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JENTADUETO is a brand name for Linagliptin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ........................................................................ 3 CONTRAINDICATIONS ............................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................ 5 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
5/1000 mg twice daily. The dosage should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 5 mg linagliptin and 2000 mg metformin hydrochloride.
JENTADUETO should be given twice daily with meals with gradual dose escalation to reduce the gastrointestinal undesirable effects associated with metformin. 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 5 mg and 1000 mg, respectively. If glycemic control is found to be reduced, alternative treatments should be considered. 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 DRUG INTERACTIONS).
5 mg twice daily (5 mg total daily dose) plus the dose of metformin already being taken. For patients switching from co-administration of linagliptin and metformin For patients switching from co-administration of linagliptin and metformin to the fixed dose combination, JENTADUETO should be initiated at the dose of linagliptin and metformin already being taken.
5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. When JENTADUETO is used in combination with a sulfonylurea; a lower dose of the sulfonylurea may be required to reduce the risk of hypoglycemia (see WARNINGS AND PRECAUTIONS).
5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken. When JENTADUETO is used in combination with basal insulin; a lower dose of the basal insulin may be required to reduce the risk of hypoglycemia (see WARNINGS AND PRECAUTIONS).
Renal Impairment:
Renal function must be assessed prior to initiation of JENTADUETO and periodically and at least annually thereafter. 73 m2 (see WARNINGS AND PRECAUTIONS). 73 m2), end stage renal disease or patients on dialysis (see CONTRAINDICATIONS).
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 JENTADUETO. The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Lactic Acidosis).
Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking JENTADUETO, since alcohol intake potentiates the effect of metformin on lactate metabolism (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Lactic Acidosis).
General JENTADUETO is contraindicated in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Cardiovascular Heart Failure:
Linagliptin An association between dipeptidyl peptidase-4 (DPP-4) inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. Before initiating JENTADUETO, consider factors that may predispose patients to a risk of heart failure, such as a history of prior heart failure and a history of renal impairment.
Monitor for signs and symptoms of heart failure after initiating therapy and discontinue JENTADUETO if this complication occurs. , acute congestive heart failure, acute myocardial infarction and other conditions characterized by hypoxemia) have been associated with lactic acidosis and may also cause prerenal azotemia (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
When such events occur in patients on JENTADUETO therapy, the drug should be promptly discontinued.
Endocrine and Metabolism Hypoglycemia:
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 WARNINGS AND PRECAUTIONS).
73 m2], end-stage renal disease, in patients on dialysis or when renal function is not known (see 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.
JENTADUETO 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 linagliptin, metformin or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container (see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS).
For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section. During pregnancy and breastfeeding (see WARNINGS AND PRECAUTIONS). During period around administration of iodinated contrast materials, because the use of such products may result in acute alteration of renal function (see WARNINGS AND PRECAUTIONS).
JENTADUETO® Product Monograph Page 5 of 66 WARNINGS AND PRECAUTIONS 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 JENTADUETO.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Linagliptin 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.
73 m2 is not recommended. 73 m2, assess the benefit and risk of continuing therapy and limit dose of the metformin to a maximum of 1000 mg daily. 73 m2 (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS). 73 m2). 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 JENTADUETO if renal function is acceptable and found to be stable (see WARNINGS AND PRECAUTIONS).
Hepatic Impairment:
Use of JENTADUETO in patients with severe hepatic impairment is contraindicated and should not be used in patients with clinical or laboratory evidence of hepatic disease (see CONTRAINDICATIONS). Metformin use in patients with impaired hepatic function has been associated with some cases of lactic acidosis (see WARNINGS AND PRECAUTIONS).
Geriatrics (≥65 years of age):
JENTADUETO should be used with caution in patients 65 years and older. Regular assessment of renal function is necessary. As metformin is excreted via the JENTADUETO® Product Monograph Page 33 of 66 kidney, and elderly patients are more likely to have decreased renal function associated with aging and be at risk of developing lactic acidosis (see WARNINGS AND PRECAUTIONS).
Pediatrics (<18 years of age):
Safety and effectiveness of JENTADUETO in pediatric patients have not been established. Therefore, JENTADUETO should not be used in this patient population. Missed Dose If a dose of JENTADUETO 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 return to the regular schedule. Two doses of JENTADUETO should not be taken at the same time. , remove unabsorbed material […]
Linagliptin JENTADUETO® Product Monograph Page 6 of 66 Caution is advised when JENTADUETO is used in combination with a sulfonylurea or insulin. When linagliptin and metformin were used in combination with a sulfonylurea, the incidence of hypoglycemia was increased over the placebo in combination with a sulfonylurea plus metformin (see ADVERSE REACTIONS).
Sulfonylureas and insulin are known to cause hypoglycemia. Therefore, to reduce the risk of hypoglycemia associated with these indications, a lower dose of sulfonylurea or insulin may be considered (see DOSAGE AND ADMINISTRATION). Metformin hydrochloride Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol.
Elderly, debilitated, or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking β-adrenergic blocking drugs.
Hypothyroidism:
Metformin hydrochloride Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism (see ADVERSE REACTIONS). Regular monitoring of TSH levels is recommended in patients with hypothyroidism (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Studies have shown that metformin reduces plasma TSH levels, often to subnormal levels, when it is administered to patients with untreated hypothyroidism or to hypothyroid patients effectively treated with levothyroxine. The metformin-induced reduction of plasma TSH levels is not observed when metformin is administered to patients with normal thyroid function.
Metformin has been suggested to enhance the inhibitory modulation of thyroid hormones on TSH secretion. Levothyroxine can reduce the hypoglycemic effect of metformin. Careful monitoring of blood glucose levels is recommended in patients with hypothyroidism treated with levothyroxine, especially when thyroid hormone therapy is initiated, changed, or stopped (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests and DRUG INTERACTIONS).
Lactic Acidosis:
Metformin hydrochloride Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with JENTADUETO; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia.
Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 μg/mL are generally found.
015 fatal cases/1000 patient-years). Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications (see DOSAGE AND ADMINISTRATION).
Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis.
In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Metformin treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates […]
The risk increases with conditions such as renal impairment, sepsis, dehydration, excess alcohol intake, hepatic impairment, and acute congestive heart failure (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Lactic Acidosis).
Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking JENTADUETO, since alcohol intake potentiates the effect of metformin on lactate metabolism (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism – Lactic Acidosis).
General JENTADUETO is contraindicated in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Cardiovascular Heart Failure:
Linagliptin An association between dipeptidyl peptidase-4 (DPP-4) inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. Before initiating JENTADUETO, consider factors that may predispose patients to a risk of heart failure, such as a history of prior heart failure and a history of renal impairment.
Monitor for signs and symptoms of heart failure after initiating therapy and discontinue JENTADUETO if this complication occurs. , acute congestive heart failure, acute myocardial infarction and other conditions characterized by hypoxemia) have been associated with lactic acidosis and may also cause prerenal azotemia (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism).
When such events occur in patients on JENTADUETO therapy, the drug should be promptly discontinued.
Endocrine and Metabolism Hypoglycemia:
Linagliptin JENTADUETO® Product Monograph Page 6 of 66 Caution is advised when JENTADUETO is used in combination with a sulfonylurea or insulin. When linagliptin and metformin were used in combination with a sulfonylurea, the incidence of hypoglycemia was increased over the placebo in combination with a sulfonylurea plus metformin (see ADVERSE REACTIONS).
Sulfonylureas and insulin are known to cause hypoglycemia. Therefore, to reduce the risk of hypoglycemia associated with these indications, a lower dose of sulfonylurea or insulin may be considered (see DOSAGE AND ADMINISTRATION). Metformin hydrochloride Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol.
Elderly, debilitated, or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking β-adrenergic blocking drugs.
Hypothyroidism:
Metformin hydrochloride Metformin induces a reduction in thyrotropin (thyroid stimulating hormone (TSH)) levels in patients with treated or untreated hypothyroidism (see ADVERSE REACTIONS). Regular monitoring of TSH levels is recommended in patients with hypothyroidism (see WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).
Studies have shown that metformin reduces plasma TSH levels, often to subnormal levels, when it is administered to patients with untreated hypothyroidism or to hypothyroid patients effectively treated with levothyroxine. The metformin-induced reduction of plasma TSH levels is not observed when metformin is administered to patients with normal thyroid function.
Metformin has been suggested to enhance the inhibitory modulation of thyroid hormones on TSH secretion. Levothyroxine can reduce the hypoglycemic effect of metformin. Careful monitoring of blood glucose levels is recommended in patients with hypothyroidism treated with levothyroxine, especially when thyroid hormone therapy is initiated, changed, or stopped (see WARNINGS AND PRECAUTIONS, […]