Usage
- Dapagliflozin + Teneligliptin is prescribed for type 2 diabetes mellitus as an adjunct to diet and exercise, particularly in patients with comorbidities. It helps improve glycemic control and prevent associated complications.
- Pharmacological Classification: Antidiabetic combination medication consisting of a SGLT2 inhibitor (Dapagliflozin) and a DPP-4 inhibitor (Teneligliptin).
- Mechanism of Action: Dapagliflozin inhibits sodium-glucose cotransporter 2 (SGLT2) in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion. Teneligliptin inhibits dipeptidyl peptidase-4 (DPP-4), increasing incretin hormone levels (like GLP-1 and GIP), which enhance insulin secretion and suppress glucagon release. This combined action effectively lowers blood glucose levels.
Alternate Names
- No internationally recognized alternate names are found in the sources, however, several brand names exist.
- Brand Names: Zita D, Glidapa Tene (various strengths).
How It Works
- Pharmacodynamics: Dapagliflozin lowers blood glucose independently of insulin by increasing urinary glucose excretion. Teneligliptin enhances glucose-dependent insulin secretion and suppresses glucagon release, improving glycemic control after meals and during fasting states. The combination offers synergistic blood sugar control.
- Pharmacokinetics: Dapagliflozin is primarily eliminated through renal excretion. Teneligliptin is metabolized, with metabolites primarily excreted renally and some hepatically.
- Mode of Action: Dapagliflozin acts on SGLT2 transporters in the kidneys, while Teneligliptin inhibits the DPP-4 enzyme.
- Receptor binding, Enzyme Inhibition, or Neurotransmitter Modulation: Dapagliflozin targets SGLT2 transporters. Teneligliptin inhibits the DPP-4 enzyme.
- Elimination Pathways: Dapagliflozin is mainly eliminated by renal excretion. Teneligliptin metabolites are excreted renally and hepatically.
Dosage
Standard Dosage
Adults:
- Dapagliflozin + Teneligliptin is available in fixed-dose combinations of Dapagliflozin 5mg/10mg + Teneligliptin 20mg.
- The usual starting dose is Dapagliflozin 5mg + Teneligliptin 20mg orally once daily, taken in the morning with or without food. The dose may be increased to Dapagliflozin 10mg + Teneligliptin 20mg if needed for better glycemic control.
Children:
- Dapagliflozin + Teneligliptin is not recommended for children as safety and effectiveness have not been established.
Special Cases:
- Elderly Patients: Caution is advised, particularly with Dapagliflozin, as elderly patients may be more susceptible to volume depletion. Renal function should be monitored.
- Patients with Renal Impairment: For patients with eGFR ≥ 45 mL/min/1.73 m², no dose adjustment is needed. For eGFR < 45 mL/min/1.73 m², the use of Dapagliflozin + Teneligliptin is not recommended for improving glycemic control in type 2 diabetes. However, for patients with heart failure or CKD, no dosage adjustment is needed for Dapagliflozin component. If eGFR < 25 mL/min/1.73 m², initiation of Dapagliflozin + Teneligliptin is not recommended; however, those already using it for HF or CKD can continue at 10mg dapagliflozin. ESRD/dialysis patients: Dapagliflozin + Teneligliptin is contraindicated.
- Patients with Hepatic Dysfunction: Mild to moderate impairment requires no dosage adjustment. Severe hepatic impairment has not been studied.
- Patients with Comorbid Conditions: Use with caution in patients with cardiovascular disease, especially heart failure. Close monitoring is needed.
Clinical Use Cases
The provided sources do not detail specific dosage recommendations for clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Dosing is primarily guided by glycemic control in patients with Type 2 diabetes, heart failure or chronic kidney disease. For special circumstances, expert consultation is recommended.
Dosage Adjustments
Dosage adjustments are based on renal function, patient response, and potential drug interactions. See “Special Cases” above for renal impairment considerations.
Side Effects
Common Side Effects
- Urinary tract infections (UTIs)
- Increased urination
- Genital mycotic infections (e.g., genital yeast infections)
- Nasopharyngitis (common cold symptoms)
- Headache
- Nausea, vomiting, diarrhoea, stomach upset
- Hypotension (low blood pressure)
Rare but Serious Side Effects
- Hypoglycemia (low blood sugar), especially with concomitant use of insulin or sulfonylureas
- Diabetic ketoacidosis
- Serious hypersensitivity reactions
Long-Term Effects
No specific long-term adverse effects unique to this combination are highlighted in the provided sources beyond those listed above. Monitor for potential renal complications and cardiovascular events.
Adverse Drug Reactions (ADR)
- Angioedema (swelling of face, lips, tongue, throat)
- Steven-Johnson syndrome (severe skin reaction)
Contraindications
- Hypersensitivity to Dapagliflozin or Teneligliptin
- Severe renal impairment, end-stage renal disease, or patients on dialysis
- Type 1 diabetes
- History of serious hypersensitivity reactions to a DPP-4 inhibitor
- Diabetic ketoacidosis
Drug Interactions
- Insulin and Sulfonylureas: Increased risk of hypoglycemia.
- Diuretics (e.g., furosemide): Increased risk of dehydration and hypotension.
- Metoprolol (antihypertensive): Potential interaction; monitoring is required.
- Other antidiabetic medications (e.g., glimepiride): Potential for additive effects and increased risk of hypoglycemia.
Pregnancy and Breastfeeding
- Pregnancy: Dapagliflozin is not recommended during the second and third trimesters of pregnancy due to potential renal risks to the fetus. Teneligliptin information is limited. Discuss potential risks with pregnant patients. Alternative diabetes medications, such as insulin and metformin, are safer.
- Breastfeeding: Dapagliflozin passes into breast milk, potentially lowering the baby’s blood sugar and impacting kidney development. Teneligliptin information is limited. Consult with patients regarding breastfeeding. Consider alternative therapies if needed.
Drug Profile Summary
- Mechanism of Action: SGLT2 inhibition (Dapagliflozin) and DPP-4 inhibition (Teneligliptin).
- Side Effects: UTIs, increased urination, genital infections, nasopharyngitis, headache, nausea, hypotension, hypoglycemia.
- Contraindications: Hypersensitivity, severe renal impairment, type 1 diabetes, diabetic ketoacidosis, history of hypersensitivity to DPP4 inhibitors.
- Drug Interactions: Insulin, sulfonylureas, diuretics, other antidiabetic medications.
- Pregnancy & Breastfeeding: Not recommended, especially during the later stages of pregnancy.
- Dosage: Adults: Dapagliflozin 5-10mg + Teneligliptin 20mg once daily. Not for children.
- Monitoring Parameters: Blood glucose, renal function, blood pressure, electrolytes.
Popular Combinations
The sources provided did not list commonly used drug combinations with Dapagliflozin + Teneligliptin. However, other antidiabetic medications, such as metformin, might be added to the regimen if further glycemic control is needed. It is important to evaluate such combinations for potential drug interactions and side effects.
Precautions
- General Precautions: Monitor renal function, blood glucose, blood pressure, and electrolytes. Assess for dehydration, especially in elderly patients.
- Specific Populations: See “Dosage - Special Cases” above.
- Lifestyle Considerations: Encourage healthy diet, exercise, and blood sugar monitoring. Advise on potential impacts of alcohol consumption (risk of hypoglycemia, dehydration).
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Dapagliflozin + Teneligliptin?
A: The standard adult dose is Dapagliflozin 5-10 mg + Teneligliptin 20 mg once daily, usually in the morning. Not recommended for children. Dose adjustments may be necessary based on renal function and other factors.
Q2: How does this combination compare to other diabetes medications?
A: It offers dual action by targeting both glucose reabsorption and incretin activity. It might be more effective in certain patients compared to monotherapy with either an SGLT2 inhibitor or a DPP-4 inhibitor alone.
Q3: What are the main side effects to watch out for?
A: UTIs, increased urination, genital infections, hypotension, and hypoglycemia.
Q4: Can this combination be used in patients with kidney disease?
A: It is not recommended for glycemic control for T2DM patients with an eGFR < 45 mL/min/1.73 m². However, patients with HF or CKD and eGFR < 45 mL/min/1.73 m² can use it for reducing risk of CKD progression and cardiovascular death; if eGFR drops below 25 ml/min/1.73 m², initiation is not recommended, but existing patients with HF or CKD may continue. Contraindicated in patients on dialysis or with ESRD.
Q5: Are there any specific dietary restrictions while taking this medication?
A: No specific dietary restrictions are associated with the drug itself. However, patients with diabetes should follow a balanced diet as advised by their doctor or a registered dietitian.
Q6: Can this medicine be used during pregnancy or breastfeeding?
A: It’s generally not recommended due to limited safety data and potential risks to the fetus or infant. Discuss alternative diabetes management strategies with pregnant or breastfeeding patients.
Q7: What should I do if a patient misses a dose?
A: Take the missed dose as soon as remembered. However, if it is almost time for the next dose, skip the missed dose and continue with the regular schedule. Do not double the dose.
Q8: How should patients monitor their response to this medication?
A: Regular blood glucose monitoring is essential. Patients should also be aware of signs of hypoglycemia and other potential side effects. Regular check-ups with their doctor are important to monitor treatment effectiveness and any emerging issues.
Q9: Are there any interactions with alcohol?
A: While no specific interactions are listed in the sources, alcohol can increase the risk of hypoglycemia, particularly in patients also taking insulin or sulfonylureas. Advise patients to monitor blood glucose carefully and seek medical advice if needed.
