Linagliptin And Metformin Hydrochloride
Generic Name: linagliptin and metformin hydrochloride
Brand Names:
Linagliptin And Metformin Hydrochloride
11 DESCRIPTION Linagliptin and metformin hydrochloride tablets for oral use contain: linagliptin and metformin hydrochloride. Linagliptin Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 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 molecular formula is C 25 H 28 N 8 O 2 and the molecular weight is 472.54 g/mol.
Overview
11 DESCRIPTION Linagliptin and metformin hydrochloride tablets for oral use contain: linagliptin and metformin hydrochloride. Linagliptin Linagliptin is an inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. The chemical name of linagliptin is 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 molecular 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 and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2 )].
Dosage
2 DOSAGE AND ADMINISTRATION • Individualize the starting dosage of linagliptin and metformin hydrochloride tablets based on the patient's current regimen ( 2.1 ) • The maximum recommended dosage is 2.5 mg linagliptin/1,000 mg metformin HCl twice daily ( 2.1 ) • Take orally twice daily with meals, with gradual dosage escalation to reduce the gastrointestinal effects due to metformin ( 2.1 ) • Prior to initiation, assess renal function with estimated glomerular filtration rate (eGFR) ( 2.2 ) o Do not use in patients with eGFR below 30 mL/min/1.73 m 2 o Initiation is not recommended in patients with eGFR between 30 to 45 mL/min/1.73 m 2 o Assess risk/benefit of continuing if eGFR falls below 45 mL/min/1.73 m 2 o Discontinue if eGFR falls below 30 mL/min/1.73 m 2 • Linagliptin and metformin hy...
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Lactic Acidosis [see Warnings and Precautions (5.1 )] • Pancreatitis [see Warnings and Precautions (5.2 )] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions (5.4 )] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.5 )] • Severe and Disabling Arthralgia [see Warnings and Precautions (5.6 )] • Bullous Pemphigoid [see Warnings and Precautions (5.7 )] • Heart Failure [see Warnings and Precautions (5.8 )] Most common adverse reactions (incidence ≥5% and more often than placebo) were nasopharyngitis and diarrhea ( 6.1 ) To report SUSPECTED A...
Interactions
7 DRUG INTERACTIONS Table 2 describes clinically relevant interactions with linagliptin and metformin hydrochloride. Table 2 Clinically Relevant Interactions with linagliptin and metformin hydrochloride Carbonic Anhydrase Inhibitors Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with linagliptin and metformin hydrochloride may increase the risk of lactic acidosis. Intervention Consider more frequent monitoring of these patients.
Warnings
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. 5 WARNINGS AND PRECAUTIONS Lactic acidosis: See boxed warning ( 5.1 ) Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue linagliptin and metformin hydrochloride. ( 5.2 ) Hypoglycemia: Consider lowering the dosage of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating linagliptin and metformin hydrochloride ( 5.3 ) Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with linagliptin and metformin hydrochloride. If hypersensitivity reactions occur discontinue linagliptin and metformin hydrochloride, treat promptly, and monitor until signs and symptoms resolve. 4 CONTRAINDICATIONS Linagliptin and metformin hydrochloride are 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 [see Warnings and Precautions (5.1 )].
Pregnancy
8.1 Pregnancy Risk Summary The limited data with linagliptin and metformin hydrochloride and linagliptin use in pregnant women are not sufficient to inform a linagliptin and metformin hydrochloride-associated or linagliptin-associated risk for major birth defects and miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defector miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Linagliptin and metformin hydrochloride tablets 2.5 mg/500 mg are yellow, oval, biconvex film-coated tablets debossed with “500” on one side and “LM” on the other side, and are supplied as follows: Bottles of 60 (NDC 72205-407-01) Bottles of 180 (NDC 72205-407-02) Linagliptin and metformin hydrochloride tablets 2.5 mg/850 mg are orange, oval, biconvex film-coat...
Frequently Asked Questions
What is Linagliptin And Metformin Hydrochloride used for?▼
1 INDICATIONS AND USAGE Linagliptin and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Linagliptin and metformin hydrochloride tablets are not recommended in patients with type 1 diabetes mellitus. Linagliptin and metformin hydrochloride tablets have not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using linagliptin and metformin hydrochloride tablets [see Warnings and Precautions (5.2 )].
What are the side effects of Linagliptin And Metformin Hydrochloride?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Lactic Acidosis [see Warnings and Precautions (5.1 )] • Pancreatitis [see Warnings and Precautions (5.2 )] • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues [see Warnings and Precautions (5.3 )] • Hypersensitivity Reactions [see Warnings and Precautions (5.4 )] • Vitamin B 12 Deficiency [see Warnings and Precautions (5.5 )] • Severe and Disabling Arthralgia [see Warnings and Precautions (5.6 )] • Bullous Pemphigoid [see Warnings and Precautions (5.7 )] • Heart Failure [see Warnings and Precautions (5.8 )] Most common adverse reactions (incidence ≥5% and more often than placebo) were nasopharyngitis and diarrhea ( 6.1 ) To report SUSPECTED A...
Can I take Linagliptin And Metformin Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary The limited data with linagliptin and metformin hydrochloride and linagliptin use in pregnant women are not sufficient to inform a linagliptin and metformin hydrochloride-associated or linagliptin-associated risk for major birth defects and miscarriage. Published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defector miscarriage risk [see Data]. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations].
What are the important warnings for Linagliptin And Metformin Hydrochloride?▼
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. 5 WARNINGS AND PRECAUTIONS Lactic acidosis: See boxed warning ( 5.1 ) Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue linagliptin and metformin hydrochloride. ( 5.2 ) Hypoglycemia: Consider lowering the dosage of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating linagliptin and metformin hydrochloride ( 5.3 ) Hypersensitivity reactions: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with linagliptin and metformin hydrochloride. If hypersensitivity reactions occur discontinue linagliptin and metformin hydrochloride, treat promptly, and monitor until signs and symptoms resolve. 4 CONTRAINDICATIONS Linagliptin and metformin hydrochloride are 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 [see Warnings and Precautions (5.1 )].
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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.