MEDICATION GUIDE LEVAQUIN [Leave ah kwin] Tablets. LEVAQUIN (levofloxacin) Oral Solution

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1 MEDICATION GUIDE LEVAQUIN [Leave ah kwin] (levflxacin) Tablets LEVAQUIN (levflxacin) Oral Slutin LEVAQUIN (levflxacin in 5% dextrse) Injectin fr Intravenus Use Read this Medicatin Guide befre yu start taking LEVAQUIN and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut LEVAQUIN? LEVAQUIN, a flurquinlne antibitic, can cause serius side effects. Sme f these serius side effects can happen at the same time and culd result in death. If yu have any f the fllwing serius side effects while yu take LEVAQUIN, yu shuld stp taking LEVAQUIN immediately and get medical help right away. 1. Tendn rupture r swelling f the tendn (tendinitis). Tendn prblems can happen in peple f all ages wh take LEVAQUIN. Tendns are tugh crds f tissue that cnnect muscles t bnes. Sme tendn prblems include pain, swelling, tears, and swelling f tendns including the back f the ankle (Achilles), shulder, hand, r ther tendn sites. The risk f getting tendn prblems while yu take LEVAQUIN is higher if yu: are ver 60 years f age are taking sterids (crticsterids) have had a kidney, heart r lung transplant. 58

2 Tendn prblems can happen in peple wh d nt have the abve risk factrs when they take LEVAQUIN. Other reasns that can increase yur risk f tendn prblems can include: physical activity r exercise kidney failure tendn prblems in the past, such as in peple with rheumatid arthritis (RA) Stp taking LEVAQUIN immediately and get medical help right away at the first sign f tendn pain, swelling r inflammatin. Avid exercise and using the affected area. The mst cmmn area f pain and swelling is the Achilles tendn at the back f yur ankle. This can als happen with ther tendns. Yu may need a different antibitic that is nt a flurquinlne t treat yur infectin. Tendn rupture can happen while yu are taking r after yu have finished taking LEVAQUIN. Tendn ruptures can happen within hurs r days f taking LEVAQUIN and have happened up t several mnths after peple have finished taking their flurquinlne. Stp taking LEVAQUIN immediately and get medical help right away if yu get any f the fllwing signs r symptms f a tendn rupture: hear r feel a snap r pp in a tendn area bruising right after an injury in a tendn area unable t mve the affected area r bear weight 2. Changes in sensatin and pssible nerve damage (Peripheral Neurpathy). Damage t the nerves in arms, hands, legs, r feet can happen in peple wh take flurquinlnes, including LEVAQUIN. Stp taking LEVAQUIN immediately and talk t yur healthcare prvider right away if yu get any f the fllwing symptms f peripheral neurpathy in yur arms, hands, legs, r feet: pain burning numbness weakness 59

3 tingling The nerve damage may be permanent. 3. Central Nervus System (CNS) effects. Seizures have been reprted in peple wh take flurquinlne antibacterial medicines, including LEVAQUIN. Tell yur healthcare prvider if yu have a histry f seizures befre yu start taking LEVAQUIN. CNS side effects may happen as sn as after taking the first dse f LEVAQUIN. Stp taking LEVAQUIN immediately and talk t yur healthcare prvider right away if yu get any f these side effects, r ther changes in md r behavir: seizures hear vices, see things, r sense things that are nt there (hallucinatins) feel restless tremrs feel anxius r nervus cnfusin depressin truble sleeping nightmares feel lightheaded r dizzy feel mre suspicius (parania) suicidal thughts r acts headaches that will nt g away, with r withut blurred visin 4. Wrsening f myasthenia gravis (a prblem that causes muscle weakness). Flurquinlnes like LEVAQUIN may cause wrsening f myasthenia gravis symptms, including muscle weakness and breathing prblems. Tell yur healthcare prvider if yu have a histry f myasthenia gravis befre yu start taking LEVAQUIN. Call yur healthcare prvider right away if yu have any wrsening muscle weakness r breathing prblems. What is LEVAQUIN? LEVAQUIN is a flurquinlne antibitic medicine used in adults age 18 years r lder t treat certain infectins caused by certain germs called bacteria. These bacterial infectins include: nscmial pneumnia cmmunity acquired pneumnia acute sinus infectin acute wrsening f chrnic brnchitis skin infectins, cmplicated and uncmplicated chrnic prstate infectin urinary tract infectins, cmplicated and uncmplicated acute kidney infectin (pyelnephritis) inhalatin anthrax plague Studies f LEVAQUIN fr use in the treatment f plague and anthrax were dne in animals nly, because plague and anthrax culd nt be studied in peple. 60

4 LEVAQUIN shuld nt be used in patients with uncmplicated urinary tract infectins, acute bacterial exacerbatin f chrnic brnchitis, r acute bacterial sinusitis if there are ther treatment ptins available. LEVAQUIN is als used t treat children wh are 6 mnths f age r lder and may have breathed in anthrax germs, have plague, r been expsed t plague germs. It is nt knwn if LEVAQUIN is safe and effective in children under 6 mnths f age. The safety and effectiveness in children treated with LEVAQUIN fr mre than 14 days is nt knwn. Wh shuld nt take LEVAQUIN? D nt take LEVAQUIN if yu have ever had a severe allergic reactin t an antibitic knwn as a flurquinlne, r if yu are allergic t levflxacin r any f the ingredients in LEVAQUIN. See the end f this leaflet fr a cmplete list f ingredients in LEVAQUIN. What shuld I tell my healthcare prvider befre taking LEVAQUIN? Befre yu take LEVAQUIN, tell yur healthcare prvider if yu: have tendn prblems; LEVAQUIN shuld nt be used in patients wh have a histry f tendn prblems have a prblem that causes muscle weakness (myasthenia gravis); LEVAQUIN shuld nt be used in patients wh have a knwn histry f myasthenia gravis have central nervus system prblems such as seizures (epilepsy) have nerve prblems; LEVAQUIN shuld nt be used in patients hw have a histry f a nerve prblem called peripheral neurpathy have r anyne in yur family has an irregular heartbeat, especially a cnditin called QT prlngatin have lw bld ptassium (hypkalemia) have bne prblems have jint prblems including rheumatid arthritis (RA) 61

5 have kidney prblems. Yu may need a lwer dse f LEVAQUIN if yur kidneys d nt wrk well. have liver prblems have diabetes r prblems with lw bld sugar (hypglycemia) are pregnant r plan t becme pregnant. It is nt knwn if LEVAQUIN will harm yur unbrn child. are breastfeeding r plan t breastfeed. It is nt knwn if LEVAQUIN passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will take LEVAQUIN r breastfeed. Yu shuld nt d bth. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. LEVAQUIN and ther medicines can affect each ther causing side effects. Especially tell yur healthcare prvider if yu take: a sterid medicine. an anti-psychtic medicine a tricyclic antidepressant a water pill (diuretic) certain medicines may keep LEVAQUIN frm wrking crrectly. Take LEVAQUIN Tablets r Oral Slutin either 2 hurs befre r 2 hurs after taking these medicines r supplements: an antacid, multivitamin, r ther medicines r supplements that have magnesium, aluminum, irn, r zinc sucralfate (Carafate ) didansine (Videx,Videx EC) a bld thinner (warfarin, Cumadin, Jantven) an ral anti-diabetes medicine r insulin 62

6 an NSAID (Nn-Steridal Anti-Inflammatry Drug). Many cmmn medicines fr pain relief are NSAIDs. Taking an NSAID while yu take LEVAQUIN r ther flurquinlnes may increase yur risk f central nervus system effects and seizures. thephylline (The-24, Elixphyllin, Thechrn, Uniphyl, Thelair ) a medicine t cntrl yur heart rate r rhythm (antiarrhythmics) Ask yur healthcare prvider if yu are nt sure if any f yur medicines are listed abve. Knw the medicines yu take. Keep a list f yur medicines and shw it t yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I take LEVAQUIN? Take LEVAQUIN exactly as yur healthcare prvider tells yu t take it. Take LEVAQUIN at abut the same time each day. Drink plenty f fluids while yu take LEVAQUIN. LEVAQUIN Tablets can be taken with r withut fd. Take LEVAQUIN Oral Slutin 1 hur befre r 2 hurs after eating. If yu miss a dse f LEVAQUIN, take it as sn as yu remember. D nt take mre than 1 dse in 1 day. LEVAQUIN fr Injectin is given by slw intravenus (I.V.) infusin int yur vein ver 60 r 90 minutes as prescribed by yur healthcare prvider. D nt skip any dses f LEVAQUIN r stp taking it, even if yu begin t feel better, until yu finish yur prescribed treatment unless: yu have tendn prblems. See What is the mst imprtant infrmatin I shuld knw abut LEVAQUIN?. yu have a nerve prblem. See What are the pssible side effects f LEVAQUIN?. yu have a central nervus sytem prblem. See What are the pssible side effects f LEVAQUIN?. 63

7 yu have a serius allergic reactin. See What are the pssible side effects f LEVAQUIN?. yur healthcare prvider tells yu t stp taking LEVAQUIN Taking all f yur LEVAQUIN dses will help make sure that all f the bacteria are killed. Taking all f yur LEVAQUIN dses will help yu lwer the chance that the bacteria will becme resistant t LEVAQUIN. If yur infectin des nt get better while yu take LEVAQUIN, it may mean that the bacteria causing yur infectin may be resistant t LEVAQUIN. If yur infectin des nt get better, call yur healthcare prvider. If yur infectin des nt get better, LEVAQUIN and ther similar antibitic medicines may nt wrk fr yu in the future. If yu take t much LEVAQUIN, call yur healthcare prvider r get medical help right away. What shuld I avid while taking LEVAQUIN? LEVAQUIN can make yu feel dizzy and lightheaded. D nt drive, perate machinery, r d ther activities that require mental alertness r crdinatin until yu knw hw LEVAQUIN affects yu. Avid sunlamps, tanning beds, and try t limit yur time in the sun. LEVAQUIN can make yur skin sensitive t the sun (phtsensitivity) and the light frm sunlamps and tanning beds. Yu culd get severe sunburn, blisters r swelling f yur skin. If yu get any f these symptms while yu take LEVAQUIN, call yur healthcare prvider right away. Yu shuld use a sunscreen and wear a hat and clthes that cver yur skin if yu have t be in sunlight. What are the pssible side effects f LEVAQUIN? LEVAQUIN can cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut LEVAQUIN? Serius allergic reactins. Allergic reactins can happen in peple taking flurquinlnes, including LEVAQUIN, even after nly 1 dse. Stp taking LEVAQUIN and get 64

8 emergency medical help right away if yu have any f the fllwing symptms f a severe allergic reactin: hives truble breathing r swallwing swelling f the lips, tngue, face thrat tightness, harseness rapid heartbeat faint skin rash Skin rash may happen in peple taking LEVAQUIN, even after nly 1 dse. Stp taking LEVAQUIN at the first sign f a skin rash and call yur healthcare prvider. Skin rash may be a sign f a mre serius reactin t LEVAQUIN. Liver damage (hepattxicity): Hepattxicity can happen in peple wh take LEVAQUIN. Call yur healthcare prvider right away if yu have unexplained symptms such as: nausea r vmiting stmach pain fever weakness abdminal pain r tenderness itching unusual tiredness lss f appetite light clred bwel mvements dark clred urine yellwing f yur skin r the whites f yur eyes 65

9 Stp taking LEVAQUIN and tell yur healthcare prvider right away if yu have yellwing f yur skin r white part f yur eyes, r if yu have dark urine. These can be signs f a serius reactin t LEVAQUIN (a liver prblem). Intestine infectin (Pseudmembranus clitis) Pseudmembranus clitis can happen with many antibitics, including LEVAQUIN. Call yur healthcare prvider right away if yu get watery diarrhea, diarrhea that des nt g away, r bldy stls. Yu may have stmach cramps and a fever. Pseudmembranus clitis can happen 2 r mre mnths after yu have finished yur antibitic. Serius heart rhythm changes (QT prlngatin and trsades de pintes) Tell yur healthcare prvider right away if yu have a change in yur heart beat (a fast r irregular heartbeat), r if yu faint. LEVAQUIN may cause a rare heart prblem knwn as prlngatin f the QT interval. This cnditin can cause an abnrmal heartbeat and can be very dangerus. The chances f this happening are higher in peple: wh are elderly with a family histry f prlnged QT interval with lw bld ptassium (hypkalemia) wh take certain medicines t cntrl heart rhythm (antiarrhythmics) Jint Prblems Increased chance f prblems with jints and tissues arund jints in children can happen. Tell yur child s healthcare prvider if yur child has any jint prblems during r after treatment with LEVAQUIN. Changes in bld sugar Peple wh take LEVAQUIN and ther flurquinlne medicines with ral anti-diabetes medicines r with insulin can get lw bld sugar 66

10 (hypglycemia) and high bld sugar (hyperglycemia). Fllw yur healthcare prvider s instructins fr hw ften t check yur bld sugar. If yu have diabetes and yu get lw bld sugar while taking LEVAQUIN, stp taking LEVAQUIN and call yur healthcare prvider right away. Yur antibitic medicine may need t be changed. Sensitivity t sunlight (phtsensitivity) See What shuld I avid while taking LEVAQUIN? The mst cmmn side effects f LEVAQUIN include: nausea headache diarrhea insmnia cnstipatin dizziness In children 6 mnths and lder wh take LEVAQUIN t treat anthrax disease r plague, vmiting is als cmmn. Lw bld pressure can happen when LEVAQUIN is given t fast by IV injectin. Tell yur healthcare prvider if yu feel dizzy r faint during a treatment with LEVAQUIN Injectin. LEVAQUIN may cause false-psitive urine screening results fr piates when testing is dne with sme cmmercially available kits. A psitive result shuld be cnfirmed using a mre specific test. These are nt all the pssible side effects f LEVAQUIN. Tell yur healthcare prvider abut any side effect that bthers yu r that des nt g away. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre LEVAQUIN? Stre LEVAQUIN Tablets at rm temperature between 59 F t 86 F (15 C t 30 C). 67

11 Keep LEVAQUIN Tablets in a tightly clsed cntainer. Stre LEVAQUIN Oral Slutin at rm temperature between 59 F t 86 F (15 C t 30 C). Keep LEVAQUIN and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f LEVAQUIN Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use LEVAQUIN fr a cnditin fr which it is nt prescribed. D nt give LEVAQUIN t ther peple, even if they have the same symptms that yu have. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut LEVAQUIN. If yu wuld like mre infrmatin abut LEVAQUIN, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut LEVAQUIN that is written fr healthcare prfessinals. Fr mre infrmatin g t r call What are the ingredients in LEVAQUIN? LEVAQUIN Tablets, LEVAQUIN Oral Slutin and LEVAQUIN Injectin Premix in Single-Use Flexible Cntainers: Active ingredient: levflxacin All LEVAQUIN Tablets: Inactive ingredients: crspvidne, hyprmellse, magnesium stearate, micrcrystalline cellulse, plyethylene glycl, plysrbate 80, titanium dixide. LEVAQUIN 250 mg Tablets als cntain synthetic red irn xide. LEVAQUIN 500 mg Tablets als cntain synthetic red irn xide and synthetic yellw irn xide. LEVAQUIN Oral Slutin: Inactive ingredients: artificial and natural flavrs, ascrbic acid, benzyl alchl, caramel clr, glycerin, hydrchlric acid, prpylene glycl, purified water, sucralse, and sucrse. It may als cntain a slutin f sdium hydrxide fr ph adjustment. 68

12 LEVAQUIN Injectin Premix in Single-Use Flexible Cntainers: Inactive ingredients: Dextrse (D5W). Slutins f hydrchlric acid and sdium hydrxide may have been added t adjust the ph. Active Ingredient Made in Japan Finished Prduct Manufactured by: Janssen Orth LLC, Gurab, Puert Ric (Tablets). Janssen Pharmaceutica N.V., Beerse, Belgium (Oral Slutin). Hspira, Inc., Austin, TX (Injectin Premix). Manufactured fr: Janssen Pharmaceuticals, Inc., Titusville, NJ Janssen Pharmaceuticals, Inc. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Revised July

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