Aptin^®

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).

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Aptin is indicated as an adjunct to diet and exercise to improve glycemic control in
patients with type 2 diabetes mellitus (T2DM):
• As monotherapy
• Initial combination with metformin when diabetes is not adequately controlled by diet and exercise alone
• In combination with other medicinal products, including insulin, when these do not provide adequate glycaemic control

Important limitations of use: Aptin 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.

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).

Pregnancy: Vildagliptin should not be used during pregnancy unless the benefit to the
mother outweighs the potential risk to the fetus.
Lactation: As it is not known whether vildagliptin is excreted in human milk, vildagliptin
should not be administered to breastfeeding women.

Use in children and adolescents
The use of vildagliptin is not recommended for use in children below 18 years.

Liver function tests (LFTs) should be performed prior to the initiation of treatment with vildagliptin. LFTs should be monitored during vildagliptin treatment at three-month intervals during the first year and periodically thereafter. There have been spontaneously reported adverse reactions of acute pancreatitis. There have been reports of severe and disabling
arthralgia in patients taking DPP-4 inhibitors. Patients receiving vildagliptin in combination with a sulfonylurea may be at risk for hypoglycaemia.

Use of vildagliptin as monotherapy or part of a combination therapy with metformin, sulfonylurea, thiazolidinedione and insulin may result in possible side effects like dizziness, headache, constipation, arthralgia, hypoglycaemia, upper respiratory tract infection, nasopharyngitis, peripheral oedema, tremor, fatigue, nausea, asthenia, weight increase, gastrooesophageal reflux disease, diarrhoea, flatulence, chills and hyperhidrosis.

Vildagliptin is contraindicated in patients with known hypersensitivity to vildagliptin or any other components of this product.

Drug interaction with medication: No clinically relevant interactions with other oral anlidiabelics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin.
Drug interaction with food and others: Not applicable.

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.

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Store in a cool (below 25°C) & dry place. Protect from light. Keep out of the reach of children.

Aptin tablet: Each tablet contains Vildagliptin INN 50 mg.

Storage
Store in a cool (below 25°C) and dry place protected from light. Keep away from the
reach of children.

Packing
Aptin tablet: Carton of 30 tablets in blister pack.