DAPAGLIFLOZIN AND SAXAGLIPTIN 10 mg/1
DAPAGLIFLOZIN AND SAXAGLIPTIN · TABLET, FILM COATED · Novadoz Pharmaceuticals LLC
DAPAGLIFLOZIN AND SAXAGLIPTIN is a tablet, film coated containing dapagliflozin and saxagliptin at 10 mg/1, taken oral. Manufactured by Novadoz Pharmaceuticals LLC.
Key Facts
- Brand Name
- DAPAGLIFLOZIN AND SAXAGLIPTIN
- Generic Name
- DAPAGLIFLOZIN AND SAXAGLIPTIN
- NDC Code (Product)
72205-438- Manufacturer
- Novadoz Pharmaceuticals LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211533
- Drug Class
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
- Marketing Start
- 04/06/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dapagliflozin and saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin and saxagliptin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [ see WARNINGS AND PRECAUTIONS (5.1) ]. Dapagliflozin and saxagliptin tablets is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor and saxagliptin a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assess renal function before initiation of therapy and periodically thereafter. ( 2.1 ) Take orally, once daily in the morning with or without food. ( 2.2 ) For patients not already taking dapagliflozin, the recommended starting dose of dapagliflozin and saxagliptin tablets is a 5 mg dapagliflozin/5 mg saxagliptin tablet once daily. ( 2.2 ) In patients tolerating 5 mg dapagliflozin and 5 mg saxagliptin once daily who require additional glycemic control, the dapagliflozin and saxagliptin tablets dose can be increased to 10 mg dapagliflozin/5 mg saxagliptin tablet once daily. ( 2.2 ) Swallow tablet whole. Do not crush, cut or chew. ( 2.2 ) Withhold dapagliflozin and saxagliptin for at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. ( 2.5 ) 2.1 Prior to Initiation of Dapagliflozin and Saxagliptin Tablets Assess renal function prior to initiation of dapagliflozin and saxagliptin tablets therapy and periodically thereafter [see WARNINGS AND PRECAUTIONS (5.4) ] . Assess volume status. In patients with volume depletion, correct this condition before initiating of dapagliflozin and saxagliptin tablets [see WARNI…
Contraindications
4 CONTRAINDICATIONS Dapagliflozin and saxagliptin is contraindicated in patients with: History of a serious hypersensitivity reactions to dapagliflozin or to saxagliptin, including anaphylactic reaction, angioedema or exfoliative skin conditions [ see WARNINGS AND PRECAUTIONS (5.8) and ADVERSE REACTIONS (6.2)]. Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m 2 ), end-stage renal disease (ESRD), or patients on dialysis [ see USE IN SPECIFIC POPULATIONS (8.6)]. History of a serious hypersensitivity reaction to dapagliflozin or to saxagliptin. ( 4 ) Moderate to severe renal impairment (eGFR <45 mL/min/1.73 m 2 ), end-stage renal disease, or patients on dialysis. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 3 : Clinically Relevant Interactions with Dapagliflozin and Saxagliptin Strong Inhibitors of CYP3A4/5 Enzymes Clinical Impact Ketoconazole significantly increased saxagliptin exposure. Similar significant increases in plasma concentrations of saxagliptin are anticipated with other strong CYP3A4/5 inhibitors (e.g., atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). Intervention Do not coadminister dapagliflozin and saxagliptin with strong cytochrome P450 3A4/5 inhibitors [see DOSAGE AND ADMINISTRATION (2.4) and CLINICAL PHARMACOLOGY (12.3) ] . Insulin or Insulin Secretagogues Clinical Impact The risk of hypoglycemia may be increased when dapagliflozin and saxagliptin is used concomitantly with insulin or insulin secretagogues (e.g., sulfonylurea) [see WARNINGS AND PRECUATIONS (5.6) ] . Intervention Concomitant use may require lower doses of insulin or the insulin secretagogue to reduce the risk of hypoglycemia. Lithium Clinical Impact Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention Monitor serum lithium concentration more frequentl…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described below or elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis [see WARNINGS AND PRECAUTIONS (5.1) ] Pancreatitis [see WARNINGS AND PRECAUTIONS (5.2) ] Heart Failure [see WARNINGS AND PRECAUTIONS (5.3) ] Volume Depletion [see WARNINGS AND PRECAUTIONS (5.4) ] Urosepsis and Pyelonephritis [see WARNINGS AND PRECAUTIONS (5.5) ] Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [see WARNINGS AND PRECAUTIONS (5.6) ] Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) [see WARNINGS AND PRECAUTIONS (5.7) ] Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.8) ] Genital Mycotic Infections [see WARNINGS AND PRECAUTIONS (5.9) ] Severe and Disabling Arthralgia [see WARNINGS AND PRECAUTIONS (5.10) ] Bullous Pemphigoid [see WARNINGS AND PRECAUTIONS (5.11) ] Adverse reactions reported in ≥5% of subjects treated with dapagliflozin and saxagliptin were: upper respiratory tract infection, urinary tract infection, and dyslipidemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369…
Frequently Asked Questions
What is DAPAGLIFLOZIN AND SAXAGLIPTIN used for?
DAPAGLIFLOZIN AND SAXAGLIPTIN contains DAPAGLIFLOZIN AND SAXAGLIPTIN. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is DAPAGLIFLOZIN AND SAXAGLIPTIN a controlled substance?
DAPAGLIFLOZIN AND SAXAGLIPTIN is not classified as a controlled substance by the DEA.
What is the generic name for DAPAGLIFLOZIN AND SAXAGLIPTIN?
The generic name for DAPAGLIFLOZIN AND SAXAGLIPTIN is DAPAGLIFLOZIN AND SAXAGLIPTIN. There are no other listed brand versions of DAPAGLIFLOZIN AND SAXAGLIPTIN.
What is the NDC code for DAPAGLIFLOZIN AND SAXAGLIPTIN 10 mg/1?
The NDC (National Drug Code) for DAPAGLIFLOZIN AND SAXAGLIPTIN 10 mg/1 is 72205-438, listed by Novadoz Pharmaceuticals LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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