GLYXAMBI- empagliflozin and linagliptin tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

EMPAGLIFLOZIN (UNII: HDC1R2M35U) (EMPAGLIFLOZIN - UNII:HDC1R2M35U), LINAGLIPTIN (UNII: 3X29ZEJ4R2) (LINAGLIPTIN - UNII:3X29ZEJ4R2)

Disponibil de la:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (nume internaţional):

empagliflozin

Compoziție:

empagliflozin 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 cardiovascular disease [see Clinical Studies (14.2)] . Limitations of Use GLYXAMBI is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)] . 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 [see Warnings and Precautions (5.2)]. GLYXAMBI is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2 . GLYXAMBI is likely to be ineffecti

Rezumat produs:

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) Bottles of 90 (NDC 0597-0182-90) Cartons containing 3 blister cards of 10 tablets each (3 × 10) (NDC 0597-0182-39), institutional pack. 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) Bottles of 90 (NDC 0597-0164-90) Cartons containing 3 blister cards of 10 tablets each (3 × 10) (NDC 0597-0164-39), institutional pack. If repackaging is required, dispense in a tight container as defined in USP. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Statutul autorizaţiei:

New Drug Application

Prospect

Boehringer Ingelheim Pharmaceuticals, Inc.
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MEDICATION GUIDE
GLYXAMBI® (GLIK-SAM-BEE)
(EMPAGLIFLOZIN AND LINAGLIPTIN TABLETS)
FOR ORAL USE
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: October
2023
What is the most important information I should know about GLYXAMBI?
GLYXAMBI can cause serious side effects, including:
•
Diabetic ketoacidosis (increased ketones in your blood or urine) in
people with type 1 and other
ketoacidosis. GLYXAMBI can cause ketoacidosis that can be
life-threatening and may lead to
death. Ketoacidosis is a serious condition which needs to be treated
in a hospital. People with type
1 diabetes have a high risk of getting ketoacidosis. People with type
2 diabetes or pancreas
problems also have an increased risk of getting ketoacidosis.
Ketoacidosis can also happen in
people who: are sick, cannot eat or drink as usual, skip meals, are on
a diet high in fat and low in
carbohydrates (ketogenic diet), take less than the usual amount of
insulin or miss insulin doses,
drink too much alcohol, have a loss of too much fluid from the body
(volume depletion), or who
have surgery. Ketoacidosis can happen even if your blood sugar is less
than 250 mg/dL. Your
healthcare provider may ask you to periodically check ketones in your
urine or blood.
Stop taking GLYXAMBI and call your healthcare provider or get medical
help right away if you
get any of the following. If possible, check for ketones in your urine
or blood, even if your blood
sugar is less than 250 mg/dL:
•
nausea
•
vomiting
•
stomach-area (abdominal) pain
•
tiredness
•
trouble breathing
•
ketones in your urine or blood
•
Inflammation of the pancreas (pancreatitis) which may be severe and
lead to death. Certain
medical problems make you more likely to get pancreatitis.
Before you start taking GLYXAMBI, tell your healthcare provider if you
have ever had:
•
inflammation of your pancreas (pancreatitis)
•
a history of alcoholism
•
stones in your gallbladder
(gallstones)
•
high

Caracteristicilor produsului

GLYXAMBI- EMPAGLIFLOZIN AND LINAGLIPTIN TABLET, FILM COATED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLYXAMBI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLYXAMBI.
GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indications and Usage (1)
10/2023
Dosage and Administration (2.4, 2.5)
10/2023
Warnings and Precautions (5.1, 5.8)
10/2023
INDICATIONS AND USAGE
GLYXAMBI is a combination of empagliflozin, a sodium-glucose
co-transporter 2 (SGLT2) inhibitor and
linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, 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 cardiovascular disease. (1)
Limitations of Use
Not recommended for use to improve glycemic control in patients with
type 1 diabetes mellitus. It may
increase the risk of diabetic ketoacidosis in these patients. (1)
Has not been studied in patients with a history of pancreatitis. (1)
Not recommended for use to improve glycemic control in adults with
type 2 diabetes mellitus with an
eGFR less than 30 mL/min/1.73 m . (1)
DOSAGE AND ADMINISTRATION
Assess renal function before initiating and as clinically indicated.
Assess volume status and correct
volume depletion before initiating. (2.1)
The recommended dosage of GLYXAMBI is 10 mg empagliflozin and 5 mg
linagliptin once daily, taken in
the morning, with or without food. (2.2)
Dosage may be increased to 25 mg empagliflozin and 5 mg linagliptin
once daily. (2.2)
Withhold GLYXAMBI for at least 3 days, if possible, prior to major
surgery or procedures associated with
prolonged fasting. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets:
10 mg empagliflozin/5 mg linagliptin (3)
25 mg empagliflozin/5 mg linagliptin (3)
CONTRAINDICATIONS
Patients on