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Dapagliflozin / Saxagliptin Dosage

Medically reviewed on August 30, 2018.

Applies to the following strengths: 10 mg-5 mg

Usual Adult Dose for Diabetes Type 2

Dapagliflozin 10 mg/saxagliptin 5 mg orally once a day in the morning

Comments:
-Volume depletion should be corrected prior to initiation.
-This combination product should only be used in patients who tolerate dapagliflozin 10 mg per day.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.

Renal Dose Adjustments

Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2): Contraindicated

Moderate renal impairment (eGFR less than 60 mL/min/1.73 m2): Do not initiate therapy
If eGFR falls persistently below 60 mL/min/1.73 m2: Therapy should be discontinued

Liver Dose Adjustments

Use with caution, especially in patients with severe hepatic impairment.

Benefit-risk for use in severe hepatic impairment should be individually assessed since safety and efficacy in this population has not been studied.

Dose Adjustments

Elderly: Dose adjustment may be required due to renal function

Concomitant Use with Strong CYP450 3A4/5 Inhibitors: Not Recommended
Examples: Ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin

Precautions

CONTRAINDICATIONS:
-Hypersensitivity to the active drugs or any of the excipients including anaphylaxis, angioedema, or exfoliative skin conditions
-Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2), ESRD, or dialysis

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Contraindicated

Other Comments

Administration advice:
-Take orally once a day in the morning with or without food
-Tablet should not be split or cut

-Missed dose: If a dose is missed, take the next dose as prescribed, unless otherwise instructed by healthcare provider; patients should not take an extra dose the next day

General:
-Correct volume depletion prior to initiating treatment.
-Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-Consider the risk and benefits of therapy in patients who have known risk factors for heart failure.

Monitoring:
-Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy.
-Verify renal function at baseline, and monitor periodically during therapy.
-Monitor for signs and symptoms of acute kidney injury.
-Monitor for LDL-C per standard of care.
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients, even if blood sugar is below 250 mg/dL.
-Monitor blood glucose and HbA1c
-Monitor for signs and symptoms of heart failure
-Monitor for signs and symptoms of pancreatitis.

Patient advice:
-Read the US FDA-approved patient labeling (Medication Guide).
-Patients should understand that while taking this drug they need to be sure to maintain adequate fluid intake to avoid adverse reactions related to volume depletion.
-Patients should understand the importance of adhering to dietary instructions and regular physical activity; they should be able to recognize the signs and symptoms of high and low blood sugar and know how to treat.
-During periods of stress such as fever, trauma, infection, or surgery, management of diabetes may change and patients should be advised to seek medical advice.
-Patients should understand that this drug will cause their urine to test positive for glucose.
-Patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to seek immediate medical attention.
-Patients should be instructed to seek medical attention promptly for signs and symptoms of acute kidney injury such as decreased urine, swelling in the legs or feet.
-Patients should be informed that acute pancreatitis, heart failure, allergic reactions, bladder cancer, bullous pemphigoid, genital mycotic infections, serious urinary tract infections, severe and persistent joint pain have occurred; they should understand the importance of reporting signs and symptoms of these conditions and when to promptly seek medical attention.
-Patients should be instructed to seek immediate medical attention for symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, especially if they have a fever and are feeling unwell.
-Patients who become pregnant, are planning to become pregnant, or are breastfeeding should speak with their healthcare provider.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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