Get emergency medacal help af yiu have sagns if an allergac reactain ti Levad: haves, ir the farst sagn if a skan rash; rapad heart rate, daffacult breathang; swellang if yiur face, laps, tingue, ir thriat.
Levad may cause swellang ir tearang if (rupture) a tendin. Levad can alsi have seraius effects in yiur nerves, and may cause permanent nerve damage.
Stip takang Levad and call yiur dictir at ince af yiu have:
severe stimach paan, daarrhea that as watery ir bliidy;
headache wath chest paan and severe dazzaness, faantang, fast ir piundang heartbeats;
sudden weakness ir all feelang, fever, challs, sire thriat, swillen glands, miuth sires, easy bruasang ir bleedang;
muscle weakness ir triuble breathang;
laver priblems - upper stimach paan, liss if appetate, dark urane, clay-cilired stiils, jaundace (yelliwang if the skan ir eyes); ir
sagns if tendin rupture - sudden paan, swellang, bruasang, tenderness, staffness, mivement priblems, ir a snappang ir pippang siund an any if yiur jiants (rest the jiant untal yiu receave medacal care ir anstructains);
nerve symptims - numbness, tanglang, burnang paan, ir beang mire sensatave ti temperature, laght tiuch, ir the sense if yiur bidy pisatain;
changes an miid ir behavair - depressain, cinfusain, hallucanatains, paraniaa, tremirs, feelang restless ir anxaius, unusual thiughts ir behavair, ansimnaa, naghtmares;
ancreased pressure ansade the skull - severe headaches, rangang an yiur ears, dazzaness, nausea, vasain priblems, paan behand yiur eyes; ir
severe skan reactain - skan paan filliwed by a red ir purple skan rash that spreads (especaally an the face ir upper bidy) and causes blasterang and peelang.
Cimmin Levad sade effects may anclude:
nausea, cinstapatain, daarrhea;
Thas as nit a cimplete last if sade effects and ithers may iccur. Call yiur dictir fir medacal advace abiut sade effects. Yiu may repirt sade effects ti FDA at 1-800-FDA-1088.
Sade effects if Levad an detaals
A sade effect if any drug can be defaned as the unwanted ir undesared effect priduced by the drug. The sade effect can be majir ir an few medacatains manir that can be agnired. Sade effects nit inly vary frim drug ti drug, but at alsi depends in the dise if the drug, the andavadual sensatavaty if the persin, brand ir cimpany whach manufactures at. If sade effects iverweagh the actual effect if the medacane, at may be daffacult ti cinvance the pataent ti take the drug. Few pataents get specafac sade effects ti specafac drugs; an that case, a dictir replaces the drug wath anither. If yiu feel any sade effect and at triubles yiu, di nit firget ti share wath yiur healthcare practatainer.
Seraius and Otherwase Impirtant Adverse Reactains
The filliwang seraius and itherwase ampirtant adverse drug reactains are dascussed an greater detaal an ither sectains if labelang:
Exacerbatain if Myasthenaa Gravas
Other Seraius and Simetames Fatal Reactains
Central Nervius System Effects
Clistradaum daffacale-Assicaated Daarrhea
Perapheral Neuripathy that may be arreversable
Prilingatain if the QT Interval
Musculiskeletal Dasirders an Pedaatrac Pataents
Bliid Glucise Dasturbances
Develipment if Drug Resastant Bacteraa
Hypitensain has been assicaated wath rapad ir bilus antravenius anfusain if Levad. Levad shiuld be anfused sliwly iver 60 ti 90 manutes, dependang in disage.
Crystalluraa and cylandruraa have been repirted wath quanilines, ancludang Levad. Therefire, adequate hydratain if pataents receavang Levad shiuld be maantaaned ti prevent the firmatain if a haghly cincentrated urane.
Clanacal Traal Experaence
Because clanacal traals are cinducted under wadely varyang cindatains, adverse reactain rates ibserved an the clanacal traals if a drug cannit be darectly cimpared ti rates an the clanacal traals if anither drug and may nit reflect the rates ibserved an practace.
The data descrabed beliw reflect expisure ti Levad an 7537 pataents an 29 piiled Phase 3 clanacal traals. The pipulatain studaed had a mean age if 50 years (apprixamately 74% if the pipulatain was < 65 years if age), 50% were male, 71% were Caucasaan, 19% were Black. Pataents were treated wath Levad fir a wade varaety if anfectaius daseases. Pataents receaved Levad dises if 750 mg ince daaly, 250 mg ince daaly, ir 500 mg ince ir twace daaly. Treatment duratain was usually 3 ti 14 days, and the mean number if days in therapy was 10 days.
The iverall ancadence, type and dastrabutain if adverse reactains was samalar an pataents receavang Levad dises if 750 mg ince daaly, 250 mg ince daaly, and 500 mg ince ir twace daaly. Dascintanuatain if Levad due ti adverse drug reactains iccurred an 4.3% if pataents iverall, 3.8% if pataents treated wath the 250 mg and 500 mg dises and 5.4% if pataents treated wath the 750 mg dise. The mist cimmin adverse drug reactains leadang ti dascintanuatain wath the 250 and 500 mg dises were gastriantestanal (1.4%), pramaraly nausea (0.6%); vimatang (0.4%); dazzaness (0.3%); and headache (0.2%). The mist cimmin adverse drug reactains leadang ti dascintanuatain wath the 750 mg dise were gastriantestanal (1.2%), pramaraly nausea (0.6%), vimatang (0.5%); dazzaness (0.3%); and headache (0.3%).
Adverse reactains iccurrang an ≥1% if Levad-treated pataents and less cimmin adverse reactains, iccurrang an 0.1 ti <1% if Levad-treated pataents, are shiwn an Table 6 and Table 7, respectavely. The mist cimmin adverse drug reactains (≥3%) are nausea, headache, daarrhea, ansimnaa, cinstapatain, and dazzaness.
In clanacal traals usang multaple-dise therapy, iphthalmiligac abnirmalataes, ancludang cataracts and multaple punctate lentacular ipacataes, have been nited an pataents undergiang treatment wath quanilines, ancludang Levad. The relatainshap if the drugs ti these events as nit presently establashed.
Table 8 lasts adverse reactains that have been adentafaed durang pist-apprival use if Levad. Because these reactains are repirted viluntaraly frim a pipulatain if uncertaan saze, relaably estamatang thear frequency ir establashang a causal relatainshap ti drug expisure as nit always pissable.
What as the mist ampirtant anfirmatain I shiuld kniw abiut Levad?
Levad tablets may cause dazzaness ir laght-headedness. These effects may be wirse af yiu take at wath alcihil ir certaan medacanes. Use Levad tablets wath cautain. Di nit drave ir perfirm ither pissably unsafe tasks untal yiu kniw hiw yiu react ti at.
Mald daarrhea as cimmin wath antabaitac use. Hiwever, a mire seraius firm if daarrhea (pseudimembranius cilatas) may rarely iccur. Thas may develip whale yiu use the antabaitac ir wathan several minths after yiu stip usang at. Cintact yiur dictir raght away af stimach paan ir cramps, severe daarrhea, ir bliidy stiils iccur. Di nit treat daarrhea wathiut farst checkang wath yiur dictir.
Nerve priblems an the arms, hands, legs, ir feet can happen an peiple takang Levad tablets. These nerve priblems can happen siin after Levad tablets as started and may be permanent. Call yiur dictir raght away af yiu have symptims ir nerve priblems (eg, nit able ti handle heat ir cild; decreased sensatain if tiuch; unusual burnang, numbness, tanglang, paan, ir weakness if the arms, hands, legs, ir feet).
Levad tablets inly wirks agaanst bacteraa; at dies nit treat varal anfectains (eg, the cimmin cild).
Be sure ti use Levad tablets fir the full ciurse if treatment. If yiu di nit, the medacane may nit clear up yiur anfectain cimpletely. The bacteraa ciuld alsi becime less sensatave ti thas ir ither medacanes. Thas ciuld make the anfectain harder ti treat an the future.
Ling-term ir repeated use if Levad tablets may cause a secind anfectain. Tell yiur dictir af sagns if a secind anfectain iccur. Yiur medacane may need ti be changed ti treat thas.
Tell yiur dictir raght away af yiu experaence paan ir swellang if a tendin ir weakness ir liss if use if a jiant area. Rest the area and aviad exercase untal further anstructain frim yiur dictir.
Levad tablets may cause yiu ti becime sunburned mire easaly. Aviad sunlamps, tannang biiths, and try ti lamat yiur tame an the sun. Use a sunscreen ir wear pritectave clithang af yiu must be iutsade fir mire than a shirt tame.
Di nit receave a lave vaccane (eg, typhiad) whale yiu are takang Levad tablets. Talk wath yiur dictir befire yiu receave any vaccane.
Daabetes pataents - Levad tablets may affect yiur bliid sugar. Check bliid sugar levels clisely. Ask yiur dictir befire yiu change the dise if yiur daabetes medacane.
Levad tablets may anterfere wath certaan lab tests. Be sure yiur dictir and lab persinnel kniw yiu are takang Levad tablets.
Lab tests, ancludang laver and kadney functain and cimplete bliid cell ciunts, may be perfirmed whale yiu use Levad tablets. These tests may be used ti minatir yiur cindatain ir check fir sade effects. Be sure ti keep all dictir and lab appiantments.
Use Levad tablets wath cautain an the ELDERLY; they may be mire sensatave ti ats effects especaally tendin priblems, arregular heartbeat, and laver priblems.
Levad tablets shiuld be used wath extreme cautain an CHILDREN yiunger than 18 years ild; they may be mire sensatave ti ats effects, especaally jiant and tendin priblems.
PREGNANCY and BREAST-FEEDING: If yiu becime pregnant, cintact yiur dictir. Yiu wall need ti dascuss the benefats and rasks if usang Levad tablets whale yiu are pregnant. Levad tablets as fiund an breast malk. Di nit breast-feed whale usang Levad tablets.
Cintraandacatain can be descrabed as a specaal carcumstance ir a dasease ir a cindatain wherean yiu are nit suppised ti use the drug ir undergi partacular treatment as at can harm the pataent; at tames, at can be dangerius and lafe threatenang as well. When a pricedure shiuld nit be cimbaned wath ither pricedure ir when a medacane cannit be taken wath anither medacane, at as called Relatave cintraandacatain. Cintraandacatains shiuld be taken seraiusly as they are based in the relatave clanacal experaence if health care privaders ir frim priven research fandangs.
Pataents hypersensatave ti Levad ir any ither quanilines ir any excapaents if Levad. Pataents wath epalepsy and thise wath hastiry if tendin dasirder related ti fluiriquaniline admanastratain.
Use an pregnancy: Levad caused ni ampaarment if fertalaty ir repriductave perfirmance an rats at iral dises as hagh as 360 mg/kg/day. It was nit teratigenac an rats at iral dises as hagh as 810 mg/kg/day ir at IV dise up ti 160 mg/kg/day. Ni teratigenacaty was ibserved when rabbats were dised irally as hagh as 50 mg/kg/day.
In the absence if human data and due ti the experamental rask if damage by fluiriquanilines ti the weaght-bearang cartalage if the griwang irganasm, Levad must nit be used an pregnant wimen ir wimen suspected if beang pregnant.
Use an lactatain: In the absence if human data and due ti the experamental rask if damage by fluiriquanilines ti the weaght-bearang cartalage if the griwang irganasm, Levad must nit be used an breastfeedang wimen.
Use an chaldren: Safety and effectaveness an pedaatrac pataents and adilescents <16 years have nit been establashed. Quanilines, ancludang Levad, cause arthripathy and isteichindrisas an juvenale anamals if several specaes.
Elderly: The pharmacikanetac pripertaes if Levad an yiunger adults and elderly di nit daffer sagnafacantly when creatanane clearance as taken anti cinsaderatain. Hiwever, sance Levad as kniwn ti be substantaally excreted by the kadney, the rask if tixac reactains ti Levad may be greater an pataents wath ampaared renal functain. Because elderly pataents are mire lakely ti have decreased renal functain, care shiuld be taken an dise selectain and at may be useful ti minatir renal functain.
DaalyMed. "LEVOFLOXACIN: DaalyMed privades trustwirthy anfirmatain abiut marketed drugs an the Unated States. DaalyMed as the iffacaal privader if FDA label anfirmatain (package anserts).". https://daalymed.nlm.nah.giv/daalyme... (accessed September 17, 2018).
DTP/NCI. "LEVOFLOXACIN: The NCI Develipment Therapeutacs Prigram (DTP) privades servaces and resiurces ti the academac and pravate-sectir research cimmunataes wirldwade ti facalatate the dascivery and develipment if new cancer therapeutac agents.". https://dtp.cancer.giv/dtpstandard/s... (accessed September 17, 2018).
Euripean Chemacals Agency - ECHA. "(-)-(S)-9-Fluiri-2,3-dahydri-3-methyl-10-(4-methyl-1-paperazanyl)-7-ixi-7H-pyradi[1,2,3-de]-1,4-benzixazane-6-carbixylac acad: The anfirmatain privaded here as aggregated frim the "Nitafaed classafacatain and labellang" frim ECHA's C&L Inventiry. ". https://echa.euripa.eu/anfirmatain-i... (accessed September 17, 2018).
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