Sitagliptin Phosphate Monohydrate USP
Antidiabetic (DPP-4 Inhibitor)
BRAND NAME: SB-SITA
GENERIC NAME WITH SPECIFICATION: Sitagliptin Phosphate Monohydrate USP
STRENGTH: 50 mg & 100 mg
SB-Sita 50 Tablet : Each Film Coated Tablet contains Sitagliptin Phosphate Monohydrate USP equivalent
to Sitagliptin 50 mg.
SB-Sita 100 Tablet : Each Film Coated Tablet contains Sitagliptin Phosphate Monohydrate USP equivalent to
Sitagliptin 100 mg.
SB-Sita is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes
mellitus. SB-Sita is indicated as monotherapy and also indicated for use in combination with Metformin,
Sulfonylurea or Thiazolidinediones when diet and exercise plus the single agent does not result in adequate
DOSAGE & ADMINISTRATION:
- The recommended dose of SB-Sita is 100 mg once daily. SB-Sita can be taken with or without food.
- For patients with mild renal insufficiency (creatinine clearance [CrCI]>50ml/min), no dosage adjustment is required.
- For patients with moderate renal insufficiency ( CrCI>30 to <50 ml/min ), the dose of SB-Sita is 50 mg once daily.
- For patients with severe renal insufficiency (CrCI<30 ml/min) or with end-stage renal disease (ESRD)
requiring hemodialysis or peritoneal dialysis, the dose of SB-Sita is 25 mg once daily.
Safety and effectiveness of Sitagliptin in pediatric patients under 18 years of age have not been established.
No overall differences in safety or effectiveness were observed between subjects over 65 years. The drug is
excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should
be taken in dose selection in the elderly.
Adverse reactions like upper respiratory tract infection, nasopharyngitis, and headache can occur. Hypoglyce-
mia occurs in patients treated with the combination of Sitagliptin and Sulfonylurea, with or without Metformin.
Hypersensitivity reactions such as anaphylaxis, angioedema, and exfoliative skin conditions including
Stevens-Johnson syndrome can occur.
USE IN PREGNANCY & LACTATION:
Pregnancy: Pregnancy Category B. Safety of Sitagliptin in pregnant women has not been established.
Sitagliptin should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.
Nursing Mothers: It is not known whether Sitagliptin is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when Sitagliptin is administered to a nursing woman.
SB-Sita 50 Tablet : : Each box contains 20 film coated Tablets in Alu-Alu blister pack.
SB-Sita 100 Tablet : Each box contains 20 film coated Tablets in Alu-Alu blister pack.
SB-SITA 50 mg MRP 300 TK
SB-SITA 100 mg MRP 560 TK