SEGLUROMET 2.5 mg/1
ertugliflozin and metformin hydrochloride · TABLET, FILM COATED · Merck Sharp & Dohme LLC
SEGLUROMET is a tablet, film coated containing ertugliflozin and metformin hydrochloride at 2.5 mg/1, taken oral. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- SEGLUROMET
- Generic Name
- ertugliflozin and metformin hydrochloride
- NDC Code (Product)
0006-5369- Manufacturer
- Merck Sharp & Dohme LLC
- Strength
- 2.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA209806
- Marketing Start
- 12/19/2017
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 SEGLUROMET ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SEGLUROMET is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin, 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 use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.2) ].
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Assess renal function prior to initiation and as clinically indicated. ( 2.1 ) Correct volume depletion before initiation. ( 2.1 ) Individualize the starting dosage based on the patient's current regimen. ( 2.2 ) Maximum recommended dosage is 7.5 mg ertugliflozin/1,000 mg metformin orally twice daily. ( 2.2 ) Take orally twice daily with meals, with gradual dose escalation. ( 2.2 ) Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Use is not recommended in patients with an eGFR less than 45 mL/min/1.73 m 2 . ( 2.2 ) Use is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ), end stage-renal disease (ESRD), or on dialysis. ( 2.2 ) SEGLUROMET may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures. ( 2.3 ) Withhold SEGLUROMET for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting. ( 2.4 ) 2.1 Prior to Initiation of SEGLUROMET Assess renal function before initiating SEGLUROMET and as clinically indicated [see Warnings and Precautions (5.2) ] . Assess volume status. In patients with vo…
Contraindications
4 CONTRAINDICATIONS SEGLUROMET is contraindicated in patients with: Hypersensitivity to ertugliflozin, metformin, or any excipient in SEGLUROMET. Reactions such as angioedema or anaphylaxis have occurred [see Adverse Reactions (6.2) ]. Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ), end stage-renal disease (ESRD), or on dialysis [see Use in Specific Populations (8.6) ] . Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ), end stage-renal disease, or patients on dialysis. ( 4 ) Metabolic acidosis, including diabetic ketoacidosis. ( 4 ) Hypersensitivity to ertugliflozin, metformin or any excipient. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 3: Clinically Significant Drug Interactions with SEGLUROMET Carbonic Anhydrase Inhibitors Clinical Impact: The risk of lactic acidosis may increase due to concomitant use of Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) with metformin. These drugs frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Intervention: more frequent monitoring of these patients. Drugs that Reduce Metformin Clearance Clinical Impact: The risk of lactic acidosis may increase due to 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) which increase systemic exposure to metformin Intervention Consider the benefits and risks of concomitant use. Alcohol Clinical Impact: Potentiate the effect of metformin on lactate metabolism. Intervention: Warn patients against excessive alcohol intake while receiving SEGLUROMET. Insulin or Insulin Secreta…
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: Lactic Acidosis [see Boxed Warning and Warnings and Precautions (5.1) ] Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis [see Warnings and Precautions (5.2) ] Lower Limb Amputation [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 with Insulin or Insulin Secretagogues [see Warnings and Precautions (5.6) ] Necrotizing Fasciitis of the Perineum (Fournier's Gangrene) [see Warnings and Precautions (5.7) ] Genital Mycotic Infections [see Warnings and Precautions (5.8) ] Vitamin B 12 Deficiency [see Warnings and Precautions (5.9) ] Most common adverse reactions associated with ertugliflozin (incidence ≥5%) were female genital mycotic infections. ( 6.1 ) Most common adverse reactions associated with metformin (incidence ≥5%) were diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-…
Frequently Asked Questions
What is SEGLUROMET used for?
SEGLUROMET contains ertugliflozin and metformin hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is SEGLUROMET a controlled substance?
SEGLUROMET is not classified as a controlled substance by the DEA.
What is the generic name for SEGLUROMET?
The generic name for SEGLUROMET is ertugliflozin and metformin hydrochloride. There are no other listed brand versions of ertugliflozin and metformin hydrochloride.
What is the NDC code for SEGLUROMET 2.5 mg/1?
The NDC (National Drug Code) for SEGLUROMET 2.5 mg/1 is 0006-5369, listed by Merck Sharp & Dohme LLC.
Other SEGLUROMET Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)