BRAND NAME: SB-Vilda

GENERIC NAME: Vildagliptin INN

STRENGTH: 50 mg

COMPOSITION

SB-Vilda 50 Tablet: Each Tablet contains Vildagliptin INN 50 mg.

INDICATIONS

SB-Vilda 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.

DOSAGE AND ADMINISTRATION

The recommended dose of SB-Vilda is

• 50 mg or 100 mg daily for monotherapy.
• 50 mg twice daily (morning and evening) when used in dual combination with Metformin or a Thiazolidinedione;
• 50 mg once daily in the morning when used in dual combination with a Sulphonylurea.

SB-Vilda may be taken with or without a meal. No dosage adjustment is required in the elderly, or in patients with mild renal impairment.

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.

CONTRAINDICATIONS

Vildagliptin is contraindicated in patients with:

• Hypersensitivity to the active substance or to any of the excipients
• Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis

ADVERSE 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

There are no adequate data on the use of Vildagliptin in pregnant women; hence the potential risk for human is unknown.It is not known whether Vildagliptin is excreted in human milk. Due to lack of human data, Vildagliptin should not be used during lactation.

Pregnancy Category: C

PACKAGING

SB-Vilda 50 Tablet: Each box contains 20 Tablets in Alu-Alu blister pack.