DESCRIPTION
COMPOSITION
Vildos INDICATIONS
Vildos is indicated as an adjunct to diet and exercise to enhance glycemic control in patients with type 2 diabetes.
It are often given as monotherapy, in dual combination with metformin, a sulphonylurea (SU), a thiazolidinedione (TZD) or insulin when diet.
exercise and one antidiabetic agent don't lead to adequate glycemic control.
Vildos DOSAGE AND ADMINISTRATION
The management of antidiabetic therapy should be individualized.
The recommended dose of Vildos is 50mg or 100mg daily for monotherapy and in dual combination with metformin, a TZD or insulin.
The 50mg dose should be administered once daily within the morning. The 100mg dose should be administered as two divided doses of 50mg given within the morning and evening.
When employed in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50mg once daily administered within the morning. during this patient population, vildagliptin 100mg daily was no more practical than vildagliptin 50mg once daily. If tighter glycemic control is required on the highest of the utmost recommended daily dose of vildagliptin, the addition of other antidiabetic drugs like metformin, an SU, a TZD or insulin is also considered.
Patients with hepatic or renal impairment Vildos isn't recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST >2.5 times the upper limit of normal.
No dosage adjustment of Vildos is required in patients with mild renal impairmenit. However, Vildos isn't recommended in patients with moderate or severe renal impairment or End Stage Renal Disease (ESRD) on hemodialysis (see also sections.
SPECIAL WARNINGS AND PRECAUTIONS
Elderly patients
In patients treated with Vildos >65 years old and >75 vears old, no differences were observed within the overall safety, tolerability or efficacy between this elderly population and younger patients.
No dosage adjustments are therefore necessary within the elderly patients (see also section PHARMACOKINETICS under Special Populations).
Pediatric patients
Vildos has not been studied in patients under 18 years of age; therefore, the employment of Viidos in pediatric patients isn't recommended (see also section PHARMACOKINETICS under Special Populations).
SPECIAL WARNINGS AND PRECAUTIONS
Vildos isn't a substitute for insulin in insulin-requiring patients.
Vildos is contraindicated in patients with known hypersensitivity to Vildagliptin or to any 50 vildos mg Tablets (Vildagliptin) Vildos mustn't be utilized in patients with lype 1 diabetes or for the treatment of diabetic ketoacidosis.
INTERACTIONS
Vildagliptin encompasses a low potential for drug interactions, Since vildagliptin isn't a cytochrome P450 (CYP) enzyme substrate nor does it inhibit neither induces CYP 450 enzymes, it's not going to interact with co-medications that are substrates, inhibitors or inducers of those enzymes.
Drug Interaction Studies Were conducted wÃth commonly co-prescribed Medication for Patient with type-2 Diabete or Medication with A Narrow Therapeutic Window. As a results of these studies no clinically relevant interactions with other oral antidiabetics glibenciamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin.
Vildos during PREGNANCY AND LACTATION
Fertility studies are performed in rats at doses up to 200 times the human dose and revelad no evidence of fertility or early embryonic development because of vildagliptin.
WARNINGS AND PRECAUTIONS FOR USE.
Elderly In otherwise healthy elderly subject (>70 years), the exposure to Vildagliptin (100mg once daily) was increased by 32% with 18% increased in peak plasma concentration compared to younger healthy subjects (18 to 40 years).
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