Linagliptin

What is Linagliptin?

• Linagliptin (TRADJENTA) is a dipeptidyl peptidase-4 (DPP-4) inhibitor used in combination with diet and exercise in the therapy of type 2 diabetes.

Linagliptin

Linagliptin2

What are the uses of this medicine?

• TRADJENTA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Limitations of Use:

• TRADJENTA is not for people with type 1 diabetes.
• TRADJENTA is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
• If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.
• It is not known if TRADJENTA is safe and effective in children under 18 years of age.

How does this medicine work?

• Linagliptin (lin" a glip' tin) is an inhibitor of dipeptidyl peptidase-4, which is the major enzyme responsible for the degradation of glucagon-like peptide-1 (GLP-1), an important gastrointestinal hormone (incretin) that increases glucose dependent insulin secretion by the pancreas.
• By prolonging the effect of GLP-1, linagliptin increases insulin levels and lowers blood glucose, thereby improving glycemic control in patients with type 2 diabetes.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to linagliptin or any of the ingredients in TRADJENTA.

What drug interactions can this medicine cause?

• The efficacy of TRADJENTA may be reduced when administered in combination (e.g., with rifampin).
• Use of alternative treatments is strongly recommended.
• Coadministration of TRADJENTA with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Is this medicine FDA approved?

• Linagliptin was approved for use in the United States in 2011 and was the third DPP-4 inhibitor introduced into clinical practice.
• Its current indications are for management of glycemic control in type 2 diabetes used in combination with diet and exercise, with or without other oral hypoglycemic agents or insulin.

How should this medicine be used?

Recommended dosage:

• The recommended dose of TRADJENTA is 5 mg once daily.

Administration:

• Take 1 tablet 1 time each day with or without food.
• If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of TRADJENTA at the same time.
• Your doctor may tell you to take TRADJENTA along with other diabetes medicines. Low blood sugar can happen more often when TRADJENTA is taken with certain other diabetes medicines.
• If you take too much TRADJENTA, call your doctor or local poison control center or go to the nearest hospital emergency room right away.
• Check your blood sugar as your doctor tells you to.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg

This medicine is available in fallowing brand namesː

• TRADJENTA

What side effects can this medication cause?

The most common side effects of this medicine include:

• stuffy or runny nose
• sore throat
• cough
• diarrhea

TRADJENTA can cause serious side effects, including:

• Inflammation of the pancreas (pancreatitis)
• Heart failure
• Low blood sugar (hypoglycemia)
• Allergic (hypersensitivity) reactions
• Joint pain
• Skin reaction

What special precautions should I follow?

• There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue TRADJENTA.
• Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of TRADJENTA in patients who have known risk factors for heart failure. Monitor for signs and symptoms.
• Insulin secretagogues and insulin are known to cause hypoglycemia. The use of TRADJENTA in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin was associated with a higher rate of hypoglycemia.
• Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, and exfoliative skin conditions) have occurred with TRADJENTA. If hypersensitivity reactions occur, discontinue TRADJENTA, treat promptly, and monitor until signs and symptoms resolve.
• Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
• There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA.

What to do in case of emergency/overdose?

Management of overdosage:

• In the event of an overdose with TRADJENTA, contact the Poison Control Center. Removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely.

Can this medicine be used in pregnancy?

• The limited data with TRADJENTA use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• Safety and effectiveness of TRADJENTA in pediatric patients under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: linagliptin
• Inactive Ingredients: mannitol, pregelatinized starch, corn starch, copovidone, and magnesium stearate. The film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and red ferric oxide.

Who manufactures and distributes this medicine?

• Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA.

Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany.

• TRADJENTA is a registered trademark of and used under license from Boehringer Ingelheim International GmbH

What should I know about storage and disposal of this medication?

• Store TRADJENTA at room temperature between 68°F and 77°F (20°C and 25°C).

Antidiabetics

•  Alpha-Glucosidase Inhibitors
  • Acarbose
  • Miglitol
• Incretin-Based Drugs
  • Dipeptidyl Peptidase-4 (DPP-4) Inhibitors
    • Alogliptin
    • Linagliptin
    • Saxagliptin
    • Sitagliptin
  • Glucagon-Like Peptide-1 (GLP-1) Analogues
    • Albiglutide
    • Dulaglutide
    • Exenatide
    • Liraglutide
    • Lixisenatide
•  Insulin
• Metformin
• Metiglinide Analogues
  • Nateglinide
  • Repaglinide
• Pramlintide
• Sodium Glucose Cotransporter-2 (SGLT-2) Inhibitors
  • Canagliflozin
  • Dapagliflozin
  • Empagliflozin
• Sulfonylureas
  • First Generation Sulfonylureas
    • Acetohexamide
    • Chlorpropamide
    • Tolazamide
    • Tolbutamide
  • Second Generation Sulfonylureas
    • Gliclazide
    • Glimepiride
    • Glipizide
    • Glyburide (Glibenclamide)
• Thiazolidinediones
  • Pioglitazone
  • Rosiglitazone
  • Troglitazone

• Dailymed label info on Linagliptin
• FDA Linagliptin

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