| Document Date: 2014-08-12 12:33:09
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City CONTRAINDICATIONS / Reference / / Company N (%) Patient Subgroup / Bristol-Myers Squibb / / IndustryTerm Monitor for signs and symptoms / food / / MedicalCondition polyuria / Genital Mycotic Infections FARXIGA / Genital Mycotic Infections / genitourinary tract infection / Urinary tract infections Back pain / vulvovaginal candidiasis / vaginitis / pre existing tumors / pre-existing bladder tumors / cancer / cystitis / female genital mycotic infections / nasopharyngitis / hematuria / Carcinogenesis / urinary tract infection / Symptomatic hypotension / Nausea / Dyslipidemia / contraction / active bladder cancer / Bladder Cancer / genital infection / Diabetes / vulvitis / hypovolemia / orthostatic hypotension / genital mycotic infections* Nasopharyngitis / vulvovaginal mycotic infection / urethritis / serious hypersensitivity / orthostatic hypotension / fungal genital infection / genital candidiasis / diabetes mellitus / diabetic ketoacidosis / prostatitis / urticaria / penile infection / angioedema / infective / genital infection / pyelonephritis / anaphylactic reactions / Hypersensitivity / balanitis / infection / urinary tract infections / vulval abscess / vulvovaginitis / bladder cancers / renal failure / end-stage renal disease / Constipation / Hypoglycemia / kidney infection / Infections / microvascular disease / Hypotension FARXIGA / vaginal infection / Influenza / Hypotension / dehydration / mycotic infections / / MedicalTreatment dialysis / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Position Major / / Product Pioglitazone / Glipizide / glucagon / Glimepiride / / Technology Geriatrics / Pharmacokinetics / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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• Hypoglycemia: In patients taking insulin or an insulin secretagogue with FARXIGA, consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. (5.3) • Genital mycotic infection