Indications

Linaab E tablet in ndicated an an acunet to dat and axarciss to improve glycamlc contral in adulte with typa 2 diabales mallitu.

Pharmacology

Lnag/ptim inhiblis DPP-4 enzyme which daciinas the ineretin harmonas glueagon-liks papiide-1GLP-) and glucots-dapandant insuinatrapc polypaptide (GIP). Linag/iptin Inereaoss tha cancantratior of activw ineretin
hormonas, atimulating the misaoe of inauln In a glucnos-dependen marner and decreasing the leve of glueagan. Doth Ineretin ormonas ars Invoived in th pyalolagical guation af gluenen homacatatle. Incram
hormones are sacied at a low banal evel throughout tha day and levelerios Immadatsly after maal inaks. GLP-1and GiP Inersate Insulin blonynthada.and sncretion fram pancrue bata caile in tha prasancn af normal
and elwvabed blood gluenes levele. Purtharmors, GLP-/ also raducas glucagon scretion fram pancrese alpha calis, raulng in a reducian in hapatie gluccas sutput.

Empaglifarin is an inhibitor of Sodium-glucoas ca-trarporter 2 (SGLT2), SGLT2 in the pradominant transporterrspandibe for rborption of glueaes from kidnwy back ints the eireulation. Dy inhibiting SGLT2,
Erpaglifarin reduca renl utsorpian of filtered glucoas and lowers the rerl threchald for glueses, and tharsby Inereaoes urinary glucoen acretior

Dosage & Administration

Rscommanded dess: 10 mg Empaglifoain and 5 mg Linagliptin ance daily, takan in the moming, with ar withaut food.

Ineraand dona: Doun may be Incmaned to 25 mg Empaglifodin and 5 mg Linagliptin onon daily.

Runal Impaired patients: Aasacs rerl function befars initiating this tablet. Do not: initlaie this tablat if aGFR in elow 45 ml,(min/1.75 m2 Dincantirn taing thie tablat if aGFR falis balow 45ml/min/1.73 m2

Interaction

Dluretics: Caadminiztration of Empagifozin with diuratic rauled in inereaced urine voluma and freguncy of volde, which might anhance tha poantiall for volume depietior

Inaulin or inaulin Sacretagoguat Coadminixiraon of Empagfcain with inauin or insuin sacretagogues inereaoas the rik for lhypaglycamia.

Inducars of P-glycopratein ar CYPSM Cnaymas: Rifampin dacreasad Linagplin asposurs, sugganting that the affeacy af Linaglptin may be reduced whan administared in corrbinatianwith a strong P-gp orCYPSA4
Inducar

Positive Urina Glucass Taet: SGLT2 inhiblor Increace urnary glucoie wxcretion and will laad to poaitive urina gluescs tacte.

ntarferance with 1.5-anhydroglucitol (1,5-AG) Anray: Measurmants of 1,5-AG ars urrellabe im assasing glycamle cantra in patlante taking SGLT2 inhibitors.

inducars ofP-glycopratain ar CYPSM Cnaymat: Rifampin dacreasad nagiptin axpomure, mggating tht tha affeacy of Iinagliptin may be mduced whan administard in combination with a eirang P-gp arCYPSA
Inducet

Contraindications

Swvere renal impalrmant, and-etage renal disaaon, ar dialynix.
Hiatory of hyparsanaitivity rction to Linagipin, much at anapylas, angsedema, eufallative skin canditiane, urticaria, or bronchla hyparsctivity
Hietory of saroun hyparsansitivity rwaction to Empag fazin

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Side Etfects

The fol owing important adverse reactions are decribed below and slawwhare in the labeling. Pancraatiti, Katoacdonie, Valurna Deplation, Lrsespale and Pyelonphriti. Hypoglycamia with Concomitant Uee with Intulin
and inauin Sacratagoguet, Nacrotiring Fasciitix of the Parinsum (Fourier's Gangrena), Gantal Mycotic inectione, Hyparsantivity Reactione, Savers and Diabling Arthraigla, Dulout Pemphigold. Haart Fallune.

Pregnancy & Lactation

Thit ln not recommanded during th sncond and thind trimacar of pregnancy: Tha limitad aallable data of this tabat in pregrn waman ans not suffclant to dutemine a drug-ansoclaed rik for majar birth defecte and
mincarriage. Thare ar riska to the mothar and fetu ausoclabed with poorly conrolied dibetas in pregnancy.

Precautions & Warnings

Pracaution should be taken in sore dioess conditiona lios Panereatitle. Hypotenion, Katoacldosle, Aeute kdnwy Injury and Impairmant in renl funetion, Ursesptle and Pysionapliti, Hypoglycamia, Ganital yeotie
Infectiane. Hypersanditwity atc.

Pancreatitie: Acute panereatitie, ncluding fatal panereatitie, has been raported in patanta treated with Linag/ptin.

Ka/taacidodit: Raport of katsacidoa, a sarious iife-theestenng condition reguiring urgant heapital zan haw baan idantifad in einical triale and postmarkating survellane in patente with type iand type 2 dlabwinn
malituc recalving todium gluccas co-transporter-2 (SGLTa] Inhibitors. Incuding Empagfcoin. Fata caas af katoacidonit havnbeamreported in ptiente taking Empag/iferin.

Voluma Duplation: Empagiiforin can caune inravaacular wolurna deplation which may samatimas manifest as symptornatic hypoterdom or acute trarlan changes in cnuanin

Uronaptis and Pyelonaphritic: Thars hawe been partmarbaling raporte of serlous urinary tract infecone including ursespele and pyelonphritis regulring hospitallration in patients. receiving SGLT2 Inhbitore, Including
Empagiifarin. Treatmant with SGLT2 Inhibltore increanas the risk for urinary tract infectiont.

Hypoglycamia with Concomitant Lss with insulin &ingulin Secretagogune: Inaulin and inauin sacretagagues ars known to caute hypaglycamla.

Nacrotizing Fauciitis of the Perineum (Fournier's Gangrans): Rsparte of nacratiing farciitis of tha parinaurn [Fourniar's gangrena), a rare but sarious and ife-thratning ncrotiring infecon requring urgant urgcal
Intervantion hrs baan Idanifad in postmarkating survellanee in patants with dabates mallitus racalving SGLT2 Inhibitor, Including Empaglfoain.

Ganital Mycotic infectione: Empagiiforin increates tha ritk for ganital mycatic Infecone. . Hyparsenaitivity Raactiont. Savare and Dicabling Arthralgla Dulloun Pemphigold.

Haart Fallur An astociatian batwan DPP-4 inhibior tmirant and haart fallurs haa bean obsarved in cardlovascular outcoras tria for two othar mambars of the DPP-4 inhibitor dlact. Thacs trials wvaluated patsante
with type 2 diabetes mellitus and atharcaclerstic cardiovancular dimass.

Overdose Effects

n the wvent of an swwrdson with this tablat, cantact Polson Conrol Danter. Employ tha umal supportive maasarssag, rroww unabasrbed ratarial fromn the gastmointastinal tract, employ einca monitoring, and Ineitute
mupportive traatrant| as dictatad by tha patiene ciinical satut. Ramowal of Empag foein by hamodialyts as not baan shudied and remaval of Linagliptin by harodialyax or paritoneal dalyrs li unlikaly.

Therapeutic Class

Sodium-glucaon Cotransportar-2 (SGLT2) inhlbitors