Sitagliptin
Brand names: JANUMET, JANUVIA, JUVISYNC, STEGLUJAN, Sitagliptin Phosphate/Metformin Hydrochloride, ZITUVIO, Sitagliptin
Warnings
Pancreatitis - "postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis"; Heart Failure - association observed with DPP-4 inhibitors in cardiovascular trials; Acute Renal Failure - "postmarketing reports of worsening renal function, including acute renal failure"; Hypoglycemia risk increased when combined with insulin or insulin secretagogues; Hypersensitivity Reactions including anaphylaxis, angioedema, Stevens-Johnson syndrome; Arthralgia - severe joint pain reported with DPP-4 inhibitors; Bullous Pemphigoid, a blistering condition requiring hospitalization.
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 )
Overdose
10 OVERDOSAGE In the event of an overdose with JANUVIA, contact the Poison Control Center. In the event of an overdose, it is reasonable to employ supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy as dictated by the patient's clinical status. Sitagliptin is modestly dialyzable. In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
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) .]
Uses
"JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus." Not for type 1 diabetes or patients with pancreatitis history.
Dosage forms & strengths
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 with end-stage renal disease (ESRD) 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.
All identified pills
112
BROWN ROUND · Sitagliptin
112
BROWN ROUND · Sitagliptin
8 manufacturers
221
PINK ROUND · Sitagliptin
3 manufacturers
227
BROWN ROUND · Sitagliptin
277
BROWN ROUND · Sitagliptin
9 manufacturers
515
PINK OVAL · Sitagliptin
533
RED OVAL · Sitagliptin
535
ORANGE OVAL · Sitagliptin
537
RED OVAL · Sitagliptin
554
BROWN OVAL · Sitagliptin
555
BROWN OVAL · Sitagliptin
575
PINK OVAL · Sitagliptin
575
PINK OVAL · Sitagliptin
2 manufacturers
577
RED OVAL · Sitagliptin
577
RED OVAL · Sitagliptin
2 manufacturers
753
PINK ROUND · Sitagliptin
757
PINK OVAL · Sitagliptin
773
ORANGE OVAL · Sitagliptin
78
BLUE OVAL · Sitagliptin
80
GREEN OVAL · Sitagliptin
81
BLUE OVAL · Sitagliptin
Side effects
Reactions occurring in >=5% of patients and more common than placebo: "upper respiratory tract infection, nasopharyngitis and headache." Hypoglycemia more common when combined with sulfonylureas or insulin.