XIGDUO XR 10 mg/1
dapagliflozin and metformin hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · AstraZeneca Pharmaceuticals LP
XIGDUO XR is a tablet, film coated, extended release containing dapagliflozin and metformin hydrochloride at 10 mg/1, taken oral. Manufactured by AstraZeneca Pharmaceuticals LP.
Key Facts
- Brand Name
- XIGDUO XR
- Generic Name
- dapagliflozin and metformin hydrochloride
- NDC Code (Product)
0310-6270- Manufacturer
- AstraZeneca Pharmaceuticals LP
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA205649
- Marketing Start
- 10/29/2014
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. • Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. Limitations of Use • XIGDUO XR is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ] . • Because of the metformin HCl component, the use of XIGDUO XR is limited to patients with type 2 diabetes mellitus for all indications. • XIGDUO X…
Dosage & Administration
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. ( 2.3 ) • See Full Prescribing Information for dosage recommendations in patients with renal impairment. ( 2.4 ) • XIGDUO XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. ( 2.5 ) • Withhold XIGDUO XR for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.6 ) 2.1 Testing Prior to Initiation of XIGDUO XR • Assess renal function prior to …
Contraindications
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. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with dapagliflozin [see Adverse Reactions (6.1) ] . • Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin [see Warnings and Precautions (5.1) and Warnings and Precautions (5.2) ] . • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) or end-stage renal disease. ( 4 ) • History of serious hypersensitivity to dapagliflozin, metformin HCl, or any of the excipients in XIGDUO XR. ( 4 ) • Metabolic acidosis, including diabetic ketoacidosis. ( 4 )
Drug 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. Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2]/multidrug and toxin extrusion [MATE] inhibitors, such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] . Intervention Consider the benefits and risks of concomitant use. Alcohol Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate metabolism. Intervention Warn patients against excessive alcohol intake while rec…
Adverse Reactions
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 reactions reported in >5% of patients treated with XIGDUO XR were female genital mycotic infection, nasopharyngitis, urinary tract infection, diarrhea, and headache. ( 6.1 ) • Adverse reactions reported in >5% of patients treated with metformin extended-release are: diarrhea and nausea/vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1…
Frequently Asked Questions
What is XIGDUO XR used for?
XIGDUO XR contains dapagliflozin and metformin hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is XIGDUO XR a controlled substance?
XIGDUO XR is not classified as a controlled substance by the DEA.
What is the generic name for XIGDUO XR?
The generic name for XIGDUO XR is dapagliflozin and metformin hydrochloride. There are 9 other brand versions of dapagliflozin and metformin hydrochloride.
What is the NDC code for XIGDUO XR 10 mg/1?
The NDC (National Drug Code) for XIGDUO XR 10 mg/1 is 0310-6270, listed by AstraZeneca Pharmaceuticals LP.
Other XIGDUO XR Dosages
Other Dapagliflozin Brands
See all →- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5 mg/172205-435
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10 mg/172205-437
- Dapagliflozin and Metformin Hydrochloride10 mg/133342-407
- Dapagliflozin and Metformin Hydrochloride5 mg/133342-408
- Dapagliflozin and Metformin hydrochloride5 mg/159651-155
- Dapagliflozin and Metformin Hydrochloride5 mg/133342-406
- Dapagliflozin and Metformin Hydrochloride10 mg/133342-409
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5 mg/172205-434
- Dapagliflozin and Metformin Hydrochloride5 mg/163304-026
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)