Linagliptin
Generic Name: linagliptin
Brand Names:
Linagliptin
11 DESCRIPTION Linagliptin tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- The empirical formula is C 25 H 28 N 8 O 2 and the molecular weight is 472.54 g/mol.
Overview
11 DESCRIPTION Linagliptin tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Linagliptin is described chemically as 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- The empirical formula is C 25 H 28 N 8 O 2 and the molecular weight is 472.54 g/mol.
Uses
1 INDICATIONS AND USAGE Linagliptin 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 Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Linagliptin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ] . Limitations of Use Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose of linagliptin is 5 mg once daily (2.1) Linagliptin can be taken with or without food (2.1) 2.1 Recommended Dosing The recommended dose of linagliptin is 5 mg once daily. Linagliptin tablets can be taken with or without food.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Use with Medications Known to Cause Hypoglycemia [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.5) ] Bullous Pemphigoid [see Warnings and Precautions (5.6) ] Adverse reactions reported in ≥5% of patients treated with linagliptin and more commonly than in patients treated with placebo included nasopharyngitis (6.1) To report SUSPECTED ADVERSE REACTIONS, contact HEC Pharm USA Inc. at 1-267-348-3664 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Strong P-glycoprotein/CYP3A4 inducer: The efficacy of linagliptin may be reduced when administered in combination (e.g., with rifampin). Use of alternative treatments is strongly recommended. (7.1) 7.1 Inducers of P-glycoprotein or CYP3A4 Enzymes Rifampin decreased linagliptin exposure, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer [see Clinical Pharmacology (12.3) ] .
Warnings
5 WARNINGS AND PRECAUTIONS Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue linagliptin. (5.1) Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of linagliptin in patients who have known risk factors for heart failure. Monitor for signs and symptoms. (5.2) Hypoglycemia: When used with an insulin secretagogue (e.g., sulfonylurea (SU)) or insulin, consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia (5.3) Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with linagliptin. 4 CONTRAINDICATIONS Linagliptin is contraindicated in patients with a history of a hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial Linagliptin is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in linagliptin tablets, reactions such as anaphylaxis, angioedema, exfoliative skin...
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Linagliptin tablets are available as white or off-white, round, biconvex, film-coated tablets containing 5 mg of linagliptin. Linagliptin tablets are debossed with “S75” on one side and blank on the other side. They are supplied as follows: Bottles of 30 (NDC 48792-7865-1) If repackaging is required, dispense in a tight container as defined in USP.
Frequently Asked Questions
What is Linagliptin used for?▼
1 INDICATIONS AND USAGE Linagliptin 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 Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Linagliptin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1) ] . Limitations of Use Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
What are the side effects of Linagliptin?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1) ] Heart Failure [see Warnings and Precautions (5.2) ] Use with Medications Known to Cause Hypoglycemia [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Severe and Disabling Arthralgia [see Warnings and Precautions (5.5) ] Bullous Pemphigoid [see Warnings and Precautions (5.6) ] Adverse reactions reported in ≥5% of patients treated with linagliptin and more commonly than in patients treated with placebo included nasopharyngitis (6.1) To report SUSPECTED ADVERSE REACTIONS, contact HEC Pharm USA Inc. at 1-267-348-3664 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the important warnings for Linagliptin?▼
5 WARNINGS AND PRECAUTIONS Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue linagliptin. (5.1) Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of linagliptin in patients who have known risk factors for heart failure. Monitor for signs and symptoms. (5.2) Hypoglycemia: When used with an insulin secretagogue (e.g., sulfonylurea (SU)) or insulin, consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia (5.3) Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with linagliptin. 4 CONTRAINDICATIONS Linagliptin is contraindicated in patients with a history of a hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial Linagliptin is contraindicated in patients with hypersensitivity to linagliptin or any of the excipients in linagliptin tablets, reactions such as anaphylaxis, angioedema, exfoliative skin...
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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.