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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 or by entering the drug name at
Drugs@FDA
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.
DF 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
Public Citizen list
this drug for LIMITED USEAGE
Limited Use
Generic drug name:
ofloxacin (oh FLOKS a sin)
Brand name(s):
FLOXIN (Ortho-McNeil Pharmaceuticals)
GENERIC: not available
FAMILY:
Fluoroquinolones
Ofloxacin
FLOXIN JOHNSON RW (OFLOXACIN) FDA Approval Date: DEC 28, 1990
Brand Names: Floxin, Ocuflox
FLOXIN (ofloxacin)
and
FLOXIN I.V. (ofloxacin)
[Safety Label changes, September 11, 1996: R.W. Johnson]
- WARNINGS
:
The second paragraph detailing severe and sometimes fatal events
that have been reported in patients receiving quinolones, including
ofloxacin, has been revised to indicate that some of these events
are due to hypersensitivity, with those occurring with ofloxacin
treatment no longer characterized as extremely rare.
A new paragraph has been added that indicates the reporting of
ruptures of the shoulder, hand and Achilles tendons that required
surgical repair or resulted in prolonged disability with ofloxacin
and other quinolones. Ofloxacin should be discontinued if pain,
inflammation or tendon rupture is experienced by the patient, who
should rest and refrain from exercise until the diagnosis of
tendonitis or tendon rupture has been confidently excluded. Tendon
rupture can occur at any time during or after therapy with
ofloxacin.
The paragraph concerning syphilis and gonorrhea with respect to
ofloxacin treatment has been revised to indicate that those patients
treated with ofloxacin for gonorrhea who have a positive follow-up
serologic test for syphilis after three months should be treated
with an appropriate antimicrobial.
PRECAUTIONS:
Information for Patients: Section has been revised thusly:
The statement that cautioned against taking mineral supplements,
vitamins with iron or minerals, calcium-, aluminum- or
magnesium-based antacids or sucralfate within two hours before or
after ofloxacin has been removed.
The statement that ofloxacin can be taken without regard to
meals has been removed.
A new statement has been added that indicates patients should be
advised that ofloxacin treatment is to be discontinued and their
physician informed if they experience pain, inflammation or tendon
rupture, and to rest and refrain from exercise until the diagnosis
of tendonitis or tendon rupture has been confidently excluded.
A new statement has been added that indicates the reporting of
convulsions in patients taking quinolones, including ofloxacin, and
that patients are to notify their physician before taking ofloxacin
if they have a history of this condition
http://www.fda.gov/medwatch/SAFETY/LABEL/sep96.htm#floxin
Adverse Drug reactions associated with Ofloxcin:
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.
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.
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.
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.
Additional events:
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
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
Hepatic: elevated: alkaline pHospHatase, AST
(SGOT), ALT (SGPT)
Serum chemistry: hyperglycemia, hypoglycemia,
elevated creatinine, elevated BUN
Urinary: glucosuria, proteinuria,
alkalinuria, hyposthenuria, hematuria, pyuria
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 (see WARNINGS
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
Hematopoietic: prolongation of prothrombin time.
Serum chemistry: acidosis, elevation
of: serum triglycerides, serum cholesterol, serum potassium, liver function tests including: GGTP, LDH, bilirubin.
Urinary: albuminuria, candiduria.
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 other 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.
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.
Serious and occasionally fatal hypersensitivity
(anapHylactic) reactions, some following the first dose, have been reported in
patients receiving systemic quinolones, including ofloxacin. 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.
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.
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.
Quinolones, including ofloxacin, have been shown to cause
arthropathy in immature animals after oral
administration; however, topical ocular administration of
ofloxacin to immature animals has not shown any
arthropathy.
Source:
http://www.rxlist.com/cgi/generic/oflox.htm
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