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Rx Item-Steglujan 15Mg/100mg Tab 90 Merck

NDC No.00006-5368-06 0006-5368-06 UPC/GTIN No..3-00065-36806-1 MPN 6803 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, PharmaSTEGLUJAN 15MG/100MG TAB  Merck  Generic Name:
ERTUGLIFLOZIN/SITAGLIPTIN

Description:
STEGLUJAN TB 15-100MG 30UU 

NDC:
00006-5368-03 0006-5368-03 00006536803 0006536803 
UPC:
300065-36803Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.STEGLUJAN 15MG/100MG TAB  Merck  Generic Name:
ERTUGLIFLOZIN/SITAGLIPTIN

Description:
STEGLUJAN TB 15-100MG 30UU 

NDC:
00006-5368-03 0006-5368-03 00006536803 0006536803 
UPC:
300065-36803STEGLUJAN 5MG/100MG TAB 30 Merck Generic Name:
ERTUGLIFLOZIN/SITAGLIPTIN

Description:
STEGLUJAN TB 5-100MG 30UU 
NDC:
00006-5367-03 0006-5367-03 00006536703 0006536703 
UPC:
300065-367033

Rx Item-Steglujan 15Mg/100mg Tab 90 Merck

$1979.64$1885.37

NDC No.00006-5368-06 0006-5368-06 UPC/GTIN No..3-00065-36806-1 MPN 6803 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 Practice Can Order This Rx Item. Rx Item No.Rx725349 725349 Steglujan 15Mg/100mg Tab 90 By Merck NDC No.00006536806 0006536806 UPC No.300065-368061 300065368061 Other Name Ertuglifl oz in/Sitagliptin<

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use STEGLUJAN safely and effectively. See full prescribing information for STEGLUJAN.

STEGLUJAN� (ertugliflozin and sitagliptin) tablets, for oral use
Initial U.S. Approval: 2017
RECENT MAJOR CHANGES
Warnings and Precautions
Necrotizing Fasciitis of the Perineum (5.9) 10/2018
INDICATIONS AND USAGE
STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. (1)

Limitations of Use:

Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1)
Has not been studied in patients with a history of pancreatitis. (1, 5.1)
DOSAGE AND ADMINISTRATION
Recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food. (2.1)
Increase dose to 15 mg ertugliflozin/100 mg sitagliptin once daily in those tolerating STEGLUJAN and needing additional glycemic control. (2.1)
Assess renal function before initiating STEGLUJAN and periodically thereafter (2.2):
Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.
Initiation is not recommended in patients with an eGFR of 30 to less than 60 mL/min/1.73 m2.
Continued use is not recommended in patients with an eGFR persistently between 30 and less than 60 mL/min/1.73 m2.
DOSAGE FORMS AND STRENGTHS
Tablets:

Ertugliflozin 5 mg and sitagliptin 100 mg (3)
Ertugliflozin 15 mg and sitagliptin 100 mg (3)
CONTRAINDICATIONS
Severe renal impairment, end stage renal disease, or dialysis. (4, 5.4)
History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. (4, 5.11, 6.2)
History of serious hypersensitivity reaction to ertugliflozin. (4)
WARNINGS AND PRECAUTIONS
Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking sitagliptin, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue. (5.1)
Hypotension: May occur particularly in patients with renal impairment, the elderly, or patients on diuretics. Before initiating assess and correct volume status. Monitor for signs and symptoms during therapy. (5.2)
Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, evaluate and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. (5.3)
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. There have been postmarketing reports of acute renal failure in patients taking sitagliptin, sometimes requiring dialysis. Monitor renal function. (5.4)
Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. (5.5)
Lower Limb Amputation: Before initiating, consider factors that may increase risk of amputation. Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur. (5.6)
Heart Failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. (5.7)
Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. (5.8)
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)
Genital Mycotic Infections: Monitor and treat if indicated. (5.10)
Hypersensitivity: There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. In such cases, promptly discontinue, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. (5.11)
Increased LDL-C: Monitor and treat as appropriate. (5.12)
Severe and Disabling 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 if appropriate. (5.13)
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. (5.14)
ADVERSE REACTIONS
Most common adverse reactions associated with ertugliflozin (incidence ≥5%): female genital mycotic infections. (6.1)
Most common adverse reactions associated with sitagliptin (incidence ≥5%): upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin studies, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS
Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. (8.1)
Lactation: Breastfeeding not recommended. (8.2)
Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume. (5.2, 8.5)
Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function. (5.2, 5.4, 8.6)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2018

NDC No.00006-5368-06 0006-5368-06 UPC/GTIN No..3-00065-36806-1 MPN 6803 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, Pharma
STEGLUJAN 15MG/100MG TAB
NDC No.00006-5368-06 0006-5368-06 UPC/GTIN No..3-00065-36806-1 MPN 6803 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, Pharma

STEGLUJAN 15MG/100MG TAB  Merck  Generic Name:
ERTUGLIFLOZIN/SITAGLIPTIN

Description:
STEGLUJAN TB 15-100MG 30UU 

NDC:
00006-5368-03 0006-5368-03 00006536803 0006536803 
UPC:
300065-36803
STEGLUJAN 15MG/100MG TAB
STEGLUJAN 15MG/100MG TAB Merck Generic Name: ERTUGLIFLOZIN/SITAGLIPTIN Description: STEGLUJAN TB 15-100MG 30UU NDC: 00006-5368-03 0006-5368-03 00006536803 0006536803 UPC: 300065-36803

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

STEGLUJAN 15MG/100MG TAB  Merck  Generic Name:
ERTUGLIFLOZIN/SITAGLIPTIN

Description:
STEGLUJAN TB 15-100MG 30UU 

NDC:
00006-5368-03 0006-5368-03 00006536803 0006536803 
UPC:
300065-36803
STEGLUJAN 15MG/100MG TAB
STEGLUJAN 15MG/100MG TAB Merck Generic Name: ERTUGLIFLOZIN/SITAGLIPTIN Description: STEGLUJAN TB 15-100MG 30UU NDC: 00006-5368-03 0006-5368-03 00006536803 0006536803 UPC: 300065-36803

STEGLUJAN 5MG/100MG TAB 30 Merck Generic Name:
ERTUGLIFLOZIN/SITAGLIPTIN

Description:
STEGLUJAN TB 5-100MG 30UU 
NDC:
00006-5367-03 0006-5367-03 00006536703 0006536703 
UPC:
300065-367033
STEGLUJAN 5MG/100MG TAB 30 Mer
STEGLUJAN 5MG/100MG TAB 30 Merck Generic Name: ERTUGLIFLOZIN/SITAGLIPTIN Description: STEGLUJAN TB 5-100MG 30UU NDC: 00006-5367-03 0006-5367-03 00006536703 0006536703 UPC: 300065-367033