Sitagliptin is a dipeptidyl peptidase 4 inhibitor sold in the U.S. under 5 brand and generic names, for type 2 diabetes mellitus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Brynovin (application NDA219122). Other sitagliptin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dose of BRYNOVIN is 100 mg orally once daily (4 mL). BRYNOVIN can be taken with or without food. ( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2 . ( 2.2 ) Dosage Adjustment in Patients with Renal Impairment ( 2.2 ) eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 eGFR less than 30 mL/min/1.73 m 2 (including patients with end stage renal disease [ESRD] on dialysis) 50 mg once daily (2 mL) 25 mg once daily (1 mL) 2.1 Recommended Dosage and Administration Measure the BRYNOVIN dose using a calibrated oral syringe or oral dosing cup scored using metric units of measurements (i.e., mL). The recommended dosage of BRYNOVIN is 100 mg (4 mL) taken orally once daily. BRYNOVIN can be taken with or without food [see Clinical Pharmacology ( 12.3 )] . 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of BRYNOVIN and periodically thereafter [see Use in Specific Populations ( 8.6 )] . For patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m 2 to less than 90 mL/min/1.73 m 2 , no dosage adjustment for BRYNOVIN is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 ), the dosage of BRYNOVIN is 50 mg (2 mL) once daily. For patients…
The following adverse reactions are also discussed elsewhere in the labeling: • Pancreatitis [ see Warnings and Precautions ( 5.1 ) ] • Heart Failure [ see Warnings and Precautions ( 5.2 ) ] • Acute Renal Failure [ see Warnings and Precautions ( 5.3 ) ] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [ see Warnings and Precautions ( 5.4 ) ] • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.5 ) ] • Severe and Disabling Arthralgia [ see Warnings and Precautions ( 5.6 ) ] • Bullous Pemphigoid [ see Warnings and Precautions ( 5.7 ) ] Most common adverse reactions (incidence ≥5%) are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin trials, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 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 reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of BRYNOVIN has been established for glycemic control in patients with type 2…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Solution | — | — | View → | |
| 2 | 70/100 | Prescription | Tablet | — | — |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| SZ;217 | 100 mg | brown | round | — |
| SZ;216 | 50 mg | pink | round | — |
| 554 | 5 mg / 100 mg | brown | oval | — |
| 555 | 15 mg / 100 mg | brown | oval | — |
| 1806 | 100 mg / 1000 mg | brown | oval | — |
| 1805 | 50 mg / 1000 mg |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
BRYNOVIN is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin or any of the excipients in BRYNOVIN. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.2 )]. History of a serious hypersensitivity reaction to sitagliptin or any of the excipients in BRYNOVIN, such as anaphylaxis or angioedema. ( 4 )
Concomitant Use with Insulin or Insulin Secretagogues BRYNOVIN lowers blood glucose in patients with type 2 diabetes mellitus. Coadministration of BRYNOVIN with insulin or an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. [See Warnings and Precautions ( 5.4 )].
| 3 | Not yet rated | Prescription | Tablet | — | — | View → |
| 4 | Not yet rated | Prescription | Tablet | — | — | View → |
| 5 | Not yet rated | Prescription | Tablet | — | — | View → |
| yellow |
| oval |
| — |
| 1805 | 50 mg / 1000 mg | yellow | oval | — |
|---|
| 1804 | 50 mg / 500 mg | orange | oval | — |
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| 1806 | 100 mg / 1000 mg | brown | oval | — |
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| SM01 | 50 mg / 500 mg | pink | oval | — |
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| 1804 | 50 mg / 500 mg | orange | oval | — |
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| SM03 | 50 mg / 1000 mg | red | oval | — |
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