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REDDY-SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is a brand name for Sitagliptin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • Reddy-Sitagliptin and Metformin Hydrochloride (sitagliptin / metformin hydrochloride) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus inadequately controlled on metformin or in patients already being treated with the combination of…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The dosage of Reddy-Sitagliptin and Metformin Hydrochloride should be Page 6 of 68 individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin hydrochloride.
Dose escalation should be gradual to reduce the gastrointestinal side effects associated with metformin use. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin-containing products in patients with renal impairment.
73 m2 is 50 mg and 1000 mg, respectively. , sulfonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). • Concomitant Use with Medication(s) that May Decrease Renal Function Caution should be exercised when using concomitant medication(s) that may decrease renal function (like diuretics, particularly loop diuretics) or may interfere with the disposition of metformin, such as cationic drugs, that are eliminated by renal tubular secretion, due to the increased risk of developing lactic acidosis during co-administration (see 9 DRUG INTERACTIONS).
2 Recommended Dose and Dosage Adjustment Reddy-Sitagliptin and Metformin Hydrochloride is available in the following dosage strengths: • 50 mg sitagliptin/500 mg metformin hydrochloride • 50 mg sitagliptin/850 mg metformin hydrochloride • 50 mg sitagliptin/1000 mg metformin hydrochloride One Reddy-Sitagliptin and Metformin Hydrochloride tablet should be taken orally twice a day with meals to reduce the risk of gastrointestinal side effects associated with metformin use.
Tablets are to be swallowed whole. In patients on metformin (alone or in combination with a sulfonylurea, pioglitazone, or insulin), the recommended total daily dose of Reddy-Sitagliptin and Metformin Hydrochloride is 100 mg sitagliptin and the nearest therapeutically appropriate dose of metformin already being taken.
In patients already treated with sitagliptin and metformin, switching to Reddy-Sitagliptin and Metformin Hydrochloride may be initiated at the dose of sitagliptin and metformin already being taken.
Page 7 of 68 Renal Impairment:
). For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • During pregnancy and breastfeeding (see 7 WARNINGS AND PRECAUTIONS, Special populations). • During period around administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function (see 7 WARNINGS AND PRECAUTIONS).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Lactic Acidosis • Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with Reddy-Sitagliptin and Metformin Hydrochloride (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Lactic Acidosis).
• Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking Reddy-Sitagliptin and Metformin Hydrochloride, since alcohol intake potentiates the effect of metformin on lactate metabolism (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Lactic Acidosis).
1 Dosing Considerations • The dosage of Reddy-Sitagliptin and Metformin Hydrochloride should be Page 6 of 68 individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin hydrochloride.
Dose escalation should be gradual to reduce the gastrointestinal side effects associated with metformin use. Factors that may increase the risk of lactic acidosis should be reviewed before considering initiation of metformin-containing products in patients with renal impairment.
73 m2 is 50 mg and 1000 mg, respectively. , sulfonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). • Concomitant Use with Medication(s) that May Decrease Renal Function Caution should be exercised when using concomitant medication(s) that may decrease renal function (like diuretics, particularly loop diuretics) or may interfere with the disposition of metformin, such as cationic drugs, that are eliminated by renal tubular secretion, due to the increased risk of developing lactic acidosis during co-administration (see
, Endocrine and Metabolism, and Special Populations). 2 CONTRAINDICATIONS • Unstable and / or insulin-dependent (type 1) diabetes mellitus. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, history of ketoacidosis with or without coma.
• In patients with a history of lactic acidosis, irrespective of precipitating factors (see 7 WARNINGS AND PRECAUTIONS). 73 m2)], end-stage renal disease, in patients on dialysis or when renal function is not known (see 7 WARNINGS AND PRECAUTIONS).
• In excessive alcohol intake, acute or chronic. • In patients suffering from severe hepatic dysfunction, since severe hepatic dysfunction has been associated with some cases of lactic acidosis, Reddy- Sitagliptin and Metformin Hydrochloride should not be used in patients with clinical or laboratory evidence of hepatic disease.
• In cases of cardiovascular collapse and in disease states associated with hypoxemia such as cardiorespiratory insufficiency, which are often associated with hyperlactacidemia. • During stress conditions, such as severe infections, trauma or surgery and the recovery phase thereafter.
• In patients suffering from severe dehydration or shock. • Known hypersensitivity to sitagliptin, metformin or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS and
• Unstable and / or insulin-dependent (type 1) diabetes mellitus. • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, history of ketoacidosis with or without coma. • In patients with a history of lactic acidosis, irrespective of precipitating factors (see 7 WARNINGS AND PRECAUTIONS).
73 m2)], end-stage renal disease, in patients on dialysis or when renal function is not known (see 7 WARNINGS AND PRECAUTIONS). • In excessive alcohol intake, acute or chronic. • In patients suffering from severe hepatic dysfunction, since severe hepatic dysfunction has been associated with some cases of lactic acidosis, Reddy- Sitagliptin and Metformin Hydrochloride should not be used in patients with clinical or laboratory evidence of hepatic disease.
• In cases of cardiovascular collapse and in disease states associated with hypoxemia such as cardiorespiratory insufficiency, which are often associated with hyperlactacidemia. • During stress conditions, such as severe infections, trauma or surgery and the recovery phase thereafter.
• In patients suffering from severe dehydration or shock. • Known hypersensitivity to sitagliptin, metformin or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section. • During pregnancy and breastfeeding (see 7 WARNINGS AND PRECAUTIONS, Special populations). • During period around administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function (see 7 WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sitagliptin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Renal function must be assessed prior to initiation of Reddy-Sitagliptin and Metformin Hydrochloride and periodically thereafter because there is a dosage adjustment based upon renal function. 73 m2 (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
73 m2), end stage renal disease or patients on dialysis (see 2 CONTRAINDICATIONS). 73 m2). 73 m2 because these patients require a lower dosage of sitagliptin than what is available in the fixed combination Reddy-Sitagliptin and Metformin Hydrochloride product.
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 Reddy-Sitagliptin and Metformin Hydrochloride if renal function is acceptable and found to be stable (see 7 WARNINGS AND PRECAUTIONS).
Hepatic Impairment:
Reddy-Sitagliptin and Metformin Hydrochloride is contraindicated in patients with severe hepatic impairment and should not be used in patients with clinical or laboratory evidence of hepatic disease (see 2 CONTRAINDICATIONS). Metformin use in patients with impaired hepatic function has been associated with some cases of lactic acidosis (see 7 WARNINGS AND PRECAUTIONS).
Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
Reddy-Sitagliptin and Metformin Hydrochloride should be used with caution in patients 65 years and older. Regular assessment of renal function is necessary. Metformin and sitagliptin are excreted by the kidneys, and elderly patients are more likely to have decreased renal function associated with aging and be at risk of developing lactic acidosis (see 7 WARNINGS AND PRECAUTION, Special Populations).
4 Administration Reddy-Sitagliptin and Metformin Hydrochloride should be taken orally with meals. 5 Missed Dose If a dose of Reddy-Sitagliptin and Metformin Hydrochloride is missed, it should be taken as soon as the patient remembers.
If he / she does not remember until it is time for the next dose, the missed dose should be skipped and returned to the regular schedule. A double dose of Reddy-Sitagliptin and Metformin Hydrochloride should not be taken at the same time.
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