0000003788 00000 n Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL).
Discontinue LEVAQUINOther serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including LEVAQUINSerious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including LEVAQUINPost-marketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with LEVAQUINIf CDAD is suspected or confirmed, ongoing antibiotic use not directed against In immature rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis. 0000037001 00000 n Levofloxacin undergoes limited metabolism in humans and is primarily excreted as unchanged drug in the urine. 290 0 obj <> endobj xref 290 23 0000000016 00000 n No levofloxacin crystals were found in any of the urine samples freshly collected from subjects receiving LEVAQUINThere are no significant differences in levofloxacin pharmacokinetics between young and elderly subjects when the subjects' differences in creatinine clearance are taken into consideration. Dermal levofloxacin concentrations in the hairless mice ranged from 25 to 42 mcg/g at the highest levofloxacin dose level (300 mg/kg/day) used in the photo-carcinogenicity study. 0000001463 00000 n You could get severe sunburn, blisters or swelling of your skin. US�߿W��m��嗭V���EU輑�\��,�}#L�a�iJf�ܢ������q�b�-l��V�d�c�5g�MM�z /��Y{j�[Z� ѕF�����9O���U@Y>�[� 3w��%i�� gז�1Ȅ{��D�L yX��%i%(1�``�ph�euUKX�cH��B���h�ͮ�xJ.��!�:��DEÌ 0000022843 00000 n
The cause for the increased risk has not been identified. Other fluoroquinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, "V" area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure. Dosage Adjustments In Patients With Renal Impairment (CLcr Less Than 60 mL/min, and CLcr 120 mL/min or Greater) 2.3 The mean ± SD peak and trough plasma concentrations attained following multiple once-daily oral dosage regimens were approximately 5.7 ± 1.4 and 0.5 ± 0.2 mcg/mL after the 500 mg doses, and 8.6 ± 1.9 and 1.1 ± 0.4 mcg/mL after the 750 mg doses, respectively. Therefore, excessive exposure to these sources of light should be avoided. 0000000736 00000 n Therefore, precaution should be taken when using LEVAQUINThe pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration.
2.1.
0000021315 00000 n First, the levofloxacin package insert is referenced to see what AUC is achievable with oral dosing.
0000018288 00000 n 0000004175 00000 n 0000003102 00000 n 0000000946 00000 n x�c```�[���@�� Y8Z��A#�� FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE . Authored By: Wesley Kufel, PharmD, BCPS, AAHIVP and Bryan T. Mogle, PharmD, BCPS, AAHIVP Dr. Kufel and Dr. Mogle are co-authors […] Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with renal impairment (creatinine clearance < 50 mL/min), requiring dosage adjustment in such patients to avoid accumulation. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:Crystalluria and cylindruria have been reported with quinolones, including LEVAQUINBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The data described below reflect exposure to LEVAQUINThe overall incidence, type and distribution of adverse reactions was similar in patients receiving LEVAQUINIn clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including LEVAQUINTable 6 lists adverse reactions that have been identified during post-approval use of LEVAQUINWhile the chelation by divalent cations is less marked than with other fluoroquinolones, concurrent administration of LEVAQUINDisturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent.
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