Dayvus 50

White, round, flat tablet, beveled on both sides with engraved 50 on one side and plain on the other.
Each tablet contains Vildagliptin 50 mg.

Pharmacology: Pharmacodynamics: Vildagliptin is a complete dipeptidyl peptidase (DPP)-4 inhibitor; which results in increased postprandial and fasting endogenous levels of the incretins glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) from gut and intestine. Increased levels of these hormones improves glucose-dependent insulin secretion (pancreas secretes insulin when blood sugar is too high after food consumption). However, these hormones are rapidly degraded by the proteolytic enzyme DPP-4. Inhibition of DPP-4 enzyme resulting in prolonged serum level and activity of GLP-1 and GIP; thereby facilitating insulin secretion and decreasing glucagon secretion in type 2 diabetes mellitus.
Pharmacokinetics: Time to peak concentration: 1.7 hours.
Bioavailability: 85%. Concomitant intake of food does not influence the oral bioavailability.
Protein binding: 9.3%.
V_d: 71 L.
Metabolism: Possible hydrolysis via kidneys and dipeptidyl peptidase-4. Not metabolized via CYP450 enzymes.
Excretion: Renal: 85% (major route of elimination), 23% unchanged, fecal: 15%.
Elimination half-life: 3 hours.

Dayvus 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 sulfonylurea (SU), when diet, exercise and SU alone do not result in adequate glycemic control, with a thiazolidinedione (TZD) when diet, exercise and TZD alone 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.
Dayvus 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.
Dayvus is also indicated as initial combination therapy with metformin in patients with T2DM whose diabetes is not adequately controlled by diet and exercise alone.

Adult: Vildagliptin may take with or without food.
Monotherapy or combination (dual therapy) with metformin or thiazolidinedione or insulin (with or without metformin): 50 mg orally once daily in the morning or twice daily in the morning and evening.
Triple therapy in combination with a sulfonylurea and metformin: 50 mg orally twice daily in the morning and evening.
When using dual combination with a sulfonylurea: 50 mg once daily in morning.
If tighter glycemic control is required on the top of the maximum recommended daily dose of vildagliptin, the addition of other antidiabetic drugs such as metformin, SU, TZD or insulin may be considered.
Dose adjustment: Renal impairment: mild (CrCl ≥50 mL/min): no dose adjustment necessary.
Renal impairment: moderate to severe or ESRD: Initial 50 mg orally once daily (maximum 50 mg per day).
Hepatic impairment including patients with a pre-treatment ALT or AST >2.5x the upper limit of normal: use not recommended.
Geriatric (65 years or older): no dose adjustment is necessary.

Mild to moderate toxicity: Limited data. Clinical events may be similar to effects reported with therapeutic use.
Severe toxicity: Has not been reported.
Management of mild to moderate toxicity: Treatment is symptomatic and supportive. Monitor for symptoms of hypoglycemia (diaphoresis, palpitations, tremor, and change in mentation). Treat significant fluid loss with IV fluids; antidiarrheal agents as indicated.
Management of severe toxicity: Limited data. Treatment is symptomatic and supportive treat with dextrose as necessary. Monitor for neurologic symptoms in patients with hypoglycemia.
Decontamination: Emesis is not indicated. Activated charcoal may be considered following a significant ingestion if the airway is protected.

Hypersensitivity to vildagliptin or to any component of the product.
Ketoacidosis.

Based on the notification of the Ministry of Public Health: Do not use the drug in patients who are hypersensitive to vildagliptin.
Do not use the drug in type 1 diabetes mellitus, ketoacidosis, severe infection and severe injury.
Avoid using the drug in pregnancy. Be cautious in breast-feeding women.
Should not use the drug with alcohol.
This drug may increase the risk of severe joint pain.

Type 1 diabetes; not recommended.
Diabetic ketoacidosis; not recommended.
Galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; use not recommended, as product contains lactose.
Use is not recommend in patients with preexisting hepatic impairment, including patients with a pre-treatment ALT or AST >2.5x the upper limit of normal.
Hepatic dysfunction (e.g., hepatitis) has been reported; monitoring recommended and discontinuation may be necessary.
Discontinue therapy if ALT or AST is persistently >3 times the upper limit of normal or if jaundice or other signs of hepatic dysfunction occur. Do not reinitiate therapy, even after hepatic function normalizes.
Renal: Moderate or severe renal (CrCl <50 mL/min), or ESRD; dosage adjustment necessary.
Use in Children: Safety and efficacy not established in pediatric patients younger than 18 years.

Vildagliptin should not be used in pregnant women, weigh the potential benefits of drug treatment against potential risks before prescribing this drug during pregnancy.
It is not known if vildagliptin is excreted in breast milk, avoid using in breast-feeding women.

Neurologic: Dizziness, headache, nausea, tremor.
Respiratory: Nasopharyngitis, upper respiratory tract infection.
Gastrointestinal: Acute pancreatitis, constipation, hepatic dysfunction.
Musculoskeletal: Arthralgia, peripheral oedema, asthenia.
Hematologic: Hypoglycemia.
Dermatologic: Hyperhidrosis, skin lesions (exfoliative and bullous pemphigoid).

Not metabolize via CYP 450 enzymes and it is not likely to interact with co-mediations, inhibitors or inducers of these enzymes.
Concurrent use of antidiabetic agents and somatostatin analogues may result in impaired glucose regulation.
Concurrent use of fluoroquinolones and antidiabetic agents may result in changes in blood glucose and increased risk of hypoglycemia or hyperglycemia.
Concurrent use of hydroxychloroquine or chloroquine and antidiabetic agents may result in hypoglycemia.
Concurrent use of thioctic acid and antidiabetic agents may result in increased risk of hypoglycemia.
Concurrent use of antidiabetic agents and beta-adrenergic blockers may result in hypoglycemia or hyperglycemia; decreased symptoms of hypoglycemia.

Store at below 30°C.

Antidiabetic Agents

A10BH02 - vildagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

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