Indications

Budiason-FG Inhaler in indicated far the maintrnen trtrnant of patients with chronle abstructws pulmonry disaas [COPO], This inhalar is nat indicated for the mlief of acute branchospaum or for the traatmant af
acthms

Composition

Fach puff containt
Formaterall Fumarate 55 meg an Farmotarol Furnarate Dihydrabe Ph. Eur.
Glycapyrronurn Dromide Ph. Eur. 10.4 mcg
Dudeconide Ph. Gur: 102 mcg

Pharmacology

Thit inhalar ln a praesuriznd marnd-doas inhaler that dallvwrs a cambination af micanized Dudasanidn, an inhaled cortleontrold (05), mieranized glycopyrrolae an anticholinargie, and micronned formoterol furnarate,
an Inhalad long-acting bata2-adrenargic agonet [a LAnA), for oral inhlation. ICS madicinas mch as udesanide hap to dacmas infammation in the unge. Infammation in the lunge can lnad to brsthing prableme.
Anticholinargic madicinas, such an glycopyrrolae, and LAnA.madicnn, mch as farmotarol fumarat halp the muscles around the alnways in the lunga. atay mond ta prwvent ymptorna, nuch as whearing, cough chantt
tightnaet, and shortrinss of breath.

Dosage & Administration

The rcommandad dosage of is twa inhalation twice dally, ance in the maming and aginin the wuening. by oral inhalalan. Do nat tak more than two inhalations twce dally. Aftar Inhalation, rines mouth with water
without ewalkrwing

Interaction

Strong cytacrame P450 304 Inhibltare (ng. ritoravi): Liee with cauian. May caute systarnic coriicactarold affact.
Other adrenargic druge may potentiate affect: Los with caution.
Dluretica, xanthna dariatiee or staroide may potantiate Iypokalamla or ECG changat. Lioe with cautian.
Honnamina addaos inhibitors and tricyclic antidspressants: Uss with ecrame caution. May potantiate affect of formaterol furnarate on cardlovascular mytamn.
Dets-blockare: Les with cauton. May block branchodiatory affacie ofbata-agonitta and praduca anvarw branchospaum.
Anticholinargics: May Intaract addfwly with cancamitantly utd arischolnargic madicationt. Jwoid adminitraon of the spray with ather anticho inargie-cantalning druge.

Contraindications

Thi in cantraindicated in paants who hawe damontratad hypararivity to budatonids, glycopyrrolabe, formatarl, or any af tha noplenite.

Side Etfects

Sarlous atthma-mlated wwants-hoapitallzalane. Intubation, daath. Candids albicara infecton, Inereaced riak af pnauronis, immunosuppresdan and risk of infectior, ypercartelam and acerl upprection
paradoaical bronchospatm. hypereritvity reactiona Including anaphylue, cardiavancuar affecte, reduction in sona minaral denaity, worsaning of rurrow-angie glaucoma and cataracte, worsaning af urinary rbenon

Pragnancy & Lactation

Tharw arw no adequate and wel-cantrolled hudias with thi Inhalar or with two af ts Indiwidual companants. Glycapyrrats or Formotaral Fumarata, In pragnant wornen to inform a drug-astoclated rick. Thare are no
awalabie data on tha affecte of this inhler an th brsattfed child or an mik production. Dudeconide, Iks athar ICS, In presant in hurnan mik. Thars are no available data on the prsance of Glycnpyrrate or Formotarsl
Fumarate in uman mlk. Tha deeslopmanta and haalth banatte af breastlesding should be coridared along with the mothar's clinical nand for this inhaler and any patential advarss affecte on tha brwatfed child fromn
thie Inhaler or fram the undariying maternal condition.

Precautions & Warnings

The safety and affeacy of this Inhaler in patlante with aathma haww notbean establinhed. thin Inhaler ix nat indicaied for the treatrnant of authra. This inhlar as not baan shudied in patante with acuialy duterorating
COPO. Tha ws of thit Inhaler in thie satting lenat appropriate. This Inhaler ahould not be wnd for tha ralief of acutn ymptame, In, as rescun tharapy for the treatmant of acute aplsodas afbronchoapaun. Thiinhalar han
not baan studiad in the rllef of acute syrptorne and sodra doans thould nat ba uned for that purponn. Acute symptams should be tratd with an inhaled short-acting bata2-aganiat. Vihan baginning treatman with thit
Inhaler, patlente wo huww baen taking Inhald, thart-acting bata2-agonise on a regular badle jng., four fimae a day) should bn inetructed to disconinun the reguiar uen off thaos druge and usn tham only for mympornatie
mllef of acute respiratory symptorne. whan prescribing thi inhaler, tha haaltheare providar shoud alto prescribe an Inhaled, thort acting bata 2-agonist and instruct the palsant on how it should be und. increating
Inhalnd bata 3-agonist uoe in a tigrul af deteriorating ditsass far which prompt madical attienon le Indicabed.

Tha dally douage of this inhaler thould nat be Incranted beyond the recommanded dees. As with othar iinhaled druge containing bata2-adrenargie agents, this inhaler thoud nat be uted more offen than recommandad. at
highar douas than recommanded, or in conjunction with ohar madcatione contalning LAnA, at an seerdses may resuit. Clnically tignifcant cardisvaacular affects and fatalisas ave bean reportad in ausadation with
eucarzive ute of Inhaled syrrgathorimatie drugt.

Patiente uning this inhaler should nat uss anothar madicina contalning a LAnA [e.g.aamatersl, forreterol fumarate, arformotaral tartrabe, ndacataro) for any remon.

thie Inhaler containe budasonids, an IDS. Localired infections of the mouth and pharyn with Candida albeane hawe occurred in subjecta treated with orally inhuled drug pesducts cantalning budaconide. Vihan nuch an
nfaction daelop. It should be treated with appropriats local or syutemic [La., oral) ardfungal therapy whils treatmard with thix inhaler continust.

Lower respiratory tract intacians. Including prwumonia, hae baen mparted following the inhaled administration of corticotersidt. Physicana should remaiwiglant for tha pacsble deusopreant of prisumora in patlanx
with COPO an the diinical festures of pnaumonia and euacertsona frequantly overiap.

Patente whe arw uting druge thatt mpprece the irmuna syatamn are mare succapbieto infection than halthy Indildualt. Chicken pox and maadas, farecrpla, can have a more sarlous or aven faltal caursa in
mscaptible children araduite uting corticoeteridit.

Particular care ix nnnded farpatlent who haws been trarferred from syatarrically activn corticasherolde ta ICS bacaun deathe dun to adrerl inuffclancy hawe sccurred in patiarde during and aftar tranafur fram
wytarric corticosteroide to lace nystemically avallabin iDS. Pasents who haen baan prewioutly maintalnad on 20 mg or more per day af prednitors jor ite aquivalent) may be mast cuncaptisle.

Tffecte of bucsonide an the HPA.as.are not aboarved with the therapeutic dacss of budaconide In thit Inhaler. Howwver, aoccsading the recommended donage or co-adminxtraon with a strang cytochrome P450 3A4
DYPS/] Inhibitor may nacult in HPA dyafunction.

it ix pousible that syutemic corticoateraid affecte, such an hyparcorticiem and adrenal supprecsion [including acrerl crd) may appear in a aal number of patente who an candtus to tha effecie. if such affects
oecur, appropriats tharapy tould be Initlated an rded.

Caution should be wxrclned whan conaidaring tha co-administration af this Inhaler with long-barrnkwaconazole, and ahar knawn atrong CYPSM4 inhlbitors e.griorlr, atazanavir clariheamyein, indinadir,
Pracoruole, nafarodona, nalfruvi, caquirir, tethromydn) bacauns adiveros affacta relatd to inereased syutamic eaponure to budaconide may accur.

As with otharinhaled theraple, thi inhaler can produen paradadeal bronchopaam, whic may be lfe threatening. if paradadeal bronchospaam sccurs fallowing doning with thix inhaler. It chould be traated imrnadiataly
with an Inhaled, thort-acting bronchodlator, this Inaler ahould be discornund immaciaely and altarrlvn therapy thoud be inatituted.

Immadlata hyparsenaitivity racisans hawe bean raported after administration af Dudaconide. Glyenpyrrlatw or Formotarol Fumarabe, the corponant of this inhaler. ifsigne nggeding allargie reactione accur, in
particular, anglodara including diffeulses in braathing or swallawing. wweling of tongue. llp, and faca), urticaria, or skim ranh, thic inhalar should be stapped at once and altemats treatman should be cansidared

Formatari furarats, lke atharbata0-agonikte, can produce a cinically aigrfcant cardlovaseular aflact in soma patere au maacurd by inereanss in puse rate, kystolc or dastolc blood preasuns, and aluo cardiac
arthythmian, much a supraventricular tachycardia and eodrasystoles. If such affecte accur, thit inhaler may nead to be discontinund. in acdition, bata-agonets avn bean reportad to praduce alectrocardlograpic
changa, mch an fattaning af the Twaen, prolongation of tha QTe Intarval, and S angmant depreasian, although the cinical sigrifcancs of thas findings n unknown. Tharefore, ths inhaler should ba uaed with caution in
patlane with cardlovascular disordars. aspacially cornary inuffclaney: cardlac arrhythmis, and hypartarmion

Use in Special Populations

Hipattic impairmant: Dudaconide and formotarol fumarabe nyserle expomure may incrns in patlers with asewr hapatic impalnmanit. Montar patiene for aigne af increaned drug espamurn.

Aunal impalrman: in patiante with aevers renal impalrmant, uss should be corldared only if the potardia barwdt of the treatmant outwelge the ritk

Padiatric Lis: This ix nat indicated for us in chadren. The safety and affectivermes of thic apray have not seen aatablithad in padiatric palsents.

Garlatric Uon: Dased an awalable data, no adjustmant of the dacage af Thin in gariatric patent is rcwssary, ut graater annativity in sorne older indivldual cannot be rulad aut.

Overdose Effects

Na caos of overdoas have baan nparted with thit inhaler, tharefore, the iske ausaclated with owerdacage for the indlwidual camponants dascribed balow apply to this inhaler. Tratmant of avardosaga coruista. of
discortinuation af this Inhaler togathar with inetitution of appropriate symptoratic and/ar supportive thrapy. Tha Judclous us of a cardionalactive bata-recegtor blocker may be conaldared, bearing in mind that nuch
madication can praduea bronchaspaurn. Cardlac monitoring le racommanded in cans of owerdacags.

Budasonide: ifuned at aucacaive douns forprolongad perlode, systemic corticcaterid affecte, nuch an hyparcorticiem may scour.

Glycopyrrolatw: High dacse of Glycapyrlata, a camponant of this inhaler, may land ts anticholinargie algna and syrrgtome such as naunss, wamiting, diazineus, lighthededras, blued wialon, inereannd Intraocular
preecun (cauing pain, witlon disturbances arreddening of th wyal, obtipation, ar diffcuitie inwoiding.

Formaterol Fumarate: An overdoss of Formetarol Fumarate would licaly lad to an weaggaralan of affects that are typleal fareta2-agonles: salzurw, angin, hypertenalon, hypotenalon, tacycardia, atrial and
ventricular tachyarrhythmia, marvoutnac, hasdacha, tremar, palpitaona, mude crampe, rausas, dizsinas, denp disturtncae, matabolic addoat, hyparglycamis, hypokalamla. A with all rympathamimatie
madicatione, cardiac amast, and aven dasth may be actoclatad with overdonage of Formoterol Fumrats.

Therapeutic Class

Combined bronchadilator

Storage Conditions

Prcsuriand canlttar, do not puncture, brak or Inelnaratn wven whan ampty as canlixter may aplods. Avold expasune ta diract munigh orheat. Cn youriinhalaregularly aa par direction. Do not atore above 30'C. Ensp
In a dry placn. Probact from Iight and kep out of the rac of children. Kasp away fram wyat. Discard within thres mantha aftar remaving frorn the foll pouch. For bast maulte, tha canister shoud ba alt som tamparaturn
bafore utn. Shaks well bafare aach uns.