Do Not UseGeneric drug name:
Ofloxacin Brand name(s):
FLOXIN (Ortho-McNeil Pharmaceuticals)
NOTE: Levofloxacin is a 'mirror image' of Ofloxacin and
patients taking Floxin should refer to the Levofloxacin warnings as
well.
All brand names are trademarks of their respected manufacturers.
The information being provided below is to be considered a quick
reference guide.
For complete information please view the
complete package insert at:
www.rxlist.com
PDF version of the package insert can be found at the FDA website following this link. Remember Adobe Reader is required to view this.
http://www.fda.gov/cder/foi/label/2004
Listed in Public Citizen
as a
Limited Use drug
Numerous other, safer antibiotics are approved to treat the
same infections as this drug.
Read the FDA Mandated Label Changes, October 2004,for Floxin
Peripheral Neuropathy
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small
and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and
weakness have been reported in patients receiving quinolones.
QUINOLONES MAY HAVE THE POTENTIAL
TO PROLONG THE QTc INTERVAL OF THE ELECTROCARDIOGRAM IN SOME PATIENTS. DUE TO THE LACK OF CLINICAL EXPERIENCE, GATIFLOXACIN SHOULD BE AVOIDED IN PATIENTS WITH KNOWN PROLONGATION OF THE QTc INTERVAL, PATIENTS WITH UNCORRECTED HYPOKALEMIA, AND PATIENTS RECEIVING CLASS IA (E.G. QUINIDINE, PROCAINAMIDE) OR CLASS III (E.G. AMIODARONE, SOTALOL) ANTIARRHYTHMIC AGENTS.Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. Tendon rupture can occur during or after therapy with quinolones.
Quinolones may
cause central nervous system (CNS) events including nervousness, agitation, insomnia, anxiety, nightmares, or paranoia.As with other quinolones, disturbances of
blood glucose, including symptomatic hyper- and hypoglycemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic (e. g., glyburide) or with insulin. In these patients, the monitoring of blood glucose is recommended.
Adverse Drug reactions associated with Ofloxacin:
Peripheral
neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy
affecting small and/or large axons resulting in paresthesias, hypoesthesias,
dysesthesias and
weakness have been reported in patients receiving quinolones, including
ofloxacin. Ofloxacin should be discontinued if the patient experiences symptoms
of neuropathy including pain, burning, tingling, numbness, and/or weakness or
other alterations of sensation including light touch, pain, temperature,
position sense, and vibratory sensation in order to prevent the development of
an irreversible condition.
Convulsions, increased intracranial pressure, and toxic psychosis have been
reported in patients receiving quinolones, including ofloxacin. Quinolones,
including ofloxacin, may also cause central nervous system stimulation which may
lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness,
confusion, hallucinations, paranoia and depression, nightmares, insomnia, and
rarely suicidal thoughts or acts. These reactions may occur following the first
dose.
Achilles and other tendon ruptures that required surgical repair or resulted in prolonged disability have been reported with quinolones. Post-marketing surveillance reports indicate that the risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. The systemic administration of quinolones, including ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.
Ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones.
CRYSTALLURIA and CYLINDRURIA HAVE BEEN REPORTED with quinolones.
Non-steroidal anti-inflammatory drugs: The concomitant administration of a non-steroidal anti-inflammatory drug, with a quinolone, including ofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
Serious and occasionally fatal hypersensitivity (anapHylactic/anapHylactoid) reactions have been reported in patients receiving therapy with quinolones, including ofloxacin. These reactions often occur following the first dose. Some reactions were accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling, etc.), airway obstruction (including bronchospasm, shortness of breath and acute respiratory distress), dyspnea, urticaria/hives, itching, and other serious skin reactions.
Serious and sometimes fatal events of uncertain etiology have been reported in patients receiving therapy with quinolones including, extremely rarely, ofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: fever, rash or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens- Johnson Syndrome, etc.); vasculitis, arthralgia, myalgia, serum sickness; allergic pneumonitis; interstitial nepHritis, acute renal insufficiency/failure; hepatitis, jaundice, acute hepatic necrosis/failure; anemia including hemolytic and aplastic, thrombocytopenia, including thrombotic thrombocytopenic purpura, leukopenia, agranulocytosis, pancytopenia, and/or other hematologic abnormalities.
Moderate to severe phototoxicity reactions have been observed in patients exposed to direct sunlight while receiving some drugs in this class, including ofloxacin.
As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported.
Pregnancy Warning
Ofloxacin and moxifloxacin caused fetal harm in animal studies, including decreased fetal body weight and increased death when given by mouth. Because of the potential for serious adverse effects to the fetus, these drugs should not be used by pregnant women unless there is no safer substitute.
Breast-feeding Warning
These drugs are excreted in human milk.
Because of the potential for serious adverse effects in
nursing infants, you should not take these drugs while
nursing.
In nursing women a single 200 mg oral dose of ofloxacin resulted in concentrations of ofloxacin
in milk that were similar to those found in plasma.
Additional events:
Nausea, headache, insomnia, external genital pruritus in women, dizziness , vaginitis, diarrhea, vomiting, abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pHaryngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances, and constipation.
Body as a whole: asthenia, chills, malaise, extremity pain, pain, epistaxis
Cardiovascular System: cardiac arrest, edema, hypertension, hypotension, palpitations, vasodilation
Gastrointestinal System: dyspepsia
Genital/Reproductive System: burning, irritation, pain and rash of the female genitalia, dysmenorrhea, menorrhagia, metrorrhagia
Musculoskeletal System: arthralgia, myalgia
Nervous System: seizures, anxiety, cognitive change, depression, dream abnormality, euphoria, hallucinations, paresthesia, syncope, vertigo, tremor, confusion
Nutritional/Metabolic: thirst, weight loss
Respiratory System: respiratory arrest, cough, rhinorrhea
Skin/Hypersensitivity: angiodema, diapHoresis, urticaria, vasculitis
Urinary System: dysuria, urinary frequency, urinary retention
Post-Marketing Adverse Events:
Cardiovascular System: cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, syncope
Endocrine/Metabolic: hyper- or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents
Gastrointestinal System: hepatic dysfunction including: hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis; instestinal perforation; pseudomembranous colitis, GI hemorrhage; hiccough, painful oral mucosa, pyrosis
Genital/Reproductive System: vaginal candidiasis
Hematopoietic: anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, ecchymosis/burning
Musculoskeletal: tendinitis/rupture: weakness
Nervous System: nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; pHobia, agitation, restlessness, agreesiveness/hostility, manic reaction, emotional lability; peripHeral neuropathy, ataxia, incoordination; possible exacerbation of: myasthenia gravis and extrapyramidal disorders; dyspHasia, lightheadedness
Respiratory System: dyspnea, bronchospasm, allergic pneumonitis, stridor
Skin/Hypersensitivity: anapHylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson Syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, pHotosensitivity, vesiculobullous eruption
Special Senses: diplopia, nystagmus, blurred vision, disturbances of: taste, smell, hearing and equilibrium, usually reversible following discontinuation.
Urinary System: anuria, polyuria, renal calculi, renal failure, interstitial nepHritis, hematuria
Laboratory Abnormalities
The following laboratory abnormalities appeared in
patients receiving multiple doses of ofloxacin.
Hematopoietic: anemia, leukopenia, leukocytosis, neutropenia, neutropHilia, increased band forms, lympHocytopenia, eosinopHilia, lympHocytosis, thrombocytopenia, thrombocytosis, elevated ESR prolongation of prothrombin time.
Hepatic: elevated: alkaline pHospHatase, AST (SGOT), ALT (SGPT)
Serum chemistry: hyperglycemia, hypoglycemia, elevated creatinine, elevated BUN acidosis, elevation of: serum triglycerides, serum cholesterol, serum potassium, liver function tests including: GGTP, LDH, bilirubin.
Urinary: glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria
albuminuria, candiduria.Serious Adverse Reactions:
In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones.
CRYSTALLURIA and CYLINDRURIA HAVE BEEN REPORTED with quinolones.
Non-steroidal anti-inflammatory drugs: The concomitant administration of a non-steroidal anti-inflammatory drug, with a quinolone, including ofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
Serious and occasionally fatal hypersensitivity (anapHylactic/anapHylactoid) reactions have been reported in patients receiving therapy with quinolones, including ofloxacin. These reactions often occur following the first dose. Some reactions were accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling, etc.), airway obstruction (including bronchospasm, shortness of breath and acute respiratory distress), dyspnea, urticaria/hives, itching, and other serious skin reactions. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pHaryngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical opHthalmic ofloxacin.
Serious and sometimes fatal events of uncertain etiology have been reported in patients receiving therapy with quinolones including, extremely rarely, ofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: fever, rash or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens- Johnson Syndrome, etc.); vasculitis, arthralgia, myalgia, serum sickness; allergic pneumonitis; interstitial nepHritis, acute renal insufficiency/failure; hepatitis, jaundice, acute hepatic necrosis/failure; anemia including hemolytic and aplastic, thrombocytopenia, including thrombotic thrombocytopenic purpura, leukopenia, agranulocytosis, pancytopenia, and/or other hematologic abnormalities.
Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including ofloxacin. Quinolones, including ofloxacin, may also cause central nervous system stimulation which may lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ofloxacin, and may range in severity from mild to life-threatening.
Moderate to severe phototoxicity reactions have been observed in patients exposed to direct sunlight while receiving some drugs in this class, including ofloxacin.
As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported.
As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.
The systemic administration of quinolones, including ofloxacin, has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.
Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration.
Source:
http://www.rxlist.com/cgi/generic/oflox.htm