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Glyxambi
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)