Sitagliptin Phosphate 25 mg/1
Sitagliptin Phosphate · TABLET, FILM COATED · Sandoz Inc
Sitagliptin phosphate is an oral tablet used to help control blood sugar levels in people with type 2 diabetes. It works by increasing the amount of insulin your body produces when blood sugar is high.
Key Facts
- Brand Name
- Sitagliptin Phosphate
- Generic Name
- Sitagliptin Phosphate
- NDC Code (Product)
0781-5766- Manufacturer
- Sandoz Inc
- Strength
- 25 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202387
- Marketing Start
- 01/14/2026
Recall History
Aidapak Services, LLC
Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62992_1, EXP: 5/23/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: W002860, EXP: 6/7/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZITUVIMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) 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: ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ( 1 ) ZITUVIMET has not been studied in patients with a history of pancreatitis. ( 1 ) ZITUVIMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ZITUVIMET has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using ZITUVIMET. [see Warnings and Precautions ( 5.2 )].
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take ZITUVIMET orally twice daily with meals. ( 2.1 ) Individualize the dosage of ZITUVIMET on the basis of the patient's current regimen, effectiveness, and tolerability. ( 2.1 ) The maximum recommended daily dose is 100 mg of sitagliptin and 2,000 mg of metformin HCl. ( 2.1 ) The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCl twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin. ( 2.1 ) The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin HCl 850 mg twice daily, the recommended starting dose of ZITUVIMET is 50 mg sitagliptin and 1,000 mg metformin HCl twice daily. ( 2.1 ) Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) ○ Do not use in patients with eGFR below 30 mL/min/1.73 m 2 ○ ZITUVIMET is not recommended in patients with eGFR between 30 and less than 45 mL/min/1.73 m 2 . ZITUVIMET may need to be d…
Contraindications
4 CONTRAINDICATIONS 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 to ZITUVIMET, sitagliptin, or metformin, such as anaphylaxis or angioedema. (4) ZITUVIMET is contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m 2 ) [see Warnings and Precautions ( 5.1 )]. Acute or chronic metabolic acidosis, including diabetic ketoacidosis. History of a serious hypersensitivity reaction to sitagliptin, metformin, or any of the excipients in ZITUVIMET. Serious hypersensitivity reactions including anaphylaxis or angioedema have been reported. [see Warnings and Precautions ( 5.7 ) and Adverse Reactions ( 6.2 )].
Drug Interactions
7 DRUG INTERACTIONS Table 4 presents clinically significant drug interactions with ZITUVIMET: Table 4: Clinically Significant Drug Interactions with ZITUVIMET Carbonic Anhydrase Inhibitors Clinical Impact: Carbonic anhydrase inhibitors frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with ZITUVIMET may increase the risk for lactic acidosis. Intervention: Consider more frequent monitoring of these patients. Examples: Topiramate, zonisamide, acetazolamide or dichlorphenamide. 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 [OCT 2 ] / multidrug and toxin extrusion [MATE] inhibitors) 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 with ZITUVIMET. Examples: Ranolazine, vandetanib, dolutegravir, and cimetidine. Alcohol Clinical Impact: Alcohol is known to potentiate the effect of …
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the prescribing information: Lactic Acidosis [see Warnings and Precautions ( 5.1 )] Pancreatitis [see Warnings and Precautions ( 5.2 )] Heart Failure [see Warnings and Precautions ( 5.3 )] Acute Renal Failure [see Warnings and Precautions ( 5.4 )] Vitamin B12 Deficiency [see Warnings and Precautions ( 5.5 )] Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Severe and Disabling Arthralgia [see Warnings and Precautions ( 5.8 )] Bullous Pemphigoid [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (incidence ≥5% of patients simultaneously started on sitagliptin and metformin and more commonly than in patients treated with placebo were diarrhea, upper respiratory tract infection, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse react…
Frequently Asked Questions
What is Sitagliptin Phosphate used for?
Sitagliptin phosphate is an oral tablet used to help control blood sugar levels in people with type 2 diabetes. It works by increasing the amount of insulin your body produces when blood sugar is high.
Is Sitagliptin Phosphate a controlled substance?
Sitagliptin Phosphate is not classified as a controlled substance by the DEA.
What is the generic name for Sitagliptin Phosphate?
The generic name for Sitagliptin Phosphate is Sitagliptin Phosphate. There are no other listed brand versions of Sitagliptin Phosphate.
What is the NDC code for Sitagliptin Phosphate 25 mg/1?
The NDC (National Drug Code) for Sitagliptin Phosphate 25 mg/1 is 0781-5766, listed by Sandoz Inc.
Other Sitagliptin Phosphate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)