Indications

Limpa tablat in Indicated an an adjunet to diat and woarcien to impravn glycamic cantrol in acuts with typa 2 dlabes meilitun.

Pharmacology

Linagptin inhiblte DPP-4 enzyme which daciines the Incretin haronas glucagon-liks papide-GLP-) and glucose-depandant insuinatrapic polypaptide (GIP). Linaglptin Increaoss tha cancantratior of activw ineretin
hormonas, atimulatng the minaoe afinaulin in a glucsos-dependan mannarand dacreasing the lve.of glueagan. Doth Ineretin hormonas ars involved in th plylolagical meguiation af gluccn homactatie. Incram
hormonas are sacmied at a low baeal el throughout the day and lwvelerios immadataly after masl intaks. GLP-Aand GiP Inersatn insuin blonytheds.and sacretion fram pancewde bata caile in tha precnce af normal
and alwvabad blood glucnes leele. Furtharmors, GLP-A also naduces glucagon sacretion fram pancreste alpha calls, raung in a recucton In haptie gluccas sutput.

Empagiiferin is an inhibitor of Sodium-glucoas ca-transporter 2 (SGLT3), SGLT2 in the pradominant transporterrspandbie for reborption of glueses from kidnwy back into the eireulation. Dy inhibiting SGLT2,
Empagiiferin reduca renal mtsorption of flared gluccas and lowers the renl threshald for glueses, and tharby Inereaoe urinary glucoen ecretlon.

Dosage & Administration

Rscommanded dese: 10 mg Empaglfoain and 5 mg Linagliptin ance dally, taen in the moring, with ar withaut food.

neraaned dona: Dorn may be Inemassd to 25 rg Empaglifozin and 5 mg Linagliptin onon daily

Runal Impaired patiante: Aasac rerl function befare initiating this tablat. Do not initlaie this tabla if aGFR in below 45 ml,(min/173 m2 Discantirn taking thie tabat if aGFR fas balow 45ml/min/1.73 m2

Interaction

Olurstice: Caadministration of Empagiforin with dluratic rsulted in inereaced urine voluma and frequncy of volde, which might anhance the poental for voluma daplation

ngulin or insulin Sacretagoguat Coadministralian of Empagificain with inauin or insuin scretagoguet inereaos the rick for Inypaglycemia.

Inducar ofP-glycopratein ar CYPSM Cnaymat: Rifampin decreasad Linagptin asposurs, nuggaating that the effeacy af Lnagliptin may be rduced whan administared in corrbintianwith a strong P-gp orCYPSA4
nducer.

Pasitiwe Urina Glucass Tast: SGLT2 nhbitor Increate urnary glucose axcretion and will laad to poaitive urin gluescs tacte.

Intarferance with 1.5-anhydroglucitol (15-AG) Anray: Maacunmante of 15-AG ars urellabe inasseesing glycamic cantra in patlene taking SGLT2 inhibitore

inducars offP-glycopratain ar CYPSM Cnayman: Rifampin dacreasad nagiptin axpomure, mggasting tht tha affeacy of Inagliptin may be mduced whan administered in combnation with a etrang P-gp or CYP3A4
Inducer

Contraindications

Savere renal impalrmant, and-etage renal dinnao, ar dlalyaln.
Hitory of hyparsansitivity rcton to Linagipin, mch as anaphylast, angisedama, aufallative skin canditians, urticaria, or bronchia hyparnsactivity
Hietory of ssroun hyparsanaitivity raction to Empag faan

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Side Effects

The fol owing Important adverse reactions arn deucribed below and eawwhare in the labeling. Pancraatite, Katcacdon. Valurna Deplation, Lrsesple and Pyelonsphritir. Hypoglycamia with Concamitant Ues with Intulin
and inauin Sacretagoguer, Necrotiring Fasciti of the Parinsum (Fourier's Gangrena), Ganital Mycotic infectione, Hypersantivity Resctione, Savere and Disabling Arthralgia, Dulout Pamphigold. Haart Fallure.

Pregnancy & Lactatiion

Thit ln mot recommanded during the sacond and thind trimacars of pregnancy: The Iimited aallable data of this tabat in pregran waman ans not suffclant to determine a drug-assoclaed rik for majar birth dafecte and
mincarriags. Thare are riske to the motharand fetur ausoclaed with poorly conrolied diabetas in pragnancy.

Precautions & Warnings

Pracaution should be taken in sore diosass conditiona lios Panereatitl. Hypoention, Katoacidonle, Aeute kdnwy Injury and Impairment in renl funetion, Usespals and Pyslonapiti, Hypoglyceria, Gantal ycotie
nfscians. Hyparsanditwity atc.

Pancreatitie: Acute panereattie, including fatal panereatitie, has been rported in patanta treated with Linaglptin.

Kntaacidodin: Raports of katsacidods, a sarious ife-theestenng condition reguiring urgant heapitaliaan hw baan idantifad in eiinical triale and poetmrkating srvellane in patene with typa iand type 2 dlabeten
malituc ecalving sodium gluccas ca-transportar-2 SGLT3] inhibitors, Including Empagficdin. Fatal canss af stoscldo havnbenreported in patante taking Empaglifarin.

Voluma Deplation: Empagiforin can caus intravaacular wolure depletion which may samatimes manifest as symptoratic hypotendom or acute trartiant changen in cruatnina

Uronaptls and Pyelonaphritis Thars haws bean pastrarbsing reports of sarlous urinary tract infections ncluding ursespele and pyelorphritis regulring hospitallration in patants. recelving SGLT2 Inhbltors, Including
Empaglifarin. Treatmant with SGLT2 Inhibitore ncreanes the risk for urinary tract infectiont.

Hypoglycemia with Concomitant Uss with insulin &inaulin Secretagogunt: Inaulin and inauin ssceetagaguns ars knawn to caute hypaglycamla.

Nacrotizing Fauciitis of the Perinaum (Fourniar's Gangrans): Rsparts of nacrataing farcits of tha parinaurn [Foumlar's gangrena), a rare but sarisus and fe-thrtning nacrotiring infecon requiring urgent murgical
Intervntan, hrs bean idantifad in postmarkating survellance in patents with dabatas malitus racalving SGLT2 inhibitor. Including Empaglifoain.

Ganital Mycotic infectione Empagliforin Increates tha ritk for ganital mycatic Infecone. . Hyparsanaitivity Raction. Savare and Dicabling Arthralgla Dullous Pmphigold.

Heart Fallure: An associatian batween DPP-4 Inhlbitor tmtmant and haart fallurs haa been obsarved in cardiovascular outcoras trials for two othar mambars of the DPP-4 inhibitor clact. Thas trials wvaluated patarite
with type 2 diabetes mellue and atharcaclerstic cardiovascular diceans

Overdose Effects

In the wventof an owwrdson with thin tablet, cantact Polson Conirol Danter. Employ tha umal supportive maamarasag, rarnoww unabarbed ratarlal from the gastmointastinal tract, amplny einica monitoring, and ineituts
mupportive tratmant| as dictatad by tha patianfe ciinical etatu. Ramowal of Empag fodin by hamodalyte as not bean thudied, and remaval of Linagiptin by haredialyte or paritoneal dalyre li unlkaly.

Therapeutic Class

Sodium-glucsen Cotransporter-2 (SGLT2) inhlbitorn