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Trixibet® (Empagliflozin,Linagliptin,Metformin)

Trixibet® (Empagliflozin,Linagliptin,Metformin)

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• 5 mg Empagliflozin/2.5 mg Linagliptin/1000 mg Metformin HCl extended-release

• 10 mg Empagliflozin/5 mg Linagliptin/1000 mg Metformin HCl extended-release

• 12.5 mg Empagliflozin/2.5 mg Linagliptin/1000 mg Metformin HCl extended-release

• 25 mg Empagliflozin/5 mg Linagliptin/1000 mg Metformin HCl extended-release




INDICATIONS
Trixibet® is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, 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. 
Limitations of Use:
• Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.
•Has not been studied in patients with a history of pancreatitis.

It is not known if Trixibet® is safe and effective in children.
DOSAGE AND ADMINISTRATION

Assess renal function before initiating and as clinically indicated.
Individualize the starting dose of Trixibet® ER based on the patient’s current regimen and renal function.
Initiation of Trixibet® ER is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2, due to the metformin component. 
The maximum recommended dose of Trixibet® ER is 25 mg empagliflozin, 5 mg linagliptin and 2000 mg metformin HCl. 
Take Trixibet® ER once daily with a meal in the morning. Swallow tablets whole. Do not split, crush, dissolve, or chew

WARNINGS AND PRECAUTIONS

- Lactic Acidosis
- Inflammation of the pancreas (Pancreatitis) 
- Ketoacidosis (increased ketones in your blood or urine)
- Dehydration
- Serious urinary tract infections
-Low blood sugar (hypoglycemia)
- A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum)
- Vaginal yeast infection
- Yeast infection of the penis (balanitis)
- Allergic (hypersensitivity) reactions
- Low vitamin B12 (vitamin B12 deficiency(
- Joint pain
- Skin reaction
- Heart failure

DRUG INTERACTIONS
Since the drug interactions with Trixibet® ER are not limited to the following medicines tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and other medicines you bought without a prescription. 
Tell your healthcare provider before taking Trixibet® ER if you are taking any of the following medicines. The following medicines may reduce how well Trixibet® ER works:
- Carbonic Anhydrase Inhibitors (e.g., Topiramate, zonisamide, acetazolamide or dichlorphenamide) 
- Drugs that Reduce Metformin Clearance (e.g., ranolazine, vandetanib, dolutegravir, and cimetidine) 
- Alcohol
- Diuretics – a medicine to lower blood pressure or treat edema
- Insulin or Insulin Secretagogues (e.g., sulfonylurea) 
- Drugs Affecting Glycemic Control (e.g., thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid) 
- Lithium- an antipsychotic drug
- Rifampin – an antibiotic 
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