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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)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
GLYXAMBI
Empagliflozin
Linagliptin
Non-Clinical Toxicology
GLYXAMBI is contraindicated in patients with:If phenytoin or other hepatic enzyme inducers are taken concurrently with disopyramide, lower plasma levels of disopyramide may occur. Monitoring of disopyramide plasma levels is recommended in such concurrent use to avoid ineffective therapy. Other antiarrhythmic drugs (e.g., quinidine, procainamide, lidocaine, propranolol) have occasionally been used concurrently with disopyramide. Excessive widening of the QRS complex and/or prolongation of the Q-T interval may occur in these situations (see ). In healthy subjects, no significant drug-drug interaction was observed when disopyramide was coadministered with either propranolol or diazepam. Concomitant administration of disopyramide and quinidine resulted in slight increases in plasma disopyramide levels and slight decreases in plasma quinidine levels. Disopyramide does not increase serum digoxin levels.
Until data on possible interactions between verapamil and disopyramide phosphate are obtained, disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration.
Although potent inhibitors of CYP3A4 (e.g., ketoconazole) have not been studied clinically, studies have shown that erythromycin and oleandomycin inhibit the metabolism of disopyramide. Cases of life-threatening interactions have been reported for disopyramide when given with clarithromycin and erythromycin indicating that co-administration of disopyramide with inhibitors of CYP3A4 could result in potentially fatal interaction.
There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking linagliptin. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue GLYXAMBI and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using GLYXAMBI.
The following important adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
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