Aptin Tablet View larger

Aptin Tablet

132

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Vildagliptin
50 mg
ACI Limited

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Indications

Vildagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
  • As monotherapy
  • In dual combination with Metformin, a Sulphonylurea, a Thiazolidinedione, or Insulin when diet, exercise and a single antidiabetic agent do not result in adequate glycemic control.

Therapeutic Class

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Side Effects

The majority of adverse reactions were mild and transient, not requiring treatment discontinuations. Rare case of hepatic dysfunction is seen. Clinical trials of up to and more than 2 years’ duration did not show any additional safety signals or unforeseen risks when use this drug.

Pregnancy & Lactation

Pregnancy: There are no adequate data on the use of Vildagliptin in pregnant women; hence the potential risk for human is unknown.

Lactation: It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Vildagliptin should not be used during lactation.

Precautions & Warnings

Caution should be exercised in patients aged 75 years and older due to limited clinical experience. It is recommended that Liver Function Tests (LFTs) are monitored prior to initiation of Vildagliptin, at three monthly intervals in the first year and periodically thereafter. If transaminase levels are increased, patients should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality (ies) return(s) to normal. If AST or ALT persist at 3 x ULN, Vildagliptin treatment should be stopped. Patients who develop jaundice or other signs of liver dysfunction should discontinue Vildagliptin. Following withdrawal of treatment with Vildagliptin and LFT normalization, treatment with Vildagliptin should not be reinitiated. Due to limited clinical experience, use with caution in patients with congestive heart failure of New York Heart Association (NYHA) functional class I–II, and do not use in patients with NYHA functional class III-IV. Vildagliptin is not recommended in patients with moderate to severe renal impairment.