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Glyxambi

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Overview

What is Glyxambi?

GLYXAMBI tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: empagliflozin and linagliptin.

Empagliflozin

The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S).

The molecular formula is CHClO and the molecular weight is 450.91. The structural formula is:

Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene.

Linagliptin

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 CHNO and the molecular weight is 472.54. The structural formula is:

Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water. Linagliptin is soluble in methanol, sparingly soluble in ethanol, very slightly soluble in isopropanol, and very slightly soluble in acetone.

GLYXAMBI



What does Glyxambi look like?



What are the available doses of Glyxambi?

Tablets:

10 mg empagliflozin/5 mg linagliptin

25 mg empagliflozin/5 mg linagliptin ()

What should I talk to my health care provider before I take Glyxambi?

How should I use Glyxambi?

GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.

Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease . However, the effectiveness of GLYXAMBI on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established.

Limitations of Use

[see Warnings and Precautions ()]

GLYXAMBI has 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 GLYXAMBI

The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily.

In patients with volume depletion, correcting this condition prior to initiation of GLYXAMBI is recommended

No studies have been performed specifically examining the safety and efficacy of GLYXAMBI in patients previously treated with other oral antihyperglycemic agents and switched to GLYXAMBI. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.


What interacts with Glyxambi?

Sorry No Records found


What are the warnings of Glyxambi?

Sorry No Records found


What are the precautions of Glyxambi?

Sorry No Records found


What are the side effects of Glyxambi?

Sorry No records found


What should I look out for while using Glyxambi?

GLYXAMBI is contraindicated in patients with:


What might happen if I take too much Glyxambi?

In the event of an overdose with GLYXAMBI, contact the Poison Control Center. Employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Removal of empagliflozin by hemodialysis has not been studied, and removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely.


How should I store and handle Glyxambi?

Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. Store LONHALA Inhalation Solution in the protective foil pouch at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Always use the MAGNAIR Replacement Handset parts that come with each LONHALA MAGNAIR refill prescription. Keep out of the reach of children. GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)GLYXAMBI (empagliflozin and linagliptin) tablets are available in 10 mg/5 mg and 25 mg/5 mg strengths as follows:10 mg/5 mg tablets:Bottles of 30 (NDC 0597-0182-30)Bottles of 90 (NDC 0597-0182-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0182-39), institutional pack.25 mg/5 mg tablets:Bottles of 30 (NDC 0597-0164-30)Bottles of 90 (NDC 0597-0164-90)Cartons containing 3 blister cards of 10 tablets each (3 x 10) (NDC 0597-0164-39), institutional pack.If repackaging is required, dispense in a tight container as defined in USP.StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F)