Diabetic Ketoacidosis Treatments
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Generic Name
Empagliflozin
Brand Names
Glyxambi, Jardiance
FDA approval date: August 01, 2014
Classification: Sodium-Glucose Cotransporter 2 Inhibitor
Form: Tablet
What is Glyxambi (Empagliflozin)?
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. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established CV disease [see Clinical Studies (1.
Approved To Treat
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Brand Information
Glyxambi (empagliflozin and linagliptin)
1INDICATIONS AND USAGE
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
Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease
2DOSAGE FORMS AND STRENGTHS
GLYXAMBI tablets available as:
- 10 mg empagliflozin/5 mg linagliptin are pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "10/5".
- 25 mg empagliflozin/5 mg linagliptin are pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "25/5".
3CONTRAINDICATIONS
GLYXAMBI is contraindicated in patients:
- with a hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred
4ADVERSE REACTIONS
The following important adverse reactions are described below and elsewhere in the labeling:
- Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis
- Pancreatitis
- Volume Depletion
- Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections
- Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
- Lower Limb Amputation
- Hypersensitivity Reactions
- Severe and Disabling Arthralgia
- Bullous Pemphigoid
- Heart Failure
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
Additional adverse reactions have been identified during postapproval use of linagliptin and empagliflozin. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Acute pancreatitis, including fatal pancreatitis [see , constipation, mouth ulceration, stomatitis
Immune System Disorders: Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
Infections: Necrotizing fasciitis of the perineum (Fournier's gangrene), urosepsis and pyelonephritis
Metabolism and Nutrition Disorders: Ketoacidosis
Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis, severe and disabling arthralgia
Renal and Urinary Disorders: Acute kidney injury
Skin and Subcutaneous Tissue Disorders: Bullous pemphigoid, skin reactions (e.g., rash, urticaria)
5DRUG INTERACTIONS
Table 3 describes clinically relevant interactions with GLYXAMBI.
6OVERDOSAGE
In the event of an overdose with GLYXAMBI, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Removal of empagliflozin by hemodialysis has not been studied, and removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely.
7DESCRIPTION
GLYXAMBI tablets for oral use contain: empagliflozin and linagliptin.
8HOW SUPPLIED/STORAGE AND HANDLING
GLYXAMBI tablets are available as follows:
10 mg/5 mg tablets: pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "10/5".
Bottles of 30 (NDC 0597-0182-30)
25 mg/5 mg tablets: pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "25/5".
Bottles of 30 (NDC 0597-0164-30)
If repackaging is required, dispense in a tight container as defined in USP.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
10PRINCIPAL DISPLAY PANEL - 10 mg/5 mg Tablet Bottle Label
NDC 0597-0182-90
Glyxambi
(empagliflozin and
10 mg/5 mg
DISPENSE WITH ACCOMPANYING MEDICATION GUIDE
90 tablets
Boehringer
11PRINCIPAL DISPLAY PANEL - 25 mg/5 mg Tablet Bottle Label
NDC 0597-0164-90
Glyxambi
(empagliflozin and
25 mg/5 mg
DISPENSE WITH ACCOMPANYING MEDICATION GUIDE
90 tablets
Boehringer
