Finished product reference
Dapagliflozin / Metformin Hydrochloride
Tablet, Extended Release · Oral · 10 mg/500 mg
- List code
- 52865
- Salt form
- Propanediol
- Pharmacologic class
- Sodium-Glucose Cotransporter 2 Inhibitor
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.
What it is and how it works
Mechanism of Action Dapagliflozin Sodium-glucose cotransporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, dapagliflozin reduces reabsorption of filtered glucose, and thereby promotes urinary glucose excretion. Dapagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule.
Mechanism class: Sodium-Glucose Transporter 2 Inhibitors
Indications
Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride extended-release tablets, are 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.
Dosage and administration (summary)
Assess renal function prior to initiating and then as clinically indicated. Assess volume status and correct volume depletion before initiating. Individualize the starting dosage based on the patient’s current treatment. Administer orally once daily in the morning with food. To improve glycemic control, for patients not already taking dapagliflozin, the recommended starting dosage for dapagliflozin is 5 mg once daily. For indications in adults related to heart failure and chronic kidney disease the recommended dosage of dapagliflozin is 10 mg once daily. Do not exceed a daily dosage of 10 mg dapagliflozin/2,000 mg metformin HCl extended-release.
Contraindications
Dapagliflozin and metformin hydrochloride extended-release tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) or end-stage renal disease . History of a serious hypersensitivity reaction to dapagliflozin, metformin HCl, or any of the excipients in dapagliflozin and metformin hydrochloride extended-release tablets. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported with dapagliflozin .
Warnings and precautions
Lactic Acidosis : See boxed warning. 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 dapagliflozin and metformin hydrochloride extended-release tablets if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting.
Pregnancy
Pregnancy Risk Summary Based on animal data showing adverse renal effects, dapagliflozin and metformin hydrochloride extended-release tablets are not recommended during the second and third trimesters of pregnancy.
Storage and supply
How Supplied Dapagliflozin and metformin hydrochloride extended-release tablets have markings on both sides, and are available in the strengths and packages listed in Table 21. Table 21: Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets Presentations Tablet Strength Film-Coated Tablet Color/Shape Tablet Markings Pack Size NDC Code …
Source: Dapagliflozin And Metformin Hydrochloride (Dapagliflozin And Metformin Hydrochloride) — US FDA prescribing information, 2026-03-18, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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