BRAND NAME: SB-SITA

GENERIC NAME WITH SPECIFICATION: Sitagliptin Phosphate Monohydrate USP

STRENGTH: 50 mg & 100 mg

COMPOSITION:

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.

INDICATION:

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

glycemic control.

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.

PEDIATRIC USE:

Safety and effectiveness of Sitagliptin in pediatric patients under 18 years of age have not been established.

GERIATRIC USE:

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.

SIDE EFFECTS:

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.

CONTRAINDICATIONS:

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.

AVAILABLE PACKAGING:

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.

PRICE :

SB-SITA 50 mg MRP 300 TK

SB-SITA 100 mg MRP 560 TK