Sitagliptin-Plus Sandoz Dosage/Direction for Use

General: The dose of antihyperglycaemic therapy with Sitagliptin-Plus Sandoz should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin.
Method of administration: Sitagliptin-Plus Sandoz should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal adverse reactions associated with metformin.
Sitagliptin-Plus Sandoz must not be split or divided before swallowing.
Dosing Recommendations: The starting dose of Sitagliptin-Plus Sandoz should be based on the patient's current regimen.
Sitagliptin-Plus Sandoz should be given twice daily with meals. The following doses are available: 50 mg sitagliptin/500 mg metformin hydrochloride; 50 mg sitagliptin/1000 mg metformin hydrochloride.
As initial therapy: For patients with type 2 diabetes mellitus, whose hyperglycemia is inadequately controlled with diet and exercise alone, the recommended starting dose of Sitagliptin-Plus Sandoz is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients may be titrated up to 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.
For patients inadequately controlled on metformin monotherapy: For patients inadequately controlled on metformin alone, the usual starting dose of Sitagliptin-Plus Sandoz should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients inadequately controlled on sitagliptin monotherapy: For patients inadequately controlled on sitagliptin alone, the usual starting dose of Sitagliptin-Plus Sandoz is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily. Patients may be titrated up to 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily. Patients taking sitagliptin monotherapy dose adjusted for renal impairment should not be switched to Sitagliptin-Plus Sandoz.
For patients switching from co-administration of sitagliptin and metformin: For patients switching from co-administration of sitagliptin and metformin, Sitagliptin-Plus Sandoz should be initiated at the dose of sitagliptin and metformin already being taken.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or a sulfonylurea: The usual starting dose of Sitagliptin-Plus Sandoz should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating a sulphonylurea may require lower sulfonylurea doses to reduce the risk of sulfonylurea-induced hypoglycemia.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or a PPARγ agonist (i.e. thiazolidinediones): The usual starting dose of Sitagliptin-Plus Sandoz should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered.
For patients inadequately controlled on dual combination therapy with any two of the following three antihyperglycemic agents: sitagliptin, metformin or insulin: The usual starting dose of Sitagliptin-Plus Sandoz should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose). In determining the starting dose of the metformin component, the patient's level of glycemic control and current dose (if any) of metformin should be considered. Gradual dose escalation to reduce the gastrointestinal (GI) side effects associated with metformin should be considered. Patients currently on or initiating insulin therapy may require lower doses of insulin to reduce the risk of hypoglycemia.
No studies have been performed specifically examining the safety and efficacy of Sitagliptin-Plus Sandoz in patients previously treated with other oral antihyperglycemic agents and switched to Sitagliptin-Plus Sandoz. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
All patients should continue their recommended diet with an adequate distribution of carbohydrate intake during the day.
Use in renal impairment: No dose adjustment is needed for patients with mild renal impairment (glomerular filtration rate [GFR] ≥60 mL/min).
A GFR should be assessed before initiation of treatment with metformin-containing products 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 3-6 months.
The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Factors that may increase the risk of lactic acidosis (see Precautions) should be reviewed before considering initiation of metformin in patients with GFR <60 mL/min.
Sitagliptin-Plus Sandoz is not recommended in patients with an eGFR ≥30 mL/min/1.73 m² and <45 mL/min/1.73 m² because these patients require a lower dosage of sitagliptin than what is available in the fixed combination Sitagliptin-Plus Sandoz product.
Sitagliptin-Plus Sandoz is contraindicated in patients with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
If no adequate strength of Sitagliptin-Plus Sandoz is available, individual mono components should be used instead of the fixed-dose combination. (See Table 1.)

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Discontinuation for iodinated contrast imaging procedures: Discontinue Sitagliptin-Plus Sandoz at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR ≥30 to <60 mL/min/1.73 m²; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Sitagliptin-Plus Sandoz if renal function is acceptable.
Use in Hepatic impairment: Sitagliptin-Plus Sandoz must not be used in patients with hepatic impairment.
Use in Elderly: As metformin and sitagliptin are excreted by the kidney, Sitagliptin-Plus Sandoz should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly.
Paediatric population: Sitagliptin-Plus Sandoz should not be used in children and adolescents 10 to 17 years of age because of insufficient efficacy. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions. Sitagliptin-Plus Sandoz has not been studied in paediatric patients under 10 years of age.