PATIENT INFORMATION AzaSite (A-zuh-site) (azithromycin ophthalmic solution) 1%

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1 PATIENT INFORMATION AzaSite (A-zuh-site) (azithrmycin phthalmic slutin) 1% Read this Patient Infrmatin befre yu start using AzaSite and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur dctr abut yur medical cnditin r treatment. What is AzaSite? AzaSite is a prescriptin sterile eye drp slutin. AzaSite is used t treat bacterial cnjunctivitis which is an infectin f the eye caused by certain bacteria. It is nt knwn if AzaSite is safe and effective in children less than 1 year f age. Infrmatin abut bacterial cnjunctivitis. Bacterial cnjunctivitis is a bacterial infectin f the mucus membranes which line the inside f the eyelids. Symptms may include redness f the eye and discharge. The infectin can be spread t ther peple and t bth eyes. Wh shuld nt use AzaSite? D nt use AzaSite if yu are allergic t azithrmycin r any f the ingredients in AzaSite. See the end f this Patient Infrmatin leaflet fr a cmplete list f the ingredients in AzaSite. What shuld I tell my dctr befre using AzaSite? Befre yu use AzaSite, tell yur dctr if yu: wear cntact lenses. D nt wear cntact lenses if yu have signs r symptms f bacterial cnjunctivitis. are pregnant r plan t becme pregnant. It is nt knwn if AzaSite will harm yur unbrn baby. Talk t yur dctr if yu are pregnant r plan t becme pregnant. are breast-feeding r plan t breast-feed. It is nt knwn if AzaSite passes int yur breast milk. Talk t yur dctr abut the best way t feed yur baby if yu are using AzaSite. Tell yur dctr abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. Knw the medicines yu take. Keep a list f them t shw yur dctrs and pharmacist when yu get a new medicine. Hw shuld I use AzaSite? Read the Instructins fr Use at the end f this Patient Infrmatin leaflet fr the right way t use AzaSite. Use AzaSite exactly as yur dctr tells yu t use it. Fr the first 2 days place 1 drp f AzaSite in yur eye (r eyes) each mrning and 1 drp in yur eye (r eyes) each evening. Wait 8 t 12 hurs after placing yur mrning drps befre yu place evening drps in yur eye (r eyes). 1

2 Fr the next 5 days place 1 drp f AzaSite in yur eye (r eyes) 1 time each day. Make sure yu cntinue t use AzaSite as directed by yur dctr even if yu feel better after yu start using it. Skipping drps can increase the chances that: yur medicine will nt wrk well Bacteria can develp resistance, which means in the future yur bacterial cnjunctivitis may nt imprve frm AzaSite r ther drugs that treat infectins frm bacteria. What shuld I be aware f while using AzaSite? D nt wear cntact lenses if yu have signs r symptms f bacterial cnjunctivitis and until yu have finished yur prescribed curse f treatment. The symptms f bacterial cnjunctivitis may include: discharge cming frm the eye eye redness eye irritatin Only yur dctr can tell yu if yu have bacterial cnjunctivitis. Severe allergic reactins have been reprted rarely when azithrmycin has been taken by muth. Serius rash r serius allergic reactins may ccur. Azithrmycin, the active ingredient in AzaSite, may cause a serius rash r a serius allergic reactin. Bth f these reactins may need t be treated in a hspital and may be life-threatening. Stp taking AzaSite and call yur dctr right away r get emergency help if yu have any f these symptms: skin rash, hives, sres in yur muth, r yur skin blisters and peels swelling f yur face, eyes, lips, tngue, r thrat truble swallwing r breathing Increased risk f ther infectins caused by bacteria r fungi. Using AzaSite fr a lng time may cause ther bacteria r fungi t grw. If this happens yu may get a new infectin. Tell yur dctr right away if yur symptms d nt get better. What are the pssible side effects f AzaSite? The mst cmmn side effect f AzaSite is eye irritatin. Other side effects seen with AzaSite include: eye burning, stinging and irritatin when the drp hits yur eye irritatin n yur eyelid and the skin arund yur eye a feeling f discmfrt and irritatin r that smething is in yur eye dry eye eye pain eye itching discharge cming frm yur eye changes t the surface f yur eye blurred visin changes in yur taste hives and rash n yur skin 2

3 stuffy nse and sinus infectin swelling arund yur eye r f yur face Tell yur dctr abut any side effect that bthers yu r that des nt g away. These are nt all f the pssible side effects f AzaSite. Fr mre infrmatin, ask yur dctr r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre AzaSite? Befre yu pen yur AzaSite, stre it in the refrigeratr between 36 F t 46 F (2 C t 8 C). After yu pen yur AzaSite, stre it at rm temperature r the refrigeratr between 36 F t 77 F (2 C t 25 C). AzaSite shuld nt be stred fr mre than 14 days after pening. After 14 days, thrw the AzaSite bttle away. Safely thrw away medicine that is ut f date r n lnger needed. Keep AzaSite and all medicines ut f reach f children. General infrmatin abut the safe and effective use f AzaSite Medicines are smetimes prescribed fr purpses ther than thse listed in a Patient Infrmatin leaflet. D nt use AzaSite fr a cnditin fr which it was nt prescribed. D nt give AzaSite t ther peple, even if they have the same symptms that yu have. It may harm them. This Patient Infrmatin summarizes the mst imprtant infrmatin abut AzaSite. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur pharmacist r dctr fr infrmatin abut AzaSite that is written fr health prfessinals. Fr mre infrmatin, g t r call What are the ingredients in AzaSite? Active ingredient: azithrmycin Inactive ingredients: 0.003% benzalknium chlride, mannitl, citric acid, sdium citrate, plxamer 407, plycarbphil, edetate disdium (EDTA), sdium chlride, water, and sdium hydrxide. 3

4 Instructins fr Use AzaSite (A-zuh-site) (azithrmycin phthalmic slutin) 1% Read this Instructins fr Use fr AzaSite befre yu start using it and each time yu get a refill. There may be new infrmatin. This leaflet des nt take the place f talking t yur dctr abut yur medical cnditin r treatment. Imprtant: AzaSite is fr use as an eye drp nly. The checklist belw tells yu when t use yur medicine fr each eye that has bacterial cnjunctivitis: Day 1: 1 drp in the mrning and 1 drp in the evening Day 2: 1 drp in the mrning and 1 drp in the evening Day 3: 1 drp anytime during the day Day 4: 1 drp anytime during the day Day 5: 1 drp anytime during the day Day 6: 1 drp anytime during the day Day 7: 1 drp anytime during the day This is a ttal f 9 drps f AzaSite fr each infected eye. Avid letting the applicatr tip tuch yur eye, yur fingers, r ther bjects. If a drp misses yur eye, try again. Fllw the steps belw t use AzaSite crrectly. Befre using a new bttle f AzaSite: Figure A Turn the white cap clckwise until it cmes ff. Thrw away the white cap. See Figure A Figure B Hld the bttle straight, turn the tan cap cunterclckwise until it cmes ff. Put the tan cap back n the bttle and clse tightly. (This lets ut the air.) See Figure B Wash yur hands each time yu use AzaSite. T use AzaSite: 4

5 Figure C Step 1. Turn the clsed bttle upside dwn. See Figure C Figure D Step 2. Shake yur hand firmly. This helps mve the medicine int the tip f the bttle. See Figure D Figure E Step 3. Hld the bttle upside dwn and take ff the tan cap. See Figure E Figure F Step 4. Tilt yur head back. Hld the bttle ver yur eye and gently squeeze the bttle t let 1 drp int each eye that has bacterial cnjunctivitis. Put the tan cap back n the bttle and clse tightly. See Figure F If a drp des nt cme ut f the bttle, repeat steps ne t fur. This Patient Infrmatin and Instructins fr Use have been apprved by the U.S. Fd and Drug Administratin. Manufactured by: Catalent Pharma Slutins, LLC Wdstck, IL U.S. Patent Ns.: 6,159,458; 6,239,113; 6,569,443; 6,861,411; 7,056,893; and Patents Pending AzaSite is a registered trademark f InSite Visin Inc. Cpyright 2011 Inspire Pharmaceuticals, Inc., a subsidiary f Merck & C., Inc. All rights reserved. Revised: 10/2012 USPPI-OS R002 5