent
Gastrointestinal irritation	Chest pain CNS toxicity Diarrhea Dyspepsia Fever Musculoskeletal pain Nausea Skin rash Vomiting

Rare/Very Rare

Acute abdominal pain Acute cognitive impairment Agitation Alopecia Anorexia Arthralgia Arthritis Ataxia Back pain Chills Constipation Crystalluria Delirium Depression Diplopia Disturbance of attention Dizziness Drowsy Dysesthesia Dysgeusia Dysphagia Epistaxis Flatulence Flushing Gait abnormality Gastritis General weakness Headache disorder Hiccups Hyperhidrosis Hypoesthesia Insomnia Lymphadenopathy Malaise Memory impairment Migraine Muscle weakness Myalgia Nervousness Nightmares Nystagmus Oral candidiasis Pain Palpitations Paranoid disorder Paresthesia Parosmia Peripheral edema Peripheral neuropathy Petechiae Polyuria Pruritus of skin Skin photosensitivity Skin pigmentation enhancement Stomatitis Symptoms of anxiety Tachycardia Thrombophlebitis Tinnitus Tremor Urinary retention Urticaria Vaginitis Visual changes Vulvovaginal candidiasis

There are no adequate and controlled studies to date using ciprofloxacin in pregnant women. Because ciprofloxacin, like most other fluoroquinolones, causes arthropathy in immature animals, the drug should not be used in pregnant women unless potential benefits justify potential risks to the fetus and mother. CDC states that oral ciprofloxacin is the preferred drug for initial anti-infective postexposure prophylaxis in pregnant and postpartum women following a suspected or confirmed exposure to aerosolized B.

anthracis spores in the context of biologic warfare or bioterrorism. CDC also states that oral ciprofloxacin is the preferred drug for treatment of uncomplicated cutaneous anthrax and IV ciprofloxacin is the preferred bactericidal component of a multiple-drug regimen for treatment of systemic anthrax in pregnant and postpartum women when such infections occur in the context of biologic warfare or bioterrorism. An expert review of published data regarding clinical experience with use of ciprofloxacin during pregnancy concluded that therapeutic doses of the drug during pregnancy are unlikely to pose a substantial teratogenic risk, but that data are insufficient to state that there is no risk.

Although some safety data are available from several postmarketing epidemiology studies involving short-term, first-trimester exposures to ciprofloxacin, these studies are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. In one controlled prospective observational study of 200 women exposed to fluoroquinolones during pregnancy (68% were first-trimester exposures, 52.5% of exposures involved ciprofloxacin), in utero exposure to fluoroquinolones during embryogenesis did not appear to be associated with an increased risk of major congenital malformations (incidence was 2.2% in the fluoroquinolone group and 2.6% in the control group; background incidence is 1-5%). There also was no evidence of increases in the rates of spontaneous abortion, prematurity, or low birthweight and no clinically important increase in musculoskeletal dysfunction in the ciprofloxacin-exposed children followed to 1 year of age.

In another prospective follow-up study that included 549 pregnancies with fluoroquinolone exposure (93% were first-trimester exposures, 70 first-trimester exposures involved ciprofloxacin), there was no increase in the rates of spontaneous abortion, prematurity, or low birthweight, and the malformation rate was similar to the background incidence rate with no evidence of any specific patterns of congenital abnormalities. Reproduction studies in rats and mice using oral ciprofloxacin dosages up to 100 mg/kg (0.6 and 0.3 times, respectively, the maximum daily human dosage of 1 g based on BSA) have not revealed evidence of harm to the fetus. In rabbits, oral ciprofloxacin dosages of 30 and 100 mg/kg (approximately 0.4 and 1.3 times, respectively, the highest recommended therapeutic dosage based on BSA) caused GI toxicity resulting in maternal weight loss and an increased incidence of abortion, but there was no evidence of teratogenicity.

IV ciprofloxacin given to rabbits at dosages up to 20 mg/kg (approximately 0.3 times the highest recommended therapeutic dosage based on BSA) has not resulted in maternal toxicity, embryotoxicity, or teratogenicity.

Ciprofloxacin is distributed into milk, but the amount of the drug absorbed by a nursing infant is unknown. Because of the potential for serious adverse effects of ciprofloxacin (including articular damage) in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. AAP considers ciprofloxacin to be usually compatible with breast-feeding since the amount of the fluoroquinolone potentially absorbed by nursing infants would be small and no observable change in infants associated with such exposure has been reported to date.

CDC states that recommendations for use of ciprofloxacin in breast-feeding women for postexposure prophylaxis following a suspected or confirmed exposure to aerosolized B. anthracis spores in the context of biologic warfare or bioterrorism and for treatment of uncomplicated cutaneous anthrax or systemic anthrax in such situations are the same as those for other adults.

No enhanced Geriatric Use information available for this drug.