Saxagliptin and Metformin Hydrochloride 1000 mg/1
Saxagliptin and Metformin Hydrochloride · TABLET, FILM COATED, EXTENDED RELEASE · Dr.Reddys Laboratories Inc
Saxagliptin and Metformin Hydrochloride is a tablet, film coated, extended release containing saxagliptin and metformin hydrochloride at 1000 mg/1, taken oral. Manufactured by Dr.Reddys Laboratories Inc.
Key Facts
- Brand Name
- Saxagliptin and Metformin Hydrochloride
- Generic Name
- Saxagliptin and Metformin Hydrochloride
- NDC Code (Product)
43598-619- Manufacturer
- Dr.Reddys Laboratories Inc
- Strength
- 1000 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207678
- Marketing Start
- 08/09/2023
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 Saxagliptin and metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ( 14 )]. Saxagliptin and metformin hydrochloride extended-release tablets are a combination of saxagliptin, a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin hydrochloride (HCl), a biguanide, 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 the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. ( 1.1 ) 1.1 Limitations of Use Saxagliptin and metformin hydrochloride extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer once daily with the evening meal. ( 2.1 ) Individualize the starting dosage based on the patient’s current regimen then adjust the dosage based on effectiveness and tolerability. ( 2.1 ) Do not exceed a daily dosage of 5 mg saxagliptin/2,000 mg metformin HCl extended-release. ( 2.1 ) Swallow whole. Never crush, cut, or chew. ( 2.1 ) Limit the saxagliptin dosage to 2.5 mg daily for patients also taking strong cytochrome P450 3A4/5 inhibitors (e.g., ketoconazole). ( 2.3 , 7.1 ) Assess renal function prior to initiation of saxagliptin and metformin hydrochloride extended-release tablets and periodically thereafter. ( 2.2 ) o Do not use in patients with eGFR below 30 mL/min/1.73 m 2 . o Initiation is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 . o Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m 2 . o Limit the saxagliptin component to 2.5 mg daily if eGFR is less than 45 mL/min/1.73 m 2 . o Discontinue if eGFR falls below 30 mL/min/1.73 m 2 . Saxagliptin and metformin hydrochloride extended-release tablets may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. (…
Contraindications
4 CONTRAINDICATIONS Saxagliptin and metformin hydrochloride extended-release tablets are contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ). Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin. A history of a serious hypersensitivity reaction to saxagliptin, metformin HCl, or any of the ingredients in saxagliptin and metformin hydrochloride extended-release tablets. Reactions such as anaphylaxis, angioedema, or exfoliative skin conditions have been reported [see Warnings and Precautions ( 5.6 ) and Adverse Reactions ( 6.2 )]. • Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ). ( 4 ) • Metabolic acidosis, including diabetic ketoacidosis. ( 4 ) • History of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to saxagliptin, metformin HCl, or any of the ingredients in saxagliptin and metformin hydrochloride extended-release tablets. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A4/5 inhibitors (e.g., ketoconazole) : Coadministration with saxagliptin and metformin hydrochloride extended-release tablets significantly increases saxagliptin concentrations. Limit saxagliptin and metformin hydrochloride extended-release tablets dosage to 2.5 mg/1,000 mg once daily when coadministered with a strong CYP3A4/5 inhibitor. ( 2.3 , 7.1 ) Carbonic anhydrase inhibitors: May increase risk of lactic acidosis. Consider more frequent monitoring. ( 7.2 ) Drugs that reduce metformin clearance: May increase risk of lactic acidosis. Consider benefits and risks of concomitant use. ( 7.3 ) See full prescribing information for additional drug interactions. ( 7 ) 7.1 Strong Inhibitors of CYP3A4/5 Enzymes 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). The dose of saxagliptin and metformin hydrochloride extended-release tablets should be limited to 2.5 mg of saxagliptinwhen coadministered with a…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Lactic Acidosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] Pancreatitis [see Warnings and Precautions ( 5.2 )] Heart Failure [see Warnings and Precautions ( 5.3 )] Vitamin B 12 Concentrations [see Warnings and Precautions ( 5.4 )] Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Severe and disabling arthralgia [see Warnings and Precautions ( 5.7 )] Bullous pemphigoid [see Warnings and Precautions ( 5.8 )] • Most common adverse reactions with metformin HCl extended-release (incidence >5% and more often than placebo) are: diarrhea and nausea/vomiting. ( 6.1 ) • Most common adverse reactions with saxagliptin (incidence ≥5% and more often than placebo) are: upper respiratory tract infection, urinary tract infection, and headache. ( 6.1 ) • Adverse reactions with coadministered saxagliptin and metformin HCl (incidence ≥5% and more often than placebo) are: headache and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTI…
Frequently Asked Questions
What is Saxagliptin and Metformin Hydrochloride used for?
Saxagliptin and Metformin Hydrochloride contains Saxagliptin and Metformin Hydrochloride. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Saxagliptin and Metformin Hydrochloride a controlled substance?
Saxagliptin and Metformin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Saxagliptin and Metformin Hydrochloride?
The generic name for Saxagliptin and Metformin Hydrochloride is Saxagliptin and Metformin Hydrochloride. There are no other listed brand versions of Saxagliptin and Metformin Hydrochloride.
What is the NDC code for Saxagliptin and Metformin Hydrochloride 1000 mg/1?
The NDC (National Drug Code) for Saxagliptin and Metformin Hydrochloride 1000 mg/1 is 43598-619, listed by Dr.Reddys Laboratories Inc.
Other Saxagliptin and Metformin Hydrochloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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