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Rx Item-QTERNMET XR 5/2.5/1000 BY ASTRA ZENECA 60 TAB

RX00310-6950-60Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-QTERNMET XR 5/2.5/1000 BY ASTRA ZENECA 60 TAB

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5 mg dapagliflozin /2.5 mg saxagliptin /1000 mg metformin HCl NDC No. 00310-6950-60 0310-6950-60 0310695060 00310695060 UPC/GTIN No. 3-03106-95060-7 303106950607 303106950607 MPN No.95060 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item. for: Diabetes Type 2

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How Supplied QTERNMET XR (dapagliflozin, saxagliptin, and metformin HCl) extended-release tablets are available in packages as listed: Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Pack Size NDC Code 2.5 mg dapagliflozin /2.5 mg saxagliptin /1000 mg metformin HCl Light brown to brown biconvex, oval “3001” debossed on one side Bottles of 60 0310-6925-60 45 Reference ID: 4428078
Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Pack Size NDC Code 5 mg dapagliflozin /2.5 mg saxagliptin /1000 mg metformin HCl Green biconvex, oval “3002” debossed on one side Bottles of 60 0310-6950-60 5 mg dapagliflozin /5 mg saxagliptin /1000 mg metformin HCl Pink biconvex, oval “3003” debossed on one side Bottles of 30 0310-6975-30 10 mg dapagliflozin /5 mg saxagliptin /1000 mg metformin HCl Gray biconvex, oval “3004” debossed on one side Bottles of 30 0310-6990-30 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use QTERNMET XR safely and effectively. See full prescribing information for QTERNMET XR. QTERNMET® XR (dapagliflozin, saxagliptin, and metformin hydrochloride) extended-release tablets, for oral use Initial U.S. Approval: 2019 WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. •Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. (5.1) •Risk factors include renal impairment, concomitant use of certain drugs, age >65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high-risk groups are provided in the Full Prescribing Information. (5.1) •If lactic acidosis is suspected, discontinue QTERNMET XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. (5.1) ---------------------------INDICATIONS AND USAGE -------------------------­QTERNMET XR is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a dipeptidyl peptidase-4 (DPP-4) inhibitor and a biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use •Is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1) •QTERNMET XR initiation is intended only for patients currently taking metformin. ( 1) ----------------------DOSAGE AND ADMINISTRATION ---------------------­•Assess renal function before initiation of therapy and periodically thereafter. (2.1) •Individualize the starting total daily dose of QTERNMET XR based on the patient’s current regimen, effectiveness, and tolerability. (2.2) •Take QTERNMET XR orally, once daily in the morning with food. (2.2) •For patients not currently taking dapagliflozin, the recommended starting total daily dose of QTERNMET XR is a 5 mg dapagliflozin/5 mg saxagliptin/1000 mg or 2000 mg metformin hydrochloride (HCl) once daily. (2. 2) •The maximum recommended daily dose is 10 mg dapagliflozin, 5 mg saxagliptin and 2000 mg metformin HCl. (2.2) •Swallow tablet whole. Do not crush, cut or chew. ( 2.2) •Discontinue QTERNMET XR at the time of, or prior to, an iodinated contrast imaging procedure. ( 2.5) ----------------------DOSAGE FORMS AND STRENGTHS -------------------­•Tablet: 2.5 mg dapagliflozin/2.5 mg saxagliptin/1000 mg metformin HCl extended-release (3) •Tablet: 5 mg dapagliflozin/2.5 mg saxagliptin/1000 mg metformin HCl extended-release (3) •Tablet: 5 mg dapagliflozin/5 mg saxagliptin/1000 mg metformin HCl extended-release (3) •Tablet: 10 mg dapagliflozin/5 mg saxagliptin/1000 mg metformin HCl extended-release (3) ------------------------------CONTRAINDICATIONS ----------------------------­•History of a serious hypersensitivity reaction to dapagliflozin, saxagliptin, or metformin, including anaphylaxis, angioedema, or exfoliative skin conditions. ( 4, 5.9, 6.2) •Moderate to severe renal impairment (eGFR <45 mL/min/1.73 m2), end-stage renal disease (ESRD), or patients on dialysis. (4) •Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. (4) -----------------------WARNINGS AND PRECAUTIONS ---------------------­Lactic acidosis: See boxed warning (2.2, 4, 5.1) Pancreatitis: If pancreatitis is suspected, promptly discontinue. ( 5.2, 6.2) Heart Failure: Consider the risks and benefits of QTERNMET XR in patients who have known risk factors for heart failure. Monitor patients. (5.3) Hypotension: Before initiating QTERNMET XR, assess volume status and correct hypovolemia in the elderly, in patients with renal impairment or low systolic blood pressure, and in patients on loop diuretics. Monitor for signs and symptoms during therapy. (5.4, 6.1) Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis regardless of blood glucose level. If suspected, discontinue QTERNMET XR, evaluate and treat promptly. Before initiating QTERNMET XR, consider risk factors for ketoacidosis. Patients on QTERNMET XR may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. (5.5, 6.2) Acute Kidney Injury and Impairment in Renal Function: Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. Monitor renal function during therapy. (5.6, 6.2) Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated. (5.7, 6.2) Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating QTERNMET XR in combination with these agents. (5.8, 6.1) Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment. (5.9) Hypersensitivity Reactions (e.g., urticaria, facial edema): There have been postmarketing reports of serious hypersensitivity reactions treated with saxagliptin, such as anaphylaxis, angioedema, and exfoliative skin conditions. Promptly discontinue QTERNMET XR, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. (5.10, 6.2) Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Measure hematological parameters annually. (5.11, 6.1) Genital Mycotic Infections: Monitor and treat if indicated. (5.12, 6.1) Increased LDL-C: Monitor and treat per standard of care. (5.13, 6.1) Bladder Cancer: An imbalance in bladder cancers was observed in clinical studies with dapagliflozin. QTERNMET XR should not be used in patients with active bladder cancer and should be used with caution in patients with a prior history of bladder cancer. (5.14) Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate. (5.15, 6.1, 6.2) Bullous Pemphigoid: There have been postmarketing reports of bullous pemphigoid requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue QTERNMET XR. (5.16) Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with QTERNMET XR. (5.17) ------------------------------ADVERSE REACTIONS ----------------------------­Adverse reactions reported in ?5% of subjects treated with dapagliflozin and saxagliptin plus metformin were: upper respiratory tract infection, urinary tract infection, and dyslipidemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------------DRUG INTERACTIONS ----------------------------­Strong CYP3A4/5 Inhibitors (e.g., Ketoconazole): Do not coadminister QTERNMET XR with strong cytochrome P450 3A4/5 inhibitors. (2.4, 7) Carbonic anhydrase inhibitors: May increase the risk of lactic acidosis. Consider more frequent monitoring. (7) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine): May increase the accumulation of metformin. Consider the benefits and risks of concomitant use. (7) Alcohol: Can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake. (7) 1 Reference ID: 4428078
-----------------------USE IN SPECIFIC POPULATIONS ---------------------­Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. (8.1) Lactation: QTERNMET XR is not recommended when breastfeeding. (8.2) Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. ( 8.3) Geriatrics: Higher incidence of adverse reactions related to volume depletion and reduced renal function. (5.4, 5.6, 8.5) FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LACTIC ACIDOSIS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Prior to Initiation of QTERNMET XR 2.2 Dosage 2.3 Patients with Renal Impairment 2.4 Use with Strong CYP3A4/5 Inhibitors 2.5 Discontinuation for Iodinated Contrast Imaging Procedures 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Lactic Acidosis 5.2 Pancreatitis 5.3 Heart Failure 5.4 Hypotension 5.5 Ketoacidosis 5.6 Acute Kidney Injury and Impairment in Renal Function 5.7 Urosepsis and Pyelonephritis 5.8 Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues 5.9 Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) 5.10 Hypersensitivity Reactions 5.11 Vitamin B12 Concentrations 5.12 Genital Mycotic Infections 5.13 Increases in Low-Density Lipoprotein Cholesterol (LDL–C) 5.14 Bladder Cancer 5.15 Severe and Disabling Arthralgia 5.16 Bullous Pemphigoid 5.17 Macrovascular Outcomes 6 ADVERSE REACTIONS Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function. (2.2, 5.6, 6.1, 8.6) Hepatic Impairment: Avoid use of QTERNMET XR in patients with clinical or laboratory evidence of hepatic impairment. (2.3, 8.7) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Revised: 5/201

RX00310-6950-60
Rx Item-QTERNMET XR 5/2.5/1000 BY ASTRA
RX00310-6950-60

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-QTERNMET XR 5/2.5/1000 BY ASTRA
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop