Sitazuca MH Dosage/Direction for Use

Posology: The dose of anti-hyperglycaemic therapy with Sitagliptin phosphate/Metformin hydrochloride Tablets 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.
Adults with normal renal function (GFR ≥90 mL/min): For patients inadequately controlled on maximal tolerated dose of metformin monotherapy: For patients not adequately controlled on metformin alone, the usual starting dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
For patients switching from co-administration of sitagliptin and metformin: For patients switching from co-administration of sitagliptin and metformin, Sitagliptin phosphate/Metformin hydrochloride Tablets should be initiated at the dose of sitagliptin and metformin already being taken.
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a sulphonylurea: The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Sitagliptin phosphate/Metformin hydrochloride Tablets are used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see Precautions).
For patients inadequately controlled on dual combination therapy with the maximal tolerated dose of metformin and a PPARγ agonist: The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin: The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken. When Sitagliptin phosphate/Metformin hydrochloride Tablets is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see Precautions).
For the different doses on metformin, Sitagliptin phosphate/Metformin hydrochloride Tablets are available in strengths of 50 mg sitagliptin and 500 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
All patients should continue their recommended diet with an adequate distribution of carbohydrate intake during the day.
Special populations: 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.
If no adequate strength of Sitagliptin phosphate/Metformin hydrochloride Tablets is available, individual monocomponents should be used instead of the fixed-dose combination. (See Table 3.)

Click on icon to see table/diagram/image

Hepatic impairment: Sitagliptin phosphate/Metformin hydrochloride Tablets must not be used in patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly: As metformin and sitagliptin are excreted by the kidney, Sitagliptin phosphate/Metformin hydrochloride Tablets 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 (see Contraindications and Precautions).
Paediatric population: Sitagliptin phosphate/Metformin hydrochloride Tablets 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 phosphate/Metformin hydrochloride Tablets has not been studied in paediatric patients under 10 years of age.
Method of administration: Sitagliptin phosphate/Metformin hydrochloride Tablets should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.