Uses of Zomelis 50 tablet (Vildagliptin)

Zomelis 50 mg

Composition of  :

Vildagliptin IP. ...................... 50 mg
Excipients ......................... Q.S

INDICATIONS 

Zomelis is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM).

as monotherapy 
in dual combination

• with metformin, when diet, exercise and metformin alone do not result in adequate glycemic control.
• with a sulfonylurea (SU), when diet, exercise and a SU alone do not result in adequate glycemic control.
• with a thiazolidinedione (TZD) when diet, exercise and a TZD do not result in adequate glycemic control.

in triple combination

• with a sulfonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycemic control.

Zomelis is also indicated in combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycemic control.

Zomelis is also indicated as initial combination therapy with metformin in patients with T2DM whose diabetes is not adequately controlled by diet and exercise alone.

DOSAGE REGIMEN AND ADMINISTRATION
Dosage Regimen
The management of antidiabetic therapy should be individualized. The recommended dose of Zomelis is 50 mg once or twice daily.

The maximum daily dose of zomelis is 100 mg.

For monotherapy, and for combination with metformin, with a TZD or with insulin (with or without metformin), the recommended dose of Zomelis is 50 mg or 100 mg daily. When use in dual combination with a sulfonylurea, the recommended dose of vildagliptin is 50 mg once daily. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.

For triple combination with metformin and a SU, the recommended dose of Zomelis is 100 mg daily.

If tighter glycemic control is required on the top of the maximum recommended daily dose of vildagliptin, the addition of other anti diabetic drugs such as metformin, an SU, a TZD or insulin may be considered.

Special populations
Renal Impairments
No dosage adjustment of Zomelis is required in patients with mild renal impairment. In patients with moderate or severe renal impairment or End stage renal disease (ESRD), the recommended of zomelis 50 mg once daily.

Hepatic Impairment 
Zomelis 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).

Hepatic enzyme monitoring 
Rase cases of hepatic dysfunction (including hepatitis) have been reported. In these cases, the patients were generally asymptomatic without clinical sequelae and liver function teste (LFTs) returned to normal after discontinuation of treatment. LFTs should be performed prior to the initiation of treatment with zomelis. LFTs should be monitored during Zomelis treatment at three month intervals during the first year and periodically thereafter. Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormally (ies) return to normal. Should an increased in AST or ALT of 3x ULN or greater persist, withdrawal of therapy with zomelis is recommended. Patients who develop jaundice or other signs suggestive of live dysfunction should discontinue zomelis and contact their physician immediately. Following withdrawal of treatment with zomelis and LFT normalization, vildagliptin treatment should not be reinitiated.