Description
Indications
These combination tablets are prescribed to manage blood glucose levels in adults with type 2 diabetes mellitus. They are used as an adjunct to diet and exercise to improve glycemic control in patients whose blood sugar levels are not adequately controlled with single agents or dual therapy.
Mechanism of Action
- Dapagliflozin: A sodium-glucose co-transporter 2 (SGLT2) inhibitor that reduces glucose reabsorption in the kidneys, increasing glucose excretion in urine.
- Sitagliptin: A dipeptidyl peptidase-4 (DPP-4) inhibitor that increases the levels of incretin hormones, which increase insulin release and decrease glucagon levels in the bloodstream.
- Metformin Hydrochloride (Extended Release): A biguanide that decreases hepatic glucose production, decreases intestinal glucose absorption and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Dosage and Administration
- The typical starting dose is one tablet once daily, taken with food to reduce the risk of gastrointestinal side effects from metformin.
- Dosage may be adjusted based on the patient’s response and tolerance, but the maximum recommended dose should not be exceeded.
- Swallow the tablet whole; do not crush, chew, or split the tablet.
Contraindications
- Severe renal impairment.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- Hypersensitivity to dapagliflozin, sitagliptin, metformin, or any other tablet components.
Warnings and Precautions
- Monitor renal function before and during treatment.
- Assess for signs and symptoms of lactic acidosis, particularly in patients with risk factors for renal impairment, hepatic impairment, and congestive heart failure.
- Be aware of the risk of hypoglycemia when used in combination with insulin or insulin secretagogues.
- Watch for signs of pancreatitis and discontinue use if suspected.
- Correct volume depletion before initiation of dapagliflozin therapy.
- Discontinue use in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.
Side Effects
- Common: Upper respiratory tract infection, urinary tract infection, gastrointestinal disturbances (such as nausea, diarrhea, and abdominal pain), and headache.
- Profound: Lactic acidosis, pancreatitis, severe renal impairment, and hypersensitivity reactions.
Storage
- Store at room temperature between 20°C to 25°C (68°F to 77°F) in a tight, light-resistant container.
- Keep out of reach of children.
Patient Counseling Information
- Educate patients on the signs and symptoms of lactic acidosis and advise them to discontinue the medication and seek medical attention immediately if they experience such symptoms.
- Inform patients of the potential for dehydration and advise them to drink adequate fluids.
- Advise patients on the importance of maintaining a proper diet and exercise regimen.
- Discuss the importance of regularly monitoring blood glucose levels, renal function, and other relevant lab parameters.
- Educate patients about the signs and symptoms of urinary tract infections and yeast infections, and instruct them to report any such symptoms to their healthcare provider.
Disclaimer
This information is intended to provide an overview of Dapagliflozin, Sitagliptin and Metformin Hydrochloride tablet (Extended Release) tablet usage. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.