VILDAGLUSE PLUS 50MG/1000MG 30TAB; metformin, vildagliptin, blood glucose regulators .
ACTIVE-INGREDIENT OF VILDAGLUSE PLUS 50MG/1000MG 30TAB
each film coated tablet of vildagluse plus 50/1000 mg contains ; 50 mg vildagliptin and 1000 mg metformin hydrochloride .
INDICATION OF VILDAGLUSE PLUS 50MG/1000MG 30TAB
for patients with type 2 diabetes mellitus ( T2DM ) : vildagluse plus is indicated as an adjunct to diet and exercise to improve glycaemic control in patients whose diabetes is not adequately controlled on metaformin alone or who are already treated with the combination of vidagliptin and metformin , as separate tablets . treatment should not be initiated with this fixed – dose combination . vildagluse plus is indicated in combination with a sulfonylurea ( i.e. triple combination therapy ) as an adjunct to diet and exercise in patients inadequately controlled with metformin and a sulfonylurea . vildagluse plus is indicated as add- on to insulin as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control .
DOSAGE OF VILDAGLUSE PLUS 50MG/1000MG 30TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
posology : LIFE THREATENING LACTIC ACIDOSIS CAN OCCUR DUE TO ACCUMULATION OF METFORMIN . THE MAIN RISK FACTOR IS RENAL IMPAIRMENT . OTHER RISK FACTORS INCLUDE OLD AGE ASSOCIATED WITH REDUCED RENAL FUNCTION AND HIGH DOSES OF METAFORMIN ABOVE 2 G PER DAY . to minimize the risk of lactic acidosis , only one strength of vildagluse plus should be prescribed and used at any one time . patients should also be advised to discard their previous metformin medication when initiated on vildagluse plus . adults : the use of antihyperglycaemic therapy in the managment of T2D should be individualized on the basis of effectiveness and tolerability . the recommended starting dose of vildagluse plus should be based on the patient’s current regimen of valdagliptin and /or metformin . vildagluse plus should be given with meals to reduce the gastrointestinal side effects associated with metformin . when using vildagluse plus , the maximum daily dose of vildagliptin ( 100 mg ) should not exceeded . starting dose for patients inadequately controlled on metformin monotherapy : based on the patient’s current dose of metformin , vildagluse plus may be intiated at either the 50 mg /500 , 50 mg /850 mg or 50 mg/1000 mg tablet strength twice daily . starting dose patients switching from combination therapy of vidagliptin plus metformin as separated tablets : vildagluse plus may be initiated with with may be initiated with either the 50 mg/500 mg . 50 mg /850 mg or 1000 mg tablets strength based on the dose of vildagliptin or metformin already beging taken . use in combination with as sulfony lurea or with insulin : the dose of vildagluse plus 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 being taken . special populations : elderly : vildagluse plus treament should be initiated in patients ≥80 years of age ulless measurement of creatine clearance demonstrates that renal renal function is not reduced . renal impairment : vildaglipptin : no dosage adjustment is required in patients with mid renal impairment . the use of vildagliptin is not recommended in patients with moderate or severe renal impairment or in patients with ESRD on haemodialysis . metformin : in patients with decreased renal function ( based on measured creatinine clearance ) , the plasma and blood half-life of metformin is prolonged and renal clearance is decreased in proportion to the decrease in creatinine clearance . hepatic impairment :; vildagliptin is not recommended in patients with hepatic impairment including patients with pre-treatment ALT or AST > 2.5 x the upper limit of normal . metformin : no pharmacokinetic studies of metformin have been conducted in subjects with hepatic insufficiency . padiatric population : the safety and effectiveness of vildagluse plus in paediatric patients have not been established . therefore , vildagluse plus is not recommended for use in children below 18 years of age . method of administration : oral use : taking vildagluse plus with or just after food may reduced gastrointestinal symptoms associated with metformin .
OVER-DOSAGE OF VILDAGLUSE PLUS 50MG/1000MG 30TAB
CONTRA-INDICATION OF VILDAGLUSE PLUS 50MG/1000MG 30TAB
hypersensitivity : vildaglus is contraindicated in patients with renal disease or renal dysfunction ( e.g, as suggested by serum creatinine levels >/= 1.5 mg/dl (> 135 µmol /l ) in males and >/= 1.4 mg/dl (> 110 µmol ) in females or abdominal creatinine cleartance ) , which may also result from conditions such as cardiovascular collapse ( shock ) , acute myocardial , and septicaemia . congestive heart failure : vildagluse plus is contraindicated in patients with congestive heart failure requiring pharmacologic treatment . metabolic acidosis : vildagluse plus is contraindicated in patients with acute or chronic metabolic acidosis , including diabetic ketoacidosis , with or without coma , diabetic ketoacidosis should be treated with insulin . radiologic studies : vildagluse plus should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast meterials , because use of such products may result in acute alteration of renal function .
STORAGE OF VILDAGLUSE PLUS 50MG/1000MG 30TAB
store at a temperature not exceeding 30 C , in a dry place . Store in the original package in order to protect from moisure . Keep out of reach of children .
PACK OF VILDAGLUSE PLUS 50MG/1000MG 30TAB
carton box containing 1,2 or 3 9AL/AL) blister contains 10 film coated tablets and an inner leaflet .
VILDAGLUSE PLUS 50MG/1000MG 30TAB MANUFACTURED BY
DBK for pharmaceutical industries (DBK PHARMA) .
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