GALVUSMET
Galvus Met 50mg/500mg 1 Tablet
₱33.00
- SKU:
- 018566
- Generic Name:
- Vildagliptin + Metformin
Galvus Met 50mg/500mg 1 Tablet
₱33.00
| Generic Name | Vildagliptin + Metformin Hydrochloride |
| Strength | 50 mg/500 mg |
| Indication/Usage | Galvus Met® is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control: • as initial therapy when diabetes is not adequately controlled by diet and exercise alone • as therapy in patients inadequately controlled with metformin hydrochloride or vildagliptin alone or who are already treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets • as combination therapy- in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycemic control |
| Dosage and Administration | Dosage Regimen The use of antihyperglycemic therapy in the management of type 2 diabetes should be individualized on the basis of effectiveness and tolerability. Do not exceed the maximum daily dose of vildagliptin (100 mg). The recommended starting dose should be based on the patient’s condition and/or current regimen of vildagliptin and/or metformin hydrochloride. Starting dose for patients inadequately controlled on vildagliptin monotherapy Based on the usual starting doses of metformin hydrochloride (500 mg twice daily or 850 mg once daily), initiate treatment at the 50 mg/500 mg tablet strength twice daily and gradually titrated after assessing the adequacy of therapeutic response. Starting dose for patients inadequately controlled on metformin hydrochloride monotherapy Based on the patient’s current dose of metformin hydrochloride, initiate treatment at either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1,000 mg tablet strength twice daily. Starting dose for patients switching from combination therapy of vildagliptin plus metformin hydrochloride as separate tablets Treatment may be initiated with either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1,000 mg tablet strength based on the dose of vildagliptin or metformin already being taken. Starting dose for treatment naïve patients In naïve patients, treatment may be initiated at 50 mg/500 mg once daily and gradually titrated to a maximum dose of 50mg/1000 mg twice daily after assessing the adequacy of therapeutic response. Use in combination with SU (sulfonylurea) or with insulin: The dose 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. Method of administration For oral use Administer with meals to reduce the gastrointestinal side effects associated with metformin hydrochloride. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. |
| Warning and Precautions | Vildagliptin/Metformin Not a substitute for insulin in patients requiring insulin. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Vildagliptin Patients with hepatic impairment Vildagliptin is not recommended in patients with hepatic impairment, including patients with pre- treatment ALT or AST >2.5x the ULN. Hepatic enzyme monitoring Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin. Vildagliptin+metformin (Galvus Met®) is not recommended in patients with hepatic impairment. Heart failure There is no experience of vildagliptin use in clinical studies in patients with NYHA functional class IV and therefore use is not recommended in these patients. Metformin Hydrochloride Lactic acidosis Interactions Concomitant medications that may affect renal function or metformin hydrochloride disposition, Administration of intravascular iodinated contrast materials, Hypoxic states, Surgical procedures, Alcohol intake, Patients with hepatic impairment, Vitamin B12 levels, Change in clinical status of patients with previously controlled type 2 diabetes, Hypoglycemia, Loss of control of blood glucose |
| Drug Interaction | Vildagliptin Vildagliptin has low potential for drug interactions. Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate nor does it inhibit or induce CYP 450 enzymes, it is not likely to interact with co-medications that are substrates, inhibitors or inducers of these enzymes. Metformin Hydrochloride The following is known about metformin: Furosemide Furosemide increased Cmax and blood AUC of metformin with no change in renal clearance of metformin. Metformin decreased Cmax, blood AUC of furosemide, with no change in renal clearance of furosemide. Nifedipine Nifedipine increased absorption, Cmax and AUC of metformin, and increased excretion of metformin in urine. Metformin had minimal effects on nifedipine. Glyburide Glyburide produced no changes in metformin PK/PD parameters. Decreases in Cmax, blood AUC of glyburide were observed, but were highly variable. Therefore the clinical significance of this finding was unclear. Iodinated contrast agents Metformin-containing products (such as vildagliptin+metformin (Galvus Met®)) must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable Drugs that reduce metformin clearance Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin. Other Some drugs can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics. When starting or using such products in combination with metformin-containing products (such vildagliptin+metformin (Galvus Met®), close monitoring of renal function is necessary. Certain drugs tend to cause hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. Close monitoring of glycemic control and metformin dose adjustments are recommended when such drugs are administered or withdrawn for these patients. There is an increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic impairment) due to metformin. Avoid consumption of alcohol and medicinal products containing alcohol. |
| Requires Prescription? (Yes or No) | Yes |
