Aptin tablet: Each tablet contains Vildagliptin INN 50 mg.
Aptin is a preparation of Vildagliptin. Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidylpeptidase-4 (DPP-4) inhibitor that improves glycemic control. Vildagliptin inhibition of DPP-4 results in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
Route of administration : Aptin is taken in oral route. II can be taken with or without meals. The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided doses of 50 mg given in the morning and evening. If a dose of Aptin is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
The recommended dose of Aptin is 50 mg once or twice daily. The maximum daily dose of Aptin is 100 mg.
For monotherapy and for combination with metformin or with a thiazolidinedione (TZD), the recommended dose of Aptin is 50 mg or 100 mg daily.
The recommended dose of Aptin is 100 mg daily in combination with insulin (with or without metformin).
When used in dual combination with a sulfonylurea (SU), the recommended dose of vildagliptin is 50 mg once daily.
For triple combination with metformin and a SU, the recommended dose of Aptin is 100 mg daily. When used in combination with a sulfonylurea, a lower dose of the sulfonylurea may be considered to reduce the risk of hypoglycaemia.
Renal impairment : No dose adjustment of Aptin is required in patients with mild renal impairment (creatinine clearance .:: 50 ml/min). In patients with moderate or severe renal impairment or End Stage Renal Disease (ESRD) on haemodialysis, the recommended dose of Aptin is 50 mg once daily.
Hepatic impairment : Aptin is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5x the upper limit of normal (ULN).
Sulfonylureas and insulin increase the risk of hypoglycemia (dose reduction may be warranted); ACE inhibitors may increase risk of angioedema; thiazides, corticosteroids, and sympathomimetics may attenuate glycemic control.
Vildagliptin is contraindicated in patients with known hypersensitivity to vildagliptin or any other components of this product.
Common: Dizziness, headache, constipation, arthralgia, hypoglycemia, upper respiratory tract infection, nasopharyngitis, peripheral edema, tremor, fatigue, nausea, asthenia, weight increase, GERD, diarrhea, flatulence, chills, hyperhidrosis.
Overdose
In the event of an overdose, supportive management is recommended. Vildagliptin cannot be removed by haemodialysis. However, the major hydrolysis metabolite (LAY151) can be removed by haemodialysis.
Category C. Not recommended during pregnancy unless benefit outweighs potential fetal risk. Lactation: Excretion in human milk unknown; avoid use in breastfeeding women.
Store below 25°C in a cool, dry place. Protect from light and moisture. Keep out of the reach of children.