Dapagliflozin And Metformin Hydrochloride
Generic Name: dapagliflozin and metformin hydrochloride
Brand Names:
Xigduo Xr
11 DESCRIPTION XIGDUO XR tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C 21 H 25 ClO 6 •C 3 H 8 O 2 •H 2 O and the formula weight is 502.98.
Overview
11 DESCRIPTION XIGDUO XR tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1S)-, compounded with (2S)-1,2-propanediol, hydrate (1:1:1). The empirical formula is C 21 H 25 ClO 6 •C 3 H 8 O 2 •H 2 O and the formula weight is 502.98.
Uses
1 INDICATIONS AND USAGE XIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end‑stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure.
Dosage
2 DOSAGE AND ADMINISTRATION • Assess renal function prior to initiating and then as clinically indicated. ( 2.1 ) • Assess volume status and correct volume depletion before initiating. ( 2.1 ) • Individualize the starting dosage based on the patient’s current treatment. ( 2.3 ) • Administer orally once daily in the morning with food. ( 2.2 ) • To improve glycemic control, for patients aged 10 years and older not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. ( 2.3 ) • For indications in adults related to heart failure and chronic kidney disease the recommended dosage of dapagliflozin is 10 mg once daily. ( 2.3 ) • Do not exceed a daily dosage of 10 mg dapagliflozin/2,000 mg metformin HCl extended-release.
Side Effects
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.2) ] • Volume Depletion [see Warnings and Precautions (5.3) ] • Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4) ] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5) ] • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions (5.6) ] • Vitamin B 12 Concentrations [see Warnings and Precautions (5.7) ] • Genital Mycotic Infections [see Warnings and Precautions (5.8) ] • Adverse rea...
Interactions
7 DRUG INTERACTIONS Table 6: Clinically Relevant Interactions with XIGDUO XR Carbonic Anhydrase Inhibitors Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with XIGDUO XR may increase the risk for lactic acidosis. Intervention Consider more frequent monitoring of these patients.
Warnings
WARNING: LACTIC ACIDOSIS • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by non‑specific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. 5 WARNINGS AND PRECAUTIONS • Lactic Acidosis : See boxed warning. ( 5.1 ) • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue XIGDUO XR if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. (5.2) • Volume Depletion: Before initiating XIGDUO XR, assess and correct volume status in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. 4 CONTRAINDICATIONS XIGDUO XR is contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) or end-stage renal disease [see Warnings and Precautions (5.1) ] . • History of a serious hypersensitivity reaction to dapagliflozin, metformin HCl, or any of the excipients in XIGDUO XR.
Pregnancy
8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, XIGDUO XR is not recommended during the second and third trimesters of pregnancy. Limited data with XIGDUO XR or dapagliflozin in pregnant women are not sufficient to determine drug‑associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied XIGDUO ® XR (dapagliflozin and metformin HCl extended-release) tablets have markings on one side, are plain on the reverse side, and are available in the strengths and packages listed in Table 21.
Frequently Asked Questions
What is Dapagliflozin And Metformin Hydrochloride used for?▼
1 INDICATIONS AND USAGE XIGDUO XR is a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of XIGDUO XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: • Sustained eGFR decline, end‑stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. • Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure.
What are the side effects of Dapagliflozin And Metformin Hydrochloride?▼
6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: • Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see Warnings and Precautions (5.2) ] • Volume Depletion [see Warnings and Precautions (5.3) ] • Urosepsis and Pyelonephritis [see Warnings and Precautions (5.4) ] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.5) ] • Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see Warnings and Precautions (5.6) ] • Vitamin B 12 Concentrations [see Warnings and Precautions (5.7) ] • Genital Mycotic Infections [see Warnings and Precautions (5.8) ] • Adverse rea...
Can I take Dapagliflozin And Metformin Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary Based on animal data showing adverse renal effects, XIGDUO XR is not recommended during the second and third trimesters of pregnancy. Limited data with XIGDUO XR or dapagliflozin in pregnant women are not sufficient to determine drug‑associated risk for major birth defects or miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk (see Data) .
What are the important warnings for Dapagliflozin And Metformin Hydrochloride?▼
WARNING: LACTIC ACIDOSIS • Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by non‑specific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. 5 WARNINGS AND PRECAUTIONS • Lactic Acidosis : See boxed warning. ( 5.1 ) • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue XIGDUO XR if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. (5.2) • Volume Depletion: Before initiating XIGDUO XR, assess and correct volume status in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. 4 CONTRAINDICATIONS XIGDUO XR is contraindicated in patients with: • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) or end-stage renal disease [see Warnings and Precautions (5.1) ] . • History of a serious hypersensitivity reaction to dapagliflozin, metformin HCl, or any of the excipients in XIGDUO XR.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.