Dapagliflozin and Metformin Hydrochloride 5 mg/1
Dapagliflozin and Metformin Hydrochloride · TABLET, EXTENDED RELEASE · Macleods Pharmaceuticals Limited
Dapagliflozin and Metformin Hydrochloride is a tablet, extended release containing dapagliflozin and metformin hydrochloride at 5 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.
Key Facts
- Brand Name
- Dapagliflozin and Metformin Hydrochloride
- Generic Name
- Dapagliflozin and Metformin Hydrochloride
- NDC Code (Product)
33342-406- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 5 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211559
- Drug Class
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Marketing Start
- 04/06/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, 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 Dapagliflozin and metformin HCl extended-release tablets are 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 dapaglifl…
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 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 ) Dapagliflozin and metformin HCl extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. ( 2.5 ) Withhold Dapagliflozin and metformin HCl extended-release tablets for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.6 ) 2.1 Testing Prior to Initia…
Contraindications
4 CONTRAINDICATIONS Dapagliflozin and metformin HCl extended-release 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 dapagliflozin and metformin HCl extended-release. 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/1.73m 2 ) or end-stage renal disease. ( 4 ) History of serious hypersensitivity to dapagliflozin, metformin HCl, or any of the excipients in dapagliflozin and metformin HCl extended-release. ( 4 ) Metabolic acidosis, including diabetic ketoacidosis. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 6: Clinically Relevant Interactions with Dapagliflozin and Metformin Hydrochloride Extended-Release 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 withdapagliflozin and metformin hydrochloride extended-release 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 metfo…
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 B12 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 dapagliflozin and metformin HCl extended-release 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 Novadoz Pharmaceuticals LLC at 1-…
Frequently Asked Questions
What is Dapagliflozin and Metformin Hydrochloride used for?
Dapagliflozin and Metformin Hydrochloride contains Dapagliflozin and Metformin Hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Dapagliflozin and Metformin Hydrochloride a controlled substance?
Dapagliflozin and Metformin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Dapagliflozin and Metformin Hydrochloride?
The generic name for Dapagliflozin and Metformin Hydrochloride is Dapagliflozin and Metformin Hydrochloride. There are 7 other brand versions of Dapagliflozin and Metformin Hydrochloride.
What is the NDC code for Dapagliflozin and Metformin Hydrochloride 5 mg/1?
The NDC (National Drug Code) for Dapagliflozin and Metformin Hydrochloride 5 mg/1 is 33342-406, listed by Macleods Pharmaceuticals Limited.