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GLYXAMBI- empagliflozin and linagliptin tablet, film coated


  1. Patient Information
  2. Who Should Not Take Glyxambi?do Not Take Glyxambi If You:
  3. Active Ingredients:
  4. Inactive Ingredients:
  5. Revised: 7/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Instructions
Instruct patients to read the Medication Guide before starting GLYXAMBI therapy and to reread it each time the prescription is renewed. Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

Inform patients of the potential risks and benefits of GLYXAMBI and of alternative modes of therapy. Also, inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.

Instruct patients to take GLYXAMBI only as prescribed. If a dose is missed, it should be taken as soon as the patient remembers. Advise patients not to double their next dose.

Advise pregnant women, and females of reproductive potential of the potential risk to a fetus with treatment with GLYXAMBI[see Use in Specific Populations (8.1)]. Instruct females of reproductive potential to report pregnancies to their physicians as soon as possible.

Advise women that breastfeeding is not recommended during treatment with GLYXAMBI[see Use in Specific Populations (8.2)].

Pancreatitis
Inform patients that acute pancreatitis has been reported during postmarketing use of linagliptin. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue GLYXAMBI promptly and contact their physician if persistent severe abdominal pain occurs[see Warnings and Precautions (5.1)].

Heart Failure
Inform patients of the signs and symptoms of heart failure. Before initiating GLYXAMBI, patients should be asked about a history of heart failure or other risk factors for heart failure including moderate to severe renal impairment. Instruct patients to contact their healthcare provider as soon as possible if they experience symptoms of heart failure, including increasing shortness of breath, rapid increase in weight or swelling of the feet[see Warnings and Precautions (5.2)].

Hypoglycemia
Inform patients that the incidence of hypoglycemia is increased when empagliflozin, linagliptin, or GLYXAMBI is added to a sulfonylurea or insulin and that a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Hypotension
Inform patients that hypotension may occur with GLYXAMBI and advise them to contact their healthcare provider if they experience such symptoms[see Warnings and Precautions (5.3)]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.

Ketoacidosis
Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of empagliflozin. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue GLYXAMBI and seek medical advice immediately[see Warnings and Precautions (5.4)].

Acute Kidney Injury
Inform patients that acute kidney injury has been reported during use of empagliflozin. Advise patients to seek medical advice immediately if they have reduced oral intake (such as due to acute illness or fasting) or increased fluid losses (such as due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue GLYXAMBI use in those settings[see Warnings and Precautions (5.5)].

Serious Urinary Tract Infections
Inform patients of the potential for urinary tract infections, which may be serious. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur[see Warnings and Precautions (5.6)].

Necrotizing Fasciitis of the Perineum (Fournier s Gangrene)
Inform patients that necrotizing infections of the perineum (Fournier s gangrene) have occurred with empagliflozin, a component of GLYXAMBI. Counsel patients to promptly seek medical attention if they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, along with a fever above 100.4 F or malaise[see Warnings and Precautions (5.8)].

Genital Mycotic Infections in Females (e.g., Vulvovaginitis)
Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections. Advise them of treatment options and when to seek medical advice[see Warnings and Precautions (5.9)].

Genital Mycotic Infections in Males (e.g., Balanitis or Balanoposthitis)
Inform male patients that yeast infection of penis (e.g., balanitis or balanoposthitis) may occur, especially in uncircumcised males and patients with chronic and recurrent infections. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice[see Warnings and Precautions (5.9)].

Hypersensitivity Reactions
Inform patients that serious allergic reactions, such as anaphylaxis, angioedema, and exfoliative skin conditions, have been reported during postmarketing use of linagliptin or empagliflozin, components of GLYXAMBI. If symptoms of allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking GLYXAMBI and seek medical advice promptly[see Warnings and Precautions (5.10)].

Severe and Disabling Arthralgia
Inform patients that severe and disabling joint pain may occur with this class of drugs. The time to onset of symptoms can range from one day to years. Instruct patients to seek medical advice if severe joint pain occurs[see Warnings and Precautions (5.12)].

Bullous Pemphigoid
Inform patients that bullous pemphigoid may occur with this class of drugs. Instruct patients to seek medical advice if blisters or erosions occur[see Warnings and Precautions (5.13)].

Laboratory Tests
Inform patients that renal function should be assessed prior to initiation of GLYXAMBI and monitored periodically thereafter.

Inform patients that elevated glucose in urinalysis is expected when taking GLYXAMBI.

Inform patients that response to all diabetic therapies should be monitored by periodic measurements of blood glucose and HbA1c levels, with a goal of decreasing these levels toward the normal range. Hemoglobin A1c is especially useful for evaluating long-term glycemic control.


Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Marketed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
and
Eli Lilly and Company
Indianapolis, IN 46285 USA

Licensed from:
Boehringer Ingelheim International GmbH, Ingelheim, Germany

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Glyxambi , Jardiance , Tradjenta and EMPA-REG OUTCOME trademarks under license.

The other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright 2018 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

IT5885MJ232018


Who Should Not Take Glyxambi?do Not Take Glyxambi If You: 

  • have severe kidney problems or are on dialysis
  • are allergic to linagliptin (TRADJENTA), empagliflozin (JARDIANCE) or any of the ingredients in GLYXAMBI.
    • Take GLYXAMBI exactly as your doctor tells you to take it.
    • Take GLYXAMBI 1 time each day in the morning, with or without food.
    • If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of GLYXAMBI at the same time.
    • Your doctor may tell you to take GLYXAMBI along with other diabetes medicines. Low blood sugar can happen more often when GLYXAMBI is taken with certain other diabetes medicines.
      • Store GLYXAMBI at room temperature between 68 F to 77 F (20 C to 25 C).
      Keep GLYXAMBI and all medicines out of the reach of children.General information about the safe and effective use of GLYXAMBI.
      Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GLYXAMBI for a condition for which it was not prescribed. Do not give GLYXAMBI to other people, even if they have the same symptoms that you have. It may harm them.
      This Medication Guide summarizes the most important information about GLYXAMBI. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about GLYXAMBI that is written for health professionals.
      For more information about GLYXAMBI including current prescribing information and Medication Guide, go to www.glyxambi.com, or scan the code below, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906.

      code

Active Ingredients: 

empagliflozin and linagliptin

Inactive Ingredients: 

mannitol, pregelatinized starch, corn starch, copovidone, crospovidone, talc and magnesium stearate. The film coating contains the following inactive ingredients: hypromellose, mannitol, talc, titanium dioxide, polyethylene glycol.
10 mg/5 mg tablets also contain yellow ferric oxide.
25 mg/5 mg tablets also contain red ferric oxide.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company, Indianapolis, IN 46285 USA
Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany

Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the Glyxambi , Jardiance , Tradjenta , EMPA-REG OUTCOME , and CARMELINA trademarks under license.

The other trademarks referenced are owned by third parties not affiliated with Boehringer Ingelheim Pharmaceuticals, Inc.

Copyright 2019 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

IT5885NG102019

Glyxambi 10 mg/5 mg Label

label-10mg-5mg-0597-0182-30

Glyxambi 10 mg/5 mg Label, Professional Sample

label-10mg-5mg-0597-0182-07

Glyxambi 10 mg/5 mg Carton

carton-10mg-5mg-0597-0182-39

Glyxambi 25 mg/5 mg Label

label-25mg-5mg-0597-0164-90

Glyxambi 25 mg/5 mg Carton

carton-25mg-5mg-0597-0164-39

Glyxambi 25 mg/5 mg Carton, Professional Sample

carton-25mg-5mg-0597-0164-07
GLYXAMBI
empagliflozin and linagliptin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0597-0182
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
empagliflozin(UNII: HDC1R2M35U) (empagliflozin - UNII:HDC1R2M35U)empagliflozin10 mg
linagliptin(UNII: 3X29ZEJ4R2) (linagliptin - UNII:3X29ZEJ4R2)linagliptin5 mg
Product Characteristics
ColorYELLOW (pale yellow)Scoreno score
ShapeTRIANGLESize8mm
FlavorImprint Code10;5
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0182-707 in 1 CARTON01/30/201505/01/2017
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0597-0182-071 in 1 CARTON01/30/2015
27 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0597-0182-0330 in 1 BOTTLE; Type 0: Not a Combination Product01/30/201509/30/2016
4NDC:0597-0182-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/30/2015
5NDC:0597-0182-3930 in 1 CARTON01/30/2015
51 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:0597-0182-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20607301/30/2015
GLYXAMBI
empagliflozin and linagliptin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0597-0164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
empagliflozin(UNII: HDC1R2M35U) (empagliflozin - UNII:HDC1R2M35U)empagliflozin25 mg
linagliptin(UNII: 3X29ZEJ4R2) (linagliptin - UNII:3X29ZEJ4R2)linagliptin5 mg
Product Characteristics
ColorPINK (pale pink)Scoreno score
ShapeTRIANGLESize8mm
FlavorImprint Code25;5
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0164-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/30/2015
2NDC:0597-0164-3930 in 1 CARTON01/30/2015
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0597-0164-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/30/2015
4NDC:0597-0164-707 in 1 CARTON01/30/201505/01/2017
41 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0597-0164-071 in 1 CARTON01/30/2015
57 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20607301/30/2015
Labeler -Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant -Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
Boehringer Ingelheim Pharma GmbH and Co. KG551147440PACK(0597-0182, 0597-0164) , LABEL(0597-0182, 0597-0164) , MANUFACTURE(0597-0182, 0597-0164) , API MANUFACTURE(0597-0182, 0597-0164) , ANALYSIS(0597-0164, 0597-0182)
Establishment
NameAddressID/FEIBusiness Operations
West-Ward Columbus Inc.058839929PACK(0597-0182, 0597-0164) , LABEL(0597-0182, 0597-0164)
Establishment
NameAddressID/FEIBusiness Operations
Sixarp, LLC - Praxis Packaging Solutions016329513PACK(0597-0182) , LABEL(0597-0164)

Revised: 7/2019document Id: 

357652a4-d9be-45d2-b2c5-002baf5b682cSet id: ddbab689-f76c-488c-9613-4168d41dd730Version: 13Effective Time: 20190716Boehringer Ingelheim Pharmaceuticals, Inc.



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