Tendon problems can happen in people of all ages who take levofloxacin. Tendons are tough cords of tissue that connect muscles to bones.

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1 Medicatin Guide LEVOFLOXACIN (LEE ve FLOX a sin) INJECTION, 25 mg/ml and LEVOFLOXACIN (LEE ve FLOX a sin) INJECTION in 5% Dextrse fr Intravenus Use Read this Medicatin Guide befre yu start taking levflxacin 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 levflxacin? Levflxacin, 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 levflxacin, yu shuld stp taking levflxacin 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 levflxacin. 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 levflxacin is higher if yu: are ver 60 years f age are taking sterids (crticsterids) have had a kidney, heart r lung transplant. Tendn prblems can happen in peple wh d nt have the abve risk factrs when they take levflxacin. 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)

2 Stp taking levflxacin 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 levflxacin. Tendn ruptures can happen within hurs r days f taking levflxacin and have happened up t several mnths after peple have finished taking their flurquinlne. Stp taking levflxacin 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 levflxacin. Stp taking levflxacin 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

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 levflxacin. Tell yur healthcare prvider if yu have a histry f seizures befre yu start taking levflxacin. CNS side effects may happen as sn as after taking the first dse f levflxacin. Stp taking levflxacin 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 levflxacin 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 levflxacin. Call yur healthcare prvider right away if yu have any wrsening muscle weakness r breathing prblems. What is levflxacin? Levflxacin 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

4 Studies f levflxacin fr use in the treatment f plague and anthrax were dne in animals nly, because plague and anthrax culd nt be studied in peple. Levflxacin 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. Levflxacin 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 levflxacin is safe and effective in children under 6 mnths f age. The safety and effectiveness in children treated with levflxacin fr mre than 14 days is nt knwn. Wh shuld nt take levflxacin? D nt take levflxacin 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 levflxacin. See the end f this leaflet fr a cmplete list f ingredients in levflxacin. What shuld I tell my healthcare prvider befre taking levflxacin? Befre yu take levflxacin, tell yur healthcare prvider if yu: have tendn prblems; levflxacin shuld nt be used in patients wh have a histry f tendn prblems have a prblem that causes muscle weakness (myasthenia gravis); levflxacin 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; levflxacin 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)

5 have bne prblems have jint prblems including rheumatid arthritis (RA) have kidney prblems. Yu may need a lwer dse f levflxacin 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 levflxacin will harm yur unbrn child. are breastfeeding r plan t breastfeed. It is nt knwn if levflxacin passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will take levflxacin 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. Levflxacin 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 levflxacin frm wrking crrectly. a bld thinner (warfarin, Cumadin, Jantven) an ral anti-diabetes medicine r insulin an NSAID (Nn-Steridal Anti-Inflammatry Drug). Many cmmn medicines fr pain relief are NSAIDs. Taking an NSAID while yu take levflxacin r ther

6 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 Levflxacin? Take levflxacin exactly as yur healthcare prvider tells yu t take it. Take levflxacin at abut the same time each day. Drink plenty f fluids while yu take levflxacin. If yu miss a dse f levflxacin, take it as sn as yu remember. D nt take mre than 1 dse in 1 day. Levflxacin 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 levflxacin 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 Levflxacin?. yu have a nerve prblem. See What are the pssible side effects f Levflxacin?. yu have a central nervus sytem prblem. See What are the pssible side effects f Levflxacin?. yu have a serius allergic reactin. See What are the pssible side effects f Levflxacin?. yur healthcare prvider tells yu t stp taking Levflxacin

7 Taking all f yur levflxacin dses will help make sure that all f the bacteria are killed. Taking all f yur levflxacin dses will help yu lwer the chance that the bacteria will becme resistant t levflxacin. If yur infectin des nt get better while yu take levflxacin, it may mean that the bacteria causing yur infectin may be resistant t levflxacin. If yur infectin des nt get better, call yur healthcare prvider. If yur infectin des nt get better, levflxacin and ther similar antibitic medicines may nt wrk fr yu in the future. If yu take t much levflxacin, call yur healthcare prvider r get medical help right away. What shuld I avid while taking Levflxacin? Levflxacin 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 levflxacin affects yu. Avid sunlamps, tanning beds, and try t limit yur time in the sun. Levflxacin 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 levflxacin, 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 levflxacin? Levflxacin can cause serius side effects, including: See What is the mst imprtant infrmatin I shuld knw abut Levflxacin? Serius allergic reactins. Allergic reactins can happen in peple taking flurquinlnes, including levflxacin, even after nly 1 dse. Stp taking levflxacin and get 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

8 thrat tightness, harseness rapid heartbeat faint skin rash Skin rash may happen in peple taking levflxacin, even after nly 1 dse. Stp taking levflxacin at the first sign f a skin rash and immediately call yur healthcare prvider. Skin rash may be a sign f a mre serius reactin t levflxacin. Liver damage (hepattxicity): Hepattxicity can happen in peple wh take levflxacin. 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 Stp taking levflxacin 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 levflxacin (a liver prblem).

9 Intestine infectin (Pseudmembranus clitis) Pseudmembranus clitis can happen with many antibitics, including levflxacin. 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. Levflxacin 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 levflxacin. Changes in bld sugar Peple wh take levflxacin and ther flurquinlne medicines with ral anti-diabetes medicines r with insulin can get lw bld sugar (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 levflxacin, stp taking levflxacin 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 levflxacin? The mst cmmn side effects f levflxacin include:

10 nausea headache diarrhea insmnia cnstipatin dizziness In children 6 mnths and lder wh take levflxacin t treat anthrax disease r plague, vmiting is als cmmn. Lw bld pressure can happen when levflxacin is given t fast by IV injectin. Tell yur healthcare prvider if yu feel dizzy r faint during a treatment with Levflxacin Injectin. Levflxacin 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 levflxacin. 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 Levflxacin? Levflxacin injectin in single-use vials shuld be stred at C (68-77 F). Levflxacin injectin in single-use vials shuld be stred at cntrlled rm temperature and prtected frm light. Levflxacin Injectin in 5% Dextrse (Premix) in Single-Use Flexible Cntainers shuld be stred at C (68-77 F). Levflxacin Injectin in 5% Dextrse (Premix) in Single- Use Flexible Cntainers shuld be stred at cntrlled rm temperature and prtected frm light. Avid excessive heat and prtect frm freezing.

11 Keep LEVOFLOXACIN and all medicines ut f the reach f children. General infrmatin abut the safe and effective use f Levflxacin Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use levflxacin fr a cnditin fr which it is nt prescribed. D nt give levflxacin 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 levflxacin. If yu wuld like mre infrmatin abut levflxacin, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut levflxacin that is written fr healthcare prfessinals. What are the ingredients in levflxacin? Levflxacin Injectin in Single-Use Vials: Active ingredient: Levflxacin Inactive ingredients: Water fr Injectin. Levflxacin fr Injectin Single Use Vials d nt cntain any preservatives. Levflxacin Injectin in 5% Dextrse (Premix) in Single-Use Flexible Cntainers: Active ingredient: Levflxacin Inactive ingredients: Dextrse (D5W). Slutins f hydrchlric acid and sdium hydrxide may have been added t adjust the ph. Active Ingredient Made in India. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Manufactured fr: Claris Lifesciences Inc. Nrth Brunswick, NJ By: Claris Injectables Ltd., Gujarat, India. 06/