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Metvildazone 50 mg/1000 mg

Dietary supplements
Product

Metvildazone 50 mg/1000 mg film-coated tablets

Active

Ferrous fumarate (73 mg eq. to 24 mg of elemental iron) / Zinc sulfate H2O (27.4 mg eq. to 10 mg of elemental Zinc) / Copper Sulfate 5H2O (2.5 mg Eq.

amlodipine (10) / olmesartan medoxomil (40) / Hydrochlorothiazide (12.5)

to 0.9mg of elemental Copper) / Vitamin B6 (2 mg) / Folic acid (0.5 mg) /           Vitamin B12 (0.002 mg)

Category
Dietary supplements
Indication

Metvildazone is indicated in the treatment of type 2 diabetes mellitus

-Metvildazone is indicated in the treatment of adult patients who are unable to achieve sufficient glycemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.

-Metvildazone is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.

-Metvildazone is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycemic control.

Dose

Adults with normal renal function (GFR ≥ 90 ml/min)

The dose of antihyperglycemic therapy with metvildazoneshould be individualised on the basis of the patient’s current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin. metvildazone may be initiated at either the 50 mg/850 mg or 50 mg/1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.

  • For patients inadequately controlled at their maximal tolerated dose of metformin monotherapy:

The starting dose of metvildazone should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.

  • For patients switching from co-administration of vildagliptin and metformin as separate tablets: metvildazone should be initiated at the dose of vildagliptin and metformin already being taken.
  • For patients inadequately controlled on dual combination with metformin and a sulphonylurea:

The doses of metvildazone should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When metvildazone is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of Hypoglycemia.

  • For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin:

The dose of metvildazone should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.

The safety and efficacy of vildagliptin and metformin as triple oral therapy in combination with a thiazolidinedione have not been established.

Special populations Elderly (≥ 65 years)

As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients

taking metvildazone should have their renal function monitored regularly (see Special warnings and precautions for use and Pharmacokinetic properties).

Renal impairment

A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.

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The maximum daily dose of metformin should preferably to be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis (see Special warnings and precautions for use) should be reviewed before considering initiation of metformin in patients with GFR<60 ml/min.

If no adequate strength of metvildazone is available, individual monocomponents should be used instead of the fixed dose combination.

 

  GFR ml/min   Metformin   Vildagliptin
  60-89   Maximum daily dose is 3000 mg.

Dose reduction may be considered in   rRelation to declining renal function.

No dose adjustment.
  45-59   Maximum daily dose is 2000 mg.

The starting dose is at most half of  the  maximum dose.

   Maximal daily dose is 50 mg.
  30-44   Maximum daily dose is 1000 mg.

The starting dose is at most half of  the maximum dose.

  <30   Metformin is contraindicated.

Hepatic impairment

Metvildazoneshould not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see Contraindications, Special warnings and precautions for use and Undesirable effects).

Pediatric population

Metvildazoneis not recommended for use in children and adolescents (< 18 years). The safety and efficacy of metvildazonein children and adolescents (< 18 years) have not been established. No data are available.