ProglinMet Dosage/Direction for Use

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. Administer with meals to reduce the gastrointestinal side effects associated with 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 titrate 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, treatment may be initiated at either the 50 mg/500 mg, 50 mg/850 mg or 50 mg/1 g 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 of naïve patients: In naïve patients, treatment may be initiated at 50 mg/500 mg once daily and gradually titrated to a maximum dose of 50 mg/1 g 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.
General target population: Adults 18 years of age and above.
Special Populations: Renal impairment: A GFR should be assessed before initiation of treatment with metformin-containing products [such as vildagliptin + metformin (ProglinMet)] 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 to 6 months.
The maximum daily dose of metformin should preferably be divided into 2 to 3 daily doses. Factors that may increase the risk of lactic acidosis (see Precautions) should be reviewed before considering initiation of metformin-containing products [such as vildagliptin + metformin (ProglinMet)] in patients with GFR <60 mL/min. Vildagliptin + metformin (ProglinMet) is contraindicated in patients with GFR <30 mL/min because of its metformin component (see Contraindications).
The following dosing recommendations apply to metformin and vildagliptin, used separately or in combination, in patients with renal impairment. If no adequate strength of vildagliptin + metformin (ProglinMet) is available, individual components should be used instead of the fixed-dose combination. (See Table 1.)

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Hepatic impairment: Use is not recommended in patients with clinical or laboratory evidence of hepatic impairment including patients with a pre-treatment ALT or AST >2.5x ULN (see Precautions).
Pediatric patients (below 18 years): The safety and effectiveness in pediatric patients have not been established. Therefore, use is not recommended in children below 18 years of age.
Geriatric patients (65 years or above): As metformin is excreted via the kidneys, and elderly patients tend to exhibit decreased renal function, elderly patients should have their renal function monitored regularly. The dosage for elderly patients should be adjusted based on renal function (see Contraindications and Precautions).
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.