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Levofloxacin | See downloads for: Adobe Files |
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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
PDF version of the package insert can be found at
the FDA website following this link. Remember Adobe Reader is required to view
this. Public Citizen list this drug for LIMITED USEAGE Limited Use
Peripheral Neuropathy QUINOLONES MAY HAVE THE POTENTIAL
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.Changes to the monograph (2001) LEVAQUIN (levofloxacin) Tablets & Injection [December 18, 2001: ORTHO-McNEIL] JOHNSON RW LEVOFLOXACIN FDA Approval Date: DEC 20, 1996 LEVAQUIN WARNINGS Second sentence added to the last paragraph concerning tendon rupture as follows: Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially in the elderly. PRECAUTIONS General The following paragraph concerning QTc prolongation was revised to read: Some quinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. During post-marketing surveillance, rare cases of torsades de pointes have been reported in patients taking levofloxacin. These reports generally involved patientsCarcinogenesis, Mutagenesis, Impairment of Fertility The following sentences were added to the first paragraph to read: Levofloxacin did not shorten the time to tumor development of UV-induced skin tumors in hairless albino (Skh-1) mice at any levofloxacin dose level and was therefore not photo-carcinogenic under conditions of this study. Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 µg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study. By comparison, dermal levofloxacin concentrations in human subjects receiving 750 mg of levofloxacin averaged approximately 11.8 µg/g at Cmax. Levofloxacin Name Brands: Quixin, Levaquin, Elequin, DR-3355 The complete package insert can be viewed at www.rxlist.com The following has been associated with levofloxacin therapy: 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 levofloxacin.
Levofloxacin 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 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, including levofloxacin.Allergic pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphoria, abnormal EEG, encephalopathy, erythema multiforme, hemolytic anemia, multi-system organ failure, palpitation, paresthesia, Stevens-Johnson Syndrome, tendon rupture, vasodilation. Non-steroidal anti-inflammatory drugs: The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including levofloxacin, may increase the rick of CNS stimulation and convulsive seizures. Convulsions and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose.Ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones. As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported. Crystalluria and cylindruria have been reported with quinolones. Pregnancy Warning Breast-feeding Warning Adverse reactions associated with Levofloxacin: diarrhea, nausea, vaginitis, pruritus, rash, abdominal pain, genital, moniliasis, dizziness, dyspepsia, insomnia, taste perversion, vomiting, anorexia, anxiety, constipation, edema, fatigue, headache, increased sweating, leukorrhea, malaise, nervousness, sleep disorders, tremor, urticaria, nausea, dyspepsia, vaginitis, pruritus, pain, chest pain, back pain, arthralgia, dry mouth, dyspnea,edema, fatigue, fever, genital pruritus, increased sweating, nervousness, pharyngitis, rhinitis, skin disorder, somnolence, taste perversion cardia failure, hypertension, leukorrhea, myocardial infarction, myalgia, purpura, tinnitus, tremor, urticaria.abnormal coordination, abnormal dreaming, abnormal hepatic function, abnormal platelets, abnormal renal function, abnormal vision, acute renal failure, aggravated diabetes mellitus, aggressive reaction, anemia, angina pectoris, ARDS, arrhythmia, arthritis, asthma, bradycardia, cardiac arrest, cerebrovascular disorder, circulatory failure, coma, confusion, convulsions (seizures), coronary thrombosis, delirium, depression, diplopia, embolism-blood clot, emotionally lability, erythema nodosum, G.I. hemorrhage, granulocytopenia, hallucination, heartblock, hepatic coma, hypoglycemia, hypotension, impaired concentration, increased LDH, jaundice, leukocytosis, leukopenia, lymphadenopathy, manic reaction, mental deficiency, muscle weakness, pancreatitis, paralysis, paranoia, postural hypotension, pseudomembranous colitis, rhabdomyolysis, sleep disorders, speech disorder, stupor, syncope, tachycardia, tendinitis, thrombocytopenia, vertigo, weight decrease, WBC abnormal not otherwise specified. Ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones. Crystalluria and cylindruria have been reported with quinolones. Blood chemistry: decreased glucose, decreased lymphocytes Post-Marketing Adverse Reactions: Additional serious adverse events reported from the marketing experience with levofloxacin: Allergic pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphoria, abnormal EEG, encephalopathy, erythema multiforme, hemolytic anemia, multi-system organ failure, palpitation, paresthesia, Stevens-Johnson Syndrome, tendon rupture, vasodilation. Non-steroidal anti-inflammatory drugs: The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including levofloxacin, may increase the rick of CNS stimulation and convulsive seizures. Convulsions and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose.Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressoramines, and airway management, as clinically indicated.Serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones. 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 necrotysis, Stevens-Johnson Syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities. The drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity and supportive measures instituted.Pseudomembranous colitis has been reported with nearly all antibacterial agents, including levofloxacin, 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 drugs in this class. Excessive exposure to sunlight should be avoided. As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported.As with any potent antimicrobial drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during therapy.Levofloxacin may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash, hives, or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.Levofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested. In immature dogs (4-5 months old), oral doses of levofloxacin resulted in arthropathic lesions. Administration at oral doses produced arthropathy in juvenile rats.C rystalluria has been observed in some intravenous rat studies.In mice, the CNS stimulatory effect of quinolones is enhanced by concomitant administration of non-steroidal and anti-inflammatory drugs.Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single dose of levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents. In immature rats and dogs, the oral and intravenous administration of levofloxacin increased the incidence and severity of osteochondrosis. Other fluoroquinolones also produce similar erosions in the weight bearing joints and other signs of arthropathy in immature animals of various species.In dogs, levofloxacin administered at 6 mg/kg/day or higher by rapid intravenous injection produced hypotensive effects. These effects were considered to be related to histamine release.Among patients receiving multiple-dose therapy, 3.7% discontinued therapy with levofloxacin due to adverse experiences.
The complete package insert can be viewed at www.rxlist.com
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