Sitagliptin Hydrochloride Oral
Generic Name: sitagliptin hydrochloride oral
Brand Names:
Brynovin
11 DESCRIPTION BRYNOVIN (sitagliptin) oral solution contains sitagliptin hydrochloride (HCl), an orally-active inhibitor of the DPP-4 enzyme. Sitagliptin HCl is described chemically as ((3R)-3-Amino-1-(3-(trifluoromethy1)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-y1)-4-(2,4,5-trifluorophenyl)butan-l-one HCl monohydrate. The empirical formula is C 16 H 15 F 6 N 5 O•HCl.H 2 O and the molecular weight is 461.79.
Overview
11 DESCRIPTION BRYNOVIN (sitagliptin) oral solution contains sitagliptin hydrochloride (HCl), an orally-active inhibitor of the DPP-4 enzyme. Sitagliptin HCl is described chemically as ((3R)-3-Amino-1-(3-(trifluoromethy1)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-y1)-4-(2,4,5-trifluorophenyl)butan-l-one HCl monohydrate. The empirical formula is C 16 H 15 F 6 N 5 O•HCl.H 2 O and the molecular weight is 461.79.
Uses
1 INDICATIONS & USAGE BRYNOVIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRYNOVIN is not recommended in patients with type 1 diabetes. BRYNOVIN 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 BRYNOVIN. [see Warnings and Precautions ( 5.1 )] . BRYNOVIN is 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: • BRYNOVIN is not recommended in patients with type 1 diabetes.
Dosage
2 DOSAGE & ADMINISTRATION 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.
Side Effects
6 ADVERSE REACTIONS 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.
Interactions
7 DRUG INTERACTIONS 7.1 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 )].
Warnings
5 WARNINGS AND PRECAUTIONS • Pancreatitis : There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue BRYNOVIN. ( 5.1 ) • Heart failure : Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of BRYNOVIN in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.2 ) • Acute Renal Failure : Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating BRYNOVIN and periodically thereafter. 4 CONTRAINDICATIONS 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 )].
Pregnancy
8.1 Pregnancy Risk Summary The limited available data with sitagliptin in pregnant women are not sufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC [see Data].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING BRYNOVIN (sitagliptin) oral solution 25 mg/mL is supplied as a clear colorless, to nearly colorless aqueous solution in an amber glass bottle with a child resistant closure. Each bottle contains 120 mL oral solution, NDC 24338-017-01 Storage Store refrigerated at 2°C to 8°C (36°F to 46°F) [see USP]; Protect from light. Avoid excessive heat and freezing.
Frequently Asked Questions
What is Sitagliptin Hydrochloride Oral used for?▼
1 INDICATIONS & USAGE BRYNOVIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRYNOVIN is not recommended in patients with type 1 diabetes. BRYNOVIN 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 BRYNOVIN. [see Warnings and Precautions ( 5.1 )] . BRYNOVIN is 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: • BRYNOVIN is not recommended in patients with type 1 diabetes.
What are the side effects of Sitagliptin Hydrochloride Oral?▼
6 ADVERSE REACTIONS 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.
Can I take Sitagliptin Hydrochloride Oral during pregnancy?▼
8.1 Pregnancy Risk Summary The limited available data with sitagliptin in pregnant women are not sufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC [see Data].
What are the important warnings for Sitagliptin Hydrochloride Oral?▼
5 WARNINGS AND PRECAUTIONS • Pancreatitis : There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue BRYNOVIN. ( 5.1 ) • Heart failure : Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of BRYNOVIN in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.2 ) • Acute Renal Failure : Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating BRYNOVIN and periodically thereafter. 4 CONTRAINDICATIONS 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 )].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.