Drugplain

JANUVIA 50 mg/1

sitagliptin · TABLET, FILM COATED · Merck Sharp & Dohme LLC

No Recall History
Plain English

JANUVIA is a tablet, film coated containing sitagliptin at 50 mg/1, taken oral. Manufactured by Merck Sharp & Dohme LLC.

Key Facts

Brand Name
JANUVIA
Generic Name
sitagliptin
NDC Code (Product)
0006-0112
Manufacturer
Merck Sharp & Dohme LLC
Strength
50 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA021995
Marketing Start
10/16/2006

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

blood glucose increased4,473 reports
nausea3,853 reports
diarrhoea3,528 reports
drug ineffective3,487 reports
fatigue2,933 reports
headache2,538 reports
dizziness2,455 reports
vomiting2,377 reports
dyspnoea2,360 reports
pancreatitis2,214 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE JANUVIA ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA is 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. ( 1 ) Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes ( 1 ) JANUVIA has not been studied in patients with a history of pancreatitis. ( 1 , 5.1 ) Limitations of Use JANUVIA should not be used in patients with type 1 diabetes. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUVIA. [See Warnings and Precautions (5.1) .]

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. ( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2 . ( 2.2 ) Dosage Adjustment in Patients with Renal Impairment ( 2.2 ) eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 eGFR less than 30 mL/min/1.73 m 2 (including patients with end stage renal disease [ESRD] on dialysis) 50 mg once daily 25 mg once daily 2.1 Recommended Dosing The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of JANUVIA and periodically thereafter. For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m 2 to less than 90 mL/min/1.73 m 2 , no dosage adjustment for JANUVIA is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 ), the dose of JANUVIA is 50 mg once daily. For patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) or wit…

Contraindications

4 CONTRAINDICATIONS History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions (5.5) ; Adverse Reactions (6.2) .] History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema ( 5.5 , 6.2 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Insulin Secretagogues or Insulin Coadministration of JANUVIA with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.4) .]

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Acute Renal Failure [see Warnings and Precautions (5.3) ] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.6) ] Bullous Pemphigoid [see Warnings and Precautions (5.7) ] Adverse reactions reported in ≥5% of patients treated with JANUVIA and more commonly than in patients treated with placebo are: 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 JANUVIA compared to placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in th…

Frequently Asked Questions

What is JANUVIA used for?

JANUVIA contains sitagliptin. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is JANUVIA a controlled substance?

JANUVIA is not classified as a controlled substance by the DEA.

What is the generic name for JANUVIA?

The generic name for JANUVIA is sitagliptin. There are 10 other brand versions of sitagliptin.

What is the NDC code for JANUVIA 50 mg/1?

The NDC (National Drug Code) for JANUVIA 50 mg/1 is 0006-0112, listed by Merck Sharp & Dohme LLC.

Product NDC

0006-0112

Package NDC

0006-0112-28

Other Sitagliptin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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