- Approval Id
- d1ded5a19e453239
- Drug Name
- JANUVIA™ 50 MG TABLET
- Product Name
- JANUVIA™ 50 MG TABLET
- Approval Number
- SIN13258P
- Approval Date
- 2007-04-23
- Registrant
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Licence Holder
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Recommended Dosing</strong><br>
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.</p>
<p><strong>2.2 Patients with Renal Impairment</strong><br>
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter.</p>
<p>For patients with mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m<sup>2</sup> to < 90 mL/min/1.73 m<sup>2</sup>), no dosage adjustment for JANUVIA is required.</p>
<p>For patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m<sup>2</sup> to < 60 mL/min/1.73 m<sup>2</sup>), no dosage adjustment for JANUVIA is required.</p>
<p>For patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m<sup>2</sup> to < 45 mL/min/1.73 m<sup>2</sup>), the dose of JANUVIA is 50 mg once daily.</p>
<p>For patients with severe renal impairment (eGFR ≥ 15 mL/min/1.73 m<sup>2</sup> to < 30 mL/min/1.73 m<sup>2</sup>) or with end-stage renal disease (ESRD) (eGFR < 15 mL/min/1.73 m<sup>2</sup>), including those requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.</p>
<p><strong>2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin</strong><br>
When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. <em>[See Warnings and Precautions (5.3) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.]</em></p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p><strong>1.1 Monotherapy</strong><br>
JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.</p>
<p><strong>1.2 Combination with Metformin</strong><br>
JANUVIA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycemic control.</p>
<p><strong>1.3 Combination with a Sulfonylurea</strong><br>
JANUVIA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control.</p>
<p><strong>1.4 Combination with a PPARγ agonist</strong><br>
JANUVIA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with a PPARγ agonist (e.g., thiazolidinediones) when the single agent alone, with diet and exercise, does not provide adequate glycemic control.</p>
<p><strong>1.5 Combination with Metformin and a Sulfonylurea</strong><br>
JANUVIA is indicated in patients with type 2 diabetes mellitus to improve glycemic control in combination with metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control.</p>
<p><strong>1.6 Combination with Insulin</strong><br>
JANUVIA is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycemic control.</p>
<p><strong>1.7 Important Limitations of Use</strong><br>
JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.</p>
<p>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. <em>[See Warnings and Precautions (5.1) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.]</em></p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. <em>[See Warnings and Precautions (5.4); Adverse Reactions (6.2) – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.]</em></p>
- Atc Code
- A10BH01
- Atc Item Name
- sitagliptin
- Pharma Manufacturer Name
- MSD PHARMA (SINGAPORE) PTE. LTD.
